Integrating Biospecimen Science Approaches into Clinical Assay Development (U01)

Funding Agency:
National Institutes of Health

This Funding Opportunity Announcement (FOA) will support extramural research to investigate and mitigate challenges facing clinical assay development and subsequent analytical validation due to preanalytical variability in tumor tissue biopsies and blood biospecimens utilized as “liquid biopsies.” Extramural research funded under this FOA may include investigations of preanalytical variability associated with the procurement and study of small biopsies (core biopsies, small excision samples), pleural aspirates, and blood utilized for liquid biopsies. Investigator-designed experiments will explore how different biospecimen preanalytical conditions affect emerging and clinically relevant biomarkers quantified by a variety of testing platforms. The results from this research program will improve the understanding of how analytical quantification of clinically relevant biomarkers is affected by variation in biospecimen collection, processing, and storage procedures. The overall goal is to expedite biomarker clinical assay development through evidence-based standardization of biopsy handling practices.


  • Letter of Intent Due Date(s): 30 days prior to the application due date
  • Application Due Date(s): November 28, 2018; March 14, 2019; July 11, 2019; November 7, 2019; March 11, 2020; July 9, 2020; November 9, 2020; March 15, 2021; July 11, 2021

​PAR-18-947 Expiration Date July 12, 2021

Agency Website

Eligibility Requirements

A multidisciplinary research team is encouraged.



Amount Description

Application budgets are limited to $250,000 direct costs per year.

The maximum project period is five years.

Funding Type





Medical - Basic Science
Medical - Clinical Science

External Deadline

March 11, 2020