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This article has been updated from a previous version to correct the names of the CE platforms used to run Asuragen's assay.
 
NEW YORK – The US Food and Drug Administration late on Friday authorized marketing of Asuragen’s AmplideX Fragile X Dx and Carrier Screen Kit, the first genetic test for fragile X syndrome (FXS).
 
The assay is intended to aid in diagnosing FXS and is to be used alongside the evaluation of a patient’s family history and clinical signs and symptoms, FDA said.
 
The test is also intended for use in

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The US Food and Drug Administration is to announce stricter standards for emergency authorizations of SARS-CoV-2 vaccines, reports the Washington Post.

The Associated Press reports Johnson & Johnson is starting a late-stage clinical trial of its candidate SARS-CoV-2 vaccine.

Bloomberg reports the budget of Operation Warp Speed is actually $18 billion, higher than the number typically cited.

In Genome Research this week: genomic analysis reveals role of super-spreaders in SARS-CoV-2, epigenetic drivers of cancer, and more.

Oct
09
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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.