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April 6, 2022

US FDA grants EUA for Helix COVID-19 self-collection kit

The Helix COVID-19 Self-Collection Kit will be available to consumers from participating pharmacies and urgent care centres.

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Helix’s SARS-CoV-2 Test and Helix COVID-19 Self-Collection Kit for use with a Locker System.

The test is designed for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens.

The samples can be self-collected using the Helix Self-Collection Kit without supervision by individuals aged 18 years or above who are suspected of having Covid-19 by a healthcare provider.

Helix stated that the kit will soon be available to consumers from participating pharmacies and urgent care centres that are authorised to supply unsupervised self-collection kits.

The kits can be retrieved from a secure locker, and results will be provided the next day.

Individuals who wish to get the kit can book an appointment at home or on-site and wait for approval from a physician.

The person will then be provided with secure access details, such as a unique locker code, which can be used to open the locker, retrieve the collection kit and begin the self-collection process.

The process includes self-collection of nasal swab sample, packaging, depositing it at the designated drop-off site and receiving test results. 

Helix CEO and co-founder Dr James Lu 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 authorised 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.”

Test distributors can collect the samples daily and send them to the Helix laboratory in San Diego, California.

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