What does a central lab do? Four core services

Every clinical trial relies on data from its study participants to inform decisions regarding the safety and efficacy of a potential new treatment. Clinical trial sponsors rely on the data from laboratory tests to bring clear insights that advance studies.

How to de-risk OECD 443 studies through optimized dose level selections

The European Chemicals Agency (ECHA) recently conducted a review project regarding the design of the OECD 443 (Extended One-Generation Reproductive Toxicity Study, or EOGRTS). The project’s goal was to assess the performance of the study in terms of study design, conduct and findings to determine if the study design currently prescribed gives sufficient information for regulatory hazard classification.

Integrating technologies: Ultrasound and cfDNA screening in twin pregnancies

Despite overall limited data on cell-free DNA (cfDNA) testing in twin gestations, MaterniT 21 PLUS has demonstrated high sensitivity and specificity in screening for trisomy 21 in twins from the first trimester of pregnancy (comparable to that observed in singleton pregnancies), as well as promising performance in screening for trisomies 13 and 18, according to the results of a newly published study.1 Hear from our experts about the nuances of twin pregnancy care as we combine ultrasound expertise with the latest research review on fetal cfDNA screening.

Top considerations for developing a biomarker solution and CDx strategy

When it comes to designing clinical trials with expedience and efficiency, many drug developers are choosing biomarker-driven strategies for their investigational precision medicines. As key features of developing new therapies and diagnostics, biomarkers define the disease biology, provide potential targets for new therapies and provide strong potential for market differentiation. When considered together with companion diagnostic (CDx) development, biomarkers also offer relevant clinical information that may bring deeper insights, enabling breakthroughs in various precision medicines. At the 2022 Japan Symposia, Mark Roberts, senior director of diagnostic development services, weighed in on ways drug developers can examine their biomarker and CDx strategies and enhance outcomes for their programs.

Cell and Gene Therapy Answers: The critical role of biomarkers and analytical testing in adoptive cell therapies

Adoptive cell therapies have shown great promise in treating certain cancers. As more and more adoptive cell therapies move toward regulatory approval, robust analytical testing and biomarker identification will be key to delivering the full potential of these life-changing treatments. We spoke with Akanksha Gupta, PhD, executive director for cell and gene therapy at Labcorp, to learn more about the latest advancements and remaining considerations in this rapidly evolving field.

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Advancing your global companion diagnostics program: Insights from a recent Japan symposium (Part 1)

Through companion diagnostics (CDx), a patient can receive individualized treatment designed to improve clinical outcomes while avoiding adverse effects. A key component of precision medicine, CDx can also lead to significant cost savings, cutting up to 60% of the total clinical trial research and development costs. The global CDx market thus has been growing rapidly and is estimated to reach USD 17.6 billion by 2027. It is crucial for companies developing CDx programs to choose a partner with the right capabilities and experience, especially with validations required for approval from regulatory bodies, such as the FDA. Our experience supporting successful CDx clinical trials globally has helped us gain deep insights into CDx development best practices.

Graphical Summary: ctDNA response after pembrolizumab in non-small cell lung cancer: Phase 2 adaptive trial results