Exact Sciences Doubles Down on Blood-Based Colorectal Cancer Screening with Freenome Deal
The landscape of colorectal cancer (CRC) screening is rapidly evolving, moving beyond conventional colonoscopies towards more accessible, non-invasive options. Recent developments highlight both the promise and the challenges in this space, with Exact Sciences making a notable strategic move to bolster its position. This article breaks down the key events, the implications for patients, and what to expect in the coming years.
The Rise of Liquid Biopsies & Guardant Health’s Lead
For years, the medical community has been pushing for less invasive CRC detection methods. This effort culminated in a landmark FDA approval in July 2024: Guardant Health‘s Shield became the first blood test authorized for colorectal cancer screening. This “liquid biopsy” analyzes circulating tumor DNA in the blood, offering a perhaps simpler alternative to traditional screening.
Guardant Health is already seeing substantial returns,with its precision oncology testing portfolio generating nearly $688 million in sales last year (according to thier 2024 annual report).this success underscores the growing demand for convenient and effective CRC screening.
Exact Sciences’ setback & Strategic Pivot
Exact Sciences, a major player in the CRC screening market (known for its Cologuard stool test), faced a recent hurdle. Results from a pivotal study of its internally developed blood-based test were released in August 2024 and proved disappointing.
Sensitivities were reported at 73% for colorectal cancer and only 14% for advanced precancerous lesions, with 90% specificity.
These figures fall short of the 74% sensitivity threshold required for Medicare coverage, substantially limiting the test’s commercial viability.
Faced with this challenge, Exact Sciences has strategically partnered with Freenome.
Exact Sciences & Freenome: A Collaborative Path Forward
Exact Sciences has entered into an exclusive licensing agreement with Freenome, a California-based biotech company, to commercialize Freenome’s blood-based CRC screening test, SimpleScreen. Freenome recently submitted the final module of its pre-market request to the FDA.
Here’s a breakdown of the key terms of the deal:
Exclusive Rights: Exact Sciences gains exclusive U.S. rights to current and future versions of Freenome’s test specifically for colorectal cancer screening.
Multi-Cancer Focus for Freenome: Importantly, Freenome retains the right to incorporate CRC screening into a broader multi-cancer early detection test currently in development – a test aiming to screen for over 10 cancers from a single blood sample.
Financial Commitment: Exact Sciences is committing significant capital:
Upfront Payment: A cash payment due by November 2024.
Milestone Payments: Up to $700 million tied to FDA approvals and favorable USPSTF (United States Preventive Services Taskforce) recommendations. (Specifically: $100M for first-line approval of the initial test, $100M for next-gen approval contingent on performance, and $500M for a Grade A or B USPSTF rating or specific payer coverage).
R&D Investment: $20 million over three years for joint research and development leveraging Freenome’s technology.
Royalty structure: Freenome will receive royalties ranging from 0% to 10%,dependent on test profitability. The agreement includes provisions to ensure commercial viability isn’t undermined by excessive royalty payments.
Termination Clause: Exact Sciences has the right to terminate the agreement if certain, unspecified criteria aren’t met.
What Does This Mean for the Future of CRC Screening?
This deal is a strategic win for both companies.
For Freenome: It provides crucial funding and a commercialization partner, allowing them to focus on their enterprising multi-cancer early detection program. Analysts at Leerink Partners call it “a shot in the arm.”
For Exact Sciences: It offers a promising alternative to their internally developed test, potentially accelerating their entry into the blood-based screening market. Though, they’ll likely be playing catch-up to Guardant Health.
Timeline & Expectations
While the partnership is promising, a launch is still some time away. Experts predict Exact Sciences won’t launch Freenome’s