Medical device company RapidRona has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 sample self-collection kit.
The EUA for the kit will enable the company to start testing with independent CLIA-certified laboratories.
The Chicago-based firm intends to provide convenience, ease-of-use and guaranteed turnaround times for in vitro diagnostic testing for Covid-19.
The kit and online interface could cut down efforts needed for getting oneself tested as there would be no need for scheduling, long queues, deep nasal swabs or even coming in contact with people.
With a simple cotton swab of the nostrils, patients can take the sample in the comfort of their homes.
They can have a contact-free pick-up and delivery to an authorised laboratory in RapidRona’s network in the US.
At the lab, the sample taken undergoes RT-PCR, which is the present gold standard for diagnostic accuracy. The results of the test are transmitted electronically to the patient.
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.
“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.”
“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.”
In the initial phase, the kit will be available online for patients with symptoms or known exposure.
RapidRona plans to retail the kit for $200, which includes all shipping, handling and service fees.