We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
PURITAN MEDICAL

Download Mobile App





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

By LabMedica International staff writers
Posted on 27 Nov 2020
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. More...
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.”

Related Links:
RapidRona


Gold Member
Multiplex Genetic Analyzer
MassARRAY Dx Analyzer (Europe only)
3-Part Differential Hematology Analyzer
Swelab Alfa Plus Sampler
New
DNA/RNA Extraction/Purification Kit
Nucleic Acid Extraction or Purification Kit
New
Pan-Cancer Panel
TruSight Oncology 500
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








DIASOURCE (A Biovendor Company)

Channels

Hematology

view channel
Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Immunology

view channel
Image: How the predictive test works (Photo courtesy of QMUL)

World’s First Clinical Test Predicts Best Rheumatoid Arthritis Treatment

Rheumatoid arthritis (RA) is a chronic condition affecting 1 in 100 people in the UK today, causing the immune system to attack its joints. Unlike osteoarthritis, which is caused by wear and tear, RA can... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.