US-based population genomics company Helix has secured an expanded US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its Helix Covid-19 Test.
The sequencing-based Covid-19 test was initially granted EUA for the qualitative detection of the SARS-CoV-2 nucleic acid in individuals suspected of Covid-19 by their healthcare providers.
The test uses specimens including nasopharyngeal swabs, oropharyngeal (throat) swab, mid-turbinate nasal swabs, and anterior nasal swabs.
Expanded EUA for Helix Covid-19 Test allows screening or population-based testing in asymptomatic individuals, and facilitates self-collection of samples to eliminate the need for supervision of a healthcare professional.
Helix CEO Marc Stapley said: “Scaling rapid and reliable Covid-19 testing isn’t just a science or technology problem, it’s also a significant logistical challenge.
“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.”
Helix is among the few laboratories authorised for asymptomatic Covid-19 testing
The unsupervised sample collection feature would provide organisations using Helix Covid-19 Test with enhanced flexibility in and operating the testing sites and collection centres.
Also, the expanded functionality also contributes for reduction in collection costs and mitigating shortages in clinical resources across the country, said the company.
Testing of asymptomatic individuals needs a high sensitive test, where a recent report from the FDA confirmed that Helix Covid-19 test is among the most sensitive tests.
Helix claimed that the expanded EUA has enabled it join the few laboratories authorised to test asymptomatic individuals for Covid-19, and noted that the asymptomatic testing plays crucial role in strategy for safe reopening schools and workplaces.
The company is engaged in providing Covid-19 testing services to health systems, employers, governments, retail pharmacies, and other organizations across the country.
Helix co-founder and president James Lu said: “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.
“Further, reducing the barriers to testing enables us to reach some of the most vulnerable and underserved populations in the US.”
