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Diagnostics FDA

 News Release - October 26, 2020

Helix Receives Expanded Emergency Use Authorization for On-site Unsupervised Self-Collection and Asymptomatic Screening with the Helix(R) COVID-19 Test

As one of the few tests with these indications, the Helix® COVID-19 Test provides organizations with significantly more flexibility in how they operate testing sites to support broad back-to-work and school screening

SAN MATEO, Calif., Oct. 26, 2020 -- (Healthcare Sales & Marketing Network) -- Helix, the leading population genomics company, announced that it 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."

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.

Today, Helix is providing COVID-19 testing services to health systems, employers, governments, retail pharmacies, and other organizations across the country. With these additional indications, Helix's current and future partners have significantly increased flexibility in how they roll out testing to their communities.

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.

Additional information, including important test information and limitations, is available at helix.com/COVID.

About Helix

Helix is the leading population genomics company operating at the intersection of clinical care, research, and genomics. Its end-to-end platform enables health systems, life sciences companies, and payers to advance genomic research and accelerate the integration of genomic data into clinical care. Powered by one of the world's largest CLIA / CAP next-generation sequencing labs and its proprietary Exome+® assay, Helix supports all aspects of population genomics including recruitment and engagement, clinically actionable disease screening, return of results, and basic and translational research. In response to the COVID-19 public health crisis, Helix has launched a sensitive and scalable end-to-end COVID-19 test system to meet the needs of health systems, employers, governments, and other organizations across the country. Learn more at www.helix.com.


Source: Helix

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