Microbix COVID-19 QAPs Now Available for U.S. Labs

Registration Enables Immediate Usage of SARS-CoV-2 Controls by U.S. Clinical Labs

MISSISSAUGA, Ontario, May 07, 2020 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, Microbix), an award-winning life sciences innovator and exporter, is pleased to announce U.S. availability of its SARS-CoV-2 quality assessment products (QAPs) –  FDA registration enabling immediate usage by U.S. clinical laboratories to evaluate performance, procedures, and workflow of tests that detect SARS-CoV-2 virus, the causative agent of COVID-19 disease.

Microbix has registered with the U.S. Food and Drug Administration (FDA) in compliance with Code of Federal Regulations 21, Part 807, augmenting its existing Establishment Registration #3007652384.  This permits sale of its SARS-CoV-2 Positive and Negative Controls throughout the U.S. and its territories.

It has been widely reported that the recently-deployed tests for the virus causing COVID-19 disease are providing results of questionable accuracy – sometimes giving “false negative,” or “false positive” results.  Microbix’s SARS-CoV-2 QAPs are designed to increase the reliability of nucleic-acid test (NAT) results. These Microbix QAPs can be used to support verification of new testing methods, validation of newly-placed test instruments, training of technicians, lab proficiency accreditations, and by clinical labs for systematic quality control. 

Cameron Groome, President and CEO, stated, “We’re pleased to have completed the process of registering our SARS-CoV-2 Controls to permit their sale as controls to clinical labs in the United States. Microbix will now engage with American laboratory chains, group purchasing organizations, and procurement agencies to make certain that the U.S. healthcare system can benefit from Microbix’s products that help to ensure test accuracy.”

The Microbix COVID-19 QAPs have been shown to work with multiple NAT methods used to detect the SARS-CoV-2 virus that causes COVID-19 disease, specifically tests targeting a variety of nucleic-acid targets across the genome of the virus. These Microbix products are being made available as REDxFLOQ SARS-CoV-2 for swabs, and as REDx SARS-CoV-2 for liquid aliquots.

As for all Microbix QAPs, these COVID-19 QAPs are whole-genome workflow support tools that include 100% of the genetic sequences of the virus and emulate real patient samples while being consistent, non-infectious, and stable. As such, the COVID-19 QAPs contain all known potential NAT viral targets – ensuring compatibility across current and future NATs. This broad compatibility and guaranteed utility is particularly relevant in the context of testing during a pandemic, when multiple test protocols and instrument systems are being newly-called into use.