The EUA status enables CLIA-certified laboratories to conduct the testing with RapidRona’s self-collection kit for Covid-19.
Technology-enabled medical device company RapidRona has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 sample self-collection kit.
RapidRona, the Chicago-based company, is said to leverage a network of dozens of independent CLIA-certified laboratories.
The EUA status enables these laboratories to conduct the testing with RapidRona’s self-collection kit for Covid-19.
The kit and online interface have been designed to conduct the testing, and requires no scheduling or lines, contact, and observation, said the company.
The kit allows patients to take samples at home with the use of a cotton swab of the nostrils. With contact-free pick-up, the test samples will be delivered to an authorised laboratory in RapidRona’s nationwide network.
Later, the samples undergo real-time reverse transcription-polymerase chain reaction (RT-PCR) tests to electronically deliver results to the patient.
RapidRona to initially provide testing kits via online
RapidRona will initially provide the kits online for patients with symptoms or known exposure.
The company stated that it focused on delivering convenience, ease-of-use and guaranteed turnaround times for in vitro diagnostic testing for Covid-19 as the pandemic enters into flu season.
RapidRona CEO and co-founder Heather Mlodinow said: “The investment of time and money to create a network that connects the disconnected laboratory capacity in the United States makes this the first EUA granted to a company built for adaptive matching of regional supply and demand during a pandemic.
“We offer CLIA-certified laboratories the opportunity to participate in the US testing effort as their capacity ebbs and flows.”
Recently, Lucira Health has secured FDA EUA status for its at-home self-testing Covid-19 diagnostic kit.
Lucira Covid-19 all-in-one test kit is a molecular single-use test developed for the detection of the novel coronavirus SARS-CoV-2, which is responsible for the Covid-19 disease.