CASSS Bioassays Scientific Approaches and Regulatory Strategies

CASSS Bioassays Scientific Approaches and Regulatory Strategies

BEBPA US Bioassay

BEBPA US Bioassay

Three ways to cultivate a healthy connection between food and your life

March marks the transition from winter to spring, where we look forward to warmer weather. We also observe and celebrate National Nutrition Month® (NNM) in March as well. What was once a one-week health awareness campaign expanded to the whole month in 1980, reflecting a growing interest in nutrition and its impact on well-being.On the heels of last year’s “Beyond the Table” NNM theme is this year’s “Food Connects Us.” That’s because food connects us to our health, environment, friends, family and much more. Here are three ways you and your employees can deepen a healthy connection between food and other aspects of your lives.

Analytical Validation of the Labcorp® Plasma Complete™ Test, a Cell-Free DNA Comprehensive Genomic Profiling Tool for Precision Oncology

Key takeawaysThe Labcorp Plasma Complete test demonstrates high sensitivity, specificity, accuracy and robustnessThis liquid biopsy test enables tumor molecular profiling to inform treatment decisions

Does automation improve cell-based potency assay development?

Development and usage of virtual controls on nonclinical safety assessment studies

SOT 2025 -- In vivo studies are required for assessing nonclinical safety of products to which humans become exposed. Virtual control groups (VCGs) are one emerging strategy for the reduction of animal usage; VCGs are defined as the use of an on study representative dataset generated from historical control data to reduce or replace concurrent control animals. The purpose of this work was to determine the selection criteria required to generate a robust, consistent and representative virtual control dataset for a selected range of endpoints to support regulatory and industry movement towards the use of VCGs.

Historical control data of spontaneous tumors in transgenic CByB6F1-Tg(HRAS)2Jic (Tg.rasH2) mice

SOT 2025 -- Short-term (6-month) carcinogenicity studies using genetically engineered animals have been demonstrated to be a reliable alternative model to long-term conventional carcinogenicity studies. CByB6F1-Tg(HRAS)2Jic (rasH2) is a genetically engineered hemizygous transgenic mouse containing the human c-Ha-ras proto-oncogene (c-Ha-ras) and is approved by regulatory agencies for carcinogenicity assessment. Comparative data was collected from the historical data for mortality, body weights, and spontaneous tumor incidences in vehicle control article (vehicle) administered CByB6F1-Tg(HRAS)2Jic (Tg.rasH2) mice from 6-month carcinogenicity studies and were analysed from the data compiled from multiple Labcorp Safety Assessment facilities from 2014 to 2023.

The Morris water maze -- An assessment of learning and memory in regulatory developmental and reproductive toxicology (DART) studies

SOT 2025 -- There are many water maze tasks that have been developed to evaluate learning and memory in regulatory DART studies. EPA OPPTS 870.6300 and OECD 426 test guidelines require an assessment of learning and memory on developmental neurotoxicity (DNT) studies for the testing of chemicals that may cause adverse neurodevelopmental outcomes. ICH Harmonized Tripartite Guideline S5 (R3) for the testing of pharmaceuticals intended for human use also require an assessment of learning and memory to be evaluated in a complex learning task. Test guidelines such as the EPA OPPTS 870.6300 require evidence of positive control data to demonstrate the sensitivity of the procedures being used, ensuring  that the task is sensitive to detect learning impairments by using a chemical for which learning deficits have been established. This work was performed in order to validate and optimize the Morris water maze (MWM) to support preclinical safety studies utilizing the learning and memory assessment, thereby demonstrating that the learning and memory test procedure at Labcorp can detect chemically induced changes and therefore it’s suitability for use on regulatory DART studies.

Utilizing rodent ultrasonic vocalizations as a non-invasive technique

SOT 2025 -- Inhalation toxicology studies in rats are conducted to support development of therapeutics and risk assessment of chemicals. Respiratory tract toxicity is often not detected at a clinical level in rats, until histopathology is performed following the terminal euthanasia. Squamous cell metaplasia of the larynx is an adaptive response to local irritation and can be accompanied by adverse findings such as necrosis, ulceration and inflammation. Ultrasonic vocalizations (USVs) may be behavioral and are produced by a laryngeal neuromuscular mechanism that can be influenced by structural changes. “22-kHz calls” represent a negative, perilous response, and “50-kHz calls” represent a positive response or interacting with a complex environment. The objective of this study was to test whether USVs correlate with clinical observations and microscopic pathology in the larynx following inhalation of a toxicant.

Social interaction assessment in rodents: Positive control validation of automated three-chambered social interaction test in rats

SOT 2025 -- Social interactions are fundamental and adaptive components of the biology of numerous species. The integrity of social interaction behavior is critical in maintaining social skills, interpersonal functioning and effective social relationships that define societies. Deficits in social behavior and social recognition are well-recognized in several neuropsychiatric disorders, such as autism spectrum disorders, bipolar disorders, depression, obsessive-compulsive disorders and schizophrenia. Valproic acid, used for bipolar disorders and epilepsy, can increase autism spectrum disorder risk in children when mothers are exposed during pregnancy. Anesthetics like propofol can also heighten neuropsychiatric disorder risk due to N-methyl-D-aspartic acid (NMDA) antagonism and gamma-aminobutyric acid (GABA) activity during early brain development. Complex behavioral tests, like social interaction tests, can vary based on testing conditions and laboratory proficiency. OECD guidelines emphasize that laboratories must demonstrate their capability and the sensitivity of procedures for neurotoxicity and reproductive toxicity assessments. This study aims to validate social interaction assessments using positive controls to demonstrate the reliability and reproducibility of behavior assays in preclinical safety evaluation studies.