NIH Highlighted Topic: Leveraging All of Us Biospecimens to Advance Precision Medicine Research

Overview

The National Institutes of Health (NIH) is encouraging researchers to analyze biospecimens donated by participants in the All of Us Research Program, one of the most diverse and richly characterized biobanks in existence. About 600,000 participants have provided biospecimens, linked to genomic data, electronic health records, wearables data, surveys, and physical measurements.

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Researchers approved for access to All of Us biospecimens are expected to secure their own funding for sample processing, data generation, analysis, and return of value to participants. More than 20 NIH Institutes, Centers, and Offices participate, so companies with multiomic, biomarker, or AI capabilities can fund this work through the NIH SBIR program.

Key dates and funding

• Next SBIR due dates: January 5, 2027 and April 5, 2027 (5:00 PM local time of your organization)
• Application route: NIH, CDC and FDA Parent SBIR (R43/R44), PA-27-100, Clinical Trial Optional
• Project period: normally up to 6 months for Phase I and up to 2 years for Phase II
• Topic window: NIH lists this Highlighted Topic through September 18, 2028, so it can support more than one submission cycle

Budget guidelines in PA-27-100 vary by participating Institute or Center. Total costs (direct, indirect, and fee) normally stay within these amounts:

• National Cancer Institute (NCI): Phase I $700,000, Phase II $2,500,000
• National Institute on Aging (NIA): Phase I $700,000, Phase II $3,000,000
• National Institute of Mental Health (NIMH): Phase I $700,000, Phase II $3,000,000
• National Institute of Neurological Disorders and Stroke (NINDS): Phase I $700,000, Phase II $3,000,000
• National Center for Complementary and Integrative Health (NCCIH): Phase I $700,000, Phase II SBA guideline
• National Heart, Lung, and Blood Institute (NHLBI): Phase I $400,000, Phase II $3,000,000
• National Institute on Drug Abuse (NIDA): Phase I $400,000, Phase II $3,000,000
• National Institute on Deafness and Other Communication Disorders (NIDCD): Phase I $400,000, Phase II $3,000,000
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): Phase I $400,000, Phase II $2,500,000
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): Phase I $400,000, Phase II $2,500,000
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): Phase I $400,000, Phase II $2,500,000
• National Institute of Nursing Research (NINR): Phase I $400,000, Phase II $2,500,000
• National Eye Institute (NEI): Phase I $400,000, Phase II SBA guideline
• National Human Genome Research Institute (NHGRI): Phase I $400,000, Phase II SBA guideline
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): SBA guideline for both phases
• National Institute of Dental and Craniofacial Research (NIDCR): SBA guideline for both phases
• National Institute of Environmental Health Sciences (NIEHS): SBA guideline for both phases
• National Institute on Minority Health and Health Disparities (NIMHD): SBA guideline for both phases
• National Library of Medicine (NLM): SBA guideline for both phases

NIH notes that researchers must have approval to access All of Us biospecimens. Plan for that access step alongside your SBIR timeline.

Who is eligible?

Only United States small business concerns can apply through the NIH Parent SBIR announcement. In plain terms, your company must meet these requirements:

• A for-profit business with a place of business in the United States and no more than 500 employees, including affiliates
• Generally more than 50% owned and controlled by U.S. citizens or permanent residents, or by qualifying venture capital, hedge fund, or private equity owners under SBA rules
• The Principal Investigator is primarily employed by the small business at the time of award and for the duration of the project
• No foreign organizations, foreign components, or foreign subawards (unfunded foreign collaborators and foreign consultants are permitted)
• Companies selected for funding submit the SBA foreign affiliations disclosure during the Just-in-Time process

What NIH wants funded

NIH is most interested in broad-scale biomarker and omics analyses that reduce the need for new sample collection and produce datasets other researchers can build on. Possible assays include long-read sequencing, genome-wide methylation profiling, proteomics, metabolomics, immune profiling, and other multiomic analyses.

Genomics, data science, and AI

• NHGRI: long-read sequencing to capture structural variants and repeat expansions missed by short reads, and population-scale multiomic reference datasets
• NLM: informatics and data science tools, including trustworthy and reproducible AI, scalable data integration, and benchmarking frameworks
• NEI: AI and machine learning combining molecular, retinal imaging, and health record data

Disease-focused interests

• NCI: multiomic data on cancer susceptibility and biomarkers for screening, early detection, and treatment response
• NIDDK: biomarkers for diabetes, obesity, liver, GI, and kidney disease, including links to continuous glucose monitoring data
• NIMH, NINDS, and NIA: genomic and molecular discovery in mental illness, neurological disorders, dementia, and aging
• NIAAA and NIDA: biomarkers and molecular endotypes for alcohol and substance use disorders

Environment, lifestyle, and health differences

• NIEHS: exposomics and precision environmental health
• NIMHD: biomarkers linking social, environmental, and wearable data to health outcomes
• NCCIH, NINR, NICHD, NIAMS, NIDCD, NIDCR, and NHLBI: additional mission-specific interests listed on the topic page

How to apply

NIH Highlighted Topics are not funding opportunities on their own. Small businesses apply through the NIH, CDC and FDA Parent SBIR announcement (PA-27-100) and write the application to match the interests of at least one participating Institute or Center. Read the full NIH Highlighted Topic before you start.

• Register early: SAM.gov (which issues your UEI and can take six weeks or more), Grants.gov, eRA Commons (a Signing Official plus a PI account with a linked ORCID iD), and the SBA Company Registry (proof of registration is attached to the application)
• Talk to the program officer: each Institute lists its own scientific contact, NICHD strongly encourages contact before submission, and the All of Us Research Program, ODS, ONR, and ORWH participate but do not award grants
• Check the budget: contact the participating Institute or Center early if you plan to request more than the SBA budget guideline
• Submit electronically: through NIH ASSIST, a system-to-system solution, or Grants.gov Workspace by 5:00 PM local time on January 5, 2027 or April 5, 2027

Is this a fit for your company?

This topic suits companies offering multiomic assays (proteomics, metabolomics, methylation, long-read sequencing), biomarker discovery platforms, and AI or data integration tools that can work at population scale. The strongest applications produce data that goes back into the All of Us Researcher Workbench and supports a clear commercial product, such as a diagnostic panel or analytics platform.

If that sounds like your company, book a free funding fit call with BW&CO. Our team has helped secure $350M+ in non-dilutive funding and can tell you quickly whether this topic, and which Institute, is the right target for your January or April submission.

Frequently asked questions

Is the NIH All of Us biospecimens Highlighted Topic a funding opportunity?

No. It is an NIH Highlighted Topic, which signals scientific interest but is not a notice of funding opportunity. Small businesses apply through the NIH Parent SBIR announcement (PA-27-100), with the next due dates on January 5, 2027 and April 5, 2027.

How much NIH SBIR funding is available for All of Us biospecimen research?

It depends on the Institute. Under PA-27-100, NCI, NIA, NIMH, NINDS, and NCCIH allow up to $700,000 for Phase I. NHLBI, NIA, NIDA, NIDCD, NIMH, and NINDS allow up to $3,000,000 for Phase II. Several Institutes, including NIEHS, NIMHD, and NLM, follow the SBA guideline.

Do I need approval to use All of Us biospecimens?

Yes. NIH states that researchers who have approval for access to All of Us biospecimens are expected to secure additional funding for sample processing, data generation, analysis, and return of value to participants.

What kinds of assays does NIH want run on All of Us biospecimens?

Examples include long-read sequencing, genome-wide methylation profiling, proteomics, metabolomics, immune profiling, and other multiomic analyses that produce broadly useful datasets.

Who is eligible to apply through NIH SBIR?

U.S. for-profit small businesses with no more than 500 employees, majority owned and controlled by U.S. citizens or permanent residents (or qualifying investors under SBA rules), whose Principal Investigator is primarily employed by the company. Foreign organizations and foreign subawards are not allowed.

Can BW&CO help with an NIH SBIR application for this topic?

Yes. BW&CO helps small businesses choose the right NIH Institute, align the Specific Aims with the Highlighted Topic, and build a competitive SBIR application. The firm has helped clients secure $350M+ in non-dilutive funding. Book a free funding fit call to see if your technology is a match.