For Scale Up ‘Manufacturing’ purpose the National Institutes of Health (NIH) is committing nearly $250 million to seven companies with COVID-19 testing innovations that were selected through a “Shark Tank approach.”
“With no sign of relief in sight, national demand for COVID-19 testing is estimated to increase by millions of tests per day, especially as some schools and universities resume operations in the coming month, according to press release of NIH. These seven technologies chosen are expected to meet this demand as early as September.
Four of the tests rely on state-of-the-art innovation, including next-generation sequencing, CRISPR and integrated microfluidic chips, while the three others use platforms to provide nucleic acid and viral antigen test results at point-of-care (POC).
“The RADx initiative has enabled some of the nation’s most creative biomedical device inventors to ramp up development of their testing technologies at unprecedented speed,” said NIH Director Francis S. Collins, M.D., Ph.D. “The innovations selected to date represent the diverse types of promising technologies that will serve the nation’s testing needs.”
NIH listed the following companies will support for manufacturing and scale up:
- Mesa Biotech (POC)- The Accula SARS-CoV-2 test employs a hand-held RT-PCR device and a compact, single-use cartridge that detects viral RNA at the point-of-care. Results can be read from the removable cartridge in 30 minutes.
- Quidel (POC)- The Quidel Sofia SARS Antigen FIA test kit is a lateral flow immunoassay that can be used with the company’s Sofia and Sofia 2 Analyzers. The analyzers, which have been okayed for use in nursing homes, give results within 15 minutes.]
- Talis Biomedical (POC)- The Talis One COVID-19 test is a multiplexed cartridge that is used with the company’s Talis One instrument. The test detects SARS-CoV-2 through isothermal amplification of viral RNA and an optical detection system in under 30 minutes.
- Ginkgo Bioworks (lab-based)- Through automation and next-gen sequencing, the company is expected scale up to 50,000 tests per day in September and 100,000 per day by the end of 2020.
- Helix OpCo (lab)- Helix will ship standardized kits in bulk for the collection of nasal swabs to public health departments, health care systems, employers and other customers to collect tens of thousands of samples that can be processed at once and within 24 to 48 hours.
- Fluidigm (lab)- Each BioMark HD microfluidics platform has the capacity to process thousands of SARS-CoV-2 PCR tests per day with a primary focus on saliva samples.
- Mammoth Biosciences, Inc. (lab)- The Mammoth Biosciences SARS-CoV-2 DETECTR assay uses CRISPR technology, which provides a simpler workflow and significantly faster turnaround time compared with conventional laboratory PCR tests.
NIH states, “the companies were selected as part of the NIH’s Rapid Acceleration of Diagnostics (RADx) initiative, which launched in late-April after receiving an emergency $1.5 billion from Congress to support technologies that enable rapid COVID-19 testing.” Once it opened, the initiative received more than 650 applications, which NIH whittled down to the 100 best concepts.
Those technologies then entered a one-week Shark Tank-like evaluation process of which 31 projects made the cut and move to Phase 1, a rigorous four- to six-week period of initial technology validation.
While the seven companies/test mentioned were selected first for scale up, manufacturing and delivery to the market, NIH says more than 20 companies remain actively engaged in meeting Phase 1 milestones and will be considered for Phase 2 awards in the coming weeks. The Phase 1 companies have all either received an Emergency Use Authorization from the FDA or have applications in process.
“Even after this round, NIH said there are dozens of innovations still moving through the funnel that are eligible for Phase 1 and Phase 2 funding later in the year, “NIH Director Francis S. Collins added.