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FDA Reissues EUA for Fluidigm SARS-CoV-2 Test for Use With Azova Home Collection Kit

NEW YORK – The US Food and Drug Administration on Friday reissued an Emergency Use Authorization for Fluidigm's Advanta Dx SARS-CoV-2 RT-PCR assay for use with the Azova COVID-19 Test Collection Kit. The companies have also signed an agreement to market the collection kit online, Fluidigm said on Monday.

The kit is authorized for at-home self-collection by prescription only for individuals suspected of COVID-19 by their healthcare providers. Individuals under the age of 18 may use the kit with adult supervision. Fluidigm's test originally received EUA last August. 

Under the reissued EUA, test users need to complete an online health questionnaire provided by Azova, an Alpine, Utah-based company specializing in digital health platforms, to enable a healthcare provider to issue a prescription. The individual can then order the collection kit online for home delivery.

The patient provides a saliva sample and sends the kit to a partner lab using prepaid same-day shipping, and results are shared within 12 to 72 hours of the time the lab receives the kit. Azova then sends the patient text message and email links to securely access the results, and creates "COVID Credentials" for each patient, an electronic passport that enables the patient to securely share COVID testing information with others.

"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," Cheryl Lee Eberting, founder and CEO of Azova, said in a statement. "By combining a powerful digital health platform with this assay, Azova and Fluidigm are opening up much greater access to COVID-19 testing solutions."

Fluidigm's Advanta Dx SARS-CoV-2 RT-PCR assay is an extraction-free, saliva-based test that runs on the company's BioMark HD microfluidics platform. The test received FDA EUA in August and CE marking in January.