The Clinical Laboratory Evaluation Program (CLEP) within the Wadsworth Center regulates clinical laboratory testing in New York State. Among its regulatory responsibilities, CLEP is currently the only regulatory agency in the United States that conducts formal review of Laboratory Developed Tests (LDTs). While clinical laboratories outside New York State may develop and use LDTs without FDA approval, any laboratory seeking to test New York State specimens must obtain CLEP approval.
CLEP’s subject matter experts are nationally and internationally recognized in their respective fields and are frequently asked to contribute to the development of guidance, standards, and best practices beyond New York State. Dr. Kate DeRosa, PhD, is a CLEP subject matter expert in genetic testing. In this role, Dr. DeRosa reviews genetic testing LDTs, including assays for cystic fibrosis, cancer predisposition, prenatal screening, and pharmacogenomic sensitivity.
In recognition of her expertise and leadership within the clinical laboratory community, Dr. DeRosa was invited to participate in the Clinical and Laboratory Standards Institute (CLSI). CLSI is a not-for-profit organization that develops consensus-based clinical laboratory standards and best practice documents that are recognized and adopted internationally by laboratories, accreditation bodies, and government agencies. Dr. DeRosa serves on a CLSI Document Development Committee that is developing a best practices document to guide laboratories in the evaluation and validation of LDTs.
Dr. DeRosa has now been invited to join the CLSI Expert Panel on Evaluation Protocols. Expert Panels are responsible for proposing new document projects, reviewing draft documents produced by Document Development Committees, evaluating proposals for new standards, and advising CLSI committees and the CLSI Consensus Committee. This Expert Panel focuses on how clinical laboratories evaluate their processes and performance, including the evaluation of LDTs.
In this new role, Dr. DeRosa will have increased authority, responsibility, and influence over the development of multiple CLSI documents that directly impact clinical laboratory practice. Her participation ensures that CLEP’s regulatory experience and public health perspective are represented in international standards, while also allowing Wadsworth Center to benefit from ongoing engagement with the laboratory community.