Evaluation of a home kit for lay user collection, centrifugation, and refrigeration of capillary blood specimens

Authors:   G. Iacovetti, N. Tokunaga, M. Peevler, J. Ragar, G. J. Sommer, U. Y. Schaff

Capillary Blood Collection for Egg-cellent Reproductive Insights

W. C. Brandon, B. B. Collier, M. R. Chappell, G. Iacovetti, M. Peevler, U. Y. Schaff, G. J. Sommer, R. P. Grant

Valildation of a Novel Real-Time PCR Assay for Identification of Mycobacterium species Isolates Recovered from Clinical Culture

Authors:   A. B. Harris, R. Jadi, T. J. Urban, T. Le, K. Song, H. N. Brochu, L. K. Iyer, S. E. Dale, G. A. Capraro, D. J. Boles

A Laboratory Developed Serum Anti-Mullerian Hormone Electrochemiluminescent Immunoassay: Performance and Retrospective Analysis of Over 2.2 Million Tests in Females and Males Across Lifespan

Authors:  D. Alfego, C. Cheng, M. Bastidas, B. Bauer, K. Chun

4T1-luc2: An orthotopic mammary cancer model to support novel immuno-oncology drug discovery

Breast cancer is the second most deadly malignancy after lung cancer in woman in the United States, with an estimated 246,000 new cases and 40,450 deaths expected in 2016. Many treatment options for breast cancer exist including surgery, radiotherapy, anti-estrogen therapy, targeted therapies (e.g., trastuzumab), and chemotherapy. Despite these therapeutic advances, metastatic disease remains a significant source of mortality. Immunotherapy has seen remarkable progress in the last five years with four T cell immune checkpoint inhibitors approved. While none of these checkpoint inhibitors are approved in breast cancer, there are currently 60+ clinical trials ongoing in breast cancer with checkpoint inhibitors against PD-1 or PD-L1 and 20+ clinical trials ongoing with CTLA-4 inhibitors. 

Labcorp Expands Collaboration with Ultima Genomics to Advance Whole Genome Sequencing Applications and Oncology Testing Capabilities

BURLINGTON, N.C. , and FREMONT, Calif. , July 29, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced an expanded collaboration with Ultima Genomics to utilize its UG 100 TM sequencing solution and ppmSeq TM technology to

Melissa Usher

Melissa joined Labcorp in April of 2024 as the Quality Director of the West Division. After serving as a Medical Lab Technician in the U.S. Navy, she spent over 20 years in pharmaceutical, medical device, and biologics manufacturing. She has a wide variety of experience, having worked in laboratory, individual contributor, management, and leadership roles across Quality Control and Quality Assurance functions. She also has experience with Lean Enterprise, participating in and facilitating methodologies such as kaizen, kanban, and 5S.

Elemental impurities per USP and ICH q3d guidelines

Elemental impurities in a drug product may arise from several sources. These sources may include impurities in starting raw material, reagents, catalysts intentionally added during synthesis, contaminants due to interaction with components in the manufacturing processes or container closure systems. To keep the number of elemental impurities within the limits provided by United States Pharmacopeia (USP) 232, the concentration of these impurities should be monitored. The raw materials should be tested before they are used for manufacturing. The manufacturing components coming in contact with the drug product should also be tested for these elemental impurities since they can also be a contributing factor, especially if exposed to elements further the process, closer to the final product. These elemental impurities, —in addition to having potential toxicological effects, —may adversely impact a drug’s stability, leading to loss of efficacy or other unintended effects.

UK-REACH alternative transitional registration model (ATRm)

Public consultation on proposals being put forward by the Department for Environment, Food & Rural Affairs on an alternative transitional registration model (ATRm) is open until July 25, 2024.