Exact Sciences seeks FDA approval for ‘Cologuard 2.0’

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Madison’s Exact Sciences has applied for FDA approval of a “next generation” Cologuard test, according to the Wisconsin State Journal. The new version of its screening test for colon cancer could become available next year.

The new test, “Cologuard 2.0,” was found to be superior to the original in identifying cancer. Its false positive rate was 30% lower and necessitated fewer follow-up colonoscopies.

Meanwhile, St. Louis-based Geneoscopy, which is developing a rival colon cancer test and was sued by Exact Sciences in November over alleged infringement of a key patent, said today that it has asked for a federal review of the patent.

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