FDA issues EUA for Helix COVID-19 NGS test

Helix announced today that it received FDA emergency use authorization (EUA) for its Helix COVID-19 next-generation sequencing (NGS) test.

San Mateo, Calif.-based Helix’s NGS test is intended for the qualitative detection of nucleic acid from SARS-CoV-2 (the virus causing coronavirus) in upper respiratory specimens from individuals suspected of having COVID-19 by their healthcare provider, according to a news release.

The company said its test is highly multiplexed to enable a large number of samples to be sequenced on each instrument as part of its plan to scale its COVID-19 testing capacity to 100,000 tests per day, with eyes on even more down the road.

Helix developed the test on the back of Octant’s “SwabSeq” protocol and is set to diversify the company’s existing supply chain for its PCR-based Helix COVID-19 test which also has EUA. The company was recently selected as part of the National Institutes of Health’s R…

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NIH puts $249m into new COVID-19 tests

Quidel’s Sofia 2 point-of-care COVID-19 test. (Image from Quidel/NIH)

The National Institutes of Health (NIH) announced today that it is investing $248.7 million in new technologies to address challenges with COVID-19 testing.

The “Rapid Acceleration of Diagnostics” (RADx) initiative awarded contracts to seven biomedical diagnostic companies to support lab-based and point-of-care tests that could significantly increase the number, type and availability of tests by millions per week as early as September 2020, according to a news release.

Four of the selected technologies offer innovations in laboratory-based testing, including next-generation sequencing, CRISPR and integrated microfluidic chips for increasing testing capacity and throughput while reducing the time needed to receive results.

Remaining are three point-of-care technologies that provide nucleic acid and viral anti…

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