Ellume’s COVID-19 Home Test Automatically Reports Depersonalized Test Results to HHS and State Health Departments to Better Track Virus Spread
This unique data capability is a powerful tool for managing the pandemic
Frederick, Md. and Brisbane, Australia, April 22, 2022 — With the rise of at-home testing and a recent increase of COVID-19 cases across the United States, public health officials have expressed concern about an undercounting of cases and a lack of data that may hamper America’s pandemic response. Digital diagnostics company Ellume is today highlighting its COVID-19 Home Test’s automatic reporting function that enables test results to be securely shared with the Department of Health and Human Services (HHS) and State Health Departments – allowing for real-time insights into pandemic trends. The resulting data is deidentified and encrypted to protect consumer identity and privacy.
“The ability of the Ellume COVID-19 Home Test to automatically report depersonalized and encrypted data is a powerful and innovative tool that can help better manage the pandemic,”said Dr. Sean Parsons, Founder and Chief Executive Officer of Ellume. “Individuals are increasingly turning to rapid at-home COVID-19 tests to help keep themselves and their families safe, and our approach to data sharing provides important information to identify COVID-19 outbreaks in real time.”
The Ellume COVID-19 Home Test (ECHT) – the first over-the-counter rapid home antigen test to receive an Emergency Use Authorization from the U.S. Food and Drug Administration – is the only at-home rapid COVID-19 antigen test to offer automatic, real-time results reporting. Ellume’s test digitally transmits deidentified and encrypted test results through a secure cloud connection, providing public health officials with visibility on virus spread, both geographically and temporally – and helping pinpoint emerging hot spots before they truly catch fire. Ellume’s test results are transmitted to public health authorities in real time providing over the horizon data to allow officials to more effectively manage their community response.
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 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 authorized for use in individuals with or without symptoms. 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.
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 ellume.com.
U.S. Media Inquiries
Seven Letter for Ellume
E: [email protected]
M: +1 202-315-2386
Australian Media Inquiries
Patrick Condren, Ellume
E: Patrick.condren@
M: +61 405 186 630
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The Ellume COVID-19 Home Test 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, the emergency use of 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.
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