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RapidRona Self-Collection COVID-19 Kit Secures FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 27 Nov 2020
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RapidRona (Chicago, IL, USA) has received Emergency Use Authorization (EUA) from the FDA for its SARS-CoV-2 sample self-collection kit.

The kit aims to deliver convenience, ease-of-use, and guaranteed turnaround times for in vitro diagnostic testing for COVID-19 as the pandemic runs into flu season, testing shortages continue, and lead times among the largest testing labs increase. RapidRona leverages a growing network of dozens of independent CLIA-certified laboratories that want to help with the widely-criticized US testing shortage, but have no direct channel to do so. The EUA for the company’s Self-Collection Kit for COVID-19 samples allows it to initiate testing with these partners.

The kit and online interface were designed to take the effort out of getting tested by eliminating scheduling or lines, contact or observation, and “brain-tickling” deep nasal swabs. A patient-consumer can do a simple cotton swab of the nostrils in the comfort of their home, with contact-free pick-up and delivery to an authorized laboratory in RapidRona’s nation-wide network. The sample then undergoes RT-PCR - the current gold standard for diagnostic accuracy - and the results are electronically transmitted to the patient.

The EUA supports RapidRona’s first commercial efforts to match unmet demand to disconnected test capacity. The Self-Collection COVID-19 Kit will initially be made available online in the coming weeks for patients with symptoms or known exposure. Notification of kit availability will first be made to those on a waiting list, available at its website. When the online platform launches, the test is expected to retail for USD 200 which includes all shipping, handling and service fees.

“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. That flexibility to match lab supply with patient demand in real-time is what enables RapidRona to consistently deliver test results within 48 business hours of taking the sample.” said Heather Mlodinow, CEO and co-founder of RapidRona. “At the same time, our Self-Collection Kit allows the patient-consumer to remain safely tucked up at home, not being exposed nor exposing others to COVID-19.”

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