Freenome Appoints Industry Veteran Rob Guigley as Chief Commercial Officer

Freenome constructing business infrastructure following latest CLIA lab certification and early entry program for key well being system companions, with new take a look at launches for colorectal most cancers, lung most cancers and different indications deliberate in 2026

In beforehand introduced deal, Exact Sciences acquired unique U.S. licensing and commercialization rights to Freenome’s blood-based colorectal most cancers screening checks for as much as $885M

Freenome, an early most cancers detection firm growing blood-based checks to establish most cancers at its most treatable stage, at present introduced the appointment of trade veteran Rob Guigley as its chief business officer. This key management addition will spearhead the execution of the unique U.S. licensing and commercialization that leverages Exact Sciences’ intensive business footprint to speed up entry to Freenome’s colorectal most cancers (CRC) blood-based screening take a look at. In addition, Guigley will lead the build-out of Freenome’s core business capabilities and actions for our broader suite of future checks and platform choices.

The ready interval below the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) has expired, which satisfies one of many circumstances for closing the transaction that was initially introduced on Aug. 6, 2025. The U.S. Food and Drug Administration (FDA) is at present reviewing the Premarket Approval Application for the preliminary model of the take a look at, identified as SimpleScreen CRC within the FDA submitting, with approval anticipated within the second half of 2026.

“As we transition to this new part, we’re centered on strengthening our business management to maximise the attain of our CRC take a look at whereas aggressively advancing our multi-cancer pipeline and technology of real-world information (RWD) by means of business testing,” mentioned Aaron Elliott, Ph.D., chief govt officer of Freenome. “Rob Guigley has persistently demonstrated the flexibility to design and scale business organizations within the major care area, and his expertise shall be invaluable in making ready Freenome for future medical impression.”

Guigley joins the corporate with greater than 20 years of expertise main business organizations throughout diagnostics, digital well being and healthcare know-how, together with at Delfi Diagnostics, Invitae, Ambry Genetics and Omada Health. He will lead Freenome’s go-to-market technique with well being methods, together with growing wraparound providers to empower caregivers and integrating the corporate’s checks into major care workflows.

Guigley’s expertise with digital merchandise enabled by RWD strategically aligns with the Exact Sciences business relationship, which offers Freenome with entry to all multimodal information from sufferers to energy future AI/ML fashions throughout a number of most cancers indications. Freenome intends to launch a laboratory-developed take a look at (LDT) model of its lung most cancers screening take a look at within the second half of 2026. More than 10 different most cancers indications embedded within the present assay are additionally being pursued, knowledgeable by information from the totally enrolled, multi-cancer Vallania and Sanderson research.

“What drew me to Freenome is the mix of rigorous science, medical validation and platform power protected by a rising information moat, paired with a transparent imaginative and prescient for making early detection accessible to everybody,” Guigley mentioned. “I look ahead to working with Exact Sciences to speed up entry to SimpleScreen CRC following FDA approval, and I’m excited to construct Freenome’s business infrastructure to carry our revolutionary personalised multi-cancer take a look at portfolio to the market.”

Freenome’s multiomics discovery platform evaluates a number of biomarker lessons, together with epigenomics, transcriptomics, metabolomics and proteomics, to establish the early organic indicators of illness within the bloodstream. The firm’s objective is to create a typical lab platform with customized panels and classifiers to supply a number of checks to a person based mostly on well being profiles and guideline eligibility. Targeting high-, elevated-, and average-risk populations based mostly on the unmet want permits the checks to be optimized for increased sensitivity at clinically acceptable specificity.

Select well being methods are at present being evaluated for a SimpleScreen CRC early entry program that’s launching in January 2026, and Freenome expects the primary affected person samples to reach at its medical laboratory that month. The firm’s lab acquired its Clinical Laboratory Improvement Amendments (CLIA) certification in October, indicating it meets federal high quality requirements for accuracy and reliability.

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