BillionToOne Lifts 2026 Revenue Guidance to $460-470 Million After 47% Q3 Growth

BillionToOne raised its full-year 2026 revenue guidance to between $460 million and $470 million on its third-quarter earnings call, held on November 4, 2026. The Motley Fool reported the guidance increase alongside quarterly revenue of $123 million, up 47% year over year.

BillionToOne's Third-Quarter Revenue and Margins

BillionToOne is a precision diagnostics company that uses its QCT molecular counting platform to deliver non-invasive prenatal tests and oncology liquid biopsies from a single blood draw. The company reported a 71% gross margin for the quarter and cost of goods sold of $169 million. The quarter marked the fifth consecutive period of positive operating income under generally accepted accounting principles.

Higher average selling prices and growing oncology volume supported the results, according to the report. Co-Founder and Chief Executive Officer Oguzhan Atay said the margin profile and AI-enabled operations have made the company GAAP profitable and cash flow positive "with roughly 1/10 of the accumulated deficit of our public peers."

BillionToOne plans to launch Northstar Clear, a tissue-free minimal residual disease test, on December 15, 2026. The assay requires only a blood draw and avoids physical tumor tissue samples. Atay said: "We are excited to announce that Northstar Clear, our tissue-free MRD test will be commercially launching on December 15."

A published head-to-head study showed Northstar Response matched or beat a leading tissue-dependent test for monitoring treatment response. Atay said the results make this "the first time a tissue-free test has ever demonstrated superior head-to-head performance against the tumor-informed assay."

BillionToOne's Earlier Guidance and Revenue Records

According to akta.pro company records, BillionToOne's earlier 2026 guidance, issued in January, was $415 million to $430 million, representing 40-45% growth. The company reported full-year 2025 revenue of $305.1 million, doubling from $152.6 million in 2024, and fourth-quarter 2025 revenue of $96.1 million, up 113% year over year.

BillionToOne's Path to the Northstar Clear Launch

In November 2026, BillionToOne reported third-quarter prenatal revenue growth of 42% and oncology clinical testing revenue of $17.1 million, up 96%, with a blended gross margin of 71%, Investing.com reported. Atay presented at the 2026 UBS Global Healthcare Conference that month, discussing the company's platform differentiation and growth strategy, according to Seeking Alpha. In October 2026, Seeking Alpha reported that BillionToOne's Unity Complete prenatal screening bypasses paternal testing and expands to 130 genes, while oncology testing grew 176% year over year.

What Comes Next for Northstar Clear

BillionToOne plans to launch Northstar Clear on December 15, 2026. Atay said the company's long-term goal is "to transform molecular diagnostics, build a category-defining company and earn our place in the S&P 500."