BAW enables surface-based mass measurement. Qorvo’s BAW technology uses high frequency and surface binding that, based on results of early stage feasibility studies, suggests the potential for sensitivity and variance control similar to central labs. These two factors have limited the ubiquitous deployment of point-of-care solutions based on historical optical or fluorescence detection systems. The innovation is uniquely positioned to allow for the dual testing capability of Molecular and Immunoassays on the same cartridge and instrument interface. Beyond this, BAW allows for multiplexing (multiple analytes tested off a single sample), and the cartridge has been designed to allow measurements of multiple matrix types including whole blood, serum, plasma, saliva and more. The goal is to enable clinicians’ access to point-of-care test data in approximately 20 minutes.
*Please visit the Qorvo Omnia™ platform page for more information. The statements reflect the data submitted to the FDA under the EUA process. The Qorvo Biotechnologies IgG Antibody Test has not been reviewed by the FDA and is not available for sale. An application for Emergency Use Authorization (EUA) of this test has been submitted to the FDA and is pending. The application is for use of the test in CLIA laboratories certified to perform moderate- and high-complexity testing.
**This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.