Industry News: FDA grants emergency use authorization for home collection kit for Advanta Dx SARS-CoV-2 RT-PCR assay

Fluidigm Corporation, an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, has announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the AZOVA™ COVID-19 Test Collection Kit for use with the Fluidigm^® Advanta™ Dx SARS-CoV-2 RT-PCR Assay on the company’s Biomark™ 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 a text message and email links to securely access results. In addition, AZOVA creates COVID Credentials™ 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.

Intended Use
The Advanta Dx SARS-CoV-2 RT-PCR Assay is a real-time Reverse Transcription (RT) PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider.

Testing is limited to laboratories which are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet requirements to perform high complexity tests.

This test is also for use with saliva specimens that are self-collected at home with or without the supervision of a healthcare provider (HCP) with the AZOVA COVID-19 Test Collection Kit from individuals suspected of COVID-19 by their HCP.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in saliva during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Clinical correlation with individual history and other diagnostic information is necessary to determine individual infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for individual management decisions. Negative results must be combined with clinical observations, individual history, and epidemiological information. Negative results for SARS-CoV-2 RNA from saliva should be confirmed by testing of an alternative specimen type if clinically indicated.

The Advanta Dx SARS-CoV-2 RT-PCR Assay is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Advanta Dx SARS-CoV-2 RT-PCR Assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

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