Qorvo Gets FDA Nod to Expand Use of COVID Test
A U.S. Food and Drug Administration decision to grant broader emergency use authorization to Qorvo Biotechnologies’ COVID diagnostic test is significantly expanding the product’s reach.
Initially limited to laboratories and other moderate- to high-complexity settings, the technology
now can be used more widely in physicians’ offices, urgent-care centers, pharmacies and other point-of-care (POC) locations.
The Greensboro-based company, a subsidiary of American semiconductor corporation Qorvo (Nasdaq: QRVO), develops POC diagnostic tests that use high-frequency bulk acoustic wave (BAW) detection. It’s the same technology found in Wi-Fi routers, 5G cellular towers and mobile phones.
Qorvo Biotechnologies’ Omnia SARS-CoV-2 antigen test is designed to detect COVID in nasal swab samples taken from patients within six days of the onset of symptoms, the company said. The test also is authorized for individuals displaying no symptoms who are tested twice over three days, with 24 to 48 hours between tests.
The company uses a small desktop-sized instrument with BAW sensors that can identify low levels of a targeted antigen. The technology can produce results from a single nasal swab in about 20 minutes.
“The Qorvo Omnia platform provides a unique combination of performance, automated workflow and scalability to serve on-site testing needs in a very efficient manner,” said Qorvo Biotechnologies president Erik Allen. He said the BAW sensor can detect antigens at levels comparable to PCR molecular screening. And it can provide an advantage in sensitivity compared to over-the-counter antigen self-tests.
“As the COVID testing market transitions to an endemic state and the increase in the omicron variant drives lower viral load,” Allen pointed out, “high-quality rapid testing infrastructure is needed in POC settings.”
Nancy Johnston, executive director of the North Carolina Biotechnology Center’s Piedmont Triad office, lauded the addition to the COVID landscape. “This is an exciting example of how our diverse region contributes to global solutions through the convergence of technologies and entrepreneurial expertise,” she said of the Qorvo advance.
Qorvo said the National Institutes of Health has provided much of the funding to support the research behind its COVID-related diagnostic test platform.