Exact Sciences gained FDA premarket approval for its new, cutting-edge colorectal cancer screening test. It is also well ahead in the insurance reimbursement battle.
Exact Sciences President and CEO Kevin Conroy previously promised that 2014 will be all about getting the company's Cologuard colon cancer test to market. Now, the company will be armed with close to $120 million to get the job done.
Two diagnostics companies hoping to improve the rate of early-stage colon cancer detection made it past an FDA panel of experts in late March with mixed results.
Scientists continue to push for the development of a more precise, sensitive and cleaner colorectal cancer diagnostic. Now a research team has determined that a simple, at-home test already on the market is highly accurate.
Exact Sciences goes before an FDA panel of experts on March 27 to argue for approval of its new stool-based colorectal cancer diagnostic. But it may not be an easy sell.
VolitionRx is focusing next on a massive European clinical trial of its new colorectal cancer blood test in the wake of promising preliminary results from a smaller study in Germany. Success in the coming months will help support the company's plans to pursue a CE mark in 2014 and FDA approval the year after.
Quest Diagnostics' ongoing revamp continued this week with news that an Australian company has snatched up its colorectal cancer screening test business. Neither side is commenting on the financial details.
Israel's Given Imaging notched a best-ever second quarter, nearly doubling its net profit and increasing revenue by 11% as it wins more and more approvals for the PillCam.
Given Imaging now has Japan's regulatory sign-off for its new endoscopic pill camera, creating a new avenue for revenue growth in the world's second largest healthcare market.
Colon cancer often isn't detected until it is advanced and often harder to treat. Baylor Research Institute scientists believe they've come up with a blood test that could catch it drastically earlier--even before it formally takes hold in the body.