Commercial capacity is expected to exceed 20,000 tests per day nationwide by end of next week, 280,000 tests per week by April 1.
WASHINGTON, D.C. – Commercial laboratories have stepped up to bring critical COVID-19 testing capacity to the U.S. health care system. Following the FDA’s guidance on February 29 that provided an accelerated path for commercial laboratories to perform COVID-19 testing, commercial laboratories introduced high-throughput Laboratory Developed Tests (LDTs) to significantly expand testing capabilities across the country, with the current capacity of processing several thousand tests a day.
Once additional FDA-approved high-throughput testing is available on large diagnostic platforms next week, the industry expects its capacity to be increased to more than 20,000 tests per day. Assuming there are no delays or shortages of necessary materials and supplies, commercial capacity is expected to exceed 280,000 tests per week by April 1.
“This national emergency means commercial labs are being asked to step up in unprecedented ways, and we are answering that call,” said Julie Khani, president of ACLA. “We are committed to supporting our public health partners and rapid response efforts and will remain in constant communication with HHS and the Administration about our response, the obstacles we face, and other information as the situation evolves.”
ACLA members, including ARUP, BioReference Laboratories, LabCorp, Mayo Clinic Laboratories, Quest Diagnostics, and Sonic Healthcare are currently working on scaling up capacity and are part of a newly-formed consortium working together with the Administration, the CDC and FDA as well as state and local public health labs, hospitals and academic medical centers.
ACLA has worked closely with the CDC and other federal agencies to help anticipate any potential shortages laboratories may face down the line. As a part of this ongoing communication with federal agencies, ACLA has raised concerns about potential shortages of certain supplies that may affect testing capacity, including specimen collection swabs, N95 respirators, viral transport media, masks, gloves, and hand sanitizer.
“The Administration and HHS are supportive of our expanded efforts,” said Khani. “We’ll continue our real time communication to ensure we are being proactive in response to any supply chain issues.”
ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.