Diagnostics MedTech

FDA authorizes hand-held COVID-19 diagnostic test

In response to the coronavirus crisis, we’ve seen COVID-19 diagnostics quickly evolve from early, multistep kits to high-throughput versions to fast point-of-care tests, all in just a few weeks. Now, the FDA has granted an emergency authorization to a device that fits in the palm of your hand.

Mesa Biotech’s Accula device is designed to enable near-patient testing, available anywhere outside of the laboratory, with results in about 30 minutes.

Based on the company’s previous tests for influenza and respiratory syncytial virus, the compact diagnostic is aimed at temporary coronavirus screening sites, urgent care locations and long-term nursing facilities as well as small physician-run labs.

“This allows many units to be run side-by-side in the doctor’s office, further increasing the speed of COVID-19 diagnosis,” said Hong Cai, co-founder and CEO of Mesa Biotech, which plans to begin shipping the test in the U.S. immediately. “Accula provides a true decentralized testing solution for COVID-19 at the point of care.”

“Our test will provide a highly accessible means for healthcare professionals to access laboratory quality results close in their office to aid in the decision to isolate, treat or dismiss potential carriers of the virus,” Cai said in a statement, describing the system as a complement to centralized high-throughput testing. “The potential to reduce the growing strain on our nation’s hospitals is tremendous.”

The platform—employing a visually read PCR test using nasal and throat swabs—was developed with global epidemics in mind, with funding from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases and the Western Regional Center of Excellence for Biodefense and Emerging Infectious Disease program, as well as through the Los Alamos National Lab.

RELATED: FDA greenlights first 45-minute, point-of-care coronavirus diagnostic test

The FDA also gave an Emergency Use Authorization to a new COVID-19 diagnostic from BioFire, a subsidiary of bioMerieux. Developed in collaboration with the U.S. Department of Defense, the fully automated assay is designed to deliver results in about an hour. The company is also working on a larger respiratory panel that will detect additional pathogens in order to rule out and rule in diseases with similar symptoms to COVID-19. In addition, bioMerieux received the FDA’s go-ahead for its own coronavirus diagnostic earlier this month.

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