Seven plucky diagnostics companies win a $249M round of contracts after surviving NIH's Covid-19 'Shark Tank' competition
As US Covid-19 deaths creep past 150,000 and officials stress the importance of contact tracing, the NIH’s Rapid Acceleration of Diagnostics (RADx) program has inked contracts totaling $248.7 million to expand testing capabilities.
The seven contracts, which were chosen “Shark Tank”-style from a pool of 100 proposals, are part of an effort to bump daily testing capacity to 2% of the country’s population by late summer or fall. That would be about 6 million people per day, compared to the current 520,000 to 823,000 tests being administered daily.
In total, about 650 proposals were submitted to the RADx project. Hundreds of industry “sharks” — including some from the National Institute of Biomedical Imaging and Bioengineering’s (NIBIB) Point-of-Care Technology Research Network — evaluated applications. The NIH narrowed the pack down to 100, and intense evaluation process began.
Only 31 projects made it to Phase I RADx development, which involved four to six weeks of initial technology validation. Seven have been pushed to Phase II so far, during which developers will scale up facilities, manufacture technologies, and send products to market. More than 20 of the companies are still in Phase I, and could climb to Phase II in the coming weeks.
Dozens more proposals in the RADx “innovation funnel” still have a shot at Phase I or II funding. RADx money comes from a $1.5 billion NIH initiative announced in April, which included $500 million earmarked for diagnostic development.
“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,” HHS Secretary Alex Azar said in a prepared statement. “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.”
The seven technologies currently in Phase II range from point-of-care to lab-based testing, and from nasal to saliva sampling. The developers span from Massachusetts to California. Each developer either has a pending EUA application, or has received EUA from the FDA, which said it will prioritize review of RADx projects.
Mesa says its test will use reverse transcription-polymerase chain reaction (RT-PCR) technology to detect SARS-CoV-2 from nasal swabs within 30 minutes — all from a palm-sized device. The San Diego-based company developed the test at the Los Alamos National Laboratory, using grants from the NIH, NIAID, and Western Regional Centers for Excellence in Biodefense and Emerging Infectious Diseases.
Now it’s full steam ahead. With $15.4 million from RADx, Mesa will push the clinical deployment of its test on an accelerated timeline.
Quidel Corporation’s take on point-of-care testing involves immunofluorescence-based lateral flow immunoassay technology, used to identify nucleocapsid proteins from SARS-CoV-2. The Sofia SARS Antigen FIA test kit reports results from nasal swabs within 15 minutes, and the company’s Read Now or Batch Test Mode can return results for up to 50 samples in an hour. Quidel, headquartered in San Diego, developed the first antigen test to win FDA approval in May.
The NIH’s $71 million contract will fund the expansion of Quidel’s manufacturing lines in San Diego, increasing its output from 84 million test cassettes per year to more than 220 million. Quidel’s line of FDA-approved assays in the US includes influenza A and B, respiratory syncytial virus (RSV), group A strep, and a 15-minute finger-stick whole blood test for Lyme disease.
Talis Biomedical Corporation
Talis Biomedical produces the third point-of-care test in the RADx pipeline — a multiplexed cartridge that detects SARS-CoV-2 using isothermal amplification of viral RNA and an optical detection system. The Menlo Park, CA-based company inked a $25 million contract for its Talis One Covid-19 test, which promises results within 30 minutes that are saved on the cloud. Though Talis currently has its sights set on Covid-19, it may pursue influenza, STIs, and other infections as future indications.
Ginkgo Bioworks took home a $40 million contract to expand its operational capacity for large-scale Covid-19 testing at its automated facilities. The Boston-based biotech plans scale up to 50,000 tests per day in December, then 100,000 per day by year’s end. Results are provided within 24 to 48 hours of sample collection.
Volume is where Ginkgo shines. Its next-generation sequencing equipment (NGS) is designed to process many DNA and RNA samples on the same machine, allowing thousands of tests to occur at once. In May, Illumina pumped $70 million into the company to build infrastructure for its automated testing labs.
Helix OpCo will use $33.4 million in NIH funding to up its testing capacity to 100,000 per day by the fall. The plan is to ship nasal swab kits in bulk to public health departments, health care systems, employers and more, and return results between 24 and 48 hours later.
For now, California-based Helix uses real-time RT-PCR testing to qualitatively detect nucleic acid from SARS-CoV-2 in upper respiratory patients. But it has also filed an EUA request for its Covid-19 NGS test, a more sensitive test based on Octant Bio’s “SwabSeq” technology.
Fluidigm secured a contract of up to $37 million to upscale production of its Biomark HD microfluidics technology for Covid-19 testing, with $12 million in initial funding based on completion of milestones. One of Fluidigm’s platforms can test 6,000 samples in 24 hours, “with lower reagent requirements than comparable systems,” according to the San Francisco-based company’s website.
An upscale is in Mammoth Biosciences’ future. The San Francisco-based biotech will expand manufacturing of its DETECTR test, which uses CRISPR technology to identify nucleic acids indicative of SARS-CoV-2. The expansion is in line with Mammoth’s goal to increase and accelerate testing nationwide using its mechanisms in commercial labs.
Mammoth partnered with GlaxoSmithKline in May to develop the CRISPR-based tests. The company envisioned a quick swab test for use in homes or even airports. The University of California, San Francisco recently received EUA approval to use the DETECTR reagent set.
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