BioGX, a global provider of easy molecular diagnostic solutions since 2007, announced the Ex-US commercial release of its portable pixl™ qPCR real-time PCR platform for use with BioGX CE-IVD marked assays, enabling global access and complementing the recent US FDA EUA expanded use of Xfree™ COVID-19 Direct RT-PCR on the pixl. The pixl instrument is a benchtop 4-channel, 16-well, RT-PCR instrument that supports rapid turnaround times for batches of up to 16 samples, with integrated results interpretation on a device with the compact footprint of a touchpad. “pixl, combined with our unique Xfree chemistry, offers a low-cost direct-sample-to-answer PCR solution on a portable, compact device. pixl will provide broader access to clinical laboratories for decentralized PCR testing, enabling faster, better, low-cost near-patient molecular diagnostics,” said Shazi Iqbal, Ph.D., CEO of BioGX. This platform was previously CE-IVD marked and can be used with the following BioGX CE-IVD marked assays:
Xfree COVID-19 (N1-gene) Direct RT-PCR Xfree COVID-19 (N1/RdRp), Flu A, Flu B Xfree Group A Streptococcus
Starting January 2023, BioGX will make additional syndromic tests available on the pixl platform from its large menu of lyophilized multiplex assays, including the Research Use Only (RUO) Direct-Sample assays: Xfree Human Monkeypox (hMPXV), Xfree HSV1/HSV2/VZV and Xfree Treponema pallidum (Syphilis). The Xfree assay format is compatible with most commonly used transport/collection media types and can be validated with a wide variety of patient sample collections. Additional information can be requested by contacting BioGX at Ph: +18.104.22.16855 or [email protected] 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, Xfree and pixl are trademarks of BioGX, Inc. Source: BioGX Inc.