SOUTH SAN FRANCISCO, Calif., Jan. 26, 2021 (GLOBE NEWSWIRE) — Fluidigm Company (Nasdaq:FLDM), an progressive biotechnology instruments supplier with a imaginative and prescient to enhance life by complete well being perception, at this time introduced that Helix Specialty Diagnostics is partnering with Genomic LTC DX to offer COVID-19 testing utilizing the Advanta™ Dx SARS-CoV-2 RT-PCR Assay on the Fluidigm® Biomark™ HD system.
Each Missouri primarily based firms function main Medical Laboratory Enchancment Amendments (CLIA) licensed labs. Helix Specialty Diagnostics leads pattern assortment for the collaboration, with Genomic LTC DX processing and analyzing the saliva samples by way of the Advanta Dx Assay on the Biomark HD.
Fluidigm has acquired Emergency Use Authorization (EUA) from the U.S. Meals and Drug Administration (FDA) for the Advanta Dx SARS-CoV-2 RT-PCR Assay, an extraction-free saliva-based check to detect nucleic acid from the SARS-CoV-2 virus. The assay doesn’t require assortment by way of invasive nasopharyngeal swab, and the corporate’s submission to the FDA demonstrated one hundred pc settlement between saliva outcomes from the Advanta Dx Assay and outcomes from paired nasopharyngeal samples examined with licensed assays.
A rising physique of peer-reviewed analysis is confirming that the accuracy of saliva-based COVID-19 testing is similar to that of nasopharyngeal-based assortment. A scientific evaluate and meta-analysis revealed in JAMA Inner Medication in January 2021 said that saliva-based exams have an identical sensitivity and specificity and current a lovely different to invasive nasopharyngeal testing.
“Our expertise gathering samples and reporting scientific outcomes at scale is additional expanded by Genomic LTC DX processing check samples using the Fluidigm assay on the Biomark HD,” stated Michael Paulsen, President, Helix Specialty Diagnostics. “Excessive-throughput saliva-based PCR testing is a helpful software for faculties and universities in addition to long-term care amenities, each of that are main clients. We intend to ship 3,000 exams per day for processing by way of the Fluidigm system, offering much-needed extra capability for large-scale testing applications.
“Fast and dependable COVID-19 testing, made accessible to all who want it, is important for a sustained response to the pandemic. As the overall quantity COVID-19 instances in america exceeds 25 million, we’re gratified by the chance to associate with Genomic LTC DX and Fluidigm to satisfy the wants of our shoppers.”
“Fluidigm is dedicated to offer the know-how to allow easy, reasonably priced and accessible testing functionality to assist hold faculties and universities open and hold high-risk residents of long-term amenities wholesome,” stated Chris Linthwaite, Fluidigm President and CEO. “We’re pleased with our collaborations in Missouri in current months, beginning with Washington College in St. Louis, and later with the State of Missouri, which has deployed 4 Fluidigm programs to varied places. Moreover, we’re excited to develop into the private-sector testing market by Helix Specialty Diagnostics and Genomic LTC DX to develop testing capability for the state.
“Our saliva-based PCR check combines an reasonably priced, kitted resolution with pattern assortment that’s far simpler as in comparison with invasive swabs, and sometimes preferable for each the well being care suppliers gathering samples and the varied neighborhood populations. Moreover, our check has demonstrated one hundred pc settlement with paired samples from licensed nasopharyngeal assays. Whereas antigen testing may be an necessary factor of pandemic response, it isn’t sufficient, as PCR virus detection supplies better sensitivity.”
Fluidigm frequently conducts in silico analyses to find out the effectiveness of the Advanta Dx Assay design to detect SARS-CoV-2. Up to now, not one of the revealed viral mutations meaningfully impression the areas of the viral genome focused by the assay’s primers and probes.
The Advanta™ Dx SARS-CoV-2 RT-PCR Assay is a real-time Reverse Transcription (RT) PCR check supposed for the qualitative detection of nucleic acid from the SARS-CoV-2 in saliva specimens collected with out preservatives in a sterile container from people suspected of COVID-19 by their healthcare supplier. Testing is restricted to Laboratories that are licensed below the Medical Laboratory Enchancment Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet necessities to carry out excessive complexity exams.
Outcomes are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is usually detectable in saliva specimens through the acute section of an infection. Optimistic outcomes are indicative of the presence of SARS-CoV-2 RNA; scientific correlation with affected person historical past and different diagnostic info is critical to find out affected person an infection standing. Optimistic outcomes don’t rule out bacterial an infection or co-infection with different viruses. The agent detected might not be the particular reason behind illness. Laboratories inside america and its territories are required to report all outcomes to the suitable public well being authorities.
Damaging outcomes don’t preclude SARS-CoV-2 an infection and shouldn’t be used as the only foundation for affected person administration choices. Damaging outcomes have to be mixed with scientific observations, affected person historical past, and epidemiological info. Damaging outcomes for SARS-CoV-2 RNA from saliva ought to be confirmed by testing of an alternate specimen sort if clinically indicated.
The Advanta™ Dx SARS-CoV-2 RT-PCR Assay is meant to be used by certified and skilled scientific laboratory personnel particularly instructed and skilled within the methods of real-time PCR and in vitro diagnostic procedures. The Advanta™ Dx SARS-CoV-2 RT-PCR Assay is just for use below the Meals and Drug Administration’s Emergency Use Authorization.
Different Fluidigm merchandise are supplied for Analysis Use Solely. Not to be used in diagnostic procedures.
Fluidigm (Nasdaq:FLDM) focuses on probably the most urgent wants in translational and scientific analysis, together with most cancers, immunology, and immunotherapy. Utilizing proprietary CyTOF® and microfluidics applied sciences, we develop, manufacture, and market multi-omic options to drive significant insights in well being and illness, establish biomarkers to tell choices, and speed up the event of more practical therapies. Our clients are main educational, authorities, pharmaceutical, biotechnology, plant and animal analysis, and scientific laboratories worldwide. Along with them, we attempt to extend the standard of life for all. For extra info, go to fluidigm.com.
Fluidigm, the Fluidigm emblem, Advanta, Biomark, and CyTOF are logos and/or registered logos of Fluidigm Company in america and/or different nations. All different logos are the only property of their respective house owners.
Fluidigm’s ongoing collaboration with the Protection Superior Analysis Tasks Company (DARPA) and its Epigenetic Characterization and Remark (ECHO) program contains monetary help for improvement of progressive applications primarily based on our microfluidics know-how.
About Helix Specialty Diagnostics
Helix Specialty Diagnostics (HSD) is a CLIA licensed excessive complexity scientific testing laboratory positioned in Columbia, MO. The possession of HSD represents over 150 years of healthcare and laboratory expertise. HSD is obsessed with healthcare and about delivering prime quality outcomes to enhance affected person outcomes. Centrally positioned within the state, HSD is well-positioned to obtain samples from all areas of Missouri and the encircling states. HSD is dedicated to working with the employers to assist them by this unprecedented time.
About Genomic LTC DX
Genomic LTC DX is the wholly owned division of Boyce and Bynum Pathology Skilled Providers (BBPPS), devoted to offering entry to superior diagnostic options to sufferers and clinicians throughout the Midwest. Established in 1965, Boyce and Bynum Pathology Skilled Providers is the biggest personal anatomic pathology reference laboratory within the Midwest, providing a full spectrum of anatomic procedures and working below the directorship of multi-specialty pathologists who’re dedicated to assembly the wants of the hospitals, specialty clinics, doctor places of work, and the communities that we serve.
Ahead-Wanting Statements for Fluidigm
This press launch comprises forward-looking statements inside the that means of the Personal Securities Litigation Reform Act of 1995, together with, amongst others, statements relating to expectations for specified third events to conduct COVID-19 testing utilizing the Advanta Dx SARS-CoV-2 RT-PCR Assay, the advantages and relative accuracy of saliva-based COVID-19 testing, the numbers of Advanta Dx assays to be processed by third events, the advantages of offering exams to sure communities and clients, demand for the Fluidigm exams and enlargement of testing capability primarily based on availability of the Fluidigm exams. Ahead-looking statements are topic to quite a few dangers and uncertainties that would trigger precise outcomes to vary materially from at present anticipated outcomes, together with however not restricted to dangers regarding the potential adversarial results of the coronavirus pandemic on our enterprise and working outcomes; the attainable lack of key staff, clients, or suppliers; uncertainties in contractual relationships; our skill and/or the power of the analysis establishments using our merchandise and know-how to acquire and preserve Emergency Use Authorization from the FDA and another requisite authorizations or approvals to make use of our merchandise and know-how for diagnostic testing functions; potential adjustments in priorities or necessities for Emergency Use Authorizations or different regulatory authorizations or approvals; potential limitations of any Emergency Use Authorization or different regulatory authorizations or approvals; potential adjustments within the priorities of presidency businesses; challenges inherent in creating, manufacturing, launching, advertising, and promoting new merchandise; dangers regarding firm analysis and improvement and distribution plans and capabilities; interruptions or delays within the provide of parts or supplies for, or manufacturing of, Fluidigm merchandise; potential product efficiency and high quality points; mental property dangers; and competitors. Data on these and extra dangers and uncertainties and different info affecting Fluidigm enterprise and working outcomes is contained in Fluidigm’s Annual Report on Kind 10-Okay for the 12 months ended December 31, 2019, and in its different filings with the Securities and Alternate Fee. These forward-looking statements communicate solely as of the date hereof. Fluidigm disclaims any obligation to replace these forward-looking statements besides as could also be required by legislation.
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