PerkinElmer is the 16th company to receive an EUA for COVID-19 testing.
Waltham, Massachusetts-based PerkinElmer announced the U.S. Food and Drug Administration (FDA) had granted its New Coronavirus RT-PCR test Emergency Use Authorization (EUA). The company joins a growing list of firms that have been granted EUA for COVID-19 testing The first was Roche, which was granted use for its fully automated cobas 6800 and 8800 Systems, approved on March 13.
The FDA has created a COVID-19 Diagnostic Tests Hotline for test developers and laboratories who have questions about the EUA process or who identify shortages of testing supplies. They also have a toll-free 24-hour phone line, 1-888-INFO-FDA.
According to the site, PerkinElmer is the 16th company to receive an EUA for COVID-19 testing. Companies include Mesa Biotech, GenMark Diagnostics, Abbott Molecular, Quest Diagnostics Infectious Disease, Laboratory Corporation of America (LabCorp), Hologic, Thermo Fisher Scientific and others.
The two largest private laboratories in the U.S., LabCorp and Quest Diagnostics, told CNBC earlier this week that together they could process more than 300,000 COVID-19 tests by the end of the week.
LabCorp’s chief executive officer Adam Schechter said it is running around 20,000 tests daily and by the end of the week expects to do “a lot more” than 100,000 tests per week.
Quest’s chief executive officer Steve Rusckowski told CNBC that is conducting about 25,000 COVID-19 tests daily and expects to increase that capacity to about 30,000 by the end of the week, which would give it a weekly capacity of about 200,000.
PerkinElmer’s RT-PCR test is an in vitro diagnostic (VD) device that meets the requirements of the European In Vitro Diagnostic Directive (IVDD) and is currently available in more than 30 countries around the globe.
“Despite the challenging environment, our employees have demonstrated unwavering commitment over the past two months to combat this global pandemic,” said Prahlad Singh, president and chief executive officer of PerkinElmer. “The breadth of PerkinElmer’s total workflow solution puts us in a unique position to rapidly address the needs of our clinical diagnostics customers.”
The addition of PerkinElmer’s product is an overall good thing, as the pandemic continues to spread worldwide. There is some disagreement in terms of widespread testing.
Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization said earlier this month, “We have a simple message for all countries: Test, test, test. Test every suspected case. If they test positive, isolate them and find out who they have been in contact with two days before they developed symptoms and test those people, too.”
This is in marked contrast to what the CDC and Health and Human Services are saying in the U.S., which is to reserve the tests for people where the results would significant change the treatment strategy.
One of the earlier missteps on the part of the CDC were unreliable test kits. Although it has not yet been determined exactly what the cause was, early reports suggested lack of validation because they were rushing to get them out.
Severin Schwan, chief executive officer of Switzerland’s Roche, one of the largest manufacturers of clinical testing supplies in the world, expressed a gloomy note, saying he didn’t think the U.S. would be able to test broadly for the coronavirus for “weeks, if not months.”
“No doubt, ideally we would have broader testing, but at the moment, capacities are limited,” Schwan told CNBC on Monday. “I think this is still a couple of weeks, if not months, out, and the reason is very simple.”
The reason is that companies such as Roche and others cannot manufacture test kits fast enough to keep up with the spread of the virus.
“The industry is increasing capacities, but at the same time infection rates are even increasing faster,” Schwan said. “At the moment, capacities are limited. That is why we have to prioritize testing to higher risk patients.”
That may change as more and more tests are granted EMU, or at least until social distancing and isolation flattens the curve of tests. Meanwhile, health systems are already reporting being at or close to capacity as the number of cases increases.
