• [1], one in four adults in the United States has a disability, with 4.6% of these individuals experiencing vision disability with blindness or serious difficulty seeing even when wearing glasses. Ellume’s 215,000 square foot manufacturing facility in Frederick, Maryland will serve the home test needs of this population, while continuing to accelerate innovation in developing solutions for future public health needs.

  The development and supply of Ellume COVID-19 Home Tests has been funded in part by the NIH RADx initiative with US federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Biomedical Advanced Research and Development Authority, Department of Health and Human Services, under Contract No. 75N92020C00034 and the Department of Defense, under Contract No. W911NF2190003. 

  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 a result 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 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 enabling easy result interpretation. The test also includes a sample alert 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.

  For further information visit ellumehealth.com.

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  [1] https://www.cdc.gov/ncbddd/disabilityandhealth/infographic-disability-impacts-all.html

  Further information can be found at ellumehealth.com. 

  U.S. Media Inquiries	Australian Media Inquiries
  Seven Letter for Ellume E: [email protected] T: +1 202 315 2386	Patrick Condren, Ellume E: [email protected] M: +61 405 186 630

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• August 6, 2021
  • Approval gives U.S. healthcare professionals access to a new combination of scalability and speed.
  • QIAreach SARS-CoV-2 Antigen Test, developed in collaboration with Ellume, is easy to use and provides accurate and objective results in 2 to 15 minutes.
  • Each Digital eHub device, with capacity for up to 8 eSticks, can simultaneously run QIAGEN QIAreach SARS-CoV-2 Antigen and Antibody tests.

  GERMANTOWN, Maryland & HILDEN, Germany–(BUSINESS WIRE)– QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its QIAreach^® SARS CoV-2 Antigen Test, which is designed for environments that require a high volume of fast and accurate test results.

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• Ellume Media ContactAzova Company ContactAzova Media ContactLaunchSquad for Ellume
  E: [email protected]
  David Bean
  EVP Business Development
  P: 602-819-6291
  E: [email protected]TopSpin Communications
  Joe Waldygo, President
  P: 480-363-8774
  E: [email protected]” target=”_blank”>

• ¹: The first rapid, fully at-home test to receive Emergency Use Authorization by the FDA for at-home use without a prescription. The test delivers results in 15 minutes through a free app downloaded to a smartphone, without the need for a second test. CVS Pharmacy is the first retailer to carry the Ellume Home Test Kit. It will be in select locations in RI and MA the week of April 19, with increasing availability on CVS.com and in most CVS Pharmacy locations by the end of May.
• Abbott BinaxNOW COVID-19 Antigen Self-Test $23.99²: Reliable fully at-home test for surveillance and frequent use delivers results in 15 minutes. The box contains two tests which should be administered twice over three days with at least 36 hours between tests. The test is available at CVS.com and in 5,600 CVS Pharmacy locations as the week of April 19, with additional locations to follow.
• Pixel by Labcorp Home Collection Kit³: This PCR (polymerase chain reaction) test is the same test used by physicians across the U.S. Results typically are available within 1-2 days and can be accessed via the Pixel by Labcorp website. The test is available now at CVS.com and in select stores in AL, MA, RI and CT.

The OTC testing options are not covered by insurance and are not meant to diagnose acute COVID-19 infection or test the efficacy of COVID-19 vaccination. CVS Health has been increasing access to testing options since the start of the pandemic and has completed more than 15 million COVID-19 tests to date across more than 4,800 testing sites at select CVS Pharmacy locations, with nearly 1,000 of those locations providing rapid-result testing. With the addition of OTC testing options that can be conducted from the comfort of home, CVS Pharmacy continues to serve as a leader in COVID-19 testing, which remains a critical component of the nation’s pandemic response. More information about testing services is available at CVS.com.

About CVS Pharmacy

CVS Pharmacy, the retail division of CVS Health, is America’s leading retail pharmacy with nearly 10,000 locations, including over 1,700 pharmacies inside of Target and Schnucks grocery stores. We are committed to delivering innovative health solutions that create a simpler, more accessible experience for patients, customers and caregivers. CVS Pharmacy is the only national pharmacy to remove tobacco products from its shelves and has taken a leadership role in responding to the COVID-19 pandemic by making testing and vaccinations available at locations across the United States.For the latest product and service offerings, visit www.cvs.com or download the CVS Pharmacy app.

Media contact

Matt Blanchette
401-524-6185
[email protected]

1 The Ellume COVID-19 Home Test has not been FDA cleared or approved; but has been authorized by the FDA under an emergency use authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and 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.

2 The BinaxNOW COVID-19 Antigen Self Tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization. The tests have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and are 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.

3 Pixel by Labcorp offers this product with an FDA Emergency Use Authorization (EUA). This means that this product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA. This product has only been authorized by FDA for detection of nucleic acid from SARS-CoV-2 (i.e., the COVID-19 virus), and not for any other virus or pathogen. 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.