Keynote Speaker for this Event:
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LabCorp is engaged in numerous Companion Diagnostics (CDx) projects with its pharmaceutical partners; these projects span therapy areas and include platforms such as flow cytometry, ELISA, RT-PCR, and gene expression profiling.
Our unique position in the industry allows us to develop and validate novel or existing biomarkers through one of our eight Centers of Excellence, test those biomarkers in the clinical trial setting and then, contingent on intended use, submit to Regulatory authorities in tandem with the therapeutic – with the view to commercialization across our global network of laboratories.
A Regulatory approved LDT within the LabCorp network offers an attractive option in the reference laboratory industry and has culminated in 510(k) and pre-market approval submissions to the U.S. Food and Drug Administration (FDA).
Key Takeaway Points:
- Different models to commercialisation are available
- IVD and Regulated Laboratory Developed Test (LDT)
- Scalable commercialization pathways
- Strategies to reduce CDx development timelines by up to 12 months
- Recent case studies with FDA submissions demonstrate a different approach
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