We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
Abbott Diagnostics

Download Mobile App





Fluidigm’s Saliva-Based Advanta Dx SARS-CoV-2 RT-PCR Assay Secures FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 27 Aug 2020
Print article
Illustration
Illustration
Fluidigm Corporation (South San Francisco, CA, USA) has received Emergency Use Authorization (EUA) from the US 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.

Being saliva-based, the Advanta Dx SARS-CoV-2 RT-PCR Assay does not require collection via invasive nasopharyngeal swab. The clinical study associated with the EUA submission demonstrated 100% agreement between the saliva results from the Advanta Dx SARS-CoV-2 RT-PCR Assay and the results from paired nasopharyngeal samples tested with authorized assays.

The test is designed to be run on the Fluidigm Biomark HD microfluidics platform, providing throughput advantages that reduce the impact of capacity-constrained supply chains. The company’s microfluidics technology enables processing of more samples per batch than more traditional, microwell plate-based PCR technology. The Biomark HD platform can generate as many as 6,000 test results per day on a single system.

“Accessible and accurate testing programs that include a non-invasive, saliva-based collection option will be essential throughout duration of the COVID-19 pandemic”, said Andrew Lukowiak Ph.D, CEO of Millennium Health, a high-complexity lab certified under the Clinical Laboratory Improvement Amendments (CLIA) in the US, that has been evaluating the Advanta Dx SARS-CoV-2 RT-PCR Assay in advance of authorization. “In addition to the attractive sample input we chose the Fluidigm workflow because it combines extraordinary throughput per system with a robust supply chain from a trusted large-scale supplier. We believe this approach will enhance testing coverage in critical populations.”

“We have seen extraordinarily strong customer interest in our high-throughput saliva-based test, including many new purchases of Biomark HD systems to enable its adoption,” said Chris Linthwaite, President and CEO of Fluidigm. “We have a high degree of confidence that this new test will not only enhance testing capacity but will also significantly improve speed to results and scale. The ease of use for health care providers and patients alike will enable improved testing access to the global population. Fluidigm is excited to commercialize this easily administered saliva-based COVID-19 test during a critical phase of the pandemic. In the United States, Emergency Use Authorization for our test coincides with the total number of COVID-19 cases exceeding 5.7 million, underscoring the need for scalable and easy-to-administer testing.”

Related Links:
Fluidigm Corporation


Print article
BIOHIT  Healthcare OY

Channels

Molecular Diagnostics

view channel
Image: Photomicrograph of histology of a Ewing sarcoma in lung. The PAS stain highlights glycogen and the staining was negative with a PAS diastase stain (Photo courtesy of Nephron).

Comprehensive Molecular Profiling Matches Pediatric Patients to Therapies

A major challenge of using a comprehensive profiling approach for precision medicine is separating pathogenic from non-pathogenic molecular changes within a tumor. A program has been presented of the... Read more

Industry News

view channel
Image: Mindray Hematology Solution Helps High-Volume Lab Run 2,820,000 CBC Tests Annually (Photo courtesy of Mindray)

Mindray Hematology Solution Helps High-Volume Lab Run 2,820,000 CBC Tests Annually

High-volume laboratories face several challenges, including high instrument failure rate, errors due to several manual steps, low efficiency and long TAT, and heavier workload for the lab staff.... Read more
Copyright © 2000-2020 Globetech Media. All rights reserved.