25 Million Diagnostic Tests For Coronavirus Will Be Made By April’s End, Device Makers Say

The medical device industry projects there will be 25 million diagnostic tests made for the coronavirus strain COVID-19 for U.S. use by the end of April.

The Advanced Medical Technology Association (AdvaMed) Wednesday issued a projection that the medical device industry will have produced more than 25 million tests by the end of April that are largely molecular testing for the live virus.

“Our industry is focused on scaling up the number of tests available . . . from reagents to supplies to component parts,” Scott Whitaker, chief executive officer of AdvaMed told reporters in a conference call Wednesday morning. “The scale at which people are demanding tests requires speed over anything now.”

AdvaMed didn’t disclose which companies were producing tests but said the industry is focused on diagnostic tests that can be used to detect the Coronavirus strain COVID-19. AdvaMed’s numbers don’t include serology or antibody tests designed to detect whether someone has had the virus and are also being developed.

AdvaMed’s update comes as the Trump administration and federal agencies continue to face criticism for the lack of testing for Coronavirus. The U.S. is considered well behind other countries when it comes to the availability of testing generally.

But diagnostic companies like Abbott Laboratories, Roche, Becton Dickinson and others are ramping up production and have been focused primarily on testing those believed to have the virus as well as healthcare workers on the frontlines of the battle against the deadly virus. One such test gaining notoriety is Abbott’s ID NOW COVID-19 test that can deliver positive results in as little as five minutes and negative results in 13 minutes.

Abbott has been shipping out 50,000 ID NOW tests per day since April 1 and has been delivering on that commitment, executives said last week. “I get to see the manufacturing and the shipment output, and we haven’t fallen behind that,” Abbott chief executive Robert Ford told analysts during last week’s first quarter earnings call. “In several days we’ve beaten that number and able to get more tests out.”

But as Abbott starts to ramp up manufacturing for ID NOW in May and into June, Ford said the company will “start to roll this out into a second phase where we’ll start to be able to test more of the general population.” Abbott will ramp up from production of 1.3 million ID NOW tests a month to 2 million in June.

The FDA has escalated approvals of rapid “point-of-care” diagnostics made by other companies including Mesa Biotech and Cepheid which are also ramping up production to meet unprecedented demand.

–Forbes