BillionToOne raised 2026 revenue guidance to $460 million to $470 million.
Third-quarter revenue reached $123 million, up 47% year over year.
Northstar Clear blood test for cancer launches on December 15.
On its third quarter of 2026 earnings call, held on Nov. 4, 2026, BillionToOne (NASDAQ:BLLN) raised its full-year 2026 revenue guidance to between $460 million and $470 million. Total revenue grew 47% year over year to $123 million, marking the fifth consecutive quarter of positive operating income under generally accepted accounting principles (GAAP, standard accounting rules). Higher average selling prices (ASP, the average revenue collected per test) and growing oncology volume prove that its testing platform scales profitably. Three key takeaways stand out for long-term investors.
BillionToOne plans to launch Northstar Clear on Dec. 15, 2026, to expand into minimal residual disease (MRD, testing that detects trace cancer cells in blood). The assay requires only a blood draw and avoids physical tumor tissue samples entirely.
We are excited to announce that Northstar Clear, our tissue-free MRD test will be commercially launching on December 15.
-- Oguzhan Atay, Co-Founder and Chief Executive Officer
A published head-to-head study demonstrated that Northstar Response matched or beat a leading tissue-dependent test for monitoring treatment response. Removing the need for physical tissue eliminates processing delays and lowers test failure rates for oncologists.
The results show that Northstar Response delivers on par to superior results versus the tumor-informed assay, which, to our knowledge, makes this the first time a tissue-free test has ever demonstrated superior head-to-head performance against the tumor-informed assay.
-- Oguzhan Atay, Co-Founder and Chief Executive Officer
Gross margin reached 71% in the third quarter while cost of goods sold (COGS, the direct cost to process each test) was $169. Software automation and high test throughput help the company expand with far smaller accumulated losses than peers.
The margin profile paired with our fiscally disciplined culture and AI-enabled operations has made us GAAP profitable and cash flow positive with roughly 1/10 of the accumulated deficit of our public peers.
-- Oguzhan Atay, Co-Founder and Chief Executive Officer
Full-year revenue guidance rose to between $460 million and $470 million as health system adoption accelerates. Expanding payer coverage and proprietary software automation help protect profitability while oncology expands.
With ASPs continuing to rise in both prenatal and oncology and with ongoing cost reductions in oncology, we believe we can sustain this profile as oncology grows into a far larger share of our business.
-- Oguzhan Atay, Co-Founder and Chief Executive Officer
Hospital software integrations remain key to capturing long-term market share across major healthcare systems.
Our long-term goal remains the same: to transform molecular diagnostics, build a category-defining company and earn our place in the S&P 500.
-- Oguzhan Atay, Co-Founder and Chief Executive Officer
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