Exact Sciences Gets FDA Nod For Label Expansion Of Cologuard
Zacks Investment Research | Sep 23, 2019 09:10PM ET
Exact Sciences Corp. (NASDAQ:EXAS) announced that the FDA has approved a label expansion of its noninvasive colorectal cancer screening test, Cologuard.
The test can now be used in eligible average-risk individuals aged 45 years or older, expanding on its previous indication for 50 years or older.
As a result of the broader label, approximately 19-million average-risk people in the United States from the age group of 45-49 years can now access a new, sensitive, at-home, stool-based screening test.
Cologuard is a stool DNA-based colorectal cancer screening test for average-risk individuals. The test uses a biomarker panel, which analyzes a person's stool sample for 10 DNA markers, as well as blood in the stool.
We note that the FDA approved Cologuard for the first time in August 2014. Colorectal cancer is the second deadliest cancer in the United States and an early screening will go a long way in better management of the disease.
Given the widespread prevalence of colorectal cancer among Americans under 50 years, the expanded label bodes well for molecular diagnostics company, Exact Sciences. Notably, in May 2018, the American Cancer Society (ACS) updated its colorectal cancer screening guidelines to include people between 45 years and 49 years, while the prior ACS recommendation called for screening to begin at age 50.
The news of the approval boosted the company’s stock price, which eventually retraced by the end of the day.
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