Independent study is an important step in verifying the quality of the Qorvo Omnia Antigen Test for use

Qorvo^® (Nasdaq: QRVO), a leading provider of innovative radio frequency (RF) solutions that connect the world, announced that the Qorvo Omnia™ SARS-CoV-2 Antigen Test platform completed a key milestone for the NIH Rapid Acceleration of Diagnostics (RADx^SM) 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.”

For more information, visit www.qorvobiotech.com.

This project has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADx^SM) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health. The current contract (75N92021C00008) is funded from the Public Health and Social Services Emergency Fund through the Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services.

The Qorvo Omnia Antigen Test was granted emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) in April 2021.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 having COVID-19 by their healthcare provider within the first 6 days of symptom onset. The Qorvo Omnia platform represents a paradigm shift in diagnostic testing capability by using high frequency Bulk Acoustic Wave (BAW) sensors to achieve rapid SARS-CoV-2 (COVID-19) antigen testing. BAW sensor technology enables low LOD levels that are similar to molecular testing capability.

The Qorvo Omnia SARS-CoV-2 Antigen Test has not been FDA cleared or approved. It has been authorized by the FDA under an Emergency Use Authorization and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests. This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. Tests receiving authorization under EUA are authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.