COVID-19 Antibody Test Distributed by MEDformance is First in the U.S. to Receive Point-of-Care Authorization

McMinnville TN— September 24, 2020 — Yesterday, the U.S. Food and Drug Administration
issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care
(POC) test for COVID-19.

Point-of-Care Delivers More Timely and Convenient Results

“Authorizing point-of-care serology tests will enable more timely and convenient results for
individuals who want to understand if they have previously been infected with the virus that
causes COVID-19,” said FDA Commissioner Stephen M. Hahn, M.D. “Until today, serology test
samples were generally only able to be evaluated in a central lab, which can be time consuming
and use additional resources to transport samples and run the test. As more and more point-of-care serology tests are authorized, they will help conserve those resources and may help reduce processing time for other types of COVID-19 tests, as less time is spent on serology tests.”

The expanded authorization also makes it possible for pharmacies and clinics to administer and
potentially bill payers for the test based on specific state regulations.

Highly Accurate, Meaningful Data

The tests, which are in stock in the U.S., passed quality control and received their initial EUA
designation in July. Quality control testing from NCI labs confirmed combined estimated
performance for sensitivity of 100%, and 98.8% for specificity. According to Dr. Ramsey Kilani,
Chief Medical Officer for GSIS (a MEDformance alliance partner), “These tests may provide
useful information about antibody-mediated immunity, and are currently important pieces of the
diagnostic puzzle.”

The cost-effective tests start at $15.50 each or less based on volume to providers.

Founded in 2018, MEDformance delivers critical to care solutions for healthcare providers, large
organizations, and facilities managers. Products and services include PPE (Personal Protective
Equipment), Testing and Diagnostics, Infection Control & Prevention, Healthcare Supply Chain
Management, and Medical Devices.

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For more information, press only:
John Nycz
o) +1 (800) 795-1486 x 3
c) +1 (404) 520-0380
Email – [email protected]
Website – medformance.com

See FDA Announcement