ELLUME COVID-19 HOME TEST NOW AVAILABLE THROUGH COVID.GOV/TESTS FOR BLIND AND LOW-VISION PEOPLE

New White House initiative provides Ellume COVID-19 Home Tests, which offer enhanced accessibility for people who are blind or have low vision, at no cost to Americans across the country.

FREDERICK, Md., July 14, 2022 /PRNewswire/ -- Digital diagnostics company Ellume, applauds the Biden administration's action to make its Ellume COVID-19 Home Test (ECHT) available at no cost to Americans who are blind or have low vision through covid.gov/tests. In support of the February 24, 2022, White House announcement on improving at-home test accessibility for individuals with disabilities and older adults, Ellume has worked with the U.S. Food and Drug Administration (FDA), the U.S. Department of Health and Human Services (HHS), the National Institutes of Health's (NIH) RADx initiative and the National Federation of the Blind (NFB) to ensure ECHT is accessible to users who are blind or have low vision.

Consumers who are blind or have low vision can order the Ellume COVID-19 Home Test free-of-charge by calling 1-800-232-0233 or online at https://special.usps.com/testkits/accessible. Each order will include twelve rapid antigen tests and will ship free, while supplies last. More information regarding testing is available at covid.gov/tests.

"Ellume is incredibly proud to help make at-home COVID testing more accessible. For too long, Americans who are blind or have low vision have struggled to take advantage of this vital tool in the pandemic," said Dr. Sean Parsons, Founder and Chief Executive Officer of Ellume. "From the outset, we designed our test with consumers in mind, featuring audio step-by-step instructions and digitally generated results. In collaboration with the National Federation of the Blind, we are working to make our product the most accessible at-home test on the market. We support the White House program to make our digital tests readily available for the blind or low vision community."

"When we first assessed the Ellume test kit months ago we were surprised to find a high degree of accessibility despite a few notable barriers. We thank Ellume for its thoughtful design and for working with us to further improve the nonvisual access of their COVID tests. While there are more improvements needed in the government program, we can all be proud of the results from our COVID testing advocacy efforts that have successfully created changes in the program leading to the ability of blind Americans to receive twelve free tests per order," said Mark Riccobono, President of the National Federation of the Blind. "By working together, we have forever enhanced the accessibility of at-home-testing products for blind Americans, and we are excited for our continued collaboration."

The Ellume COVID-19 Home Test is the only available antigen test being provided through the free distribution program that is sufficiently accessible to users who are blind or have low vision, according to the NFB. The test and accompanying app offer a range of bespoke features that ensure a more user-friendly experience.

• The ECHT and app, coupled with a smartphone screen reader, enables users who are blind or have low vision to navigate the test by guiding them through each step of the testing process, minimizing human error and providing enhanced safety;
• Using Bluetooth^® connectivity, the ECHT automatically generates a fully digital result displayed in words on a user's smartphone which can be read using screen reader functionality, without the need for visual test lines to be interpreted, or photos to be taken;
• Fully digital results can be easily shared with others such as healthcare providers, employers, or family;
• Additional healthcare information and a direct link to customer support are provided to the user after testing is complete, to further support their testing experience;
• ECHT components are larger and free-standing, without the need to be housed in the carton or packaging when performing the test;
• User-designed components make handling components more manageable, and Ellume's patented Dropper system makes combining the sample and Processing Fluid easy-to-use, and
• Ellume's patented swab provides confidence in swab depth for adults and children, enhancing the likelihood of sufficient sample collection.

Ellume updated all online labeling to be fully compatible with screen reader functionality, utilizing Adobe Accessibility tools, the industry leader in developing online functions for the people who are blind or have low vision. Ellume reviewed these updates in collaboration with the NFB to ensure the documents not only pass the testing process with Adobe but are functional for real-world usage.

According to the Centers for Disease Control and Prevention (CDC)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.

For further information visit ellumehealth.com.

U.S. Media Inquiries
Seven Letter for Ellume
E: ellume@sevenletter.com
M: +1 202 315 2386

Australian Media Inquiries
Patrick Condren, Ellume
E: Patrick.condren@ellumehealth.com
M: +61 405 186 630

In the USA, 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, 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.

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

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SOURCE Ellume