logo
Share SHARE
FONT-SIZE Plus   Neg

EXACT Sciences Says It Submitted Final Module Of PMA For Cologuard To The FDA

EXACT Sciences Corp. (EXAS), a molecular diagnostics company focused on the early detection and prevention of colorectal cancer, Monday said that it submitted the final module of the premarket approval or PMA for Cologuard, the company's stool DNA or sDNA colorectal cancer screening test, to the U.S. Food and Drug Administration or FDA. The final module which was submitted on June 7, comprised of data from the company's DeeP-C clinical trial. The trial analyzed data from about 10,000 patients at 90 sites between the ages of 50 and 84 who were at average risk for colorectal cancer.

EXACT Sciences also announced that the role of COO Maneesh Arora would now also include the oversight of U.S. sales and marketing. The company is also in the search for a senior financial officer.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Denver, Colorado based low-cost carrier Frontier Airlines will expand its services to 21 cities. The airline which serves 80 cities in the U.S., Mexico and the Dominican Republic is planning to add 85 new routes. Abbott Laboratories (ABT) reported a profit for the second-quarter 2017 declined about 54.1 percent from last year, hurt by higher costs. Both adjusted earnings per share and quarterly revenues topped analysts' expectations. Abbott raised its full-year 2017 earnings per share guidance range. Consumer goods giant Unilever plc reported Thursday higher profit in its first half, with increased sales and margin. Looking ahead, the company said it is on track for another year of underlying sales growth ahead of markets.
comments powered by Disqus
Follow RTT