Diagnostics manufacturers with U.S. approval to test for the Coronavirus strain COVID-19 are promising millions of tests that will be produced weekly by the end of the month and be commercially available.
The Advanced Medical Technology Association (AdvaMed) said at least seven diagnostic companies have now received “emergency use authorization” from the U.S. Food and Drug Administration to “significantly ramp up testing” for the Coronavirus strain COVID-19.
These companies, including Abbott Laboratories, Roche and Thermo Fisher Scientific, will be producing millions of tests weekly by the end of March with “production to more than double” by April, AdvaMed confirmed.
“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,” AdvaMed president and CEO Scott Whitaker said. “The medical technology industry has always been front and center during any public health emergency, and it is no different with the coronavirus.”
These tests will be used in a variety of healthcare settings including large hospitals and academic medical centers that analysts say will help U.S. diagnostic capabilities rebound at a time the Trump administration and federal agencies have been criticized for the lack of testing for Coronavirus. The U.S. is considered well behind other countries when it comes to the availability of testing.
But big diagnostic companies are quickly coming online. Earlier this week, Abbott said the company will begin scaling up production at its U.S. manufacturing plant to reach capacity for “1 million tests per week” by the end of March.
Other companies that AdvaMed listed in an announcement Friday afternoon that have received FDA “emergency use authorizations” – some in just the last week – include:
- Roche for its cobas SARS-CoV-2 test
- Hologic’s Panther Fusion SARS-CoV-2 test
- Quidel’s Lyra SARS-CoV-2 Assay
- Thermo Fisher’s TaqPath COVID-19 Combo Kit
- DiaSorin Molecular’s Simplexa COVID-19 Direct Assay
- GenMark Diagnostics’ ePlex SARS-COV-2 Test
“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,” AdvaMedDx executive director Susan Van Meter said.