The emergence of novel gene therapies has necessitated the development of cell-based CDx assays, posing multiple technical and operational challenges. Labcorp worked with a sponsor to develop the nAbCyte™ CDx assay to determine patient eligibility for a novel gene therapy program. nAbCyte is an FDA-approved in vitro CDx device that detects neutralizing antibodies to the AAVRh74var capsid in serum specimens from patients previously diagnosed with hemophilia B. This case study illustrates how Labcorp worked with the client and regulatory agencies to overcome development hurdles with a customized approach combining scientific expertise, collaboration, strategic engagement and governance.
CASSS Bioassays 2025 -- Developing precise, accurate and reproducible cell-based potency assays in a GMP environment presents multiple challenges. Potency assay are laborious to set up, requiring on average 2-4 hours of hands-on time (HoT) for a less complex assay with many analysts reporting repetitive motion issues.
Latent autoimmune diabetes in adults (LADA) is characterized by a slower progression of autoimmune beta-cell destruction compared to classic Type 1 diabetes (T1D), often leading to its misclassification as Type 2 diabetes (T2D) at initial presentation.
Let’s connect at ARVO May 4-8 in Salt Lake City, Utah, to explore how you can advance your ocular development with Labcorp’s experience, technology and specialists
Antibody-drug conjugates (ADCs) represent a significant advancement in cancer treatment by combining the targeting ability of monoclonal antibodies with cytotoxic drugs.
Two-dimensional (2D) cell cultures have been extensively used as tools to predict preclinical outcomes before proceeding to expensive animal studies despite their limited success in replicating in vivo studies.
Model growth kinetics and response to multiple treatment types were evaluated for syngeneic Renca murine renal cell carcinoma. Immune profile characterization was performed via flow cytometry to assess changes within the immune cell subsets following different treatment types and from control tumors at different tumor volumes.
The development of a 30-color immunophenotyping panel using the Cytek Aurora™ Spectral Flow Cytometer has enabled detailed profiling of T cell, NK and B cell subsets, along with their functional states.
Analysis of UGT1A1 pharmacogenomic profiles in 564 cancer patients revealed that 53% had reduced metabolizer status, potentially increasing toxicity or reducing efficacy of UGT1A1-metabolized drugs.
PacBio amplicon sequencing was used as an orthogonal method to confirm the performance of Labcorp Pan-Heme NGS (LPH) panel to detect somatic variants in hematologic malignancies across 141 clinically relevant genes.
