NIH bets on rapid, point-of-care, and new technologies to ramp up U.S.’s capacity as pandemic escalates


Researchers and test developers continue to look for unique solutions to shorten the time for returning SARS-CoV-2 test results, as the virus’s aggressive march outpaces testing efforts, particularly in the U.S.

On July 31, the National Institutes of Health’s (NIH) Rapid Acceleration of Diagnostic Technologies (RADx Tech) program reached an important milestone, awarding $248.7 million in contracts to seven biomedical companies to scale up and deploy accurate point-of-care (POC) tests across the country by fall, as influenza season begins.

The seven technologies, which competed alongside 600 completed applications, include next-generation sequencing (NGS), CRISPR, nucleic acid, and viral antigen platforms. They are:

  • Mesa Biotech’s Accula SARS-CoV-2 hand-held real-time polymerase chain reaction (PCR) test that detects viral RNA and produces results in 30 minutes.
  • Quidel’s Sofia SARS Antigen FIA test kit, which uses a lateral flow immunoassay in conjunction with an analyzer that delivers results in 15 minutes.
  • Talis Biomedical’s Talis One COVID-19 POC test, which detects the virus in under 30 minutes through isothermal amplification of viral RNA and an optical detection system.
  • Ginkgo Bioworks’ project to scale up high-throughput NGS technologies and produce 100,000 per day by year’s end.
  • Helix OpCo’s project to ship standardized bulk test kits to various entities, ramping up nasal swab sample collections to 100,000 by the end of 2020.
  • Fluidigm’s goal to produce thousands of new PCR tests per day, with a focus on saliva samples, through its Biomark HD microfluidics platform this fall.
  • Mammoth Biosciences’s SARS-CoV-2 DETECTR assay, which uses CRISPR technology to produce a simpler workflow and greater turnaround time, which could significantly ramp up testing capacity in commercial labs.

The seven technologies were chosen from a pool of 100 “best concept” applicants. These will be the first technologies to go through RADx from scale up, manufacturing, and delivery to the marketplace. Scientists leading this effort detailed their strategy in the New England Journal of Medicine. “The RADx-tech program uses a rigorous, rapid-review process that provides independent evaluation of the technology and the potential to scale,” explained NIH Director Francis Collins, MD, and colleagues.

Source: AACC.