Labs step up capacity to meet demand for nationwide coronavirus testing

Dive Brief:

As the coronavirus public health emergency continues to escalate and after a rocky start in getting tests from the Centers for Disease Control and Prevention to states, Vice President Mike Pence said late Monday in a White House press briefing that more than 1 million tests had been distributed, with an aim to distribute another 4 million by the end of this week.
At the same time, administration officials acknowledge labs may become overwhelmed and are looking to leverage the scale of LabCorp and Quest, diagnostics giants that both in recent days have made tests for the virus available.
HHS also Monday announced that Hologic was selected to receive financial support for development of the first so-called high throughput COVID-19 diagnostic test to be capable of processing up to 1,000 tests in a 24-hour period. The administration suggested it could be made available in a "matter of weeks."

Dive Insight

The ability to rapidly diagnose COVID-19 is essential to mounting an effective U.S. public health response to help mitigate spread of the disease. Federal agencies are trying to quickly increase capacity to test Americans for the coronavirus beyond state labs, universities and hospitals.

Despite early manufacturing problems with the diagnostic tests developed by the Centers for Disease Control and Prevention, public health labs in all 50 states and the District of Columbia are currently using the CDC tests, according to Pence, who leads the White House Coronavirus Task Force.

Integrated DNA Technologies is among the manufacturers scaling up production to meet the goal of shipping 4 million CDC tests to state labs by the end of the week, according to administration officials, who estimate that 2.1 million tests will meet the needs for testing about 850,000 Americans.

However, they acknowledge that those shipments are just a drop in the bucket and will be woefully inadequate to cope with widespread transmission of COVID-19 in the U.S., which according to a leaked presentation from the American Hospital Association could be as high as 96 million Americans infected with coronavirus leading to 4.8 million hospitalizations and 480,000 deaths.

To help fill the gap, the administration is looking to leverage the diagnostic testing capabilities of large commercial labs as they ramp up capacity. Following the moves by LabCorp and Quest, Pence promised that Americans are “going to see a dramatic increase in the availability of testing.”

LabCorp and Quest were part of last week’s industry meeting with the administration that included the American Clinical Laboratory Association, in which lab execs committed to stepping up capacity to help meet the growing national demand for COVID-19 tests.

During Monday’s White House briefing, HHS Secretary Alex Azar said that the technologies leveraged by tests from LabCorp and Quest will result in “an even better experience for the patient because they are able to actually collect samples directly in doctors’ offices.”

According to Pence, the "enormous capacity" of these and other commercial labs will enable coronavirus tests to be made broadly available to the American public through physicians offices and pharmacies.

"While the Centers for Disease Control and Prevention and our nation’s public health laboratories are making valiant efforts in testing and surveillance of coronavirus infections, these labs could become overwhelmed as the number of suspected cases grows,” Rick Bright, director of the Biomedical Advanced Research and Development Authority at HHS, said in Monday's statement announcing funding for a test from Hologic.

Hologic was selected by the agency’s Office of the Assistant Secretary for Preparedness and Response to develop the first “high throughput” COVID-19 diagnostic test capable of processing up to 1,000 tests in a 24-hour period.

The test is designed for use with the company's Panther Fusion system, currently available in commercial labs in the U.S. and other countries, and will receive $699,000 in funding to accelerate the test's development.

“Rapid, high-throughput tests are critical to provide quick results for more Americans and to aid the nationwide public health response,” said BARDA’s Bright.

In a filing with the SEC on Monday, Hologic reported that its test detects the genetic material of SARS-CoV-2, the virus that causes COVID-19, providing results in less than three hours while its Panther Fusion system "provides complete sample-to-result automation with minimal user interaction and offers a broad menu of FDA-cleared tests to detect common respiratory viruses from a single patient sample."

According to HHS, development of Hologic’s diagnostic test will be completed “in a matter of weeks” at which time FDA will consider granting Emergency Use Authorization.