Clinical labs, White House tell different stories on testing backlog

Dive Brief:

The Trump administration late Monday said 250,000 coronavirus tests have been run in the last seven days, thanks to large commercial labs operating “round the clock” to meet the demand for testing. However, these labs are still getting more tests than they can run per day, according to officials, who contend the backlog will be reduced as more high-throughput testing comes online.
Despite administration assurances the nation is catching up on testing backlog, the American Clinical Laboratory Association (ACLA) contends without support from the federal government commercial labs might be forced to "retrench rather than keep building the capacity that is needed."
The administration also late Monday said the FDA will soon announce self-swabbing options available this week to enable Americans to perform their own tests, though the agency has not officially put out details. However, on Monday, it updated recommendations regarding specimen collection for COVID-19 testing using swabs, including self-collection.

Dive Insight:

The White House and commercial labs seem to be telling different narratives as far as testing is concerned.

While the administration contends the nation will be caught up on the testing backlog this week, ACLA has been sounding an alarm for days that its member labs will not be able to make necessary investments to meet future demand without more support from the U.S. government.

ACLA has asked Congress for a $5 billion emergency laboratory surge capacity fund to ensure the industry has the equipment, supplies, staffing and resources required to "sustain robust testing capacity for millions of Americans."

Although the Senate has been working on finalizing a stimulus package, with a deal between Democrats and Republicans expected on Tuesday, ACLA complained late Monday none of the bills discussed so far "contain a single provision to designate resources and support to the commercial laboratories who have stepped up to provide critical testing for health care workers, emergency responders, patients at high risk, and others in need."

Nonetheless, the vice president on Monday said HHS will be issuing "new guidance to direct all commercial labs to prioritize testing for hospitalized patients."

Pence also said FDA is in the process of reviewing less invasive methods of testing through self-collection of nasal swabs. He said it will expedite the test process, reduce the risk to healthcare providers from exposure to the coronavirus, and "minimize the drain" on personal protective equipment that is in short supply.

"This new approval from a study done by UnitedHealth Group and the Gates (Foundation) means that now self-collected nasal swabs will become available," Pence said at Monday's press briefing. "We're going to be working through FEMA with governors around the country to make sure and distribute those methods, as well as the swabs or any other supporting materials, and get those into this vast array of labs that are now stood up around the country."

The agency on Monday also updated recommendations regarding specimen collection for coronavirus tests using swabs, including self-swabbing.

"Based on available data, FDA believes that, for symptomatic patients, nasal swabs could be used that access just the front of the nose rather than the depth of the nasal cavity," per the updated guidance.