The blood-based test is designed to detect molecular residual disease without requiring a tumor sample and is expected to be available Dec 15.
BillionToOne announced the upcoming launch of Northstar Clear, a tissue-free molecular residual disease (MRD) test for patients with all solid tumors, which will be commercially available on Dec 15, 2026.
The company says the pan-cancer, blood-only design makes the test available on day one for all solid tumors. BillionToOne also says initial data in colorectal cancer will show head-to-head performance against a tumor-informed assay.
The launch follows new data on the company’s Northstar Response test. In October, BillionToOne announced peer-reviewed data published in The Journal of Liquid Biopsy from the first head-to-head comparison of Northstar Response with the most widely used tumor-informed assay in patients on active treatment for advanced cancer.
According to the company, the two assays agreed on the direction of circulating tumor DNA change in 94% of sequential pairs (67 of 71). In the four cases where the assays diverged, clinical records supported Northstar Response’s findings.
Third Quarter Results and Raised Guidance
BillionToOne announced the launch alongside its third quarter 2026 financial results. Total revenue was $123.0 million, up 47% from $83.5 million in the third quarter of 2025. Revenue by segment:
- Prenatal clinical testing revenue reached $104.3 million, an increase of 41%.
- Oncology clinical testing revenue was $17.1 million, up 96% from $8.7 million a year earlier.
The company delivered 206,000 tests in the quarter, compared with 165,000 a year earlier, an increase of 25%. Overall average selling price rose 18% to $589. Gross margin was 71%, compared with 70% in the third quarter of 2025.
BillionToOne said income from operations was $11.0 million, compared with $9.6 million a year earlier. Net income was $17.4 million, or $0.32 per diluted share. Free cash flow was $8.6 million.
The company raised its full-year 2026 revenue guidance to $460 million to $470 million, which represents 51% to 54% growth over 2025. That compares with previous guidance of $450 million to $465 million. BillionToOne also expects to continue generating profitability similar to current levels, even with significant continued investments.
“Our third quarter was another period of strong execution,” says Oguzhan Atay, cofounder and CEO of BillionToOne, in a release. “We delivered rapid growth with continued GAAP profitability, and more clinicians are choosing our tests in both prenatal and oncology.”
