Helix, a provider in population genomics, COVID-19 diagnostic testing, and viral surveillance, received FDA Emergency Use Authorization (EUA) for its SARS-CoV-2 Test and Helix COVID-19 Self-Collection Kit for use in a secure, self-service test-retrieval system.
The Helix “Locker System” allows consumers to request a COVID-19 Self-Collection Kit from participating pharmacies and urgent care centers—authorized for unsupervised self-collection—and retrieve the kit from a secure locker, test results available within the next day.
“As the Omicron variant continues to impact communities, it’s clear that COVID-19 will not be going away any time soon,” says James Lu, MD, PhD, CEO and co-founder of Helix. “There continues to be significant demand for quick and accurate PCR diagnostic testing, and this self-service system ensures that meeting demand will not strain our already overstretched front-line providers and pharmacists.”
The ability to access the Helix COVID-19 Self-Collection Kit from a secure, self-service locker empowers individuals to get tested. Individuals can simply book an appointment at home or on-site and wait for physician approval. Individuals are assigned a unique locker code which they use to retrieve their kit from the locker, self-collect a nasal swab sample, package their sample, deposit it at the designated drop-off site and receive their test results within the next day.
“With the Helix SARS-CoV-2 Test authorized for use in a locker system, we are filling and bolstering the critical need for continued diagnostic testing in both urban and rural underserved communities to deliver better health outcomes for all,” says Lu.
Helix will work with authorized distributors of the kit to align on daily or weekly testing volumes. Test distributors will refill lockers and collect samples daily and send samples to the Helix laboratory in San Diego, California. Test results are typically available within the next day, after a placed order and are returned directly to the ordering provider and patient, if desired.