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NIH Issues Contracts for Faster Covid-19 Diagnostics

Accula SARS-CoV-2 test

Accula point-of-care test to detect SARS-CoV-2 viruses (Mesa Biotech)

31 July 2020. National Institutes of Health awarded contracts to seven companies for higher-speed Covid-19 detection tests to ease current reporting delays. The agency says contracts with the seven companies are the first awards made from its Rapid Acceleration of Diagnostics (RADx) initiative, totaling $248.7 million.

The U.S. needs a much higher volume of Covid-19 diagnostics to find and monitor infected individuals, as well as trace their connections to identify other exposed persons who also may be infected. According to the Covid Tracking Project, the U.S. is testing 700,000 to 800,000 people per day in the last week of July, but the RADx project aims to boost that number to six million tests per day.

Most Covid-19 detection tests today analyze swab samples taken by clinicians from the back of the throat, then sent to remote medical labs to detect viral ribonucleic acid or RNA. At the remote labs a technique called reverse transcription – polymerase chain reaction, or RT-PCR, amplifies the tiny volume of RNA, genetic material that sends DNA code to cells to produce proteins, for sequencing and detection of the virus.

As of today, however, remote labs are backed up as the demand for testing increases, but lab staff and facilities remain largely static. Quest Diagnostics, one of the larger medical testing companies analyzing Covid-19 samples says it can process 135,000 samples per day, with customers waiting as long as 14 days for results.

NIH established the RADx program in April as crowd-sourced challenge to find the best candidates for Covid-19 diagnostics that can translate into large numbers of inexpensive and easy-to-use tests, in a relatively short period of time. RADx organizers expect to generate innovative solutions for diagnostics to detect SARS-CoV-2 viruses and antigens indicating the presence of antibodies protecting against infections. The agency says, as of today, it received 650 applications, of which 31 made the first cut, and with 20 teams still in contention.

The first seven RADx awards include point-of-care diagnostics, but also technologies to speed-up lab analysis of specimen  samples. NIH says developers of these devices and systems either have an emergency use authorization from FDA, or applied for an EUA.

The point-of care device awards are:

Mesa Biotech in San Diego. Its Accula SARS-CoV-2 test uses a fast RT-PCR analysis in a hand-held device that returns results in 30 minutes.

Quidel Corp. in San Diego. Quidel’s Sofia SARS Antigen FIA test kit uses a lateral flow technique like paper test strips that analyze swab samples for SARS-CoV-2 viral antigens, and return results in 15 minutes.

Talis Biomedical in Menlo Park, California. The company’s Talis One system captures samples on a cartridge, then conducts a faster PCR test than conventional technologies to return results in 30 minutes.

The lab-based awards are:

Gingo Bioworks in Boston. The company is scaling up its processes for sample handling and high-throughput sequencing, to analyze 50,000 samples per day by September and 100,000 samples per day by the end of the year, reporting results within 48 hours.

Helix in San Mateo, California. Helix is also scaling up its systems and capacity with more automation and high-throughput sequencing to process 50,000 samples per day by September and 100,000 samples per day by the end of the year, and reporting results within 48 hours.

Fluidigm Corp. in South San Francisco, California. The company’s BioMark HD uses microfluidics or lab-on-a-chip technology to analyze non-invasive saliva samples, and process tens of thousands of tests per day by the fall of 2020, but no delivery time targets are indicated.

Mammoth Biosciences in South San Francisco, California. Mammoth’s Detectr technology uses the gene-editing technique Crispr to cut DNA strands at specified points and read signals from the cuts indicating the presence of SARS-CoV-2 virus. Science & Enterprise reported in May that Mammoth Biosciences is partnering with drug maker GlaxoSmithKline to develop a Covid-19 point-of-care test, but the company also configures the technology for commercial labs.

“The innovations selected to date represent the diverse types of promising technologies that will serve the nation’s testing needs,” says NIH director Francis Collins in an agency statement. The contracts are expected to support scale-up and manufacturing of the companies’ devices and systems.

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