Information on the 7 companies selected thus from the NIH Shark tank competition which is offering $250 million in funding for companies that have prospects of developing rapid tests by the Autumn of 2020.
After scrutinizing several dozen submissions the National Institutes of Health has selected its first seven projects that will move on to a new phase of manufacturing and scale-up. Nearly nearly a quarter of a billion dollars is available to these firms to scale.
The NIH’s Rapid Acceleration of Diagnostics initiative, or RADx, was launched in late April, 2020 with the goal of providing millions of new coronavirus tests to the public by September. This includes high-throughput laboratory hardware capable of processing hundreds of samples per day as well as smaller machines designed for rapid testing in the field.
From more than 650 applications, the most promising 100 were put through a one-week assessment of their technology and feasibility. Thirty-one made the cut, and entered Phase 1 of the process: four to six weeks of deeper validation work and reviews conducted by a panel of experts.
These companies will graduate to Phase 2 and a final series of evaluations before clinical trials, fast-tracked regulatory approvals and $248.7 million in new funding.
“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,” HHS Secretary Alex Azar said in a statement.
Three tests will focus on providing in-person results in under a half-hour:
- Mesa Biotech’s hand-held Accula test, with a single-use, RT-PCR cartridge;
- Quidel’s Sofia antigen test kit, as an electronic, lateral flow immunoassay;
- Talis Biomedical’s Talis One viral RNA test, employing loop-mediated isothermal amplification, or LAMP.
Four are intended for the lab:
- Ginkgo Bioworks’ (describe) 50,000 tests per day in September and 100,000 per day before the end of the year.
- Helix OpCo (describe) plans to ship bulk, standardized kits for the collection of nasal swabs by public health departments, healthcare systems and employers to move tens of thousands of samples to labs for processing.
- Fluidigm (describe) will primarily focus on saliva-based samples, using its microfluidic chip platform. It aims to provide tens to hundreds of thousands of new tests per day this fall.
- Mammoth Biosciences (describe) looks to wield CRISPR technology to provide a simple, faster coronavirus lab test compared to typical PCR diagnostics. Co-founded by genome editing pioneer Jennifer Doudna, the company was also recently tapped by GlaxoSmithKline to develop a hand-held diagnostic.
The RADx initiative funnels companies through a competitive selection process. (NIH)
“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, innovations selected to date represent the diverse types of promising technologies that will serve the nation’s testing needs.” said NIH Director Francis Collins.
More than 20 companies are still engaged in RADx’s Phase 1, and will be considered for Phase 2 awards in the coming weeks, according to the NIH, with dozens more still moving through the funnel behind them.
Additional Resources/ Summary of Companies:
- Profiles of the 7 winning companies.
- Author and Publisher information.
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Company: Mesa Biotech, Inc.
Project Title: Rapid Manufacturing Scale-up for Compact Point-of-Care EUA SARS-CoV-2 RT-PCR Test
Project Description: This 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.
Company: Talis Biomedical Corp.
Project Title: Talis-One/Talis HT: Highly Scalable SARS-CoV-2 RNA Detection in Minutes, from POC to Hundred-per-Hour Throughput
Project Description: This point of care test is a multiplexed cartridge used with the compact Talis One instrument. The test detects SARS-CoV-2 through isothermal amplification of viral RNA and an optical detection system, returning a result in under 30 minutes.
Company: Quidel Corp.
Project Title: Manufacturing Capacity Scale-Up for Sofia SARS Antigen and Sofia Influenza A+B/SARS FIAs
Project Description: This test kit, a lateral flow immunoassay, is used with Sofia and Sofia 2 Analyzers in point of care settings, such as a doctor’s office or pharmacy. There are currently thousands of Quidel analyzers in place across the U.S. and HHS has identified this technology for nursing homes. The Analyzers give electronic results within 15 minutes.
Company: Mammoth Biosciences
Project Title: Detection of SARS-CoV-2 with the CRISPR-based DETECTR platform
Project Description: This assay uses CRISPR technology, which provides a simpler workflow and significantly faster turnaround time compared to conventional laboratory PCR tests. This high-throughput solution can result in a multi-fold increase in testing capacity in commercial laboratories.
Company: Fluidigm Corp.
Project Title: Scaling to Massive Throughput: 4.5 Million SARS-CoV-2 Tests per Day
Project Description: 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. With many existing Fluidigm instruments in clinical and research labs throughout the U.S., scale up and deployment of their advanced integrated fluidic chips can provide tens to hundreds of thousands of new tests per day in fall 2020.
Company: Helix OpCo, LLC
Project Title: Reproducible clinical test system for 1 million daily SARS-CoV-2 tests using amplicon sequencing
Project Description: 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 and processed within 24-48 hours using sophisticated automation processes and next generation sequencing technologies. Expected to process up to 50,000 samples/day by Sept. 2020 and 100,000/day by year’s end.
Company: Ginkgo Bioworks
Project Title: RADx-ATP Concentric: A High-Throughput Next Generation Sequencing-based Molecular Diagnostic for SARS-CoV-2
Project Description: Ginkgo is scaling up by using significant automation and next-generation sequencing technologies to process tens of thousands of tests at once. Working with universities, schools, public or private companies, and local communities, they will provide end-to-end sample collection and report results within 24-48 hours. Expected to scale up to 50,000 tests/day in Sept. 2020 and 100,000/day by year’s end.
By Conor Hale | Aug 3, 2020 11:27amNIH Shark Tank results