White House, CDC under fire for availability of coronavirus tests

Dive Brief:

Centers for Disease Control and Prevention Director Robert Redfield testified Tuesday before a House subcommittee that he "would have loved the private sector to be fully engaged 8 weeks ago" but believes "the availability of testing in the last two days through Quest and LabCorp is finally getting us where we need to be."
LabCorp began receiving specimens on March 6 and is now able to perform several thousand tests per day and says adding new equipment and staff will create additional capacity, a LabCorp spokesperson confirmed to MedTech Dive on Wednesday.
Vice President Mike Pence, who leads the White House’s Coronavirus Task Force, said "it’s those big companies that have logistics, infrastructure all over the country, have labs all over the country, that can distribute the tests, process the tests — whether it’s Quest or whether it’s LabCorp."

Dive Insight:

Amid the coronavirus outbreak, some of the largest commercial labs are stepping up testing capacity to meet growing national demand. However, the Trump administration is facing criticism from lawmakers in both parties that federal agencies did not engage those labs early enough in the public health emergency.

Redfield at the House hearing testified he believes "the availability of testing in the last two days through Quest and LabCorp is finally getting us where we need to be."

"There's a whole other system that we need testing for, clinical medicine, and I'm happy to say now with LabCorp and Quest both operational as of yesterday there's laboratory testing availability to any doctor's office," CDC's Redfield added.

LabCorp's COVID-19 test has been available since March 5 for ordering by physicians and other authorized healthcare providers anywhere in the U.S. Quest started providing its testing service on Monday.

According to LabCorp, the company began receiving specimens on March 6 and is now able to perform several thousand tests per day and says adding new equipment and staff will create additional capacity.

"We continue reviewing all opportunities to expand testing at LabCorp lab facilities across the country," said a spokesperson, who emphasized that specimens are collected by clinicians and then sent to LabCorp. "The turnaround time to provide test results is typically three to four days from the pickup of the specimen to release of the test result."

Quest was not immediately available for comment.

For its part, the CDC is under fire from congressional Democrats for what they contend were a series of missteps by the agency in developing and distributing a working test for COVID-19, including early manufacturing problems.

During Tuesday's hearing, Rep. Rosa DeLauro, D-Conn., chair of the House appropriations health subcommittee, said she was very concerned about the nation's coronavirus testing capabilities as a result of CDC's actions.

"Other countries have been testing thousands of people for weeks. But the U.S. is woefully behind the curve," DeLauro said, noting that South Korea is able to test 10,000 of its citizens per day. "The low number of positive tests in the U.S. is likely a byproduct of under-testing, as opposed to an accurate count of the prevalence of coronavirus in the U.S."

Redfield said the agency quickly obtained an emergency use authorization from FDA for its coronavirus test and as of March 4 has processed more than 1,500 tests. "Our test was probably created as fast as anybody's test in the world," Redfield testified.

While DeLauro acknowledged that CDC rapidly developed a test, she said that the majority of the initial tests sent to public health laboratories were faulty and it was weeks before replacements were distributed.

Public health labs in all 50 states and the District of Columbia are currently using the CDC tests, according to the agency. Pence said this week that more than 1 million CDC-developed tests had been distributed, with the goal of distributing another 4 million by the end of this week.

"We believe that, in the days and weeks ahead, we’re going to continue to see the availability of tests dramatically rise," said Pence.

Integrated DNA Technologies is among the manufacturers scaling up production to meet the goal of shipping 4 million target. Redfield told lawmakers that IDT asked FDA if the company could commercialize the COVID-19 test developed by CDC. "We said it's fine by us."

Although CDC's tests are now being distributed nationwide, DeLauro said the delay in getting working tests into the field is unacceptable.

Redfield responded that the agency "very rapidly developed the test" but "when it was scaled up by the contractor" to go to the public health labs "one of the reagents wasn't working correctly." Working with FDA, CDC was able to correct the problem in a "very short time" and replaced, according to Redfield.