24 November 2020 - - US-based medical device company RapidRona has received Emergency Use Authorization from the FDA for its SARS-CoV-2 sample self-collection kit, the company said.

The Chicago-based company said it is focused on delivering 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.

Our EUA, which can be found here, 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. No scheduling or lines. No contact or observation.

No "brain-tickling" deep nasal swabs. Just a simple cotton swab of the nostrils that a patient-consumer can do in the comfort of their home, with contact-free pick-up and delivery to an authorized laboratory in RapidRona's nationwide network.

The sample then undergoes RT-PCR the current gold standard for diagnostic accuracy and the results are electronically transmitted to the patient.

This 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.

RapidRona is committed to bringing faster in vitro diagnostic test results by the real-time distribution of patient demand across a nationwide network of CLIA-certified laboratories that have excess capacity.

Founded in Chicago in March as a response to the global COVID-19 pandemic, RapidRona has received an FDA Emergency Use Authorization for an unsupervised, self-collection COVID-19 kit while contracting with labs that have tens of thousands of tests per day in capacity.

The company plans to continue to augment its CLIA laboratory network, while also pursuing approval and development of additional products to leverage the testing capabilities of these dedicated partners.