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

Quick Facts

Editors Pick
Computer and printer maker Hewlett-Packard Co. said Thursday after the markets closed that its second quarter profit fell 21% from last year, hurt by lower revenue and costs related to the planned separation of the company. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations, but its quarterly revenue fell short of analysts' forecast. Accounting software maker Intuit reported a plunge in third-quarter profit, hurt by impairment charges, even as results topped Wall Street estimates, driven by growth in small business segment amid a strong tax season. Struggling teen-apparel retailer Aeropostale Inc. (ARO), Thursday said its first-quarter loss narrowed from a year ago, driven largely by stronger margins even as revenues continued to plunge dropped. Nevertheless, the company lost almost one-fifth of its market value in after-hours trade, with the...
comments powered by Disqus
RELATED NEWS
Trade EXAS now with 
Follow RTT