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Genetics & Genomics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

Aiming to improve patient access to critical drugs and tests, a group of legislators have started a caucus to shore up bipartisan support for personalized medicine.

The Logix Smart Coronavirus COVID-19 test can now be sold as an IVD in markets that accept CE-marking as valid regulatory approval, the company said.

The kits can detect more than 1,000 antimicrobial resistance gene variants, including mobilized colistin resistance (mcr) and extended-spectrum beta lactamases.  

The company said it expects to launch the Verigene II system with respiratory and gastrointestinal assays in the middle of this year.

The firm's AmplideX Fragile X Dx and Carrier Screen Kit is intended to help diagnose fragile X syndrome and assess parental risk of having a child with the syndrome.

A federal judge has ruled that drug companies, device manufacturers, and universities need to provide missing clinical data from hundreds of trials to a federal website, ScienceInsider reports.

A genetic analysis suggests red pandas might actually belong to two different species, New Scientist reports.

NPR reports that the US Centers for Disease Control and Prevention has fixed the problem with some of its SARS-CoV-2 testing kits.

In Nature this week: epigenetic factors that prevent healthy aging and more.