The FDA's molecular and clinical genetics panel unanimously gave green signal to Exact Sciences' DNA-based, noninvasive colon cancer screening test. While announcing the news, Exact Sciences Corp. said the test called Cologuard has been approved by a vote of 10-0. The FDA panel members have confidence on the test as well as its benefits will outweigh its risks.
Though it's not compulsory that the FDA has to abide by the panel's suggestion, it generally follows its advice. The approval has open the way for the Exact Sciences Corp. to have an entry in the market.
"We look forward to continuing our work with the FDA to complete its review of Cologuard and remain committed to addressing the growing unmet needs in colorectal cancer screening", said Kevin Conroy, Exact's chairman and chief executive officer.
The test requires person to submit a stool test and on the basis of the sample, early-stage cancer is detected. Exact's Cologuard is said to be better than other noninvasive approaches, said a study that assessed Cologuard.
The test involved 13,000 participants at different testing sites. It was able to detect 92% of cancers and 42% of advanced precancerous lesions. As per the advisory committee documents, Exact's Cologuard has repeatedly shown its strong performance across cancer stages and lesion sizes.
Those patients who will get positive results after taking Cologuard would be asked to undergo a colonoscopy. The documents unveiled that Exact has come up with a plan to carry out another study involving 1,830 subjects at about 20 sites. Main aim of carrying out another study would be to assess Cologuard's performance over time.
Colon cancer is the second most common cause of cancer deaths in America. More than 140,000 new cases are reported every year.
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