Close Menu

You may find more results for this query on our sister sites: 360Dx and Precision Oncology News.

Home » Business, Policy & Funding » Regulatory News & FDA Approvals » Coronavirus Test From DiaSorin Molecular Gets FDA Emergency Use Authorization

Coronavirus Test From DiaSorin Molecular Gets FDA Emergency Use Authorization

Mar 20, 2020
|
staff reporter

NEW YORK – An assay from DiaSorin Molecular to detect SARS-CoV-2, the virus that causes COVID-19, has been granted Emergency Use Authorization by the US Food and Drug Administration, the company said on Friday.

The test, called the Simplexa COVID-19 Direct assay, runs on DiaSorin's sample-to-answer Liason MDX real-time PCR instrument. It is intended to qualitatively detect nucleic acid from SARS-CoV-2 in nasopharyngeal swabs from individuals suspected of COVID-19 by their healthcare provider.

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.

The Scan

Open at Publication

Howard Hughes Medical Institute will be requiring its researchers to publish their work so it is immediately accessible to the public, ScienceInsider writes.

Truth and Science

The Huffington Post reports that Francis Collins, the director of the US National Institutes of Health, has urged Americans to recommit to reason.

Quick Tests to Be Given Out

About 150 million rapid coronavirus tests purchased by the US federal government are to be distributed to nursing homes, colleges, and the states, according to the New York Times.

Nature Papers Examine Molecular Pathways in Alzheimer's Disease, Diploid Potato Assembly, More

In Nature this week: multi-omic analysis of Alzheimer's disease brain samples, de novo assembly of a diploid potato, and more.

Oct
09
Featured Webinar

Navigating the FDA's EUA Process for Diagnostics in the Present and Future: A Stakeholder Panel Discussion

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.

What's Popular?

In Regulatory News & FDA Approvals

  1. PerkinElmer Newborn Screening Assay Receives CE-IVD Mark

  2. BioGX BV Gets CE-IVD Mark for Coronavirus, Flu, RSV Combo Test

  3. Cepheid Multiplex SARS-CoV-2, Flu, RSV Test Nabs FDA Emergency Use Authorization

  4. Centogene, Aeon Global, Akron Children's, National Jewish Health Coronavirus Tests Get FDA EUAs

Sponsorships

Privacy Policy.  Terms & Conditions.  .  Copyright © 2020 GenomeWeb, a business unit of Crain Communications.  All Rights Reserved.