Statement on Recent FDA Actions To Expand COVID-19 Testing
WASHINGTON, D.C. – Following the FDA’s actions announced on March 16, ACLA President Julie Khani released the following statement:
“The FDA’s guidance released on Saturday, February 29th cleared the regulatory hurdles to allow commercial labs to immediately begin testing patients as soon as test validation was complete, and our members began accepting specimens for testing less than a week later.
The FDA has recently taken several positive steps to make additional platforms and instruments available to provide accelerated access to diagnostic tests for patients. For example, the March 13 updated guidance expanding eligible swabs was an important step forward, as it allowed commercial laboratories to work with additional suppliers to access necessary specimen collection tools. In addition, the recent FDA approval of large automated platforms for testing is expected to dramatically increase testing capacity. 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.
ACLA is reviewing the FDA’s actions announced last night. While New York State Dept of Health has a long-established and experienced oversight program for Lab Developed Tests (LDTs), this is not the case for every state. To maintain specimen integrity and deliver the clear and reliable results that patients and clinicians depend on, it is essential that all laboratories conducting testing for COVID-19, regardless of location or state, have the appropriate expertise, equipment and training to do so.”
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.