In April 2021, Qorvo were granted emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Qorvo Omnia™ SARS-CoV-2 Antigen Test. The EUA approval is a major milestone in the collaboration between Qorvo and SCHOTT MINIFAB over the past two years.
The Qorvo Omnia™ SARS-CoV-2 Antigen Test has been 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.
Qorvo Biotechnologies are predicting that their latest instrument will be the future of COVID-19 antibody/antigen testing. The Qorvo Omnia™ with core RF technology is a versatile point-of-contact (POC) diagnostic instrument with a turnaround time of approximately 20 minutes. The Qorvo Omnia™ platform features a portable test instrument, microfluidic cartridge, and secure connectivity. The device analyses industry standard samples (serum plasma/ whole blood for the antibody test, and a standard nasal swap in lysis buffer for the antigen test) and can be used in remote settings.
The acoustic-based detection system at the core of the Qorvo Omnia™ uses a Bulk Acoustic Wave sensor – designed to deliver very high-sensitivity – to detect the changes in mass that accompany sample binding to the biosensor. This low cost, high yield, high quality technology is already common in many everyday devices, and millions of units are produced every day.
The BAW sensor technology enables low Limit of Detection (LOD) levels that are comparable to those of molecular testing capabilities (pg/mL). In clinical trials, the Qorvo Omnia™ also demonstrated 100% specificity. The samples are introduced into the platform through a microfluidics system which is integrated into a disposable cartridge. The microfluidic cartridge design enables specific binding with additional wash steps.
Qorvo needed to go to market with known partners they could trust to supply them with high quality microfluidic devices. In addition, they needed to transition to an ISO 13485 certified device that could be produced in high volume. SCHOTT MINIFAB provided the expertise to translate the prototype to volume production in a fully-automated ISO 13485, ISO 9001, GMP setting. SCHOTT MINIFAB’s broad scope of manufacturing capabilities allowed Qorvo to focus on their market, the assay, and their base technology rather than manufacturing.
“Qorvo brought the sensor technology and a legacy design which was well advanced.” Said Edward Wilkinson, Vice President & Head of Strategy, SCHOTT MINIFAB.
“In SCHOTT MINIFAB, Qorvo found a partner who could take their technologies and existing product design all way through to high volume ISO 13485 manufacturing in the millions of units per annum.” He said.
Qorvo selected SCHOTT MINIFAB as a manufacturing partner due to its high-end capabilities specifically designed for the manufacturing of microfluidic devices. These high-end capabilities include precision injection moulding, plastic bonding, and reagent integration. In addition, SCHOTT MINIFAB’s expertise allowed for the reduction in equipment requirements and process design by leveraging existing proprietary solutions. These purpose-built proprietary solutions were then combined together to create a completely bespoke automated production line for Qorvo.
“The partnership has been excellent from a Qorvo viewpoint.” said Bryan Bothwell - Director, Strategy and Business Development, Qorvo Biotechnologies.
“Qorvo were attracted to work with SCHOTT MINIFAB because they are a known entity in medical device manufacturing with the capability for scalable manufacturing.” He said.
SCHOTT MINIFAB looks forward to continuing its successful partnership with Qorvo as the Omnia™ Bulk Acoustic Wave diagnostic platform gains further market adoption.