The U.S. Government Is Running a "Shark Tank" for COVID Tests — And Seven Companies Just Won
In April 2020, as the pandemic strained testing infrastructure across the country, NIH Director Francis Collins put out a call. He wanted the nation's sharpest minds in diagnostics to step forward—and to do it fast. More than 650 research teams answered.
On Friday, the National Institutes of Health announced the first results of that sprint. Through its Rapid Acceleration of Diagnostics initiative, known as RADx, the agency is pouring $248.7 million into seven biomedical companies developing new testing technologies. The goal: add millions of tests per week to America's capacity by this fall, when schools and workplaces would need them most.
The Selection Process
The selection process borrowed from reality television. NIH winnowed roughly 100 promising concepts through a compressed, one-week "shark tank" evaluation. Thirty-one projects advanced to an initial validation phase. The seven announced Friday cleared that bar—and now receive funding specifically for manufacturing scale-up and market delivery.
According to HHS Secretary Alex Azar, the RADx initiative moved at remarkable speed to identify and select promising technologies. These tools were expected to help deliver faster results from laboratories and more test results within minutes at the point of care, which is especially important for settings like schools and nursing homes.
Point-of-Care Platforms
Three funded projects focus on returning results immediately, without sending samples to a laboratory.
Mesa Biotech — San Diego, CA
Mesa Biotech developed a hand-held device that detects viral genetic material in about 30 minutes. The system uses RT-PCR technology—the same molecular approach used in laboratory testing, shrunk to a portable format.
Quidel — San Diego, CA
Quidel already has thousands of its Sofia analyzers deployed across the country. The federal government specifically identified this system for nursing home use, and it delivers results in 15 minutes.
Talis Biomedical — Menlo Park, CA
Talis Biomedical created a compact instrument paired with a single-use cartridge that returns a result in under 30 minutes. The platform uses a technique called isothermal amplification.
High-Volume Laboratory Testing
Four companies focus on scaling up laboratory testing capacity.
Ginkgo Bioworks — Boston, MA
Ginkgo Bioworks is building an automated, sequencing-based operation capable of processing tens of thousands of samples per day. The company expects to reach 50,000 daily tests by September and double that figure by year's end.
Helix OpCo — San Mateo, CA
Helix OpCo is taking a similar approach, shipping bulk collection kits to health departments and employers, then processing pooled samples using next-generation sequencing.
Fluidigm — South San Francisco, CA
Fluidigm manufactures microfluidic instruments that can run thousands of PCR tests per day from saliva samples. This technology is already installed in many clinical laboratories nationwide.
Mammoth Biosciences — South San Francisco, CA
Mammoth Biosciences is deploying CRISPR-based detection. This method simplifies the laboratory workflow and cuts turnaround time compared with conventional PCR.
According to Bruce J. Tromberg, director of the National Institute of Biomedical Imaging and Bioengineering who leads the RADx Tech program, the announcement marked an exciting milestone. He noted that these investments will increase U.S. testing capacity exponentially over the coming months. He added that these and other technologies emerging from the RADx pipeline will guide patient care and inform public health measures to stop the spread of the virus and leave the nation better equipped to address future pathogens and other diseases.
More than 20 companies remain in active validation phases and could receive Phase 2 funding in coming weeks, according to NIH. The agency expects additional announcements as the innovation pipeline continues to narrow toward the most viable candidates.
Based on: NIH Announces First Companies to Receive Funding Through "Shark Tank" for COVID-19 Tests; National Institutes of Health; NIH Rapid Acceleration of Diagnostics (RADx) Initiative, July 2020.