| Labcorp

June 14, 2024

Advancing your global companion diagnostics program: Insights from a recent symposium

Companion diagnostics (CDx) can improve clinical outcomes and reduce costs associated with clinical trial research and development. Choosing the right partner-with expertise in antibody and tissue selection, cutoff design and regulatory approvals-is key to advancing global CDx programs.

June 14, 2024

Biocompatibility Evaluation Endpoints

Biocompatibility evaluation endpoints chart

June 14, 2024

Accelerated aging test requisition form

Accelerated aging testing sample submission form

June 14, 2024

Microbiology test requisition form

Microbiology related testing sample submission form

June 14, 2024

General testing sample submission form

Test Requisition Form - General testing sample submission form

June 14, 2024

Ethylene oxide (ETO) residuals testing form

Intended for submitting samples for sterilization testing

June 14, 2024

Daily 6-hour restraint decreases Sprague Dawley® rat body weight gain in subchronic toxicity studies

ACT 2023 -- Safety assessment of pharmaceuticals and chemicals with potential for repeated human exposure involves determining toxicity in studies that align with country-specific regulatory frameworks.

June 14, 2024

Early ctDNA molecular response enhanced through integrated analyses of cell-free DNA and matched white blood cells

Liquid biopsies represent a transformation in the management of cancer as they have the potential to detect, characterize, and monitor cancers earlier than conventional diagnostic modalities.

June 14, 2024

Liquid biopsy regulatory considerations, current utility, and future directions

The future is plasma. There is a growing body of evidence that demonstrates how incorporating liquid biopsy-based testing into cancer clinical trials can augment traditional tissue-based testing workflows and findings.

June 14, 2024

How investigational new drug studies completed at China site led to expedited regulatory approval for sponsor's orphan drug

As an emerging biotech company developing antibody based therapeutics for oncology and non-oncology indications, Transcenta needed a full suite of studies for its investigational new drug (IND) package on Osemitamab (TST001), an antibody targeting a protein overexpressed in solid tumors.

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Advancing your global companion diagnostics program: Insights from a recent symposium

Biocompatibility Evaluation Endpoints

Accelerated aging test requisition form

Microbiology test requisition form

General testing sample submission form

Ethylene oxide (ETO) residuals testing form

Daily 6-hour restraint decreases Sprague Dawley® rat body weight gain in subchronic toxicity studies

Early ctDNA molecular response enhanced through integrated analyses of cell-free DNA and matched white blood cells

Liquid biopsy regulatory considerations, current utility, and future directions

How investigational new drug studies completed at China site led to expedited regulatory approval for sponsor's orphan drug