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NIH Awards $129M to Nine Dx Firms for Rapid COVID-19 Diagnostics

NEW YORK – The National Institutes of Health said Wednesday that it is awarding more than $129.3 million in contracts to nine diagnostic firms under its Rapid Acceleration of Diagnostics (RADx) initiative to expand testing and manufacturing capacity and support development of new rapid SARS-CoV-2 tests.

The new grants come after a previous round of contracts totaling $248.7 million that were awarded in July. Some of the key considerations for RADx support include speed, cost, accessibility, and technical performance of each test, the agency said. The size of the awards for this most recent funding round was not immediately available for all grant recipients.

"Many of these tests incorporate innovations that have moved from research labs to the point of care with unprecedented speed," Bruce Tromberg, director of the National Institute of Biomedical Imaging and Bioengineering and lead for RADx Tech, said in a statement. "That process normally takes years, but RADx has brought together key experts in technology, medicine, and commercialization to bring new tests to market in only five to six months."

Point-of-care tests

MicroGem will receive up to $40.9 million to speed up the launch of its COVID-19 saliva test, which will identify SARS-CoV-2 and influenza A and B. The rapid test, which uses a microfluidic cartridge, provides results in 15 minutes and detects viruses using RT-PCR.

MatMaCorp has a portable mini-laboratory that can perform multiple RT-PCR assays in parallel, using multiple sources of reagents. It is targeted for community hospitals and clinics in underserved and rural areas. 

Maxim Biomedical received funding for its single-use, lateral flow test strip immunoassay providing results in 15 minutes without requiring an instrument or specialized equipment. 

Lab-based tests

Ceres Nanosciences was awarded a $6.5 million contract to increase manufacturing capacity for its Nanotrap Virus Particles used in COVID-19, influenza, and respiratory syncytial tests. The particles eliminate the need for RNA extraction kits, which reduces the time for sample processing and improves sensitivity for point-of-care and high-throughput assays, Ceres said. The Manassas, Virginia-based firm said it plans to supply Nanotrap particles for at least 2 million tests per week by early 2021. One of RADx's stated goals is to expand national testing capacity by addressing supply chain issues with RNA extraction kits.

Aegis Sciences will receive $6.6 million to expand its COVID-19 testing capacity to 60,000 tests per day by the end of September. The firm has a high-throughput RT-PCR SARS-CoV-2 test that can detect 400 copies of the virus per milliliter of sample from a nasal or oral swab. It is also working on a multiplexed SARS-CoV-2 and influenza A and B test for early October.

The Broad Institute has a high-throughput RT-PCR viral test for nasal swab specimens that will be scaled up to 100,000 tests per day using the money from NIH. The institute currently performs tests for more than 530 regional hospitals, nursing homes, and other facilities in Cambridge, Massachusetts. 

Sonic Healthcare was awarded a contract for an undisclosed amount to expand its capacity to 166,000 tests per day at nine of its laboratories. The firm also received critical laboratory equipment from the US Department of Health and Human Services to support testing ramp-up. Austin, Texas-based Sonic said the funding will be used to "develop comprehensive access" to testing for underserved and high-risk populations .

Illumina will use funds it received to scale up automated sample processing and next-generation sequencing for its COVIDSeq test, with the goal to expand capacity to 48,000 tests per day.

Pathgroup currently processes up to 14,000 COVID-19 RNA tests per day using Roche and Hologic instruments, but has partnered with Thermo Fisher Scientific, LGC, and Illumina to add instrumentation and automation. By December 2020, it intends to be able to perform 80,000 tests per day with results in approximately 24 hours.

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