Benzinga | Mar 1, 2021 08:32AM EST

FDA GrantsEmergency Use Authorization For AZOVA COVID-19 Test Collection Kit Home Collection Kit For Usw With Fluidigm Advanta Dx SARS-CoV-2 RT-PCR Assay

Collaboration Agreement to Market AZOVA COVID-19 Test Collection Kit Online

AZOVA Digital Health Platform Provides Patient Questionnaire, Process for Prescription, Kit Purchase, Sample Collection, and Secure Delivery of Test Results

SOUTH SAN FRANCISCO, Calif., March 01, 2021 (GLOBE NEWSWIRE) -- Fluidigm Corporation (NASDAQ:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the AZOVA(tm) COVID-19 Test Collection Kit for use with the Fluidigm(r) Advanta(tm) Dx SARS-CoV-2 RT-PCR Assay on the company's Biomark(tm) HD platform.

The kit is authorized for at-home self-collection by prescription only for individuals suspected of COVID-19 by their health care providers. Those under the age of 18 may use the kit with adult supervision.

Consumers seeking a COVID-19 test can complete an online health questionnaire provided by Fluidigm's collaboration partner, AZOVA, to enable a health care provider to assess whether a prescription is issued. If so, the consumer can then order the collection kit online for home delivery.

"We are excited about this collaboration with Fluidigm," said Cheryl Lee Eberting, MD, Founder and CEO of AZOVA. "Our goals are to enable any CLIA-certified laboratory that meets the requirements to perform high-complexity tests to process our home collection kits, and to make this kit accessible to as many consumers as possible. By combining a powerful digital health platform with this assay, AZOVA and Fluidigm are opening up much greater access to COVID-19 testing solutions.

"The patient provides a saliva sample as directed in the kit instructions and sends the kit to one of our partner labs using prepaid same-day shipping, and results are shared within 12--72 hours of the time the lab receives the kit. The patient receives text message and email links to securely access results. In addition, AZOVA creates COVID Credentials(tm) for each patient, an electronic passport that enables one to securely share COVID testing information with others."

The Advanta Dx SARS-CoV-2 RT-PCR Assay is an extraction-free saliva-based test to detect nucleic acid from the SARS-CoV-2 virus in individuals suspected by their health care providers of having COVID-19. The assay does not require collection via invasive nasopharyngeal swab, and the company's submission to the FDA demonstrated 100 percent agreement between saliva results from the Advanta Dx Assay and results from paired nasopharyngeal samples tested with authorized assays.

"Our noninvasive, saliva-based test helped deliver a much-needed testing solution for patients and first responders around the world, and we are pleased for the opportunity to introduce the Advanta Dx SARS-CoV-2 RT-PCR Assay into the home-collection market," said Chris Linthwaite, Fluidigm President and CEO. "Entering the home collection market is an important milestone for Fluidigm, and collaborations with forward-thinking companies such as AZOVA to advance into new channels represent a key strategy in fully realizing Fluidigm's role in next-generation diagnostics.

"In addition to technological innovation, collaborations in such areas as telemedicine and new digital health platforms will build upon the beachhead that we have established to penetrate new markets. The digital health revolution is here to stay, and we intend to play a leadership role in this transformation."

Fluidigm continually conducts in silico analyses to determine the effectiveness of the Advanta Dx Assay design to detect SARS-CoV-2. To date, none of the published viral mutations meaningfully impact the regions of the viral genome targeted by the assay's primers and probes.