BIRMINGHAM, Ala., December 8, 2022 (Newswire.com) – 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.
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