BioGX Expands FDA EUA with pixl™ Portable qPCR System for its Direct-Sample COVID-19 Assay

BIRMINGHAM, Ala.--(BUSINESS WIRE)--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 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.

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 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.

Additional information can be requested by contacting BioGX at Ph: +1.205.250.8055 or [e-mail].

About BioGX

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, (collectively “BioGX”), 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.

For more information on BioGX, please visit BioGX.com.

Sample-Ready, Just Add Water and Xfree are trademarks of BioGX, Inc.