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Mount Sinai-Led Consortium, Fluidigm Developing Epigenetic Coronavirus Dx

NEW YORK – Fluidigm said on Monday that it is collaborating with a consortium of medical schools led by the Icahn School of Medicine at Mount Sinai to develop an epigenetic test on Fluidigm's microfluidics platform for early detection of infection with the novel coronavirus and COVID-19 development.

As part of the Epigenetic Characterization and Observation (ECHO) program of the Defense Advanced Research Projects Agency (DARPA) of the US Department of Defense, the consortium is developing a real-time PCR test for host detection assays targeting the epigenome and viral RNA for early-stage monitoring of potentially infected individuals.

Specifically, using Fluidigm's Biomark HD system and microfluidics technology, the partners aim to develop integrated fluidic circuits that can screen 192 samples across 24 different parallel processed assays to enable early detection of viral infection. Fluidigm said in a statement that labs would potentially be able to generate more than 6,000 individual test results per day with just one hour of hands-on time, "representing a scale and parallel processing of assays not possible using microwell plates."

Led by the Icahn School of Medicine, the consortium plans to submit the test to the US Food and Drug Administration for Emergency Use Authorization.

"Speed, scale, and early detection are critical in addressing the spread of the COVID-19 pandemic, and the ability to rapidly screen a large number of samples will enhance capabilities in identification and management of infected individuals, including those who are asymptomatic," Chris Linthwaite, president and CEO of Fluidigm, said in a statement. "We believe the application of Fluidigm microfluidics technologies to epigenetic testing for COVID-19 has significant potential to increase the speed and capacity of these critical screening efforts."

"We appreciate the unique expertise Fluidigm brings to this multi-institution, DARPA-supported effort to develop an early test for COVID-19," Stuart Sealfon, principal investigator of the DARPA ECHO program and Director of the Center for Advanced Research on Diagnostic Assays at the Icahn School of Medicine, said in a statement.

Fluidigm and Mount Sinai were already partnering under a larger $27.8 million contract with DARPA’s ECHO program to develop epigenetic signatures that might be used to identify exposure to weapons of mass destruction. It is unclear whether the coronavirus project has received new funding under ECHO or is working under the previously awarded contract. Mount Sinai and Fluidigm did not immediately respond to requests for comment.