Exact Sciences Corp., the Madison developer of the stool-based Cologuard colorectal cancer screening test, said Tuesday that a patent infringement lawsuit it filed against a St. Louis startup can go forward following a judge's ruling.
The judge's decision comes just after Exact Sciences filed a second complaint against the startup and just weeks after the St. Louis company, Geneoscopy Inc., received U.S. Food and Drug Administration approval for its own stool-based test to detect colorectal cancer. Like Exact Sciences' Cologuard, Geneoscopy's test, called ColoSense, can be taken at home with samples mailed in for testing.
Exact Sciences (Nasdaq: EXAS), the maker of the Cologuard screening test for colorectal cancer, said in November 2023 it sued Geneoscopy for patent infringement. Geneoscopy in December filed a motion seeking to have the lawsuit be dismissed. Exact Sciences said Tuesday that the U.S. District Court judge for the District of Delaware denied the motion in part.
The court’s order directed Exact Sciences to file an amended complaint while denying certain technical objections Geneoscopy raised related to other claims, Geneoscopy said in a press release. The court did not address, nor was it asked to determine, whether the patent at issue is valid or enforceable.
Earlier this month, Geneoscopy said in a statement that it “continues to believe that the claims made in the litigation are without any merit.” In Wednesday's statement, Geneoscopy said it believes Exact Sciences' new complaint "is likewise baseless and will not disrupt Geneoscopy’s commercialization of ColoSense."
Geneoscopy said Wednesday it has petitioned for a reexamination of the patent in question with the U.S. Patent and Trademark Office, claiming "nothing in that patent is inventive."
On May 15, 2024, Exact Sciences filed a second complaint against Geneoscopy to defend its intellectual property against infringement regarding a new patent issued April 30 that, like the previously asserted patent, relates "to the novel sample collection technologies that have made Exact Sciences’ flagship Cologuard test so successful," Exact Sciences said Tuesday.
Exact Sciences expects its new case to proceed on a similar schedule as the existing case, given the overlapping issues.
Since 2009, Exact Sciences said it has invested hundreds of millions of dollars to study Cologuard and at-home cancer screening technology in 26 clinical trials that included 256,000 participants. As of November 2023, the company held more than 70 U.S. and over 140 internationally issued Cologuard patents, with more than 80 patent applications pending worldwide.
The second lawsuit emerges as Geneoscopy is ramping up for commercial launch of ColoSense, possibly later this year.
Following FDA approval, Geneoscopy hired two new executives to “support the commercialization” of ColoSense. Matt Sargent was hired as chief commercial officer and Tyler Aldredge was added as vice president of operations.
Geneoscopy plans to commercially launch its screening test later this year or in early 2025. The company has partnered with Burlington, North Carolina-based Labcorp (NYSE: LH) to distribute ColoSense to health care providers as part of their patient screening programs.
Founded in 2015, Geneoscopy has raised more than $100 million in financing as it's sought to bring its colorectal cancer screening test to market. It also has pursued having its technology used to detect other diseases, including inflammatory bowel disease (IBD).
Geneoscopy has 55 employees, with more than half of its workers based in St. Louis, where its headquarters is at 2220 Welsch Industrial Court.
