Close Menu

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

Home » Business, Policy & Funding » Business News » Biomeme, LumiraDx PCR Coronavirus Tests Get FDA Emergency Use Authorization

Biomeme, LumiraDx PCR Coronavirus Tests Get FDA Emergency Use Authorization

Aug 13, 2020
|
staff reporter

NEW YORK — The US Food and Drug Administration on Tuesday granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Biomeme and LumiraDx.

The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is designed to detect the virus' ORF1ab and S genes in nasopharyngeal, nasal, and oropharyngeal swab specimens, as well as nasopharyngeal wash/aspirate or nasal aspirate specimens.

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

Another Protocol Released

AstraZeneca has released its coronavirus vaccine trial protocol, according to the New York Times.

From Just Some Blood

Time magazine looks into how liquid biopsies are changing cancer care.

Numerous Countries Agree to Vaccine Plan

According to the Guardian, more than 150 countries have signed on to a global SARS-CoV-2 vaccine plan.

PNAS Papers on Hypertrophic Cardiomyopathy, Major Depression, Spanish SARS-CoV-2 Cat

In PNAS this week: similar muscle protein patterns across hypertrophic cardiomyopathy phenotypes, analysis of gene expression and brain anatomy in major depression, and more.

Sep
24
Featured Webinar

New Insights Underscore the Need to Identify NTRK Fusions in Childhood Tumors

Sponsored by
ArcherDX

NTRK fusions are oncogenic drivers in a variety of tumors.

Sep
30
Featured Webinar

Moving from Non-Invasive Prenatal Screening to Prenatal Diagnostics: An Expert Panel Discussion

Sponsored by
LGC SeraCare Life Sciences

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

Oct
08
Featured Webinar

Novel Applications of RNA-based Precision Oncology: From Drug Tolerability to Immunogenomics

Sponsored by
Genecentric

This webinar, Part 3 of the “Advances in RNA-based Biomarker Development for Precision Oncology” webinar series sponsored by GeneCentric Therapeutics, will discuss novel and emerging applications of RNA-based genomic analysis in precision oncology, form characterizing the tumor microenvironment to informing the development of immuno-oncology treatments.

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 Molecular Diagnostics

  1. UBS Downgrades Illumina to Neutral; Expresses Doubts About Grail Deal

  2. Grail Deal Will Enable Illumina to Expand From Tech Innovator to Diagnostics Provider

    Premium

  3. JP Morgan Downgrades Illumina to Neutral on Grail Deal

  4. Genome Sequencing Boosts Diagnostic Yield in Children With Unexplained Medical Complexity

  5. Illumina to Acquire Grail for $8B in Cash and Stock

Sponsorships

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