Diagnostics Manufacturers Ramping Up COVID-19 Tests to Combat Pandemic
WASHINGTON, D.C. – Several diagnostics companies have received or will soon receive FDA Emergency Use Authorizations (EUA) that will provide crucial capacity for the U.S. to significantly ramp up testing for the coronavirus (COVID-19).
“The medical technology industry has always been front and center during any public health emergency, and it is no different with the coronavirus. Many companies are adding third shifts, working 24/7, and adding new production lines in order to provide patients and health care providers what they need to detect, contain and treat this virus,” said AdvaMed President and CEO Scott Whitaker. “It truly is incredible to watch our entire medtech community rally to this global cause. We thank these diagnostics companies for rapidly developing coronavirus tests, and we thank Dr. Hahn and the FDA for working so hard to authorize them quickly.”
“AdvaMedDx member companies are among those on the forefront of the medtech industry’s response to the coronavirus,” said AdvaMedDx Executive Director Susan Van Meter. “They are increasing availability of COVID-19 testing while continuing to ensure access to all the diagnostics so fundamental to patients and health care in the U.S. and around the world.”
Companies that have received EUAs from FDA for COVID-19 tests include:
- Hologic’s Panther Fusion SARS-CoV-2 test.
- GenMark’s ePlex Test.
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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.