FDA expands coronavirus testing capacity with support of commercial labs

WASHINGTON, D.C. – ACLA is currently reviewing the FDA’s guidance for high complexity, CLIA-certified laboratories (which includes hospital, academic, and commercial laboratories) to provide coronavirus testing in advance of Emergency Use Authorization (EUA).  The guidance permits high complexity laboratories to start offering coronavirus testing as soon as validation is complete.  The FDA recommends that a laboratory submit the EUA request to the agency fifteen business days after validation.

“As part of our industry’s strong commitment to advancing public health in the U.S., commercial laboratories are ready to support increased testing capacity for the novel coronavirus response,” said Julie Khani, president of ACLA. “We are encouraged by the FDA’s decision to make additional high-quality testing available, and welcome the opportunity to further support our public health partners.”

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.

As has been publicly reported, some ACLA members are working to develop novel tests for COVID-19, as well as supporting other ways to bolster testing capacity.

In any outbreak, Centers for Disease Control and Prevention (CDC) laboratories, supported by state and local public health laboratories, have primary responsibility for diagnosing patients. Commercial laboratories stand ready to work closely with health officials to meet that demand, testing specimens sent in by clinicians. In recent public health emergencies, including the SARS and Zika outbreaks, commercial laboratories have supported public response and expanded test capacity.

Please visit the CDC’s website for the latest developments, resources and recommendations. 

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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.