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Nov 18, 2014

AdvanDx Receives FDA Clearance for MRSA Assay

The test MRSA and MSSA directly from blood culture samples in about one hour, compared to between 48 and 72 hours with other methods, the company said. 

Mar 07, 2021

FDA Issues EUA for Adaptive Biotechnologies COVID-19 T-Cell Response Test

The test leverages immune repertoire sequencing technology to identify individuals who have had a recent or prior SARS-CoV-2 infection.

Mar 05, 2021

Cue Health Over-the-Counter COVID-19 Test Gets FDA Emergency Use Authorization

The assay from San Diego-based Cue is the first molecular test authorized by the US Food and Drug Administration for home use without a doctor's prescription.

Mar 05, 2021

Woodcock on Vaccines, More

Janet Woodcock, the acting commissioner of the US Food and Drug Administration, speaks with NPR about SARS-CoV-2 testing and vaccines in the US.

Mar 05, 2021

Abbott Gets FDA EUA for Test That Detects Coronavirus, Three Other Respiratory Infections

The company also said that a previously granted EUA for its Alinity m SARS-CoV-2 assay has been expanded to include asymptomatic individuals and pooled testing.

Mar 02, 2021

Aiming for May

According to CNBC, Novavax's CEO says its vaccine could be authorized in the US as early as May.

Mar 01, 2021

And a Third

The New York Times reports that the US Food and Drug Administration has authorized Johnson & Johnson's SARS-CoV-2 vaccine.

Mar 01, 2021

FDA Reissues EUA for Fluidigm SARS-CoV-2 Test for Use With Azova Home Collection Kit

Azova's kit is for use with Fluidigm's Advanta Dx SARS-CoV-2 RT-PCR assay, an extraction-free, saliva-based COVID test that previously received EUA.

Mar 01, 2021

Eurofins Scientific Posts 17 Percent Increase in FY2020 Revenues

The company also said that it had received EUA from the US Food and Drug Administration for a non-prescription version of its COVID-19 sample collection kit.

Feb 25, 2021

Adaptive Biotechnologies Touts New Era of T Cell-Based Dx With T-Detect COVID Launch

Premium

Adaptive Cofounder and Chief Scientific Officer Harlan Robins compared the launch of the test to the unveiling of the Tesla Roadster electric sports car.

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The Scan

Analysis for the Long Term

Nature News reports the US National Institutes of Health is investing in studies of the long-term effects of COVID-19.

Pricey, But Available

The National Health Service is to offer Novartis's Zolgensma for spinal muscular atrophy later this year, according to the Guardian.

Pilot Cancer Testing Program for Taiwan

Taiwan is to launch a pilot program offering genetic testing to cancer patients, the Taipei Times reports.

PLOS Papers on TB Resistance, Squamous Cell Carcinoma Risk, MicroRNAs in SCC

In PLOS this week: loci linked to protection against tuberculosis, identification of loci associated with increased risk of squamous cell carcinoma of the aerodigestive tract, and more.

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In FDA

  1. FDA Issues EUA for Adaptive Biotechnologies COVID-19 T-Cell Response Test

  2. Cue Health Over-the-Counter COVID-19 Test Gets FDA Emergency Use Authorization

  3. Abbott Gets FDA EUA for Test That Detects Coronavirus, Three Other Respiratory Infections

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