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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. 

Click here for Clarification on Clinical Laboratory Testing Personnel Requirements; glucometry

A new research publication coauthored by the Wadsworth Center’s Division of Environmental Health Sciences highlights a link between secondhand tobacco smoke (SHS) exposure and sleep disturbances in children. SHS remains a significant public health concern, and emerging evidence suggests it can adversely affect sleep through both biological and behavioral mechanisms.

Dr. Patrick Parsons, Director of the Division of Environmental Health Sciences (DEHS) and Chief of the Laboratory of Inorganic and Nuclear Chemistry at the Wadsworth Center, delivered an invited lecture at the Eastern Analytical Symposium (EAS) on November 19, 2025, in Princeton, New Jersey. EAS is one of the premier analytical chemistry conferences in the United States, drawing experts from across the country—particularly the Northeast—to highlight advances in chemical measurement science.

Proposed regulations to amend Subpart 58-1 and the addition of Subpart 58-6 to replace Part 19 are available for public comment at

A manuscript coauthored by scientists from the New York State Department of Health’s Wadsworth Center and Bureau of Communicable Disease Control, in collaboration with the U.S. Centers for Disease Control and Prevention (CDC) and epidemiologists from the New York City Department of Health and Mental Hygiene and Westchester County Department of Health, has now been published in Open Forum Infectious Diseases and selected as the journal’s Editor’s Choice article.

Dr. Siân Owen, Principal Investigator in the Wadsworth Center’s Division of Genetics, delivered the keynote address at the 2nd Annual Buffalo Phage Meeting on December 11, 2025, at the University at Buffalo. The meeting brought together researchers, clinicians, and trainees from across Western New York to highlight advances in bacteriophage research and applications to medicine, public health, and biotechnology. 

Scientists from the Wadsworth Center’s Division of Environmental Health Sciences (DEHS) coauthored a new study published in Nature Communications that sheds light on how plastic-associated endocrine-disrupting chemicals (EDCs) may contribute to hidradenitis suppurativa (HS), a chronic inflammatory skin disease with limited treatment options.

For more than 25 years, the Environmental Proficiency Test and Validation Unit (EPTAVU), of the Wadsworth Center’s Division of Environmental Health Sciences (DEHS), produced a comprehensive suite of environmental proficiency testing (PT) samples for hundreds of laboratories accredited through the New York State Department of Health’s Environmental Laboratory Approval Program (ELAP).

Dr. Janice Pata, Director of the Wadsworth Center’s Division of Scientific Cores, delivered a virtual seminar to the Department of Biochemistry and Molecular Biophysics at Washington University School of Medicine in St. Louis on December 9, 2025.

The Wadsworth Center’s tuberculosis (TB) testing program for Mycobacterium tuberculosis is among the leading diagnostic programs in the United States and is internationally recognized for its scientific excellence and public health impact. Senior scientists from the program are regularly invited to participate in major international meetings, reflecting its global leadership in TB diagnostics and surveillance.

The Journal of the American Medical Association (JAMA) has recognized the GUARDIAN study as one of the nine most impactful, newsworthy, or novel research studies published in the past year. This distinction places GUARDIAN among JAMA’s annual “Research of the Year” selections, highlighting its significance to medicine and public health. 

The New York State Department of Health (NYSDOH) Bureau of HIV/Sexually Transmitted Infections (STI) Field Services conducts HIV rapid testing and is registered as a Limited Service Laboratory through the Clinical Laboratory Evaluation Program at the Wadsworth Center. Dr. Linda Styer, Director of the Wadsworth Center’s Bloodborne Viruses Laboratory, is the Laboratory Director for this NYSDOH Limited Service Laboratory. In this role, Dr.

Wadsworth Center scientist Dr. Kurunthachalam Kannan, Deputy Director of the Division of Environmental Health Sciences (DEHS) and Chief of the Laboratory of Organic Analytical Chemistry, delivered a prestigious invited plenary lecture at the Microplastics in Focus conference held in Newcastle, New South Wales, Australia, on November 27-28, 2025. Dr.

On December 3–4, 2025, Dr. Joseph Orsini, PhD, of the Wadsworth Center, participated in the Association of Public Health Laboratories’ (APHL) annual Newborn Screening (NBS) Face-to-Face Committee Meeting in Bethesda, Maryland. Dr. Orsini serves as Co-Chair of the national NBS Committee, which provides guidance, develops best practices, and addresses emerging challenges to ensure high-quality newborn screening programs across the United States.

The Advanced Genomics Technology Cluster (AGTC) Core at the Wadsworth Center is continuing to expand its automation capabilities to support both research and clinical sequencing workflows. As part of this effort, hands-on, advanced technical training is essential to ensure the Center can independently maintain and optimize these high-throughput systems.

The Wadsworth Center’s Division of Infectious Disease was prominently represented at the 9th European Study Group for Legionella Infections (ESGLI) Meeting, held in Palermo, Italy, from November 12-14, 2025. Danielle Wroblewski, a scientist in the Food and Waterborne Unit of the Bacterial Diseases Laboratory, was invited to deliver two presentations showcasing research conducted at the Wadsworth Center to advance the detection of Legionella in both human and environmental samples.

The New York State Department of Health’s Wadsworth Center and Division of Epidemiology have been selected to participate in a major multinational study evaluating the effectiveness of a pneumococcal vaccine currently licensed in Europe. The study fulfills a post-authorization requirement of the European Medicines Agency (EMA) and brings together leading public health institutions from Europe, the Americas, and Israel. 

A research team at the Wadsworth Center has developed an innovative, environmentally friendly method for extracting trace metals from biological samples without the use of concentrated mineral acids. Led by Dr. George Donati, Deputy Director of the Laboratory of Inorganic and Nuclear Chemistry, the study demonstrates a safer, greener alternative to conventional digestion techniques used in environmental, toxicological, and food safety testing. 

The Clinical Laboratory Evaluation Program (CLEP) within the Wadsworth Center has taken an important step to support the expansion of Hospital at Home (HaH) services in New York State. CLEP, which has regulatory oversight authority for all clinical laboratories under Article 5, Title 5 of the New York State Public Health Law (PHL), ensures that any facility performing tests on human-derived materials meets state standards for quality and safety. This authority applies not only to hospital-based laboratories but wherever testing is performed – including at home.