Diagnostic testing companies are aiming to deliver 25 million COVID-19 tests by the end of April and increase that number by the end of May, the head of medtech trade group AdvaMed said today.
But the number of available tests is less important than the U.S. healthcare system’s capacity to process all the tests that will be needed to diagnose COVID-19, AdvaMed CEO Scott Whitaker said in a telephone press conference this morning.
“We have millions of tests but our ability to process them is really what matters,” Whitaker said. “We can see the stretch and strain that it’s putting on the system right now. The same thing is happening in our laboratories.”
Added to that is the ongoing national problem of test distribution, with states, the federal government and healthcare systems all vying for the same tests, Whitaker added.
“Allocation in many ways is the toughest part because. we don’t necessarily have any windows on where the tests need to be,” he said. “So we are advising our companies on that but we’re also relying on HHS and FEMA to help us understand that better.”
Advamed is in “constant contact” the U.S. Department of Health and Human Services and the Federal Emergency Management Agency, Whitaker added. “I was speaking with the secretary for health yesterday and walking through with him to make sure we can partner better and make sure the tests are getting to the right locations, and I think we’re making progress on that.”
AdvaMed has also been coordinating with government officials and the diagnostics industry to improve workflows and determine where test processing is below capacity so patient samples might be sent there for processing, Whitaker said.
State and federal officials have been questioning the healthcare industry’s capacity to run tests, with some singling out equipment made by Abbott.
“The ecosystem is really built for the pre-coronavirus world and it will take a lot of work together to make the full healthcare system get up to speed,” Whitaker said. “We are very focused on that.”
While molecular diagnostic testing has been the main focus of interest, that is shifting to serological tests designed to detect antibodies to disease in the blood. Governments and businesses will likely rely on the results of these tests in deciding when and how to reopen the U.S. economy.
A number of companies are also developing rapid immunoassay antigen tests to detect the virus within a few days of exposure, according to Susan Van Meter, executive director of the trade group’s diagnostics segment, AdvaMedDx. These tests will produce results at the point-of-care even before COVID-19 symptoms appear, are more accurate than molecular tests and can be produced at scale, she added.
“We’re going to see millions of antigen tests available in the coming weeks,” Van Meter said.
In addition to focusing on how certain medical devices and tests can help the economy as a whole, AdvaMed is working on getting the entire medtech industry back to work, added Whitaker.
“It’s critical to the healthcare system that the medtech economy is working well,” he said.