BioGX Expands FDA EUA with pixl™ Portable qPCR System for its Direct-Sample COVID-19 Assay
Birmingham, Alabama, Nov 10, 2022 – BioGX, a global provider of easy molecular diagnostic solutions since 2007, announced that the US FDA has updated their original (June 29, 2021) Direct Sample XfreeTM COVID-19 Emergency Use Authorization to increase the shelf-life of the assay reagent to 15 months and expand its use to additional real-time PCR platforms, including BioGX’s pixlTM real-time PCR platform.
The innovative BioGX XfreeTM Direct RT-PCR product is offered as a complete lyophilized test in a single vial. Upon rehydration with water, the test enables extraction-free, direct patient sample addition to a PCR tube which can be run on the BioGX pixlTM platform, Bio Molecular Systems MIC instrument and a variety of ubiquitous, high-throughput real-time PCR platforms. The Xfree assay can accept a wide variety of patient sample collections and is compatible with most commonly used transport/collection media types.
“With the pixl platform, customers can now generate fast sample-to-answer results on a portable, compact device. We expect the expanded EUA to provide broader access to clinical laboratories for decentralized PCR-based testing, enabling faster, better, low cost near-patient molecular diagnosis,” said Shazi Iqbal, Ph.D., CEO of BioGX.
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