Freenome Secures Funding & Charts Course for Multi-Cancer Early Detection with Roche and Exact Sciences Partnerships
The landscape of cancer screening is undergoing a dramatic shift, driven by advancements in liquid biopsy technology. Freenome, a leading innovator in this space, is poised to play a significant role, recently securing significant funding and solidifying key partnerships with industry giants Roche and Exact Sciences. This article delves into Freenome’s strategy, its progress with its SimpleScreen test, and the competitive dynamics shaping the future of multi-cancer early detection.
Strategic Partnerships Fuel Growth & Expansion
Freenome’s recent financial maneuvers demonstrate a clear strategy: accelerate progress and commercialization of its blood-based cancer screening tests. A $290 million investment from Roche, building on an existing investor relationship, is a testament to the confidence in Freenome’s technology. Crucially, this deal allows Freenome to retain exclusive rights to its colorectal cancer screening capabilities within a broader, multi-cancer detection test – a strategic move that positions the company to address a significant unmet need.
Further bolstering its position, Freenome has partnered with Exact Sciences. This collaboration allows Roche to commercialize Freenome’s “kitted” multi-cancer early detection tests outside the U.S. These “kitted” tests are a game-changer, packaging the assay and software together, eliminating the need for centralized lab processing and expanding accessibility. The initial investment from Roche for this deal totaled $75 million upfront, with an additional $134 million contingent on achieving key milestones. Importantly, Freenome maintains U.S. rights for both multi-cancer early detection testing and the kitted tests themselves.
SimpleScreen: A Versioning Strategy for Continuous Improvement
Freenome isn’t aiming for a single “final” product.Instead, the company is employing a “versioning strategy,” continuously refining its assay and algorithms with each iteration of its tests. Currently under FDA review is Version 1 of SimpleScreen. The company anticipates submitting Version 2 for regulatory consideration by mid-2025.
Early data presented to investors reveals promising performance for Version 2, demonstrating 75% sensitivity in detecting Stage I colorectal cancer.Sensitivities for advanced adenoma and high-grade dysplasia reached 22% and 44% respectively. While these figures surpass initial results from Guardant Health’s Shield test, industry analysts like William Blair’s andrew Brackmann caution that this data represents final clinical validation, not the pivotal data destined for FDA submission.
“We have questions regarding the study design and patient population,” Brackmann noted,”but the results clearly indicate improvement over Version 1.” This iterative approach underscores Freenome’s commitment to maximizing the clinical utility of its tests.
Navigating a Competitive Landscape: Guardant Health & the Liquid Biopsy Market
Guardant Health currently holds a first-mover advantage in the liquid biopsy market, projecting over 80,000 tests performed this year. Though,the market potential is enormous. Leerink Partners analyst Puneet Souda estimates that approximately 11 million average-risk individuals would opt for a blood-based cancer screening test over a colonoscopy. This substantial demand creates ample opportunity for multiple players.
Freenome’s delayed submission of Version 2 (expected in the second half of 2025) provides Guardant Health with valuable time to refine its own offering, Shield Version 3. However, the sheer size of the potential market suggests a future where both companies – and others – can thrive.
Financial Strength & Path to Commercialization
Since its founding in 2014, Freenome has successfully raised over $1.3 billion. The planned merger with Perceptive Capital Solutions is expected to add approximately $330 million to that total, comprised of $90 million from the trust account and a $240 million private investment in public equity (PIPE) led by Perceptive Advisors and RA Capital. PIPE investors will acquire 24 million Freenome shares at $10 each.
Combined with existing funds, including proceeds from the Exact Sciences and Roche deals, Freenome anticipates having over $1.3 billion in resources upon completion of the merger. These funds will be strategically allocated to product development, ongoing clinical trials, and ultimately, commercialization efforts.
Looking Ahead: Merger Approval & Future Growth
The merger between Freenome and Perceptive Capital Solutions has received approval from both companies’ boards of directors and is anticipated to close
