Exact Sciences Prepares Cologuard 2.0 for FDA Approval

Almost 10 years after Exact Sciences launched the first Cologuard test, a popular colorectal cancer screening device, they have decided to produce an upgrade.

According to Kevin Conroy, the company’s Chief Executive Officer, this new and improved assay will enable higher precision levels in results, defining “a new performance standard.”

Exact Sciences is confident in their plan to file for FDA approval in 2023 following positive outcomes from a recent study, testing the new products capabilities.

In the study, the new Cologuard device had improved results across each standard compared to the decade old original. While the current Cologuard identifies symptoms of colorectal cancer with 92% sensitivity, the new one achieved 94%. In addition, the upgrade came out with a 30% reduction in false- positives, and 4% higher accuracy across negative tests.

Conroy explained that once the device is cleared to go to market, “next-generation Cologuard will meaningfully enhance the patient experience, and it comes at a critical time—when there are 60 million Americans not up to date with screening.”

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