Qorvo, Greensboro, NC, announced that the FDA has granted emergency use authorization (EUA) for the Qorvo Omnia SARS-CoV-2 Antigen Test. The test is authorized for the qualitative detection of nucleocapsid viral antigens from SARS-CoV-2 in nasal swab specimens from individuals who are suspected of covid-19.
The Qorvo Omnia platform represents a paradigm shift in diagnostic testing capability by using high frequency Bulk Acoustic Wave (BAW) sensors to achieve SARS-CoV-2 (covid-19) antigen testing in approximately 20 minutes. BAW sensor technology enables low limit of detection (LOD) levels that the company says are similar to molecular testing capability.
The Qorvo Omnia platform features a portable test instrument, microfluidic cartridge, and secure connectivity. The microfluidic cartridge design enables specific binding with additional wash steps similar to central lab instrument operation and demonstrated results including 100% specificity during clinical trials.
Fred S. Apple, PhD, a member of Qorvo Biotechnologies’ advisory board, co-medical director of the toxicology laboratory at Hennepin Healthcare/Hennepin County Medical Center, and professor of Laboratory Medicine & Pathology at the University of Minnesota, says, “This is very exciting news. FDA authorization of Qorvo’s Omnia Antigen Test provides a rapid, sensitive, and specific assessment of individuals, assisting providers trying to either rule in or rule out covid-19, comparable to many of the PCR testing platforms in use. The testing system will hopefully be an avenue to assist in opening up the United States to be closer to business as usual.”
“The FDA’s EUA is recognition that the Qorvo Omnia platform can help address the ongoing need for rapid, accurate, and clinically reliable diagnostic testing,” says James Klein, president of Qorvo Biotechnologies. “We are honored to leverage Qorvo’s technology portfolio to help public health officials respond to this global pandemic.”
Qorvo Biotechnologies is a wholly owned subsidiary of Qorvo focused on the development of point-of-care (POC) diagnostics solutions leveraging Qorvo’s BAW sensor technology. For more information, visit Qorvo Biotechnologies.