BillionToOne, Inc.
For the period ended Sep 30, 2026. Filed Nov 4, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 4, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-05.
0002070849-26-000050
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-04.
0002070849-26-000082
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 131 previous paragraphs and 132 current paragraphs.
74 unchanged; 52 reworded; 5 added; 3 removed; 2 previous and 1 current paragraphs rearranged.
Tables are not compared: 9 previous and 9 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (5)
Current report
Interest expense decreased $14.0 thousand, or 70%, for the three months ended September 30, 2026 compared to the three months ended September 30, 2025.
Current report
Other income (expense), net increased $1.6 million for the three months ended September 30, 2026 compared to the three months ended September 30, 2025. The change was primarily due to a $1.6 million loss in the fair value of our common stock warrants during the three months ended September 30, 2025.
Current report
Comparison of the nine months ended September 30, 2026 and 2025
Current report
Non-GAAP income from operations
Current report
Non-GAAP net income
Removed paragraphs (3)
Previous report
Interest expense decreased $24.0 thousand, or 75%, for the three months ended June 30, 2026 compared to the three months ended June 30, 2025.
Previous report
Comparison of the six months ended June 30, 2026 and 2025
Previous report
Non-GAAP net income (loss)
Reworded paragraphs (52)
Previous wording
Founded with the mission to remove the fear of the unknown through powerful and accessible smNGS-based diagnostics, we have swiftly transitioned from an R&D-focused company to a proven commercial organization. Since launching UNITY, our first prenatal product in 2019, we have expanded our offerings first within prenatal genetics, and then to oncology diagnostics. To date, we have processed more than one and a half million smNGS-based tests. Today, we test more than 1 in 10 babies during pregnancy in the United States, a metric that is continuing to increase rapidly every year. UNITY is the first single-gene non-invasive prenatal test (sgNIPT) that uses cfDNA to provide fetal risk assessment for recessive conditions such as sickle cell disease (SCD) and cystic fibrosis (CF) without requiring a paternal sample or invasive procedures such as amniocentesis. Since then, we have expanded our UNITY offering to cover comprehensive prenatal genetic needs from a single maternal blood draw. In 2024, our unique fetal antigen tests resulted in national medical guideline changes, enabling us to position our tests as “the new standard in prenatal care,” further contributing to both test volume and average selling price (ASP) growth, as we leveraged the guideline changes to contract with more insurance companies. By detecting and identifying an extensive array of severe but actionable genetic disorders during pregnancy, we enable substantially better outcomes for newborns via earlier therapeutic and other clinical interventions.
Current wording
Founded with the mission to remove the fear of the unknown through powerful and accessible smNGS-based diagnostics, we have swiftly transitioned from an R&D-focused company to a proven commercial organization. Since launching UNITY, our first prenatal product, in 2019, we have expanded our offerings first within prenatal genetics, and then to oncology diagnostics. To date, we have processed almost two million smNGS-based tests. Today, we test more than 1 in 10 babies during pregnancy in the United States, a metric that is continuing to increase rapidly every year. UNITY is the first single-gene non-invasive prenatal test (sgNIPT) that uses cfDNA to provide fetal risk assessment for recessive conditions such as sickle cell disease (SCD) and cystic fibrosis (CF) without requiring a paternal sample or invasive procedures such as amniocentesis. Since then, we have expanded our UNITY offering to cover comprehensive prenatal genetic needs from a single maternal blood draw. In 2024, our unique fetal antigen tests resulted in national medical guideline changes, enabling us to position our tests as “the new standard in prenatal care,” further contributing to both test volume and average selling price (ASP) growth, as we leveraged the guideline changes to contract with more insurance companies. By detecting and identifying an extensive array of severe but actionable genetic disorders during pregnancy, we enable substantially better outcomes for newborns via earlier therapeutic and other clinical interventions.
Previous wording
In the oncology setting, ultrasensitive tests with real-time insights are required to effectively detect, diagnose, and treat patients with a diverse range of mutations and solid tumor types across the cancer care continuum. In 2023, we successfully leveraged our smNGS platform to launch two complementary pan-cancer liquid biopsy tests – Northstar Select® and Northstar Response®. Our Northstar Select test is used to guide therapy selection and has been shown to detect over 50% more actionable solid tumor mutations than conventional liquid biopsies. Based on our knowledge of all widely available tests, Northstar Response is the only methylation-based assay that quantifies the amount of cancer (tumor burden) at the single molecule level without requiring a tissue biopsy, enabling real-time monitoring of patient response to therapy with unprecedented precision. Our Northstar tests give physicians extraordinary visibility into cancer profile and treatment response, enabling more informed and earlier treatment decisions that can fundamentally alter patient outcomes. We are actively developing additional diagnostic products to address critical needs across the cancer care continuum. For example, in January 2026, we launched Northstar PGx TM, in February 2026, we launched Northstar Select CHTM, and in August 2026 we announced the launch of Northstar Origin TM. Northstar PGx and Northstar Select CH are add-on applications for Northstar Select, and expand the Northstar platform beyond genomic profiling to address chemotherapy safety (PGx) and clonal hematopoiesis (CH) — two critical decision points in selecting the right therapy for patients. Northstar Origin is an add-on tissue-of-origin feature for our Northstar Select test that can benefit patients with unknown or uncertain diagnoses. Our current development efforts focus on MRD detection, leveraging our platform’s exceptional sensitivity to identify trace amounts of tumor DNA following curative-intent surgery in earlier stage cancers. We are developing a tissue-free, pan-cancer MRD test, which we expect to be commercially available in the fourth quarter of 2026.
Current wording
In the oncology setting, ultrasensitive tests with real-time insights are required to effectively detect, diagnose, and treat patients with a diverse range of mutations and solid tumor types across the cancer care continuum. In 2023, we successfully leveraged our smNGS platform to launch two complementary pan-cancer liquid biopsy tests – Northstar Select® and Northstar Response®. Our Northstar Select test is used to guide therapy selection and has been shown to detect over 50% more actionable solid tumor mutations than conventional liquid biopsies. Based on our knowledge of all widely available tests, Northstar Response is the only methylation-based assay that quantifies the amount of cancer (tumor burden) at the single molecule level without requiring a tissue biopsy, enabling real-time monitoring of patient response to therapy with unprecedented precision. Our Northstar tests give physicians extraordinary visibility into cancer profile and treatment response, enabling more informed and earlier treatment decisions that can fundamentally alter patient outcomes. We are actively developing additional diagnostic products to address critical needs across the cancer care continuum. For example, in January 2026, we launched Northstar PGx TM, in February 2026, we launched Northstar Select
Previous wording
Our business momentum is evidenced by our rapidly scaling commercial success and improving operational efficiency. Of the over one and a half million smNGS-based tests that we have processed since our initial launch, over 42% of them, or approximately 726,000 tests, were processed within the last 12 months ended June 30, 2026.
Current wording
Our business momentum is evidenced by our rapidly scaling commercial success and improving operational efficiency. Of the almost two million smNGS-based tests that we have processed since our initial launch, over 40% of them, or approximately 770,000 tests, were processed in the 12 months ended September 30, 2026.
Previous wording
Our total test volume, which represents the number of billable tests that we receive for processing during each period and which we also refer to as tests accessioned, grew to approximately 197,000 tests for the three months ended June 30, 2026, compared to 148,000 for the three months ended June 30, 2025. In addition, our total delivered and billable test volume, which represents the number of billable tests for which we deliver a result to the ordering provider each period, grew to approximately 196,000 tests for the three months ended June 30, 2026, compared to 145,000 delivered and billable tests for the three months ended June 30, 2025.
Current wording
Our total test volume, which represents the number of billable tests that we receive for processing during each period and which we also refer to as tests accessioned, grew to approximately 207,000 tests for the three months ended September 30, 2026, compared to 163,000 for the three months ended September 30, 2025. In addition, our total delivered and billable test volume, which represents the number of billable tests for which we deliver a result to the ordering provider each period, grew to approximately 206,000 tests for the three months ended September 30, 2026, compared to 165,000 delivered and billable tests for the three months ended September 30, 2025.
Previous wording
Our ASPs and revenue depend heavily on our success in achieving and maintaining broad coverage and adequate reimbursement for our molecular diagnostic tests from third-party payors. Third-party reimbursement for our tests represented more than 90% of our revenue for the six months ended June 30, 2026, and we expect government and commercial third-party payors to continue to be our primary source of payments. Coverage and reimbursement by third-party payors, including commercial health insurers, managed care organizations, and government healthcare programs such as Medicare and Medicaid, can be limited and uncertain for the types of specialized molecular diagnostic tests we offer. Each payor makes its own determination as to whether to establish a policy to cover our tests, as well as the amount it will reimburse for such tests. Payors make these determinations based on factors that include medical necessity, clinical utility, and cost-effectiveness. Reimbursement rates vary significantly by test-type, payor, and coverage determination. Historically, our market access and reimbursement teams have pursued strategies to increase our ASPs by expanding our payor coverage and reimbursement. We believe these strategies will continue to grow our ASPs over time.
Current wording
Our ASPs and revenue depend heavily on our success in achieving and maintaining broad coverage and adequate reimbursement for our molecular diagnostic tests from third-party payors. Third-party reimbursement for our tests represented more than 90% of our revenue for the nine months ended September 30, 2026, and we expect government and commercial third-party payors to continue to be our primary source of payments. Coverage and reimbursement by third-party payors, including commercial health insurers, managed care organizations, and government healthcare programs such as Medicare and Medicaid, can be limited and uncertain for the types of specialized molecular diagnostic tests we offer. Each payor makes its own determination as to whether to establish a policy to cover our tests, as well as the amount it will reimburse for such tests. Payors make these determinations based on factors that include medical necessity, clinical utility, and cost-effectiveness. Reimbursement rates vary significantly by test-type, payor, and coverage determination. Historically, our market access and reimbursement teams have pursued strategies to increase our ASPs by expanding our payor coverage and reimbursement. We believe these strategies will continue to grow our ASPs over time.
Previous wording
We actively seek ways to continuously reduce our costs-per-test and improve our gross profit margin, long-term profitability, and return on investment. For example, we have reduced COGS per test through automation and optimization of laboratory workflows, successful negotiations with suppliers, and re-design and re-validation of assays with more optimized chemistry or higher-throughput sequencing. Nevertheless, as our test volumes grow, we have made and will continue to make significant investments in state-of-the-art infrastructure to support our growth. In 2023 we successfully expanded our laboratory operations from a single facility with 36,000 square feet in Menlo Park, California by adding a second laboratory facility in Union City, California with 90,000 square feet. To further support our growth beyond our current facilities, we entered a lease for the construction of 220,000 square feet of laboratory space in Austin, Texas which includes a tenant improvement package. We expect to occupy this facility in 2027, and open for processing commercial samples in 2028. Once the facility is fully utilized, we expect our potential testing capacity to be nearly triple our current capabilities In addition, in June 2026, we entered a lease for a third laboratory facility in Union City, California with approximately 62,659 square feet of office and laboratory space, which includes a tenant improvement package. This facility, which we expect to occupy in 2027, will be dedicated to our oncology products and more than triple the current oncology-dedicated laboratory space.
Current wording
We actively seek ways to continuously reduce our costs-per-test and improve our gross profit margin, long-term profitability, and return on investment. For example, we have reduced COGS per test through automation and optimization of laboratory workflows, successful negotiations with suppliers, and re-design and re-validation of assays with more optimized chemistry or higher-throughput sequencing. Nevertheless, as our test volumes grow, we have made and will continue to make significant investments in state-of-the-art infrastructure to support our growth. In 2023 we successfully expanded our laboratory operations from a single facility with 36,000 square feet in Menlo Park, California by adding a second laboratory facility in Union City, California with 90,000 square feet. To further support our growth beyond our current facilities, we entered a lease for the construction of 229,000 square feet of laboratory space in Austin, Texas, which includes a tenant improvement package. We expect to occupy this facility in 2027, and open for processing commercial samples in 2028. Once the facility is fully utilized, we expect our potential testing capacity to be nearly triple our current capabilities. In addition, in June 2026, we entered a lease for a third laboratory facility in Union City, California with approximately 62,659 square feet of office and laboratory space, which includes a tenant improvement package. This facility, which we expect to occupy in 2027, will be dedicated to our oncology products and more than triple the current oncology-dedicated laboratory space.
Previous wording
In addition, we must simultaneously enhance our customer service capabilities, improve our billing and administrative processes, expand our quality assurance programs, incorporate new laboratory equipment and automation, and implement new technology systems, all while maintaining competitive turnaround times. As such, our expenses may increase. In order to maintain cost discipline, we will continue to re-design and optimize our processes, integrate AI into our workflows, and increasingly automate both our laboratory and non- laboratory operations. We believe that our continued focus in optimization, automation, and AI for higher operational efficiencies will drive further productivity gains.
Current wording
In addition, we must simultaneously enhance our customer service capabilities, improve our billing and administrative processes, expand our quality assurance programs, incorporate new laboratory equipment and automation, and implement new technology systems, all while maintaining competitive turnaround times. As such, our expenses may increase. In order to maintain cost discipline, we will continue to re-design and optimize our processes, integrate AI into our workflows, and increasingly automate both our laboratory and non- laboratory operations. We believe that our continued focus on optimization, automation, and AI for higher operational efficiencies will drive further productivity gains.
Previous wording
The majority of our revenue is derived from sales of our prenatal test, UNITY, and a smaller portion is derived from sales of our liquid biopsy oncology tests, Northstar. Specifically, during the year ended December 31, 2025, 91% of our revenue was from our prenatal tests, 8% of our revenue was from our oncology tests, and 1% of our revenue was from our clinical trial support and other services. Additionally, during the six months ended June 30, 2026 and 2025, approximately 88% and 93%, respectively, of our revenue was from our prenatal tests, 11% and 6%, respectively, of our revenue was from our oncology tests, and 1% and 1%, respectively, of our revenue was from our clinical trial support and other services. We market our products to health clinics and physicians or a combination of the insurance carrier and patient for fees. Revenue for tests is recognized when test results are delivered to the ordering physician.
Current wording
The majority of our revenue is derived from sales of our prenatal test, UNITY, and a smaller portion is derived from sales of our liquid biopsy oncology tests, Northstar. Specifically, during the year ended December 31, 2025, 91% of our revenue was from our prenatal tests, 8% of our revenue was from our oncology tests, and 1% of our revenue was from our clinical trial support and other services. Additionally, during the nine months ended September 30, 2026 and 2025, approximately 87% and 91%, respectively, of our revenue was from our prenatal tests, 12% and 8%, respectively, of our revenue was from our oncology tests, and 1% and 1%, respectively, of our revenue was from our clinical trial support and other services. We market our products to health clinics and physicians or a combination of the insurance carrier and patient for fees. Revenue for tests is recognized when test results are delivered to the ordering physician.
Previous wording
Our clinical trial support and other services include revenue from strategic partnerships with Johnson & Johnson that utilize our testing capabilities as part of a project to perform clinical trials and the development and commercialization of a companion diagnostic. Revenue from these strategic partnership agreements are recognized as services are performed and costs are incurred. Our revenue derived from these agreements has not been material to our results of operations.
Current wording
Our clinical trial support and other services include revenue from strategic partnerships with Johnson & Johnson that utilize our testing capabilities as part of a project to perform clinical trials and the development and commercialization of a companion diagnostic. Revenue from these strategic partnership agreements is recognized as services are performed and costs are incurred. Our revenue derived from these agreements has not been material to our results of operations.
Previous wording
Our cost of revenue consists primarily of expenses related to materials and consumables, test kits, personnel-related expenses such as salaries, stock-based compensation expense and related benefits for its operations and support personnel, shipping costs, overhead allocations, depreciation expense, facilities-related expenses and other services used in connection with delivering our services.
Current wording
Our cost of revenue consists primarily of expenses related to materials and consumables, test kits, personnel-related expenses such as salaries, stock-based compensation expense and related benefits for our operations and support personnel, shipping costs, overhead allocations, depreciation expense, facilities-related expenses and other services used in connection with delivering our services.
Previous wording
Change in fair value of term loan relates to the Oberland Capital debt where we elected the fair value option under ASC 825 and is accounted for at fair value on a recurring basis. We also elected to record interest expense related to the Oberland Capital debt as change in fair value of term loan.
Current wording
Change in fair value of term loan relates to the Oberland Capital debt where we elected the fair value option under ASC 825 and is accounted for at fair value on a recurring basis. The remaining portion of the total change in fair value not attributable to instrument-specific credit risk is recognized in change in fair value of term loan. We also elected to record interest expense related to the Oberland Capital debt as change in fair value of term loan.
Previous wording
We account for uncertain tax positions in accordance with ASC 740-10, Accounting for Uncertainty in Income Taxes. We recognize the tax effects of an uncertain tax position only if it is more likely than not to be sustained based solely on its technical merits as of the reporting date and only in an amount more likely than not to be sustained upon review by the tax authorities. Interest and penalties related to uncertain tax position are classified in the unaudited financial statements as income tax expense.
Current wording
We account for uncertain tax positions in accordance with ASC 740-10, Accounting for Uncertainty in Income Taxes. We recognize the tax effects of an uncertain tax position only if it is more likely than not to be sustained based solely on its technical merits as of the reporting date and only in an amount more likely than not to be sustained upon review by the tax authorities. Interest and penalties related to uncertain tax positions are classified in the unaudited financial statements as income tax expense.
Previous wording
The following table sets forth information derived from our statements of operations and comprehensive income (loss) for each of the periods presented:
Current wording
The following table sets forth information derived from our statements of operations and comprehensive income for each of the periods presented:
Previous wording
Revenue increased $42.9 million, or 64%, for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. This increase was driven primarily by a 35% increase in the total volume of delivered and billable tests to approximately 196,000 for the three months ended June 30, 2026 from approximately 145,000 for the three months ended June 30, 2025. The increase in revenue was also attributable to an increase in our Overall ASP of 21%. Overall ASP is the weighted average ASP across all of our prenatal and oncology products. It is computed by dividing revenue for our prenatal and oncology tests by the number of tests that are delivered and billable. The number of tests that are delivered and billable in a given period represents the number of billable tests for which we deliver a result to the ordering provider in such period.
Current wording
Revenue increased $39.5 million, or 47%, for the three months ended September 30, 2026 compared to the three months ended September 30, 2025. This increase was driven primarily by a 25% increase in the total volume of delivered and billable tests to approximately 206,000 for the three months ended September 30, 2026 from approximately 165,000 for the three months ended September 30, 2025. The increase in revenue was also attributable to an increase in our Overall ASP of 18%. Overall ASP is the weighted average ASP across all of our prenatal and oncology products. It is computed by dividing revenue for our prenatal and oncology tests by the number of tests that are delivered and billable. The number of tests that are delivered and billable in a given period represents the number of billable tests for which we deliver a result to the ordering provider in such period. Furthermore, we recognized additional revenue in the third quarter of 2026 based on better than expected results from the reprocessing of claims with a payor for test delivered in prior periods. Revenue related to services performed during prior periods that were covered by this payor contributed more than a half of the $7.6 million in revenue related to performance obligations satisfied in prior periods for the three months ended September 30, 2026.
Previous wording
The increase in test volume was driven by higher volumes of our prenatal tests primarily as a result of the expansion of our sales force for our prenatal products. In addition, volumes for both our Northstar Select and Northstar Response oncology tests increased as a result of the expansion of our oncology sales force. The increase in our ASP per test was driven by several factors. For example, we increased the number of contracts compared to last year that we have with payors for our prenatal tests and we continued to benefit from our proprietary PLA code, both of which drove increases in ASP for the three months ended June 30, 2026 compared to the same period in the prior year.
Current wording
The increase in test volume was driven by higher volumes of our prenatal tests primarily as a result of the expansion of our sales force for our prenatal products. In addition, volumes for both our Northstar Select and Northstar Response oncology tests increased as a result of the expansion of our oncology sales force. The increase in our ASP per test was driven by several factors. For example, we increased the number of contracts that we have with payors for our prenatal tests compared to last year, and we continued to benefit from our proprietary PLA code, both of which drove increases in ASP for the three months ended September 30, 2026 compared to the same period in the prior year.
Previous wording
Cost of revenue increased $9.2 million, or 40%, for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily due to an increase of $4.9 million in expenses associated with testing samples and supplies used in processing tests, phlebotomy, and related shipping costs, driven by a higher volume of tests processed; and an increase of $4.3 million in labor and consulting related expenses, including stock-based compensation, which were driven by higher test volumes and an increase in product support.
Current wording
Cost of revenue increased $10.7 million, or 43%, for the three months ended September 30, 2026 compared to the three months ended September 30, 2025. The increase was primarily due to an increase of $5.1 million in expenses associated with testing samples and supplies used in processing tests, phlebotomy, and related shipping costs, driven by a higher volume of tests processed; and an increase of $5.6 million in labor and consulting related expenses, including stock-based compensation, which were driven by higher test volumes and an increase in product support.
Previous wording
Gross profit increased $33.6 million, or 77%, for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily due to an increase in the number of tests processed and a higher Overall ASP slightly offset by a small increase in Overall Cost Per Test as the sales mix shifted towards the faster growing oncology products which have a higher cost-per-test than prenatal. Some of the increase from the shift in sales mix was offset by our programs to actively reduce variable expenses and increase efficiency from our fixed costs. Overall Cost Per Test is the weighted average cost per test across all of our prenatal and oncology products. It is computed by dividing cost of goods sold for our prenatal and oncology tests by the number of tests that are accessioned. The number of tests that are accessioned in a given period represents the number of billable tests that we receive for processing during such period. We refer to this number as our “Total Test Volume.”
Current wording
Gross profit increased $28.7 million, or 49%, for the three months ended September 30, 2026 compared to the three months ended September 30, 2025. The increase was primarily due to an increase in the number of tests processed and a higher Overall ASP slightly offset by a small increase in Overall Cost Per Test as the sales mix shifted towards the faster growing oncology products which have a higher cost-per-test than prenatal. Some of the increase from the shift in sales mix was offset by our programs to actively reduce variable expenses and increase efficiency from our fixed costs. Overall Cost Per Test is the weighted average cost per test across all of our prenatal and oncology products. It is computed by dividing cost of goods sold for our prenatal and oncology tests by the number of tests that are accessioned. The number of tests that are accessioned in a given period represents the number of billable tests that we receive for processing during such period. We refer to this number as our “Total Test Volume.”
Previous wording
Gross margin increased to 70% for the three months ended June 30, 2026 from 65% for the three months ended June 30, 2025 for the reasons described above.
Current wording
Gross margin increased to 71% for the three months ended September 30, 2026 from 70% for the three months ended September 30, 2025 for the reasons described above.
Previous wording
The increase in our Overall ASP contributed to all of the improvement of our gross margin for the three months ended June 30, 2026 as compared to the three months ended June 30, 2025. This improvement was partially offset by an increase in our Overall Cost Per Test of 3% for the three months ended June 30, 2026 as compared to the three months ended June 30, 2025. Cost Per Test for both of our oncology products and for our prenatal products declined during the three months ended June 30, 2026 compared to both the three months ended March 31, 2026 and the three months ended June 30, 2025. However, these improvements were offset by a shift in the sales mix towards oncology products which have higher costs-per-test, resulting in the increase in our Overall Cost Per Test.
Current wording
The increase in our Overall ASP contributed to all of the improvement of our gross margin for the three months ended September 30, 2026 as compared to the three months ended September 30, 2025. This improvement was partially offset by an increase in our Overall Cost Per Test of 10% for the three months ended September 30, 2026 as compared to the three months ended September 30, 2025. Cost Per Test increased slightly for our prenatal products partially offset by improvements in Cost Per Test for both of our oncology products during the three months ended September 30, 2026 compared to the three months ended September 30, 2025. However, these improvements were offset by a shift in the sales mix towards oncology products which have higher costs-per-test, resulting in the increase in our Overall Cost Per Test.
Previous wording
For the six months ended June 30, 2026, our cost of goods sold consisted of 57% of variable costs and 43% of fixed costs and for the six months ended June 30, 2025 our cost of goods sold consisted of 54% of variable costs and 46% of fixed costs. The increase in variable costs during the period was attributable primarily to an increase in test volume from prenatal testing, partially offset by efficiencies gained in our lab from the increased test volume in both prenatal and oncology testing.
Current wording
For the three months ended September 30, 2026, our cost of goods sold consisted of 56% of variable costs and 44% of fixed costs and for the three months ended September 30, 2025, our cost of goods sold consisted of 59% of variable costs and 41% of fixed costs. The decrease in variable costs during the period was attributable primarily to efficiencies gained in our lab from the increased test volume in both prenatal and oncology testing.
Previous wording
Research and development expenses increased $5.6 million, or 47%, for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily due to a $2.7 million increase in personnel costs which included $0.9 million in stock-based compensation expense, a $1.5 million increase in reagents and supplies costs, a $0.6 million increase in equipment expenses and overhead allocations, a $0.6 million increase in clinical studies expense and a $0.2 million increase in consulting and other costs. The increase in research and development expenses was primarily driven by an increase in our average research and development headcount of 28 employees during the periods presented to support our product development and innovation efforts.
Current wording
Research and development expenses increased $7.3 million, or 56%, for the three months ended September 30, 2026 compared to the three months ended September 30, 2025. The increase was primarily due to a $3.1 million increase in personnel costs which included $0.9 million in stock-based compensation expense, a $2.3 million increase in reagents and supplies costs, a $0.4 million increase in equipment expenses and overhead allocations, a $0.5 million increase in clinical studies expense and a $1.0 million increase in consulting and other costs. The increase in research and development expenses was primarily driven by an increase in our average research and development headcount of 27 employees during the periods presented to support our product development and innovation efforts.
Previous wording
Selling, general and administrative expenses increased $20.9 million, or 63%, for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily due to a $16.9 million increase in salaries, commissions and related expenditure which included $4.2 million in stock-based compensation expense, a $1.6 million increase in professional and consulting fees, a $1.0 million increase in facilities and other costs, a $0.9 million increase in allocated IT and software licenses expense and a $0.5 million increase in reimbursement collection services fees. The increase in selling, general and administrative expenses was driven by an increase in our average selling, general and administrative headcount of 139 employees during the periods presented to support our sales, marketing and other corporate strategies.
Current wording
Selling, general and administrative expenses increased $20.1 million, or 56%, for the three months ended September 30, 2026 compared to the three months ended September 30, 2025. The increase was primarily due to a $15.3 million increase in salaries, commissions and related expenditure which included $3.8 million in stock-based compensation expense, a $1.6 million increase in professional and consulting fees, a $1.4 million increase in facilities and other costs, a $1.4 million increase in allocated IT and software licenses expense and a $0.4 million increase in reimbursement collection services fees. The increase in selling, general and administrative expenses was driven by an increase in our average selling, general and administrative headcount of 135 employees during the periods presented to support our sales, marketing and other corporate strategies.
Previous wording
Interest income increased $3.2 million, or 224%, for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily due to a higher average balance of cash and cash equivalents, compared to the three months ended June 30, 2025, due to the proceeds from our IPO in November 2025.
Current wording
Interest income increased $3.4 million, or 220%, for the three months ended September 30, 2026 compared to the three months ended September 30, 2025. The increase was primarily due to a higher average balance of cash and cash equivalents, compared to the three months ended September 30, 2025, due to the proceeds from our IPO in November 2025.
Previous wording
Change in fair value of term loan increased $3.0 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was due to a change in fair value of the Oberland Capital debt of $2.2 million, primarily related to the draw of the third tranche on March 31, 2026, an increase in interest expense of $0.6 million and an increase in revenue participation payments of $0.1 million.
Current wording
Change in fair value of term loan decreased $5.4 million for the three months ended September 30, 2026 compared to the three months ended September 30, 2025. The decrease was due to a change in fair value of the Oberland Capital debt of $6.0 million offset by an increase in interest expense of $0.6 million, primarily related to the draw of the third tranche on March 31, 2026.
Previous wording
The following table sets forth information derived from our statements of operations and comprehensive income (loss) for each of the periods presented:
Current wording
The following table sets forth information derived from our statements of operations and comprehensive income for each of the periods presented:
Previous wording
Revenue increased $92.3 million, or 74%, for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. This increase was driven primarily by a 40% increase in the total volume of delivered and billable tests to approximately 384,000 for the six months ended June 30, 2026 from approximately 275,000 for the six months ended June 30, 2025. The increase in revenue was also attributable to an increase in our Overall ASP of 25%. Furthermore, new agreements with payors entered into in the first quarter of 2026 resulted in an increase in revenue related to expected payments on the reprocessing of claims for tests delivered in the first three months of 2026 and the year ended December 31, 2025. Revenue related to services performed during the year ended December 31, 2025 that were covered by these payors contributed slightly less than half of the $12.0 million in revenue related to performance obligations satisfied in prior periods for the six months ended June 30, 2026.
Current wording
Revenue increased $131.8 million, or 63%, for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. This increase was driven primarily by a 34% increase in the total volume of delivered and billable tests to approximately 590,000 for the nine months ended September 30, 2026 from approximately 441,000 for the nine months ended September 30, 2025. The increase in revenue was also attributable to an increase in our Overall ASP of 22%. Furthermore, new agreements with payors entered into in the first quarter of 2026 resulted in an increase in revenue related to expected payments on the reprocessing of claims for tests delivered in the first three months of 2026 and the year ended December 31, 2025. Revenue related to services performed during the year ended December 31, 2025 that were covered by these payors contributed slightly less than half of the $19.6 million in revenue related to performance obligations satisfied in prior periods for the nine months ended September 30, 2026.
Previous wording
The increase in test volume was driven by higher volumes of our prenatal tests primarily as a result of expansion of our sales force for our prenatal products. In addition, volumes for both our Northstar Select and Northstar Response oncology tests increased as a result of expansion of our oncology sales force. The increase in our ASP per test was driven by several factors. Over the last 12 months we have continued to increase the number of contracts we have with payors for our prenatal tests which drove increases in ASP in the six months ended June 30, 2026 compared to the same period in the prior year. In addition, we continued to benefit from a our proprietary PLA code for our prenatal tests. When utilized, the PLA code is typically reimbursed at a higher rate; this contributed to an increase in ASPs during the six months ended June 30, 2026.
Current wording
The increase in test volume was driven by higher volumes of our prenatal tests primarily as a result of expansion of our sales force for our prenatal products. In addition, volumes for both our Northstar Select and Northstar Response oncology tests increased as a result of expansion of our oncology sales force. The increase in our ASP per test was driven by several factors. Over the last 12 months we have continued to increase the number of contracts we have with payors for our prenatal tests which drove increases in ASP in the nine months ended September 30, 2026 compared to the same period in the prior year. In addition, we continued to benefit from our proprietary PLA code for our prenatal tests. When utilized, the PLA code is typically reimbursed at a higher rate; this contributed to an increase in ASPs during the nine months ended September 30, 2026.
Previous wording
Cost of revenue increased $17.5 million, or 40%, for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily due to an increase of $10.6 million in expenses associated with testing samples and supplies used in processing tests, phlebotomy, and related shipping costs, driven by a higher volume of tests processed; and an increase of $6.9 million in labor and consulting related expenses, including stock-based compensation, which were driven by higher test volumes and an increase in product support.
Current wording
Cost of revenue increased $28.3 million, or 41%, for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. The increase was primarily due to an increase of $15.7 million in expenses associated with testing samples and supplies used in processing tests, phlebotomy, and related shipping costs, driven by a higher volume of tests processed; and an increase of $12.6 million in labor and consulting related expenses, including stock-based compensation, which were driven by higher test volumes and an increase in product support.
Previous wording
Gross profit increased $74.8 million, or 92%, for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily due to an increase in the number of tests processed and a higher Overall ASP slightly offset by a small increase in Overall Cost Per Test as the sales mix shifted towards the faster growing oncology products which have a higher cost-per-test than prenatal. Some of the increase from the shift in sales mix was offset by our programs to actively reduce variable expenses and increase efficiency from our fixed costs.
Current wording
Gross profit increased $103.5 million, or 74%, for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. The increase was primarily due to an increase in the number of tests processed and a higher Overall ASP slightly offset by a small increase in Overall Cost Per Test as the sales mix shifted towards the faster growing oncology products which have a higher cost-per-test than prenatal. Some of the increase from the shift in sales mix was offset by our programs to actively reduce variable expenses and increase efficiency from our fixed costs.
Previous wording
Gross margin increased from 65% for the six months ended June 30, 2025 to 72% for the six months ended June 30, 2026 for the reasons described above.
Current wording
Gross margin increased from 67% for the nine months ended September 30, 2025 to 71% for the nine months ended September 30, 2026 for the reasons described above.
Previous wording
The increase in our Overall ASP contributed to all of the improvement of our gross profit margin for the six months ended June 30, 2026 as compared to the six months ended June 30, 2025, with Overall Cost Per Test staying relatively stable for both periods.
Current wording
The increase in our Overall ASP contributed to all of the improvement of our gross profit margin for the nine months ended September 30, 2026 as compared to the nine months ended September 30, 2025, offset by a slight increase in our Overall Cost Per Test.
Previous wording
For the three months ended June 30, 2026 and 2025, our cost of goods sold consisted of 56% of variable costs and 44% of fixed costs, remaining consistent period over period.
Current wording
For the nine months ended September 30, 2026 and 2025, our cost of goods sold consisted of 56% of variable costs and 44% of fixed costs.
Previous wording
Research and development expenses increased $9.8 million, or 44%, for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily due to a $4.9 million increase in personnel costs which included $1.5 million in stock-based compensation expense, a $2.1 million increase in reagents and supplies costs, a $1.5 million increase in equipment expenses and overhead allocations, a $0.7 million increase in clinical studies expense and a $0.5 million increase in consulting. The increase in research and development expenses was primarily driven by an increase in our average research and development headcount of 27 employees during the periods presented to support our product development and innovation efforts.
Current wording
Research and development expenses increased $17.1 million, or 49%, for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. The increase was primarily due to a $7.9 million increase in personnel costs which included $2.4 million in stock-based compensation expense, a $4.4 million increase in reagents and supplies costs, a $2.0 million increase in equipment expenses and overhead allocations, a $1.2 million increase in clinical studies expense and a $1.5 million increase in consulting. The increase in research and development expenses was primarily driven by an increase in our average research and development headcount of 27 employees during the periods presented to support our product development and innovation efforts.
Previous wording
Selling, general and administrative expenses increased $37.7 million, or 60%, for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily due to a $29.2 million increase in salaries, commissions and related expenditure which included $7.4 million in stock-based compensation expense, a $3.5 million increase in professional and consulting fees, a $2.3 million increase in facilities and other costs, a $1.7 million increase in allocated IT and software licenses expense and a $1.0 million increase in reimbursement collection services fees. The increase in selling, general and administrative expenses was driven by an increase in our average selling, general and administrative headcount of 133 employees during the periods presented to support our sales, marketing and other corporate strategies.
Current wording
Selling, general and administrative expenses increased $57.7 million, or 58%, for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. The increase was primarily due to a $44.0 million increase in salaries, commissions and related expenditure which included $11.2 million in stock-based compensation expense, a $5.0 million increase in professional and consulting fees, a $4.2 million increase in facilities and other costs, a $3.2 million increase in allocated IT and software licenses expense and a $1.4 million increase in reimbursement collection services fees. The increase in selling, general and administrative expenses was driven by an increase in our average selling, general and administrative headcount of 133 employees during the periods presented to support our sales, marketing and other corporate strategies.
Previous wording
Interest income increased by $6.4 million, or 216%, for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily due to a higher average balance of cash and cash equivalents, compared to the six months ended June 30, 2025, due to the proceeds from our IPO in November 2025.
Current wording
Interest income increased by $9.8 million, or 217%, for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. The increase was primarily due to a higher average balance of cash and cash equivalents, compared to the nine months ended September 30, 2025, due to the proceeds from our IPO in November 2025.
Previous wording
Interest expense decreased $0.1 million, or 75%, for the six months ended June 30, 2026 compared to the six months ended June 30, 2025.
Current wording
Interest expense decreased $0.1 million, or 74%, for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025.
Previous wording
Change in fair value of term loan increased $4.1 million, or 133% for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was due to a change in fair value of the Oberland Capital debt of $3.2 million, primarily related to the draw of the third tranche on March 31, 2026, an increase in interest expense of $0.6 million and an increase in revenue participation payments of $0.3 million.
Current wording
Change in fair value of term loan decreased $1.3 million, or 18% for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. The decrease was due to a change in fair value of the Oberland Capital debt of $2.8 million offset by an increase in interest expense of $1.2 million and an increase in revenue participation payments of $0.3 million, primarily related to the draw of the third tranche on March 31, 2026.
Previous wording
Other income (expense), net increased $0.3 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily due to $0.6 million in other income related to an insurance recovery offset by a $0.3 million decrease in the fair value of our Class A common stock warrants, due to the exercise of the Class A common stock warrants during the three months ended June 30, 2026.
Current wording
Other income (expense), net increased $2.2 million for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. The increase was due to $0.6 million in other income related to an insurance recovery during the nine months ended September 30, 2026 and a $1.6 million loss in the fair value of our common stock warrants during the nine months ended September 30, 2025.
Previous wording
We define Adjusted EBITDA as net income (loss) adjusted for income taxes, interest income, interest expense, depreciation and amortization expense, and certain other items which include significant non-cash items events that are highly variable, significant in size, and that we do not believe are indicative of ongoing or future business operations, which include: stock-based compensation expense; change in fair value of term loan; and change in fair value of warrant liabilities. A reconciliation of net income (loss), the most directly comparable GAAP financial measure, to Adjusted EBITDA is presented below (in thousands):
Current wording
We define Adjusted EBITDA as net income (loss) adjusted for income taxes, interest income, interest expense, depreciation and amortization expense, and certain other items which include significant non-cash items and events that are highly variable, significant in size, and that we do not believe are indicative of ongoing or future business operations, which include: stock-based compensation expense; change in fair value of term loan; and change in fair value of warrant liabilities. A reconciliation of net income (loss), the most directly comparable GAAP financial measure, to Adjusted EBITDA is presented below (in thousands):
Previous wording
We define non-GAAP income (loss) from operations as income (loss) from operations presented in accordance with GAAP, adjusted to exclude stock-based compensation expense.
Current wording
We define non-GAAP income (loss) from operations as income from operations presented in accordance with GAAP, adjusted to exclude stock-based compensation expense.
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Current report — wording carried from elsewhere
CHTM, and in August 2026 we announced the launch of Northstar Origin TM. Northstar PGx and Northstar Select CH are add-on applications for Northstar Select, and expand the Northstar platform beyond genomic profiling to address chemotherapy safety (PGx) and clonal hematopoiesis (CH) — two critical decision points in selecting the right therapy for patients. Northstar Origin is an add-on tissue-of-origin feature for our Northstar Select test that can benefit patients with unknown or uncertain diagnoses. Our current development efforts focus on MRD detection, leveraging our platform’s exceptional sensitivity to identify trace amounts of tumor DNA following curative-intent surgery in earlier stage cancers. We are developing a tissue-free, pan-cancer MRD test, which we expect to be commercially available in December of 2026.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
Other income (expense), net increased $0.6 million for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily due to $0.6 million in other income related to an insurance recovery.
Previous report — wording carried elsewhere
Non-GAAP income (loss) from operations