Benzinga | Jul 28, 2021 04:03PM EDT

Qorvo Biotechnologies Omnia SARS-CoV-2 Antigen Test Platform Validated in National Institutes of Health Funded Study

Qorvo(r) (NASDAQ:QRVO), a leading provider of innovative radio frequency (RF) solutions that connect the world, announced that the Qorvo Omnia(tm) SARS-CoV-2 Antigen Test platform completed a key milestone for the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative. Atlanta's Center for Microsystems Engineered Point-of-Care Technologies (ACME-POCT) completed two independent studies, an adult study and a pediatric study, verifying the low SARS-CoV-2 limit of detection (LOD) and high specificity/sensitivity of the Qorvo Omnia Antigen Test.



The adult and pediatric studies compared performance of the platform to the Roche cobas 6800 (1800 NDU/ml using FDA reference panel) and Hologic Panther (600 NDU/ml) RT-PCR systems, respectively. The studies demonstrated 100% sensitivity/specificity for the adult population, and 83% sensitivity and 100% specificity for the pediatric group. Three pediatric samples that tested negative on the Qorvo Omnia Antigen Test had Cycle threshold (Ct) values greater than 38 on the Hologic system, indicating very low viral loads in those samples. Sensitivity and specificity for the study were 100% below those levels. Overall, the investigators found the Qorvo Omnia platform design intuitive and easy to use while producing rapid test results compared to high-sensitivity molecular testing systems, with test results within 20 minutes from sample collection.

James Klein, president of Qorvo Biotechnologies, said, "Independent external studies are a critical step in educating the market about the capabilities of the Omnia Antigen Test and an important milestone in the evolution of the Qorvo Omnia diagnostic platform. We are pleased with the results and investigator feedback from these studies."