Why cell line screening is crucial for successful complement-dependent cytotoxicity (CDC) assay development

One of the major improvements in oncotherapy of late has been the development of monoclonal antibodies (mAbs) targeting tumor-specific antigens. The ability of these antibodies to kill tumor cells is largely dependent on their Fc effector function. While the complementarity-determining region of the molecule binds the specific tumor antigen, the Fc portion induces target-cell killing by three main mechanisms: complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). Fc effector functionality is a critical area to assess for mAb therapeutics, and cell-based potency assays are used for QC batch release and biological characterization.

Setting the foundation of success in your drug development

The primary function of biopharmaceutical development is to demonstrate that the investigational drug is both safe and efficacious for human use. And aspect of this is to have a comprehensive understanding of both the drug substance and drug product, both from a physiochemical and biological viewpoint. Accordingly, there is a regulatory expectation that any investigational biopharmaceutical will be thoroughly characterized using a wide range of analytical techniques. Due to the highly complex nature of biopharmaceuticals, this is not a trivial exercise, often involving orthogonal analytical techniques to gain deep understanding of the biopharmaceutical product. In this brochure, we outline the regulatory expectations for biopharmaceutical characterization along with the specific requirements for some of the more common modalities that are currently in development.

On-demand webinar: Developing predictive cancer models and more persistent CAR T-cell therapies through enhanced metabolic fitness

Julia Wang

Julia Wang has served as Executive Vice President and Chief Financial Officer of Labcorp since December 2024.

Prior to joining Labcorp, Julia served as CFO of BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) since 2021, which she joined in 2020 as Senior Vice President, Enterprise Optimization and Deputy CFO. While at BeiGene, she was instrumental in driving business transformations through accelerating growth, nurturing innovation and cultivating a culture of sustainable operating efficiencies.

Genomic profiling of NSCLC tumors with the TruSight oncology 500 assay provides broad coverage of clinically actionable genomic alterations and detection of known and novel associations between genomic alterations, TMB, and PD-L1

Investigators from Illumina and Labcorp medical affairs teamed up to perform the largest real-world characterization of advanced non-small cell lung cancer using the TruSight® Oncology 500 (TSO500) assay to date. In our recently published manuscript in Frontiers, we assessed the spectrum of current FDA therapy-associated and clinical trial-associated genomic variants, along with known and novel patterns of co-mutations and co-occurrence with biomarkers predictive of immunotherapy response. We retrospectively analyzed clinical TSO 500 testing data from 7,606 NSCLC  biopsy specimens submitted for testing during standard clinical care. Our data provides further characterization of NSCLC at the genomic and immune checkpoint inhibitor response biomarker level and highlights the clinical utility of broad coverage CGP testing in detecting both known and novel facets of NSCLC to inform treatment decision-making. 

Molecular Tumor Board: 82-year-old female with high grade ovarian serous adenocarcinoma and BRCA1 F709fs mutation

An 82-year-old with advanced high-grade serous ovarian cancer and a BRCA1 mutation highlights the importance of somatic and germline testing to guide therapy and using PARP inhibitors for maintenance. Join our Molecular Tumor Board to explore treatment strategies and the impact of reversion mutations on resistance management.

Graphical Summary: Comprehensive NGS profiling to enable detection of ALK gene rearrangements and MET amplifications in non-small cell lung cancer

Multiple sclerosis monitoring profile

Blood biomarkers (BBMs) are a new frontier in neurology, impacting the way physicians diagnose, manage and monitor neurodegenerative diseases such as Alzheimer’s and ALS. The promise of BBMs, particularly neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP), to change and improve multiple sclerosis (MS) patient management is now being realized.

The vital role of the primary care team: Highlights from the AHA Scientific Statement on CKM Syndrome

Cardiovascular disease (CVD), chronic kidney disease (CKD) and diabetes mellitus (DM) are among the most common chronic diseases present in the United States1 and represent 3 of the top 10 leading causes of death.2 These conditions, along with metabolic conditions more broadly, have a significant impact on individual patients as well as on the healthcare system as a whole; furthermore, the prevalence of these conditions is anticipated to increase over the next several decades,3 making the identification and management of these conditions a public health priority. Historically, these conditions have been conceptualized and treated as siloed entities, with each condition being addressed individually. There is increasing appreciation that these common health conditions are closely interconnected from a pathophysiological standpoint and should be approached and treated using a holistic, interdisciplinary approach to achieve optimal patient outcomes. In 2023, the American Heart Association (AHA) issued a scientific statement formally defining the constellation of conditions encompassing CVD, CKD and more broadly, metabolic disease (including diabetes) as cardiovascular-kidney-metabolic (CKM) syndrome and providing recommendations for the clinical management of patients with CKM.4 Both early detection and timely intervention are key to improving health outcomes for patients with CKM syndrome. The primary care team is uniquely positioned to aid in the identification, treatment and monitoring of this recently recognized syndrome.

Biologic drug and anti-drug antibody monitoring: TNF inhibitors infliximab, adalimumab and certolizumab pegol in 128,537 patient samples

Biologic drugs are used to treat auto-immune inflammatory responses associated with IBD. The body may develop anti-drug antibodies against these drugs over time and can be mitigated by ensuring an optimal dosage in patients. This poster details a review of specimens submitted to Labcorp for these drugs and anti-drug antibodies.