Exact Sciences Corp. has secured exclusive U.S. rights to current and future versions of Freenome’s blood-based colorectal cancer screening tests, expanding the company’s cancer-screening portfolio beyond its flagship stool-based Cologuard Plus product. Freenome has filed the final module of its premarket approval application with the U.S. Food and Drug Administration, with first-line approval and commercial launch of the inaugural test expected in 2026. Under the agreement, Exact Sciences will pay Freenome $75 million in cash by November 2025 and up to $700 million tied to regulatory and reimbursement milestones, including first-line FDA approvals for two test versions and a potential A or B rating from the U.S. Preventive Services Task Force. The package also includes $20 million in joint R&D funding over three years and a $50 million convertible note purchase, bringing the deal’s total potential value to roughly $885 million. Freenome is eligible for royalties that could rise to 10 % once profitability thresholds are met. The transaction intensifies competition in the fast-growing liquid-biopsy market, where Guardant Health already sells an FDA-approved blood test for colon cancer. Exact Sciences said the Freenome assay detected 81 % of colorectal cancers and 14 % of advanced precancerous lesions at 90 % specificity in the 48,995-participant PREEMPT CRC study published in JAMA. The announcement coincided with Exact Sciences’ second-quarter results, which showed revenue climbing 16 % year over year to a record $811 million. The Madison, Wisconsin-based company lifted its 2025 revenue outlook to $3.13-$3.17 billion and its adjusted EBITDA guidance midpoint by $25 million, citing momentum from Cologuard Plus and new product launches.
Exact Sciences Announces Second Quarter 2025 Results $EXAS https://t.co/0Wp8xN0pM3
$EXAS - Freenome Announces Exclusive License Agreement with Exact Sciences to Commercialize Freenome's Blood-Based Screening Test for Colorectal Cancer- https://t.co/MSW58JWVf7
Exact Sciences ($EXAS) has acquired exclusive rights to rival Freenome’s blood-based colon cancer test. The company disclosed that its own test did not quite meet the bar for Medicare coverage. News from me for @statnews https://t.co/1P7UtE903U