Ellume COVID-19 Home Test to Allow Users to Send Results Directly to Healthcare Providers

FREDERICK, Md. and BRISBANE, Australia, Dec. 13, 2021 /PRNewswire/ -- In anticipation of the U.S. Food & Drug Administration's (FDA) granting emergency use authorization to two new antiviral treatments for COVID-19, digital diagnostics company Ellume today announced that its COVID-19 Home Test (ECHT) will soon allow users to connect directly with telemedicine providers, which builds on the test's existing capability to share their result directly to healthcare providers. This direct, digital connection to telemedicine providers, currently in development, will help ensure patients have quick access to the new antiviral treatments, which typically must be taken shortly after infection to be most effective. 

"With growing concern about the threat from the new Omicron variant, people are increasingly turning to rapid at-home COVID-19 tests to help keep themselves and their families safe. By combining these tests with the new antiviral drugs, we have a powerful tool that can help better manage the pandemic and provide peace-of-mind to everyone concerned about catching or spreading the virus," said Dr. Sean Parsons, Founder and Chief Executive of Ellume. 

The new antiviral therapy coming on the market will be most effective when taken five days or less after symptoms develop, meaning that consumers need to receive a positive test and be connected to a doctor who can prescribe treatment in a short window. The advanced digital capabilities in Ellume's ECHT will address this need by allowing users to connect directly to a medical professional following a positive test. Upon receiving test results, the information is automatically transmitted to the user's smartphone and able to be reported in real time to healthcare providers, or other organizations as needed.

More than one-quarter of Americans don't have a primary care doctor, so Ellume's test will provide the option of connecting to your own healthcare provider, if you have one designated, or allowing you to choose from a selection of telemedicine providers in the area. To truly take advantage of new medications, early, accurate diagnostics can help facilitate timely treatment measures. 

With its innovative telehealth capabilities, Ellume is empowering consumers with the information they need to navigate the pandemic and the confidence that receiving treatment if needed will be as easy-as-possible.

THE ELLUME COVID-19 HOME TEST:
In developing the Ellume COVID-19 Home Test (ECHT), Ellume took a different approach than many other antigen detection products on the market – one that provides increased sensitivity without the cost, complexity and accessibility issues of a laboratory-based molecular (PCR) test. The ECHT is the only rapid home antigen test that uses fluorescent technology, which provides superior sensitivity and has previously been used exclusively by healthcare professionals. The ECHT was the first rapid home antigen test to receive an EUA and is one of the few home tests clinically proven for symptomatic and asymptomatic use without requiring serial testing. The test's swab enables deeper sample collection, offering the best compromise between sample quality and patient comfort. The test's app guides the user through the test steps and displays the results in words within 15 minutes ensuring easy result interpretation. The test also includes a sample integrity control system to identify if an insufficient sample was collected which minimizes the risk of false negative results. The ECHT was awarded a TIME Best Inventions of 2021 award and a Popular Science Best of What's New for 2021 award.   

This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA; This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

ABOUT ELLUME
Ellume is a digital diagnostics company that develops, manufactures, and commercializes high-performance, connected products for healthcare professionals and consumers. It is at the forefront of accurate, rapid and accessible testing that is integral to today's COVID-19 response and will help ensure the world is prepared for the next infectious disease pandemic. Ellume's key focus is on the detection of common infectious diseases which affect the global population across all diagnostic settings; at-home, point-of-care and in-laboratory. Ellume has a global COVID-19 and TB partnership with QIAGEN, and a range of professional products under its ellume·lab brand. Ellume is committed to developing high-quality digital diagnostics that the world can rely on in a health crisis.

Further information can be found at ellumehealth.com. 

U.S. Media Inquiries
Seven Letter for Ellume
E: [email protected]
M: +1 202-315-2386

Australian Media Inquiries
Patrick Condren, Ellume
E: [email protected]
M: +61 405 186 630

SOURCE Ellume