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MIDWET LABS TARGETING 3000 TEST A DAY USING FLDM ADVANTA

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Major Midwest Labs Targeting 3,000 Tests per Day

January 26, 2021 08:30 ET | Source: Fluidigm Corporation

SOUTH SAN FRANCISCO, Calif., Jan. 26, 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 Helix Specialty Diagnostics is partnering with Genomic LTC DX to provide COVID-19 testing using the Advanta™ Dx SARS-CoV-2 RT-PCR Assay on the Fluidigm^® Biomark™ HD system.

Both Missouri based companies operate major Clinical Laboratory Improvement Amendments (CLIA) certified labs. Helix Specialty Diagnostics leads sample collection for the collaboration, with Genomic LTC DX processing and analyzing the saliva samples via the Advanta Dx Assay on the Biomark HD.

Fluidigm has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the 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 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.

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 a similar sensitivity and specificity and present an attractive alternative to invasive nasopharyngeal testing.
“Our experience collecting samples and reporting clinical results at scale is further expanded by Genomic LTC DX processing test samples utilizing the Fluidigm assay on the Biomark HD,” said Michael Paulsen, President, Helix Specialty Diagnostics. “High-throughput saliva-based PCR testing is a valuable tool for colleges and universities as well as long-term care facilities, both of which are major customers. We intend to deliver 3,000 tests per day for processing via the Fluidigm system, providing much-needed additional capacity for large-scale testing programs.

“Rapid and reliable COVID-19 testing, made available to all who need it, is essential for a sustained response to the pandemic. As the total number COVID-19 cases in the United States exceeds 25 million, we are gratified by the opportunity to partner with Genomic LTC DX and Fluidigm to meet the needs of our clients.”
“Fluidigm is committed to provide the technology to enable simple, affordable and accessible testing capability to help keep colleges and universities open and keep high-risk residents of long-term facilities healthy,” said Chris Linthwaite, Fluidigm President and CEO. “We are proud of our collaborations in Missouri in recent months, starting with Washington University in St. Louis, and later with the State of Missouri, which has deployed four Fluidigm systems to various locations. Furthermore, we are excited to expand into the private-sector testing market through Helix Specialty Diagnostics and Genomic LTC DX to expand testing capacity for the state.

“Our saliva-based PCR test combines an affordable, kitted solution with sample collection that is far easier as compared to invasive swabs, and often preferable for both the health care providers collecting samples and the various community populations. Furthermore, our test has demonstrated 100 percent agreement with paired samples from authorized nasopharyngeal assays. While antigen testing can be an important element of pandemic response, it is not enough, as PCR virus detection provides greater sensitivity.”


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 the 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.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in saliva specimens during the acute phase of infection. 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. 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 patient management decisions. Negative results must be combined with clinical observations, patient 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 and trained 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.

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