Portable qPCR Platform Enables Faster, Better, Low-Cost Near-Patient Molecular Diagnosis

The point-of-care molecular diagnostics space seems to have gotten more crowded during COVID. Now, a portable molecular diagnostics platform with 16-well capabilities differentiates itself from most competitors who use single cartridge or single test formats.

BioGX’s (Birmingham, AL, USA) Pixl 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. The high-performance open system real-time PCR platform is equipped with 4-optical channel direct imaging fluorescence, ultra-low-light CMOS bio-imager sensor and fast Peltier-powered thermal cycler to enable reliable and accurate molecular diagnostic testing. The compact device is the ultimate solution for applications where portability, minimal space and fast turnaround times are required.

Between 1 and 16 individual patient samples can be batch tested in less than 1 hour, ensuring a fast turnaround time in any environment. With intuitive results analysis software and built-in touchscreen functionality, the portable qPCR real-time PCR platform adapts to any testing environment and boasts turnaround times of less than an hour. Pixl is a lightweight yet rugged device, with no internal moving parts that serves as a great advantage for any testing facility which requires effective molecular testing on the move. A 4-optical channel, multiplex capability, with commonly adopted excitation and emission range and filters allow for unparalleled performance with commonly used fluorophores. The system is also potentially compatible with the BioGX suite of lyophilized molecular diagnostics assays.

With the Pixl, customers can run tests on 16 patient samples, or up to 16 different tests on a single sample, with as many as four targets per test, if needed. The Pixl can report out Ct values, or it can be set up to call positive or negative test results. BioGX’s software enables sample accessioning and can create reports that can be customized to adapt to a customer’s laboratory information system. BioGX plans to target hospital and reference labs as well as physician offices with the system. The firm’s suite of lyophilized tests may also engender a particular advantage in the POC space, as a large menu could differentiate Pixl from the competition. While the current 16-well Pixl can detect four targets per sample, a future version of the 16-well platform will be able to detect five to six targets.

BioGX has 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 platform was previously CE-IVD marked and can be used with other BioGX CE-IVD marked assays including Xfree COVID-19 (N1-gene) Direct RT-PCR, Xfree COVID-19 (N1/RdRp), Flu A, Flu B, and Xfree Group A Streptococcus. BioGX will soon 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.

"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.

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