FLDM stock exploded higher after the company reported the execution of a letter contract with the National Institutes of Health, National Institute of Biomedical Imaging and Bioengineering, for a proposed project under the agency’s Rapid Acceleration of Diagnostics (RADx) program.

Fluidigm Corporation (Nasdaq:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced execution of a letter contract with the National Institutes of Health, National Institute of Biomedical Imaging and Bioengineering, for a proposed project under the agency’s Rapid Acceleration of Diagnostics (RADx) program. The project, with a total proposed budget of up to $37 million, contemplates expanding production capacity and throughput capabilities for COVID-19 testing with Fluidigm® microfluidics technology. The letter contract provides Fluidigm with access to up to $12 million of initial funding based on completion and delivery of certain validation milestones prior to execution of the definitive contract.

The RADx program fast-tracks development and commercialization of innovative technologies to significantly increase U.S. testing capacity for SARS-CoV-2, the virus that causes COVID-19. Fluidigm microfluidics technology is the basis for several COVID-19 test assays designed to be run on the Fluidigm Biomark™ HD system.

“This is an exciting milestone,” said Bruce Tromberg, PhD, Director of the National Institute of Biomedical Imaging and Bioengineering and leader of RADx Tech, one of four components of the NIH Rapid Acceleration of Diagnostics initiative. “It will help increase U.S. testing capacity exponentially. Game-changing technologies emerging from our RADx pipeline will inform public health measures to stop the spread of the virus and leave us better-equipped to address future pathogens and other diseases.”

A goal of the RADx initiative is to enable approximately 6 million daily tests in the United States by December 2020, many times the current daily testing rate. The Fluidigm project targets a production capacity of more than one million COVID-19 tests per day by the end of the first quarter of 2021. Actual production volumes may vary based on market demand and other factors.

“The NIH, the National Institute of Biomedical Imaging and Bioengineering and their partner agencies have moved with lightning speed to identify and support the technologies best-equipped to deliver millions of additional COVID-19 tests,” said Chris Linthwaite, Fluidigm President and CEO. “Fluidigm is proud to be among the very first companies to be chosen for an award in the rigorous RADx selection process.

“RADx was established in just five days following the announcement of $1.5 billion in federal stimulus funding, and the swift, focused and results-driven approach to executing on the initiative’s mission is precisely what is needed for everyone to safely return to public spaces, including work and school.

“Fluidigm technology is well-suited to help expand U.S. COVID-19 testing capacity, and we are gratified for the opportunity to partner with the NIH on this historic undertaking.”

The letter contract provides access to up to $12 million of the total proposed funding for the project prior to contract definitization. Release of funding under the letter contract will be based on achievement of milestones, which include an initial validation assessment followed by deliverables related to development of Fluidigm microfluidics technology and expansion of related manufacturing capacity.

As of July 30, 640 applications for RADx support had been submitted, with seven projects, including Fluidigm, advancing in the current round of contracts to the final, Phase 2 segment of the RADx selection process. Phase 2 includes completing the validation, approval and production processes in order to deliver a viable product in a scaled-up capacity to the U.S. public.

On July 31, 2020, Fluidigm announced that it has been awarded a $12.15M NIH manufacturing contract for its Advanta DX SARS-COV-2 RT-PCR assay for saliva, according to a NIH post on its website. Source:https://beta.sam.gov/awards/91448994%2BAWARD

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