NIH Commits $248M to Scale-Up Rapid, Advanced COVID-19 Diagnostics

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Population genomics company Helix, which received $33.4 million from the NIH’s RADx initiative, will use the funds to scale up its COVID-19 testing operations in order to process as many at 100,000 tests per day by fall. [Source: Helix]

The National Institutes of Health’s (NIH) Rapid Acceleration of Diagnostics (RADx) initiative has awarded contracts totaling $248.7 million to seven diagnostic companies to support the development and deployment of a range of new lab-based and point-of-care tests for COVID-19. The intent is to increases the country’s capacity to meet broader demand for testing in the coming months that is forecast to be millions of tests more per day than current capabilities.

“RADx moved incredibly quickly to select promising technologies through its ‘shark tank’ approach, investing in technologies that could boost America’s best-in-the-world COVID-19 testing capacity by millions more tests per day,” said Health and Human Services (HHS) Secretary Alex Azar, in a press release. “These technologies will help deliver faster results from labs and more and more test results within minutes at the point of care, which is especially important for settings like schools and nursing homes.”

NIH launched RADx in late April, leveraging $1.5 billion made available by an emergency supplemental appropriation from Congress, with an eye toward making millions of COVID-19 tests available each week, by the fall. NIH Director Francis Collins, M.D.,Ph.D., put out a nationwide call to participate in the program and, since that time, the agency has received more than 650 individual applications for rapid testing technologies.

The seven companies receiving support for the first round of diagnostic development and deployment are:

  • Mesa Biotech and its Accula SARS-CoV-2 test which 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’s Sofia SARS Antigen FIA test kit, a lateral flow immunoassay, used with Sofia and Sofia 2 Analyzers in point-of-care settings, such as a doctor’s office or pharmacy. The analyzers give electronic results within 15 minutes.
  • Talis Biomedical and its Talis One COVID-19 point of care test—a multiplexed cartridge used with the Talis One instrument that detects SARS-CoV-2 through isothermal amplification of viral RNA and an optical detection system, returning a result in under 30 minutes.
  • Ginkgo Bioworks, which is scaling up automated techniques for handling samples and high-throughput, next-generation sequencing technologies to process tens of thousands of individual tests at once. Ginkgo will provide end-to-end sample collection for public and private organizations, including schools and universities to report results within 24–48 hours from sample receipt. The company is expected scale up to 50,000 tests per day in September 2020 and 100,000 per day by the end of the year.
  • Helix, which 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 24–48 hours, using a combination automation processes and next-generation sequencing (NGS) technologies. Helix is expected to process up to 50,000 samples a day by end of September 2020 and 100,000 samples per day at the end of the year.
  • Fluidigm, which will leverage its BioMark HD microfluidics platform that has the capacity to process thousands of SARS-CoV-2 PCR tests per day with a primary focus on saliva samples. Scale up and deployment of these integrated fluidic chips can provide tens to hundreds of thousands of new tests per day in fall 2020.
  • Mammoth Biosciences via its SARS-CoV-2 DETECTR assay, which uses CRISPR technology, has developed a streamlined workflow for faster turnaround time compared to conventional laboratory PCR tests, which has the potential to result in a multi-fold increase in testing capacity in commercial laboratories.

“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., in a prepared statement. “The innovations selected to date represent the diverse types of promising technologies that will serve the nation’s testing needs.”

According to population genomics company Helix, which will receive $33.4 million from RADx, the company’s past investments in NGS technologies and refinement of its automated testing workflow that it has built to support its core business, positioned it well to roll out a large-scale COVID-19 testing operation.

The company says it has filed an additional EUA for its Helix COVID-19 NGS Test, a higher throughput and more sensitive NGS-based COVID-19 test, which is currently under review by the FDA.

“Helix operates one of the world’s largest clinical next-generation sequencing labs and we’ve invested heavily in automated workflows to support large-scale clinical testing,” said James Lu, M.D., Ph.D., co-founder and CSO of Helix, in a company press release announcing the award. “By combining these capabilities with the launch of one of the first next-generation sequencing-based COVID-19 tests, we’ll be able to significantly increase COVID-19 testing capacity.”

Helix said it will use the RADx funds to support a rapid scale-up of all parts of it COVID-19 testing operation. It anticipates being able to run as many as 100,000 tests daily by the fall, with the potential to scale further through the end of the year into 2021.

NIH said it is continuing to evaluate technologies and capabilities among the more than 650 applications it has received. It notes that “hundreds” of experts from government, academia, and industry including the National Institute of Biomedical Imaging and Bioengineering’s (NIBIB) Point-of-Care Technology Research Network (POCTRN), are contributing to RADx by evaluating applications, providing core technical and clinical resources, and guiding project teams.

While the seven tests announced today are the first to be chosen for scale up, manufacturing, and delivery to the marketplace through the initiative, more than 20 companies remain actively engaged in meeting Phase 1 milestones and will be considered for Phase 2 awards in the coming weeks. In addition, dozens of promising concepts continue to move through the RADx “innovation funnel” and may be selected for Phase 1 and/or Phase 2 funding.

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