SOUTH SAN FRANCISCO, Calif. , October 8, 2020 (GLOBE NEWSWIRE) – Fluidigm Corporation (Nasdaq: FLDM), a provider of state-of-the-art biotech equipment with a vision of life through a global fitness vision, today announced a program to expand the availability of Fluidigm® COVID-19 tests for U. S. schools and universities. But it’s not the first time The Fluidigm COVID-19 Campus Safeguard program will provide millions of non-invasive saliva-based testing for SARS-CoV-2 to eligible establishments for a fee as low as $5 according to test.
The Advanta ™ Dx SARS-CoV-2 RT-PCR check in the Fluidigm Biomark ™ HD broadband formula includes a built-in verification platform and a chain of trusted sources and can be seamlessly combined with common automation platforms.
The progression, commercialization and implementation of RT-PCR Advanta Dx SARS-CoV-2 verification is supported through a $34 million final contract with the National Institutes of Health as a component of the agency’s Rapid Diagnostic Acceleration Initiative (RADx). Drive the progression and commercialization of cutting-edge technologies to componently develop US verification capabilities. UU. para el SARS-CoV-2.
With the support of scale, the cheap saliva-based Advanta check will target all universities and schools in the United States. Many higher education systems are suffering to implement control systems to serve giant populations. Fluidigm has a large number of Biomark HD internships at university clinical laboratories in the United States that meet the needs to carry out high complexity checks in significant numbers.
Many pioneering establishments and laboratories in the United States, in addition to the University of Pennsylvania, the University of Washington at St. Louis, OU Medicine, the University of Oklahoma and the Oklahoma Medical Research Foundation (OMRF) have chosen to use Fluidigm and reactive microfluidic. generation of Americans for SARSCoV2.
“Fluidigm microfluids provide a fast and affordable testing tool,” said Joel Guthridge, PhD, Director of Clinical Research and Translational Computing Resources at OMRF. “This technique allows us to identify other positive people and temporarily assess possible exposures and hazards to our employees. scholars and their families. “
“In addition, Fluidigm avoids chain-of-origin limitations related to others and has obtained emergency use authorization from the FDA.
“We are grateful for the NIH RADx initiative, which has enabled us to increase our production capacity and enable the Fluidigm COVID-19 Campus Safeguard program. We will continue to strengthen our capacity and, during the fourth quarter, we expect to have six million tests available,” Linthwaite said. “We are excited about this opportunity to play a leading role in helping ensure the protection of academics and staff as our country continues to weather the global fitness crisis. “
Fluidigm RADx’s assignment is supported through the NIH Rapid Acceleration of Diagnostics initiative and funded in whole or in component with the federal budget of the National Institute of Bioengineering and Biomedical Imaging, National Institutes of Health, Decomposer of Health and Human Services, under contract No. 75N92020C00009 .
Purchases under the Fluidigm COVID-19 Campus Safeguard program are subject to terms and situations for U. S. schools and universities. But it’s not the first time Just until stock runs out.
https://go. fluidigm. com/campus-admin
https://go. fluidigm. com/back-to-school
The Advanta Dx SARS-CoV-2 RT-PCR Test is a real-time reverse transcription (RT) PCR test for the qualitative detection of SARS-CoV-2 nucleic acid in saliva standards collected without preservatives in a container. from Americans suspected of COVID-19 through their fitness service provider. Testing is limited to laboratories qualified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U. S. C. §263a, and meet the needs to perform controls of maximum complexity. The effects are related to the identity of the SARS-CoV-2 RNA. SARS-CoV-2 RNA is regularly detected in saliva patterns during the acute phase of infection. Positive effects imply the presence of SARS-CoV-2 RNA; Clinical correlation with the patient’s history and other diagnostic data is mandatory to determine the patient’s infection status. The positive effects do not exclude bacterial infection or co-infection with other viruses. The agent detected may not be the definitive cause of the disease. Laboratories in the United States and its territories must report all positive effects to the appropriate public fitness authorities. The negative effects do not prevent you from infection with SARS-CoV-2 and do not deserve to be used as the sole basis for patient management decisions. Negative effects deserve to be combined with clinical findings, patient history, and epidemiological data. Negative results for SARS-CoV-2 RNA in saliva deserve to be shown by checking some other type of pattern if it is clinically involved. The Advanta Dx SARS-CoV-2 RT-PCR Assay is designed for use by a staff of qualified and trained clinical laboratory workers, particularly trained and trained in real-time PCR techniques and in vitro diagnostic procedures. The Advanta Dx SARS-CoV-2 RT-PCR Test is only intended for use under Food and Drug Administration emergency use authorization.
The Advanta Dx SARS-CoV-2 RT-PCR test is designed for in vitro diagnostic use and should only be used with emergency use permission. It has not been legal or FDA approved. It is legal through the FDA under an USA for use in legal laboratories. It has only been legal for the detection of nucleic acid SRAS-CoV-2, not for other viruses or pathogens. it is allowed only for the duration of the declaration of lifestyles in cases justifying the authorization of the emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under segment 564(b) (1) of the Act, 21 USC360bbb-3 (b) (1), unless the authorization is terminated or re summoned earlier. Other Fluidigm products are intended for studies only. Do not use in diagnostic procedures.
Fluidigm, the Fluidigm logo, Advanta, Biomark and CyTOF are and/or are registered by Fluidigm Corporation in the United States and/or other countries. All others are exclusive assets of their respective owners.
Fluidigm’s ongoing collaboration with the Advanced Defense Research Projects Agency (DARPA) and its Epigenetic Characterization and Observation (ECHO) program includes money for the progression of cutting-edge systems based on our microfluidic technology.
Forward-Looking Statements for Fluidigm This press release comprises forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, adding, but not limited to, statements regarding the use of Fluidigm’s Advanta COVID-19 assays during the higher education US facilities and production capacity, in addition to the amount of testing Fluidigm expects to conduct in the fourth quarter of 2020. Forward-looking statements are subject to many dangers and uncertainties that may cause actual effects to differ materially from existing effects. expected, adding, but not limited to, dangers similar to the potential negative effects of the coronavirus pandemic on our business and operational effects in 2020; uncertainties in contrareal relationships; our ability and / or the ability of research institutes that employ our products and generation to download and maintain the FDA emergency use authorization and any other approval required to use our products and generation to test diagnostics; prospective adjustments in priorities or authorization requirements for emergency use; the prospective limits of any emergency use authorization; prospective adjustments in the priorities of government agencies; the demanding situations inherent in the development, production, launch, marketing and promotion of new products; similar dangers to the studies and plans and capacities of progression and distribution of the company; interruptions or delays in the supply of parts or fabrics for, or the manufacture of Fluidigm products; possible disturbances of the functionality and quality of the product; dangers of intellectual assets; and competition. Information on these hazards and uncertainties, as well as other data that affect Fluidigm’s business and operational effects, can be found in Fluidigm’s annual report on Form 10-K for the year ended December 31, 2019 and its other documents filed with the Securities and Exchange Commission. . These forward-looking statements speak only as of the date hereof. Fluidigm disclaims any legal responsibility to update those forward-looking statements, as required by law.
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Investors: Agnes LeeVicePresident, Investor Relations 650416 7423agnes. lee@fluidigm. com