Lab industry leaders meet with White House on COVID-19 testing

“We appreciated the opportunity to meet with Vice President Pence and members of the White House’s Coronavirus Task Force this afternoon on the critical issues related to testing capacity. As an industry, clinical labs have taken steps to meet the growing demand for national testing and are working together with the Administration, the CDC and FDA as well as state and local public health labs, hospitals and academic medical centers. Currently, clinical labs are working around the clock to bring new tests online with the goal of processing several thousand tests in the coming days. In order to meet the demands for nationwide testing, ACLA and its members urge the Administration and Congress to prioritize the following critical areas:

• Expanded Emergency Use Authorizations: We urge the Administration to take immediate steps to approve emergency use authorizations (EUAs) for as many test platforms and instruments as possible in order to provide swift and accelerated access to diagnostic tests.
• Clear Testing Guidelines: We call on the CDC to provide updated guidance to providers and clinicians so that those most in need or at high-risk for COVID-19 are able to access tests as quickly as possible in light of the expanded testing criteria.
• Funding for Vital Testing Resources and Support: We urge Congress and the Administration to immediately provide funding for additional testing resources and support, including the cost associated with developing and performing tests as well as acquiring necessary supplies, including adequate testing supplies for specimen collection and protective gear for lab technicians who are working on the frontlines of specimen testing.”

ACLA members who attended the Vice President’s meeting at the White House were:

• Jon R. Cohen, M.D., Executive Chairman, BioReference Laboratories
• Jerry W. Hussong, M.D., M.B.A., Chief Executive Officer, Sonic Healthcare USA
• Julie Khani, President of the American Clinical Laboratory Association
• William G. Morice II, M.D., Ph.D., President, Mayo Clinic Laboratories
• Sherrie L. Perkins M.D., Ph.D, Chief Executive Officer, ARUP Laboratories
• Stephen H. Rusckowski, Chairman, President and CEO, Quest Diagnostics
• Adam Schechter, President and CEO of LabCorp

COVID-19 Response Efforts

Role of Commercial Laboratories

OVERVIEW

In any outbreak, Centers for Disease Control and Prevention (CDC) laboratories, supported by state public health laboratories, have primary responsibility for diagnosing patients. In recent public health emergencies, including the SARS and Zika outbreaks, commercial laboratories have supported public response and expanded test capacity.

ACLA has a memorandum of understanding with the CDC, the Association of Public Health Laboratories, and the Council of State and Territorial Epidemiologists to strengthen coordination in the event of public health emergencies. Over the past several weeks, the CDC has been actively utilizing ACLA and the MOU to keep ACLA member laboratories with infectious disease expertise informed on the progression of the current outbreak, the government response, and how our member laboratories can best be prepared to support those efforts.

CURRENT RESPONSE EFFORTS

On Feb. 29, the FDA issued new guidance for high complexity laboratories, including commercial laboratories, to perform coronavirus testing as soon as validation is complete. Prior to Saturday’s announcement, ACLA members were already working to develop novel tests for COVID-19 and remain in close communication with our public health partners at the CDC.

As of Wednesday, March 4, 2020 ACLA members are not yet collecting, processing or transporting specimens for COVID-19 testing from patients suspected of having, or confirmed to have, COVID-19.

ACLA is committed to supporting our public health partners and rapid response efforts. We’re working closely with our members—and in close coordination with state and local public health labs, hospitals, the CDC and the FDA—to increase overall national capacity. Over the next several weeks, commercial labs are working to bring online additional testing capacity at which point we will have a more informed assessment on the number of tests that can be processed.

Key factors impacting testing capacity

There are a number of critical factors that impact commercial labs’ ability to increase testing capacity in response to COVID-19 while also maintaining ongoing diagnostic operations for millions of Americans across the country. These include:

• Expand Emergency Use Authorizations (EUAs) to allow as many diagnostic manufacturers and labs to come online with tests. We urge the Administration to take immediate steps to approve emergency use authorizations (EUAs) for as many test platforms and instruments as possible in order to provide swift and accelerated access to diagnostic tests.
• Clear guidelines around screening that ensure high-risk patients are quickly identified and tested as soon as possible. While we support expanded access to testing services, we must ensure that those patients who are particularly at high-risk for COVID-19 are prioritized for testing and that we are able to ensure accurate, reliable results as new tests begin to go “live” in the coming weeks. Testing guidelines and recommendations must also account for repeat or secondary testing in cases where public health officials may require a second validating test for quarantine status. This is particularly important as labs are coming “on-line” for the first time with new tests where there is required time to ensure accuracy and reliability in diagnosing this infectious disease.
• Clear recommendations and processes for transport and handling of specimens. Given the ongoing risk of exposure for technicians handling specimens, clinical labs must have a stable supply of protective medical equipment and clothing (including gloves, marks, etc.) for handling infectious disease specimens. There also must be clear processes for providers on how to prepare specimens for shipping and transport as needed.

• Clear validation requirements. Public agencies should clearly and transparently share information about validation requirements, regulatory changes and data-sharing standards with commercial laboratories in a timely manner.

• Increased federal funding to support expanded testing and diagnostic operations. We ask Congress to provide supplemental funding for the PHEF under Section 319(b) of the Public Health Service Act so that these resources can be made readily available to support commercial laboratory surge capacity. With a dedicated funding stream from HHS under the PHEF, commercial laboratories can invest in the materials, time, labor, and other infrastructure necessary to ensure that reliable, rapid testing to diagnose COVID-19 remains accessible when our nation needs it most.