Helix Specialty Diagnostics Partners with Genomic LTC DX to Provide COVID-19 Testing with Saliva-Based Advanta Dx SARS-CoV-2 RT-PCR Assay on Biomark HD Platform
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
“Our experience collecting samples and reporting clinical results at scale is further expanded by Genomic LTC DX processing test samples utilizing the
“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
“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
“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.”
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
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
Fluidigm (Nasdaq:FLDM) focuses on the most pressing needs in translational and clinical research, including cancer, immunology, and immunotherapy. Using proprietary CyTOF® and microfluidics technologies, we develop, manufacture, and market multi-omic solutions to drive meaningful insights in health and disease, identify biomarkers to inform decisions, and accelerate the development of more effective therapies. Our customers are leading academic, government, pharmaceutical, biotechnology, plant and animal research, and clinical laboratories worldwide. Together with them, we strive to increase the quality of life for all. For more information, visit fluidigm.com.
Fluidigm’s ongoing collaboration with the
About Genomic LTC DX
Genomic LTC DX is the wholly owned division of Boyce and Bynum Pathology Professional Services (BBPPS), dedicated to providing access to advanced diagnostic solutions to patients and clinicians across the Midwest. Established in 1965, Boyce and Bynum Pathology Professional Services is the largest private anatomic pathology reference laboratory in the Midwest, offering a full spectrum of anatomic procedures and operating under the directorship of multi-specialty pathologists who are committed to meeting the needs of the hospitals, specialty clinics, physician offices, and the communities that we serve.
Forward-Looking Statements for
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, among others, statements regarding expectations for specified third parties to conduct COVID-19 testing using the Advanta Dx SARS-CoV-2 RT-PCR Assay, the benefits and relative accuracy of saliva-based COVID-19 testing, the numbers of Advanta Dx assays to be processed by third parties, the benefits of providing tests to certain communities and customers, demand for the
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