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Utilization of Cohorts and Prospective Study Designs for Liquid Biopsy Assay Validation for Early Detection of Cancers

Notice of Special Interest (NOSI): NOT-CA-23-004

Receipt Date: January 05, 2023

Expiration Date: July 02, 2025


The NCI encourages grant applications from small businesses to develop technologies that facilitate early cancer biomarker assay development, verification, qualification, and validation utilizing statistically powered retrospective cohorts and/or through prospective studies in the appropriate populations with a sound study design.

Through this NOSI, NCI encourages applications that investigate the use of existing cohort samples and samples from ongoing prospective collections for analytical and clinical validation of assays for earlier detection of cancer.

Research areas of interest for this NOSI include but are not limited to:

  • Facilitate the development of high-throughput, sensitive assay methods to identify, verify and validate biomarkers that are useful in early detection of early-stage cancers or their lethal precursors
  • Develop, evaluate, verify, quantify, or validate promising liquid biopsy-based biomarkers in various risk populations for effective cancer detection of early-stage cancers
  • Determine the sensitivity and specificity of liquid biopsy assays to detect one or more cancers in prediagnostic specimens
  • Determine relationship between algorithm cut-points for a positive assay result depending upon the risk level of the population for which the assay is being used for cancer screening
  • Demonstrate ability to distinguish between individuals at risk of developing lethal vs. non-lethal clinical cancers
  • Develop early detection models based on longitudinal patterns of the biomarkers using serial biospecimens
  • Describe the natural history of a biomarker to determine the timeline of detection prior to clinical cancer diagnosis or through the transition from early stage to advanced stage cancer using serial biospecimens.
  • Evaluate the utility of a specified liquid biopsy early cancer detection, or detection prior to clinical cancer diagnosis, using prediagnostic specimens from asymptomatic individuals
  • Demonstrate usability of a liquid biopsy assay in clinical settings considering standard protocols (i.e., sample collection, transportation, handling, and storage of samples)
  • Updated:

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