The U.S. Centers for Medicare & Medicaid Services (CMS) has determined that the time has come to offer Medicare coverage for blood-based in vitro diagnostics as a screening tool for colorectal cancer (CRC), but there’s one catch: At present, there is no such test approved by the FDA that qualifies under the terms of the coverage memo, making this a null coverage proposition, at least for the time being.

The U.S. Preventive Services Task Force (USPSTF) appears on the verge of expanding colorectal cancer screening to individuals ages 45 to 49, based on its latest draft recommendations. If it does, Exact Sciences Corp. is ready. A study in Cancer Prevention Research demonstrated that the Madison, Wis.-based company's Cologuard multitarget stool DNA test had better than 95% specificity in individuals with nonadvanced precancerous lesions or negative findings on colonoscopy.

Shares of early cancer detection company Exact Sciences Corp. soared Tuesday morning on news it is acquiring two liquid biopsy screening companies, Thrive Earlier Detection Corp. and Base Genomics Ltd., for $2.56 billion and selling $869 million of common stock to institutional investors.

SAN FRANCISCO – Investor confidence in Exact Sciences Corp. has started to stumble in recent months. The Madison, Wis.-based company’s valuation peaked at about $15.5 billion just a few short weeks after it announced that it would acquire Genomic Health Inc. in late July. Its market cap trajectory has been uneven since and took another hit when the company preannounced 2019 earnings at the J.P. Morgan (JPM) Healthcare Conference, falling to around $13.5 billion.

Madison, Wis.-based Exact Sciences Corp., which provided an update on promising research in a collaboration with the Mayo Clinic, saw a jump in revenue during its third quarter, with 12,000 providers ordering their initial Cologuard test during the period. The company posted impressive numbers, with revenue increasing 85% to $219 million on Cologuard volume growth. The revenue came in $3 million above consensus, and the operational update was as expected, noted Sean Lavin, BTIG analyst. Even though management was upbeat, "with investor sentiment fairly weak, an in-line result was simply not good enough, and we guessed that a $5 [million]-$10 [million] beat was probably needed to nudge shares," Lavin added.