Editor: What To Know
- 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.
- This project is supported by the NIH Rapid Acceleration of Diagnostics Advanced Technology Platforms (RADx-ATP) program and has been funded in whole or in part with Federal funds from the Office of the Director, National Institutes of Health, Department of Health and Human Services, under Contract No.
- To support the rapid expansion of its testing capabilities and capacity, Helix has filed an additional EUA for the HelixⓇ COVID-19 NGS Test, a higher throughput and more sensitive COVID-19 test based on next-generation sequencing technology, which is currently under review by the FDA.
July 31, 2020
Helix today announced that it has been awarded $33.4 M in funding from the National Institutes of Health (NIH) under the Rapid Acceleration of Diagnostics program. (RADx).
Helix notes this funding was awarded as part of the Advanced Technology Platforms (ATP) subcomponent of the RADx program, which is focused on supporting scale-up of more advanced technologies that can have a near-term and significant impact on the country’s testing capacity. This includes expanding “mega-labs” that can increase testing capacity to 100,000 to 250,000 tests per day. Helix will use these funds to support rapid scaling of all aspects of its COVID-19 infrastructure and operations, with a goal of reaching a capacity of 100,000 COVID-19 tests per day by the Fall and the potential to scale even further.
“There is an urgent need for more rapid and reliable COVID-19 testing across the country. We’re honored to have received this funding from the NIH and to be able to help the country meet this need by transforming our operations and facilities into one of the country’s highest throughput COVID-19 laboratories,” said Marc Stapley, Helix President & CEO. “With this support from the NIH, we’ll be able to rapidly scale our offering to help millions of Americans access much-needed tests.”
Helix’s end-to-end test system 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.
This system currently utilizes the HelixⓇ COVID-19 Test, a real-time RT-PCR test intended for the qualitative detection of nucleic acid from 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 received Emergency Use Authorization (EUA) from the FDA on July 23, 2020 and is available nationally to health systems, employers, governments, and other organizations in need of a sensitive and scalable COVID-19 testing solution with next day results.
To support the rapid expansion of its testing capabilities and capacity, Helix has filed an additional EUA for the HelixⓇ COVID-19 NGS Test, a higher throughput and more sensitive COVID-19 test based on next-generation sequencing technology, which is currently under review by the FDA. This test, based on the “SwabSeq” protocol developed by Octant, continues to be iterated through a broad community effort involving academic and industry collaborators.
“Helix operates one of the world’s largest clinical next-generation sequencing labs and we’ve invested heavily in automated workflows to support large-scale clinical testing,” said James Lu, M.D., Ph.D., co-founder and Chief Scientific Officer at Helix. “By combining these capabilities with the launch of one of the first next-generation sequencing-based COVID-19 tests, we’ll be able to significantly increase COVID-19 testing capacity.”
“This is an exciting milestone,” said Bruce Tromberg, Ph.D., Director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and leader of RADx Tech, one of four components of the NIH RADx initiative. “It will help increase U.S. testing capacity exponentially. Game-changing technologies emerging from our RADx pipeline will inform public health measures to stop the spread of the virus and leave us better equipped to address future pathogens and other diseases.”
This project is supported by the NIH Rapid Acceleration of Diagnostics Advanced Technology Platforms (RADx-ATP) program and has been funded in whole or in part with Federal funds from the Office of the Director, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92020C00006.
The HelixⓇ COVID-19 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.
