NEW YORK (GenomeWeb News) – Exact Sciences today said that it has filed the second module of a premarket approval application for its Cologuard colorectal cancer screening test with the US Food and Drug Administration.

The module, which was submitted to the agency on Friday, was comprised of the required studies and documentation establishing the analytical sensitivity and specificity, cross-reactivity, and other similar studies on the test. The firm said that the third and final module will include clinical data from its DeeP-C trial.

Get the full story

This story is free
for registered users

Registering provides access to this and other free content.

Register now.

Already have an account?
Login Now.

In PNAS this week: The sea anemone is sequenced, a team describes a CRISPR/Cas9-based approach to label specific sites in the genome, and more. 

In a short video, CNN introduces viewers to a fecal transplant poop donor and explains how the treatments are made.

Researchers are testing the use of transgenically altered diamondback moths as an alternative to pesticides in controlling the bugs.

Two recent papers published in Science and Nature Medicine describe work that may result in a universal vaccine for the flu.

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. 

Oct
29
Sponsored by
Lucigen

This webinar will focus on a range of research and clinical applications enabled by improvements in mate pair technology for whole genome sequencing.