BioGX Launches CE-IVD Marked Multi-gene COVID-19 Point-of-Care Test at AACC
CHICAGO–(BUSINESS WIRE)–BioGX, a global provider of easy molecular diagnostic solutions, announced the launch of a point-of-care (POC) CE-Marked, three gene multiplex COVID-19 test on its pixl platform.
The test utilizes BioGX’s highly successful Xfree direct sample testing chemistry that is included in its US FDA emergency use authorized Xfree COVID-19 Direct RT-PCR test. This new multi-gene COVID-19 test targets the N1, RdRp and M gene regions for greater redundancy in detecting SARS-CoV-2 emerging variants.
This innovative POC test is simple to use and only requires the addition of one drop of sample added directly to the freeze-dried Xfree chemistry.
The BioGX pixl16 is a small, portable, 4-channel, 16-well real-time PCR platform that supports turnaround times of less than an hour for up to 16 samples. Results interpretation and reporting are integrated within the easy-to-use touchpad-based pixl instrument.
“Pixl combined with our unique Xfree chemistry offers our customers the ease-of-use and affordability of antigen-based testing with the superior sensitivity and specificity of real-time PCR testing”, said Shazi Iqbal, CEO of BioGX.
Building upon the success of its Xfree direct sample addition technology, BioGX is developing a pipeline of Xfree-pixl tests that will enable simple and affordable POC PCR testing. As with all BioGX tests, the Xfree COVID-19 3-gene Direct Sample RT-PCR kits ship globally at ambient temperature.
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.
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