This story has been updated to include a statement from Geneoscopy and to clarify that ColoSense has not yet been launched.
NEW YORK – Exact Sciences announced on Friday that it filed a patent infringement lawsuit against Geneoscopy in the US District Court for the District of Delaware.
The suit alleges that Geneoscopy's ColoSense colorectal cancer screening test infringes upon US patent number 11,634,781, which is assigned to Exact and covers its Cologuard assay, which obtained regulatory approval in 2014.
Geneoscopy plans to launch ColoSense as the first major competitor to Cologuard, following FDA approval. The St. Louis, Missouri-based company recently published the prospective CRC-PREVENT trial in the Journal of the American Medical Association earlier this month.
In its complaint, Exact Sciences claimed that ColoSense uses the '781 patent's methods for processing stool samples without permission from Exact Sciences and in violation of US patent laws. Exact Sciences said in a statement that it had sent Geneoscopy a cease-and-desist letter related to ColoSense, prompting Geneoscopy to request that the US Patent and Trademark Office reexamine the '781 patent. The USPTO, Exact Sciences said, rejected the challenge and confirmed all patentability claims of the '781 patent.
In its court filing, Exact Sciences asked for an injunction against the manufacture, use, sale, offer for sale, or importation into the United States of ColoSense and for damages to compensate Exact Sciences for the alleged infringement.
"Exact Sciences pioneered a significant scientific breakthrough that has touched millions of patient lives," Kevin Conroy, chairman and CEO of Exact Sciences, said in a statement. "We worked tirelessly to develop Cologuard, a first-of-its-kind diagnostic that has been used to screen for colorectal cancer more than 13 million times. As a company deeply rooted in innovation, we understand the vital role of intellectual property, and we will vigorously defend our patents."
In a separate statement, Geneoscopy said that it is "committed to innovation and deeply respects intellectual property rights."
"We are highly confident in the strength of our intellectual property and freedom to operate, and we strongly reject Exact Sciences’ infringement claims," the statement read. "Geneoscopy will vigorously defend its ability to bring its patented innovation to clinicians and individuals and offer more options for accurate, convenient colorectal cancer screening."
A trial date has not yet been set.