Research & Development
BioGX Expands FDA EUA with pixl Portable qPCR System for its Direct-Sample COVID-19 Assay
14 November 2022 - - The US FDA has updated their original (June 29, 2021) Direct Sample Xfree 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 pixl real-time PCR platform, US-based molecular diagnostic solutions provider BioGX said.

The innovative BioGX Xfree 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 pixl platform, Bio Molecular Systems MIC instrument and a range of ubiquitous, high-throughput real-time PCR platforms.

The Xfree assay can accept a range of patient sample collections and is compatible with most commonly used transport/collection media types.

BioGX is a leading global provider of lyophilized real-time PCR reagents for molecular diagnostics. BioGX, Inc., headquartered in Birmingham, Alabama and Dallas, TX, and its wholly owned subsidiary BioGX B.V., based in Amsterdam, The Netherlands, operates in a cGMP compliant environment certified to ISO 13485 medical device development and manufacturing standards.

The proprietary Sample-Ready technology is at the core of all product offerings for Clinical, Food Safety, Pharma QC and Water Quality molecular testing.

BioGX's 60+ multiplex real-time PCR products are marketed and sold in several countries through its Global Distribution Network.


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