Geneoscopy Strengthens Diagnostic Market Position After USPTO Invalidates Exact Sciences Patent Claims

09 February 2026 | Monday | News

Landmark PTAB decisions clear legal pathway for broader adoption of ColoSense RNA-based colorectal cancer screening test

Decision removes last patent hurdle as Geneoscopy advances ColoSense®, its RNA-based noninvasive colorectal cancer screening test

Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, announced that the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office has issued a Final Written Decision following inter partes review (IPR), finding all 10 challenged claims of Exact Sciences’ U.S. Patent No. 11,970,746 (the ’746 patent) unpatentable. This decision follows the PTAB’s July 2025 Final Written Decision invalidating all 20 claims of Exact Sciences’ U.S. Patent No. 11,634,781 (the ‘781 patent). As a result, all patent claims asserted by Exact Sciences against the company in the parties’ ongoing litigation have now been invalidated by the PTAB.

The PTAB’s ruling concluded that all claims of the ’746 patent challenged by the company before the PTAB are unpatentable in view of prior art describing stool sample collection and processing. The PTAB’s decision to invalidate all challenged claims of the ‘746 patent, following its final decision invalidating all claims of the ‘781 patent, further confirms Geneoscopy’s long-held position and clears the path for the continued commercialization of ColoSense.

“The PTAB’s final decisions on these two patents validate what we have believed all along—that the claims in both the ’781 patent and the ‘746 patent being asserted by Exact Sciences against the company should never have been issued,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “This outcome underscores that invalid patents cannot be used to limit patient access to life-saving colorectal cancer screening options like ColoSense. These final decisions are also a critical step toward protecting patient choice and advancing high-quality, innovative, noninvasive screening solutions.”

Geneoscopy filed the IPR petition after Exact Sciences initiated a patent infringement suit against the company in the U.S. District Court for the District of Delaware. The PTAB’s ruling on the ‘746 patent removes all of Exact Sciences’ patent challenges against ColoSense in that case, as all patent claims asserted against the company in the litigation have now been invalidated by the PTAB.

As part of the litigation, Geneoscopy has filed counterclaims against Exact Sciences alleging breach of contract, misappropriation of trade secrets, false advertising, and unfair competition (Exact Sciences Corporation v. Geneoscopy, Inc., C.A. No. 23-1319-MN (D. Del.)).

 

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