Close Menu

NEW YORK (GenomeWeb) – The US Food and Drug Administration today finalized two guidances on the design, development, and validation of next-generation sequencing tests.

The agency also released a third draft guidance describing a voluntary, streamlined submission process to determine whether an investigational in vitro diagnostic being codeveloped alongside a cancer drug in a trial confers significant risk and may require an investigational device exemption submission, or confers non-significant risk and is exempt.

To read the full story....

...and receive Daily News bulletins.

Already have a GenomeWeb or 360Dx account?
Login Now.

Don't have a GenomeWeb or 360Dx account?
Register for Free.

A study of families explores how children transmit SARS-CoV-2, according to the Associated Press.

US Agricultural Research Service scientists have sequenced the genome of the Asian giant hornet.

According to the Economist, pooled testing for COVID-19 could help alleviate strains on testing labs.

In Science this week: MIT researchers outline approach dubbed translatable components regression to predict treatment response among IBD patients.

Oct
09
Sponsored by
PerkinElmer

As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.