Helix SARS-CoV-2 Test with a Locker System Receives FDA Emergency Use Authorization (EUA)
Helix’s SARS-CoV-2 Test authorized for use with a Locker System Will Expand Equitable Access to Diagnostic COVID-19 Testing
SAN MATEO, Calif. April 5, 2022 – Helix, a nationwide leader in population genomics, COVID-19 diagnostic testing and viral surveillance, has received FDA Emergency Use Authorization (EUA) for its SARS-CoV-2 Test and Helix COVID-19 Self-Collection Kit for use in a secure ‘Locker System’ – the first and only SARS-CoV-2 test authorized for use with a self-service test-retrieval system.
Consumers will soon be able 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.
Dr. James Lu, CEO and co-founder of Helix, said:
“As the Omicron variant continues to impact communities, it’s clear that COVID-19 will not be going away any time soon. 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.
“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.”
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.
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, CA. 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.
In response to the COVID-19 pandemic, Helix quickly became one of the largest and most capable labs in performing high-throughput diagnostic testing nationally, processing up to 150,000 COVID-19 tests a day with up to next-day turnaround in all 50 states. Helix’s high-volume national testing footprint allowed the company to be one of the first to accurately identify the majority of Alpha cases nationally and predicted the timing of the Delta variant’s dominance in the summer of 2021. Helix is also playing an important role in tracking Omicron, recently identifying the first Delta and Omicron recombinant variant in the United States and providing real-time updates on the Omicron BA.2 variant.
Helix is the leading population genomics and viral surveillance company operating at the intersection of clinical care, research, and data analytics. Through its CLIA / CAP laboratory, its end-to-end workflow, and data analytics platforms, Helix enables health systems, life sciences companies, payers, and government partners to accelerate the integration of genomic data into patient care and public health decision making. Learn more at www.helix.com.