Qorvo (Nasdaq: QRVO), a Greensboro-based provider of RF solutions, has been awarded a $4.1 million follow-on contract with the National Institutes of Health (NIH) through the Rapid Acceleration of Diagnostics initiative.
The contract, awarded to Qorvo Biotechnologies, a wholly owned subsidiary of Qorvo, will help advance the clinical trials and market launch of both a SARS-CoV-2/ Flu Combo Assay and SARS-CoV-2 Antigen Pooling on the Qorvo Omnia diagnostic test platform. The SARS-CoV-2 virus causes coronavirus disease 2019 (Covid-19).
The SARS-CoV-2/Flu Combo Assay will simultaneously detect and differentiate between SARS-CoV-2, Flu A and Flu B in an all-in-one test using a single swab sample in approximately 20 minutes. The antigen pooling application will allow up to six samples to be processed together and tested at the same time.
Antigen pooling enables significant time and cost savings for screening groups of people who aren't experiencing SARS-CoV-2 symptoms. Qorvo continues to develop advanced testing formats for SARS-CoV-2 detection while focusing on test performance, workflow efficiencies and cost control for end users.
Combined with a previous NIH contract award of $24.4 million, this award positions Qorvo to accelerate the production and market launch of multiple Covid testing solutions using a single platform.
"Today's Covid testing market is demanding high quality testing infrastructure at the point of care with automated workflow, menu expansion and scalability to serve future needs of the pandemic,” said Philip Chesley, president of Qorvo Biotechnologies. “This contract award and continued RADx support enable Qorvo to more effectively address the expanding requirements of diverse end use settings."
The Qorvo Omnia platform represents an innovative diagnostic technique by using high frequency Bulk Acoustic Wave (BAW) sensors to achieve rapid SARS-CoV-2 (Covid-19) antigen test results. BAW sensor technology enables low limit of detection levels similar to molecular testing capability.
The project has been funded in whole or in part with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health and Department of Health and Human Services.
The Qorvo Omnia SARS-CoV-2 Antigen Test was granted emergency use authorization from the U.S. Food and Drug Administration 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 health care provider within the first six days of symptom onset.
The Qorvo Omnia SARS-CoV-2 Antigen Test is neither 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 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. These tests are only 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, unless the authorization is terminated or revoked sooner.
