Industry News: Fluidigm receives CE-IVD mark for saliva-based Advanta Dx SARS-CoV-2 RT-PCR assay for COVID-19

The extraction-free saliva-based test detects nucleic acid from the SARS-CoV-2 virus

22 Jan 2021

Fluidigm Corporation, an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, has announced that the company has received the CE-IVD mark for its Advanta™ Dx SARS-CoV-2 RT-PCR Assay, an extraction-free saliva-based test to detect nucleic acid from the SARS-CoV-2 virus. The CE-IVD mark is in conformance with the European Union In Vitro Diagnostic Directive.

The Advanta Dx SARS-CoV-2 RT-PCR Assay does not require collection via invasive nasopharyngeal swab, and the company’s clinical studies for submission demonstrated 100 percent agreement between saliva results from the Advanta Dx Assay and results from paired nasopharyngeal samples tested with authorized assays.

A growing body of peer-reviewed research is confirming that the accuracy of saliva-based COVID-19 testing is comparable to that of nasopharyngeal-based collection. A systematic review and meta-analysis published in JAMA Internal Medicine in January 2021 stated that saliva-based tests have similar sensitivity and specificity and present an attractive alternative to invasive nasopharyngeal testing.

“Since the introduction of our saliva-based COVID-19 testing solution in the United States, we have seen tremendous interest in our testing technology, and we are gratified by the opportunity to offer one of the first saliva-based COVID-19 tests to be widely available in Europe, where the total addressable market for COVID-19 testing, based on third-party and company estimates, is $5 billion to $7 billion in 2021,” said Chris Linthwaite, Fluidigm President and CEO. “The European region is currently reporting a million new infections every four days and has seen more than 27 million cases since the pandemic began.

“In the first phase of the pandemic, we served the European market via home-brew laboratory COVID-19 tests. We are excited for the opportunity to now distribute Fluidigm CE-IVD commercial kits via our direct sales force and distribution partners, including for potential screening applications that may not require an order from a health care provider. We anticipate offering the Advanta Dx SARS-CoV-2 RT-PCR Assay for as little as 5 euros per test, based on volume and other factors.

“This much-needed noninvasive testing solution is being delivered in Europe at a critical time in the global health crisis. We anticipate strong interest from private labs that support testing for travel, workplace and other environments, and we believe high-throughput Fluidigm technology and the extraction-free nature of the assay will be among key drivers in Europe. Furthermore, our assay features an integrated testing platform and a reliable supply chain that laboratories can combine with commonly available automation platforms.”

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 reverse transcription (RT) and real-time polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva from patients who are suspected of COVID-19.

Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient 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.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The Advanta Dx SARS-CoV-2 RT-PCR Assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

Other Fluidigm products are For Research Use Only. Not for use in diagnostic procedures.

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