NEW YORK (GenomeWeb News) – Exact Sciences said after the close of the market on Monday that it submitted the first module of its premarket approval submission to the US Food and Drug Administration for its Cologuard molecular diagnostic test.

The module is comprised of the required documentation detailing the manufacturing and quality control systems for Cologuard, a colorectal cancer screening test. The module was submitted on Dec. 7 and FDA has 45 days to accept the submission.

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In Science this week: caution urged in use of gene drives, and more.

NIH's Sally Rockey examines the tapped and untapped potential of the NIH peer reviewer pool.

PLOS Biology has asked researchers how they envision the future of genetics and genomics.

Representative Lamar Smith brings back a provision to require the National Science Foundation to certify that each study it funds is "in the national interest."

Sep
17
Sponsored by
Omicia

This online seminar will provide examples of how commercial and hospital-affiliated clinical labs are successfully developing and deploying high-throughput next-generation sequencing-based testing services for genetic diseases. 

Oct
15
Sponsored by
Parabase

This webinar will discuss the benefits of a rapid targeted next-generation sequencing (TNGS) panel, using dried blood spots, for second-tier newborn metabolic and hearing loss screening and its immediate utility for high-risk diagnostic testing in the neonatal intensive care unit.