Freenome building commercial infrastructure following recent CLIA lab certification and early access program for key health system partners, with new test launches for colorectal cancer, lung cancer and other indications planned in 2026
In previously announced deal, Exact Sciences acquired exclusive U.S. licensing and commercialization rights to Freenome’s blood-based colorectal cancer screening tests for up to $885M
Freenome, an early cancer detection company developing blood-based tests to identify cancer at its most treatable stage, today announced the appointment of industry veteran Rob Guigley as its chief commercial officer. This key leadership addition will spearhead the execution of the exclusive U.S. licensing and commercialization that leverages Exact Sciences’ extensive commercial footprint to accelerate access to Freenome’s colorectal cancer (CRC) blood-based screening test. In addition, Guigley will lead the build-out of Freenome’s core commercial capabilities and activities for our broader suite of future tests and platform offerings.
The waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) has expired, which satisfies one of the conditions for closing the transaction that was initially announced on Aug. 6, 2025. The U.S. Food and Drug Administration (FDA) is currently reviewing the Premarket Approval Application for the initial version of the test, known as SimpleScreen™ CRC in the FDA filing, with approval expected in the second half of 2026.
“As we transition to this new phase, we are focused on strengthening our commercial leadership to maximize the reach of our CRC test while aggressively advancing our multi-cancer pipeline and generation of real-world data (RWD) through commercial testing,” said Aaron Elliott, Ph.D., chief executive officer of Freenome. “Rob Guigley has consistently demonstrated the ability to design and scale commercial organizations in the primary care field, and his experience will be invaluable in preparing Freenome for future clinical impact.”
Guigley joins the company with more than 20 years of experience leading commercial organizations across diagnostics, digital health and healthcare technology, including at Delfi Diagnostics, Invitae, Ambry Genetics and Omada Health. He will lead Freenome’s go-to-market strategy with health systems, including developing wraparound services to empower caregivers and integrating the company’s tests into primary care workflows.
Guigley’s experience with digital products enabled by RWD strategically aligns with the Exact Sciences commercial relationship, which provides Freenome with access to all multimodal data from patients to power future AI/ML models across multiple cancer indications. Freenome intends to launch a laboratory-developed test (LDT) version of its lung cancer screening test in the second half of 2026. More than 10 other cancer indications embedded in the current assay are also being pursued, informed by data from the fully enrolled, multi-cancer Vallania and Sanderson studies.
“What drew me to Freenome is the combination of rigorous science, clinical validation and platform strength protected by a growing data moat, paired with a clear vision for making early detection accessible to everyone,” Guigley said. “I look forward to working with Exact Sciences to accelerate access to SimpleScreen CRC following FDA approval, and I’m excited to build Freenome’s commercial infrastructure to bring our innovative personalized multi-cancer test portfolio to the market.”
Freenome’s multiomics discovery platform evaluates multiple biomarker classes, including epigenomics, transcriptomics, metabolomics and proteomics, to identify the early biological signals of disease in the bloodstream. The company’s goal is to create a common lab platform with custom panels and classifiers to offer multiple tests to an individual based on health profiles and guideline eligibility. Targeting high-, elevated-, and average-risk populations based on the unmet need allows the tests to be optimized for higher sensitivity at clinically acceptable specificity.
Select health systems are currently being evaluated for a SimpleScreen CRC early access program that is launching in January 2026, and Freenome expects the first patient samples to arrive at its clinical laboratory that month. The company’s lab received its Clinical Laboratory Improvement Amendments (CLIA) certification in October, indicating it meets federal quality standards for accuracy and reliability.
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