- FDA has authorized 225-plus diagnostic tests for COVID-19 since pandemic began
- CareStart(TM) COVID-19 antigen test received FDA authorization in July 2020
- UME carries CareStart antigen kit, a powerful component of COVID-19 screening process
Since the beginning of the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) has authorized more than 225 diagnostic tests for COVID-19 in an effort to provide growing resources to combat the disease. United Medical Equipment Business Solutions Network (“UME”), a company committed to offering a comprehensive line set of COVID-19 products, recently added one of those tests — the CareStart(TM) COVID-19 rapid antigen kit — to its product line.
“The FDA strongly supports innovation in test development and we have worked tirelessly with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them,” said Jeff Shuren, MD., J.D. and director of the FDA’s Center for Devices and Radiological Health (https://ibn.fm/rVMjI).
The CareStart COVID-19 antigen test received FDA authorization in July 2020 (https://ibn.fm/iFrI8). In a letter to Access Bio Inc., the company that manufactures the test, FDA chief scientist Denise M. Hinton explained that the secretary of the Department of Health and Human Services (“HHS”) had “determined a public health emergency existed that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19.”
Hinton noted that the circumstances justify the authorization of diagnostic measures designed to detect or diagnose the virus that causes COVID-19, and therefore, “I am authorizing the emergency use of your product,” Hinton wrote.
The CareStart COVID-19 Antigen packaging material notes that “due to the highly contagious nature and global spread, SARS-CoV-2 . . . continues to have devastating impacts on healthcare systems and the world economy, including the U.S.” (https://ibn.fm/OSKkr). Systematic screening and detection of both clinical and asymptomatic systems is an essential piece of ending the SARS-CoV02 pandemic, and the CareStart antigen kit can be a key component of that screening process. The innovative test features a 10-minute processing time, identifies acute infection with 88.4% sensitivity and 100% specificity, and helps provide critical answers about active infections to patients and healthcare workers alike.
The CareStart product is part of UME’s comprehensive COVID-19 monitoring strategy, which was carefully designed with the assistance of medical experts and includes ongoing, data-driven COVID-19 testing. In addition to the CareStart COVID-19 Antigen tests, UME provides a wide array of other COVID-19 supplies and products, including sanitizers, gloves and face shields, thermometers, hoods and masks.
UMEs’ mission is to provide guidance for caregivers, veterans, the aging population and the medical community through its robust medication management and telehealth applications. In addition, the company recognizes the importance of being socially responsible as a corporation by giving back to the world through emergency assistance grants awarded to seniors, with an emphasis on veterans, by supporting nonprofits in their missions, and by supporting the American economy by providing work-at-home opportunities.
For more information, visit the company’s website at www.UnitedMedSolutions.com.
NOTE TO INVESTORS: The latest news and updates relating to United Medical Equipment are available in the company’s newsroom at https://ibn.fm/UnitedMed
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