Dive Brief:

• The American Clinical Laboratory Association, representing companies like LabCorp and Quest Diagnostics, said Sunday it is "alarmed" by the stimulus package under consideration in the Senate, calling it far short of enough funding for industry to meet the rising demand for coronavirus testing. Negotiations continued Monday morning after the package failed to get enough votes in a key Senate procedural vote Sunday. Monday's Senate vote on the bill has been pushed to noon.
• ACLA reported its member labs had conducted 183,000 tests thus far, with 54,000 on Saturday alone, but warned they will not be able to make necessary investments to meet future demand without more support from the U.S. government. The group has asked Congress to support an emergency laboratory surge capacity fund of $5 billion to ensure the industry has the equipment, supplies, staffing and resources required to "sustain robust testing capacity for millions of Americans."
• Vice President Mike Pence on Sunday said 254,000 Americans have been tested and received results for the novel coronavirus. Due to increasing capacity from commercial labs, the White House expects the country to be “caught up on the backlog in testing by the middle of the week,” while urging all private sector labs to “prioritize in-patient testing” for hospitalized patients suspected of having COVID-19.      

Dive Insight:

ACLA pointed out that while the stimulus package has "tens of billions of dollars" in aid for the airline, manufacturing, and restaurant industries "who have started to shut their doors," commercial labs need similar support from the federal government so they can continue to boost coronavirus testing capacity nationwide.

Without assistance from Congress, ACLA contends commercial labs are being "set up" to perform COVID-19 testing at a loss, "putting at risk the private sector efforts that the country is relying on for national testing."

ACLA's President Julie Khani said "without immediate certainty on testing reimbursement and funding for supplies, clinical labs will face growing capacity challenges that could lead to disruptions in test processing time and availability."   

ACLA wants a $5 billion emergency fund added to the stimulus package to help cover the cost of uncompensated COVID-19 testing, support for the continued ramping up of test capacity, as well as ensuring government buyback for required equipment and supplies, such as high-throughput testing platforms.  

The Trump administration has been touting the role of the private sector in ramping up testing after a slow rollout of a CDC test and has reiterated its reliance on high-throughput testing from companies such as Roche and Thermo Fisher, and those performed by commercial labs nationwide such as LabCorp and Quest. ​

"Tens of thousands of tests are being done every single day both through the CDC and the public health labs as well as now through the private sector commercial labs," said HHS Secretary Alex Azar in Friday's White House press briefing. "They're getting to scale. They have supplies. They have high throughput."

When asked about reports of labs not getting access to the testing supplies they need, Azar said "we do hear anecdotally occasionally of say a public health lab, or another one, that has a concern about this supply or that supply."

However, he added: "Usually, it's that the lab people do not understand that there are actually alternative supplies in the marketplace that they are perfectly free to use...they aren't listening or checking with us about all the freedom, all the capacities out there." 

According to Azar, the federal government just bought 200,000 swabs "on the open market" and they are sending them to governors around the country. "Sometimes there's a lab that doesn't understand how much flexibility they have and how much supply there is out there."

Nonetheless, the Erie County Public Health Lab in Buffalo, New York, is running out of test supplies such as reagents needed for COVID-19 diagnostic testing. The lab said on Friday it has enough material to conduct only 15 additional coronavirus tests.

Erie County Health Commissioner Gale Burstein on Saturday told MedTech Dive "clinical labs cannot use non-FDA-approved supplies for the FDA-approved COVID-19 tests that we use." Burstein said "although there are other supplies available on the market, they are not approved to use on the FDA-approved tests," adding Azar’s statement on the availability of testing materials is "contradictory" to statements from the Association of Public Health Laboratories and other labs.

APHL on Friday, along with the Association of State and Territorial Health Officials and Council of State and Territorial Epidemiologists, announced "due to the widescale shortages of laboratory supplies and reagents" they strongly recommend coronavirus testing be prioritized for healthcare workers, first responders and seniors with COVID-19 symptoms, as well as individuals with other underlying illnesses.

"While some communities may have sufficient testing supplies and/or personal protective equipment (PPE) to expand COVID-19 testing to other groups, mass testing of any American for COVID-19 at this time will quickly deplete the existing supply of testing reagents, laboratory supplies, and PPE needed to manage patients in clinical, in-patient and other residential settings," the groups said.    

This story has been updated to reflect weekend developments regarding the stimulus package.