An Introduction to Immunohistochemistry

Immunohistochemistry (IHC) is an assay that utilizes the biological collaboration of Histology and Immunology. The biochemical interactions between an antibody and antigen permit visual distribution and localization of antibody–antigen interactions. This allows morphology, antigen intensity, and spatial relationships to be determined.

TDAR Assays for In Vivo Assessment and Testing

The immune system is the body’s main defense against foreign materials and biologic agents such as bacteria, viruses, chemicals, and foreign cells and tissues. The immune response includes specific action of lymphocytes (one type of white blood cell) and is facilitated by other white blood cells, including neutrophils, monocytes, macrophages, eosinophils and basophils. The immune system can be viewed as a system controlled by negative feedback, meaning that normally it must reduce the effects of disturbance or invaders through self-regulation.

Labcorp Announces 2023 Fourth Quarter and Full Year Results

Company Provides 2024 Guidance Results from Continuing Operations for the fourth quarter and full year versus last year: Revenue: Q4 of $3.03 billion vs $2.93 billion ; Full year of $12.16 billion vs $11.86 billion Diluted EPS: Q4 of $(1.95) vs $0.42 ; Full year of $4.33 vs $10.94 Adjusted EPS: Q4

Cell and Gene Therapy Answers: Top considerations for biomarkers in gene therapies

Gene therapies show great potential for addressing previously hard-to-treat diseases. However, optimizing their safety and efficacy requires careful analytical testing. Biomarkers can provide key insights into a gene therapy's effects and mechanisms. To learn more about the crucial role of biomarkers and analytical testing in gene therapy development, we spoke with Akanksha Gupta, PhD, executive director for cell and gene therapy at Labcorp. Here, she discusses the critical role of biomarkers and analytical testing within gene therapy, as well as important considerations for the adoption of a biomarker strategy to support development efforts.

Utilization of Radiation in the Preclinical Oncology Setting

The American Cancer Society estimates that in 2017 over 1.6 million people will be diagnosed with non-skin cancers in the United States. It is known that more than 50% of all cancer patients will receive some sort of radiation therapy as part of their treatment plan. Why is it then that preclinical evaluation of drugs in combination with radiation is not mainstay in the industry? In fact, in early 2017 the Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, within the US Food and Drug Administration, wrote a commentary in the International Journal of Radiation Oncology to address this point.1 In the commentary Walker, et al., indicate that, despite the high frequency of clinical radiation use resulting in both curative and palliative outcomes, there is a paucity of drug development efforts to capitalize on the potential synergies between targeted therapies and radiation therapy.

5 Things to Know About the Evolving Requirements For SEND

As our industry approaches the one year anniversary of the implementation of SEND (Standard for the Exchange of Nonclinical Data) datasets as required by the FDA for regulatory submissions, attention is shifting to the next set of requirements. From recent notices to upcoming compliance dates, we’ve compiled five key highlights for your information that will also help you proactively prepare for the changes.

Accelerating FDA Submissions with the Trial Summary Domain

A Trial Summary (TS) domain represents an essential part of standardizing study data for electronic submissions. In July 2016, the U.S. FDA issued version 3.1 of the Study Data Technical Conformance Guide, which advised including a TS domain to identify the study start date in the submission. In clinical studies, the study start date is earliest date of informed consent from any subject enrolled in the study, whereas nonclinical studies use the study initiation (protocol finalization) date. This article reviews the importance of the study start date and makes recommendations to help ensure a successful submission for current and legacy studies.

Advancements and Challenges of Imaging in the Immuno-Oncology Space

Immunotherapy agents (IO) are increasingly being used to treat solid tumors due to their dramatic effects on tumor response. However, the assessment of tumor response is not always straightforward given their unique mechanisms of action which include enhancing immune cell infiltration and activation in tumors. Current standard imaging techniques such as fluorinated deoxy-glucose (18F-FDG) PET cannot differentiate between cancer and immune cells. These tumor immune responses can lead to radiographic pseudo-progression whereby there can be an initial “worsening” of radiographic lesions. While IO therapies can be incredibly successful, understanding when a given treatment is successful or if the regimen needs to be augmented, is paramount.1 This confounding, radiographic evidence can lead to patients continuing therapy when no benefit is present or removal of therapy prematurely due to a delay in response time.

Can We Expand Companion Diagnostics Beyond Oncology?

The majority of today’s approved companion (and complementary) diagnostics (CDx) support personalized medicine efforts in oncology, a testament to researchers’ growing knowledge regarding the genetic pathways impacted in various cancers. That understanding increases our ability to convert such knowledge of biology into treatments that specifically target disease based on a tumor’s genetic makeup. This has led to significantly improved outcomes for many patients.

ELISPOT Addresses the Complex Questions Arising From Vaccine and Novel Therapies

The accelerated arrival of novel vaccines and immunotherapies into the clinical space spurred the emergence of fields like personalized medicine, immuno-profiling and immuno-monitoring built around increasingly sophisticated testing platforms. Among them, immunoassays in the ELISpot (Enzyme-Linked ImmunoSpot) family are the most frequently used functional assays for single-cell analysis.1