Close Menu

NEW YORK — The US Food and Drug Administration on Friday granted Emergency Use Authorization for a PCR-based SARS-CoV-2 test developed by Inform Diagnostics.

The company's SARS-CoV-2 RT-PCR Assay, which is based on the US Centers for Disease Control and Prevention's CDC 2019-nCoV Real-Time RT-PCR panel, is designed to detect two regions of the virus' nucleocapsid gene in nasopharyngeal, oropharyngeal, anterior nasal, and midturbinate nasal swabs, as well as nasopharyngeal wash/aspirate or nasal aspirates and bronchoalveolar lavage specimens.

To read the full story....

...and receive Daily News bulletins.

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

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

Sep
30
Sponsored by
LGC SeraCare Life Sciences

Non-invasive prenatal testing (NIPT) continues to expand globally to support maternal-fetal patient care. 

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.