Exact Sciences confirmed that the Hart‑Scott‑Rodino Antitrust Improvements Act waiting period for its exclusive license to Freenome’s blood‑based colorectal cancer screening test expired on November 10 2025, removing a regulatory hurdle that had delayed the deal’s consummation.
The company’s agreement with Freenome includes an upfront payment of $75 million, potential milestone payments of up to $700 million, and a $50 million equity investment, giving Exact Sciences a significant financial stake in the technology’s future success.
Freenome’s PREEMPT CRC study demonstrated 81.1 % detection of colorectal cancer and 13.7 % detection of advanced precancerous lesions, with a specificity of 90.4 %. These performance metrics position the test as a competitive alternative to stool‑based options and to Guardant Health’s Shield test, which has already received FDA approval for primary screening.
The company expects FDA approval and a commercial launch of the first‑version test in 2026, after which Exact Sciences will leverage its existing commercial infrastructure and ExactNexus platform to accelerate market adoption.
Adding a blood‑based option broadens Exact Sciences’ portfolio beyond its flagship Cologuard and Cologuard Plus, appealing to patients who prefer a less invasive screening method and potentially increasing overall screening rates and revenue. The deal also strengthens the company’s competitive stance in the growing liquid‑biopsy market, where early detection and patient convenience are key differentiators.
Exact Sciences reported record revenue of $811 million in Q2 2025, a 16 % year‑over‑year increase, and has raised its full‑year guidance. The financial strength and proven commercial platform provide the resources needed to execute the Freenome partnership and support future growth in the colorectal cancer screening market.
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