Helix Receives FDA Emergency Use Authorization for the HelixⓇ COVID-19 NGS Test

One of the First Sequencing-Based COVID-19 Tests

Tuesday, September 22, 2020

Helix has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Helix COVID-19 NGS Test.

The test is an amplicon-based next-generation sequencing (NGS) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens (nasopharyngeal swabs, oropharyngeal (throat) swab, mid-turbinate nasal swabs, and anterior nasal swabs) from individuals suspected of COVID-19 by their healthcare provider.

This test is highly multiplexed to enable a large number of samples to be sequenced on each instrument and is a critical part of Helix’s plan to scale its COVID-19 capacity to 100,000 tests per day and potentially further. It was developed based on Octant’s “SwabSeq” protocol, which continues to be iterated through a broad community effort involving academic and industry collaborators. As one of the first next-generation sequencing tests authorized by the FDA, the Helix COVID-19 NGS Test will enable Helix to diversify and add redundancy to its existing supply chain for its PCR-based test, the Helix COVID-19 Test, also authorized for emergency use by the FDA.

The test will be part of Helix’s end-to-end test system, which includes a non-invasive collection kit, processing of samples in Helix’s CLIA-certified, CAP-accredited high-complexity laboratory in San Diego, next-day turnaround time, and return of results to the ordering healthcare professional, the tested individual, and public health agencies, as necessary.

Helix also announced on July 31, 2020, that it was selected by the NIH’s Rapid Acceleration of Diagnostics (RADx) program to become one of the country’s COVID-19 “mega-labs”.

“The authorization of our next-generation sequencing-based test is an important step forward in dramatically scaling our COVID-19 testing capacity while maintaining high sensitivity,” said Marc Stapley, Helix President and CEO. “Combined with the recent funding we announced from the NIH RADx program, we will quickly become one of the highest throughput COVID-19 testing labs in the country and help millions of Americans access much-needed tests with next-day turnaround time.”

“The ability to utilize next-generation sequencing technology to conduct 100,000 tests per day in the same laboratory is a logistical and scientific breakthrough,” said Rick Bright, Ph.D., Senior Advisor to the NIH Director. “This sets the country on an important path in the testing of COVID-19. The NIH’s RADx program is firmly committed to putting its resources and expertise to support the countries’ top innovators to ensure more rapid testing is available to address the COVID-19 pandemic.”

The Helix COVID-19 NGS Test has been authorized by FDA under an EUA for use by authorized laboratories. This test has not been FDA cleared or approved. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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