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What is Circulating Tumor DNA (ctDNA)?

ctDNA is fragmented DNA derived from tumors circulating the patient’s blood not associated with other cells. ctDNA fragments originate from tumors and can reflect part of tumor genome. The quantity of ctDNA depends on the type of tumor, where it is located, tumor stage and response to treatment. These features of ctDNA makes it useful in less invasive liquid biopsies to detect tumors, monitor progression of tumors and detect residual biomarkers in remission during and after treatment. Based on these reasons USFDA, has issued a draft guidance on using circulating tumor DNA (ctDNA) for early-stage solid tumor drug development. This guidance is to help drug developers use ctDNA as a biomarker early in the clinical trials and to get approval for in vitro diagnostic assays.

Why ctDNA?

  • FDA and pharma are both working to accelerate drug development
  • Currently major delay in drug development is understanding the tumor response to the drug
  • A less-invasive rapid assessment of response is provided by ctDNA assays
  • FDA is encouraging the incorporation of such assays in clinical trials
  • The number of clinical trials that are using such assays has grown exponentially in the last 5 years
  • Small and mid-size biopharma are also including these as endpoints

How can ctDNA be used as a regulatory biomarker?

The draft guidelines provided by FDA has outlined 4 different ways ctDNA can be incorporated into clinical trials involving early-stage solid tumors.

  • Patient selection based on mutation profile
  • As a marker for remission to enrich the patient population in the trial who are at a higher risk
  • As a marker for response to treatment
  • As an early endpoint in a clinical trial

REPROCELL Offering in ctDNA Analysis

  • Optimized ctDNA extraction from human plasma
  • Validated off the shelf oncology panels
  • Developing assays for stage I clinical trial for non-small cell lung cancer, where the subjects are non-smokers
  • Development and optimization custom panels based on the clinical trials and customer requirements