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.

To read the full story....

Register for Free.

...and receive Daily News bulletins.

Already have an account?
Login Now.

Congress approved a bill Friday that would increase the US National Institutes of Health's funding by $2 billion for fiscal year 2019.

UK's Labour Party calls for a ban on non-invasive prenatal testing for determining sex, BBC News reports.

Sarah Lawrence College's Laura Hercher warns in a New York Times op-ed that more people are going to need help figuring out what their consumer genetic testing results mean.

In PLOS this week: intra-tumor heterogeneity patterns, genomic analysis of Thoroughbred horse origins, and more.

Oct
02
Sponsored by
Roche

In the last few years several molecular testing methodologies — such as immunohistochemistry, PCR, and sequencing — have been approved by the US Food and Drug Administration to aid in the management of patients with lung cancer.  

Oct
11
Sponsored by
ArcherDX

This webinar will discuss a validation study for a next-generation sequencing (NGS) assay for hematological malignancies (e.g., acute myeloid leukemia, acute lymphocytic leukemia, myelodysplastic syndrome, and myeloproliferative neoplasms).