Helix has received an expanded Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Helix COVID-19 Test. With this expansion, individuals can now self-collect their samples without the supervision of a healthcare professional. Additionally, the test is now indicated for use in asymptomatic individuals for screening or population-based testing.
By eliminating the need for a healthcare professional to oversee collection, as is currently required with most COVID-19 tests, organizations using the Helix® COVID-19 Test will have significantly more flexibility in how they stand-up and operate testing sites and collection centers. This also helps to reduce collection costs and address shortages in clinical staffing across the country to ensure those resources are directed to where they are needed most.
"Scaling rapid and reliable COVID-19 testing isn't just a science or technology problem – it's also a significant logistical challenge," said Marc Stapley, Helix CEO. "This expansion of our EUA to enable on-site unsupervised self-collection helps our government, education, and employer partners significantly streamline their operations, decrease their collection costs, and more rapidly expand access to COVID-19 testing."
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With this expanded EUA, Helix also becomes one of the few laboratories authorized to test asymptomatic individuals for COVID-19, which is an important part of any strategy to reopen schools and workplaces safely. Testing asymptomatic individuals, however, requires a highly sensitive test. A recent report from the FDA comparing more than 75 other tests demonstrated that the Helix® COVID-19 test is one of the most sensitive on the market.
"Being able to broadly test individuals irrespective of symptoms is critical to ensure we're able to prevent and mitigate outbreaks and identify people as early as possible in the course of infection," said Dr. James Lu, M.D., Ph.D., co-founder and President at Helix. "Further, reducing the barriers to testing enables us to reach some of the most vulnerable and underserved populations in the US."
The Helix® COVID-19 Test is 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 from receipt of samples, and return of results to the ordering healthcare professional, the tested individual, and public health agencies. Since launching this system, Helix has maintained a median turnaround time of 14 hours from sample receipt in the Helix laboratory.