Funder: National Institutes of Health

Due Dates: June 4, 2025 | September 10, 2025 | February 4, 2026 | June 4, 2026 | September 10, 2026 | February 4, 2027 | June 4, 2027 | September 10, 2027

Funding Amounts: Up to $250,000 direct costs per year, for a maximum project period of 5 years (U01 cooperative agreement mechanism).

Summary: Supports research to address preanalytical variability in biospecimen collection and handling to improve the development and validation of clinical biomarker assays.

Key Information: Clinical trials are not allowed; applications must focus on assay development/validation, not biomarker discovery or technology development.


Description

This opportunity, offered by the National Cancer Institute (NCI) at NIH, funds extramural research to investigate and mitigate challenges in clinical assay development and analytical validation caused by preanalytical variability in biospecimen collection, processing, and storage. The program aims to generate evidence-based standards for handling tumor tissue biopsies, blood (liquid biopsies), and other biospecimens (e.g., tissue swabs, secretions, pleural/esophageal aspirates, feces, sweat, urine, CSF, breast milk, saliva) to improve the reliability and reproducibility of clinically relevant biomarker assays.

The overarching goal is to expedite the development and implementation of biomarker assays in clinical settings, particularly for cancer research and clinical trials, by reducing variability and bias introduced during biospecimen handling.


Due Dates

  • Next due date: June 4, 2025
  • Additional due dates: September 10, 2025; February 4, 2026; June 4, 2026; September 10, 2026; February 4, 2027; June 4, 2027; September 10, 2027
  • Letters of intent are requested 30 days prior to each application due date.
  • All applications are due by 5:00 PM local time of the applicant organization.

Funding Amount

  • Direct costs: Up to $250,000 per year
  • Project period: Maximum of 5 years
  • Mechanism: U01 Cooperative Agreement (substantial NIH programmatic involvement)
  • Number of awards: Contingent on NIH appropriations and the number of meritorious applications

Eligibility

Eligible applicants include:

  • Public and private institutions of higher education (domestic and foreign)
  • Nonprofits (with or without 501(c)(3) status)
  • For-profit organizations (including small businesses)
  • State, county, city, township, and special district governments
  • Native American tribal governments and organizations (federally recognized and other)
  • Independent school districts
  • Public housing authorities/Indian housing authorities
  • Faith-based and community-based organizations
  • Regional organizations
  • U.S. territories and possessions
  • Non-domestic (non-U.S.) entities and components of U.S. organizations

Note: Foreign organizations and components are eligible to apply.


Application Process

  • Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
  • Required registrations: SAM, eRA Commons, Grants.gov (can take 6+ weeks; start early).
  • Letter of intent: Not required but strongly encouraged; submit 30 days before the application due date.
  • Application forms: Use the SF424 (R&R) package and follow the NIH Research Application Guide.
  • Key attachments: Research Strategy, Specific Aims, Data Management and Sharing Plan, Resource Sharing Plan, and other standard NIH forms.
  • Page limits: Follow the NIH Table of Page Limits.
  • Review: Applications are peer reviewed for scientific and technical merit, with emphasis on significance, innovation, approach, investigator expertise, and environment.

Additional Information

  • Scope: Projects must focus on the impact of preanalytical variables on the performance of clinically relevant biomarker assays (not on biomarker discovery or technology development).
  • Non-responsive topics: Technology development (e.g., new fixatives), biomarker discovery, early detection assays, or global omics studies.
  • Multidisciplinary teams: Strongly encouraged, including clinical, laboratory, and statistical expertise.
  • Data sharing: All applications must include a Data Management and Sharing Plan.
  • Clinical trials: Not allowed under this opportunity.
  • Budget: Modular or detailed budget as appropriate; foreign applicants must use detailed budget.
  • NIH involvement: Substantial programmatic involvement is expected (U01 mechanism).

External Links


Contact Information

Contact TypeName/TitleEmailPhone
Scientific/Research ContactLokesh Agrawal, Ph.D.lokesh.agrawal@nih.gov240-276-5718
Scientific/Research ContactAbhi Rao, Ph.D.abhi.rao@nih.gov240-276-5715
Scientific/Research ContactPing Guan, Ph.D.ping.guan@nih.gov240-276-5711
Scientific/Research ContactMiguel Ossandon, Ph.D.ossandom@nih.gov240-276-5714
Peer Review ContactReferral Officer (NCI)ncirefof@dea.nci.nih.gov240-276-6390
Grants Management ContactShane WoodwardShane.Woodward@nih.gov240-276-6303
General Grants InfoNIH Grants InformationGrantsInfo@nih.gov301-480-7075
Application SupporteRA Service DeskeRA Helpdesk301-402-7469 / 866-504-9552
Grants.gov SupportGrants.gov Help Desksupport@grants.gov800-518-4726

Atom | Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed)