The FDA has given genomics firm Helix a wider emergency use authorization (EUA) for its pandemic test.
The U.S. regulator said Helix is now allowed to offer its virus test for on-site and unsupervised self-collection as well as asymptomatic screening.
In a nutshell, Helix’s new EUA means it is cutting out the need for medical staff to oversee collection, as is currently required with most COVID-19 tests, and means organizations using the Helix COVID-19 Test gain “significantly more flexibility in how they operate testing sites to support broad back-to-work and school screening,” according to the Californian company.
“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 (which is still not a full approval), Helix also becomes one of the few labs authorized to test asymptomatic individuals for COVID-19, which it said is “an important part of any strategy to reopen schools and workplaces safely.”
Recent research suggest much of the second wave of infections appears to be coming from people not showing overt signs of suffering from the virus, making community spread, especially in reopening schools and universities, tough to stamp out.
The hope is that by having quicker tests that can be handled at speed, testing those who may not be ill but still infectious can help break the wave.
“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,” added James Lu, M.D., Ph.D., co-founder and president of Helix. “Further, reducing the barriers to testing enables us to reach some of the most vulnerable and underserved populations in the U.S.”