Technology area

In-vitro diagnostic

453 funded awards, $290.3M total, FY2023-FY2025.

Data current as of 2026-05-11

Pattern read

In-vitro diagnostics in NIH SBIR has been overwhelmingly NIAID-driven: 182 of 453 records, or 40% of the tag, sit at NIAID. The pandemic-era investment in molecular and serological diagnostics is still visible in the dataset. NCI at 48 and NIGMS at 38 trail. Median award is $616K. The R44 share (246) outweighs R43 (145), and STTR (R41) at 45 is modest. Concentration is moderate at 7.3% across the top three orgs. The category mixes molecular diagnostics, serology, point-of-care assays, and lab-developed tests. If your assay is a software-driven interpretation layer rather than a chemistry product, the tag may surface as research_tool_or_assay or clinical_decision_support instead.

Fit indicators

  • NIAID dominant (~40% of tag). Infectious-disease IVDs have been the strongest lane.
  • R44 share is high. Phase II awards have been the typical mature path.

Watchouts

  • Tag boundary with point_of_care_device and research_tool_or_assay is fuzzy. If your work has a clear hardware story, point_of_care_device may be a closer match.
  • The post-pandemic NIAID slice has been receding. Do not assume the same volume going forward.

Where the money sat, by Institute / Center

IC funding decisions are set by portfolio priorities, NOFO scope, and program-officer judgment. These are funded records, not predictions of future funding.

ICNameRecordsMedian award
AI (NIAID) National Institute of Allergy and Infectious Diseases 182 $847,533
CA (NCI) National Cancer Institute 48 $799,280
GM (NIGMS) National Institute of General Medical Sciences 38 $499,868
HL (NHLBI) National Heart Lung and Blood Institute 29 $301,224
AG (NIA) National Institute on Aging 28 $499,952
NS (NINDS) National Institute of Neurological Disorders and Stroke 22 $577,218
DK (NIDDK) National Institute of Diabetes and Digestive and Kidney Diseases 18 $702,486
DA (NIDA) National Institute on Drug Abuse 15 $803,562
TR (NCATS) National Center for Advancing Translational Sciences 13 $343,297
HD (NICHD) Eunice Kennedy Shriver National Institute of Child Health and Human Development 13 $761,233
ES (NIEHS) National Institute of Environmental Health Sciences 8 $276,401
EY (NEI) National Eye Institute 8 $753,275
DE (NIDCR) National Institute of Dental and Craniofacial Research 6 $313,498
AR (NIAMS) National Institute of Arthritis and Musculoskeletal and Skin Diseases 5 $298,915
EB (NIBIB) National Institute of Biomedical Imaging and Bioengineering 5 $351,600
OD NIH Office of the Director 5 $301,703
HG (NHGRI) National Human Genome Research Institute 3 $390,584
AT (NCCIH) National Center for Complementary and Integrative Health 3 $920,285
AA (NIAAA) National Institute on Alcohol Abuse and Alcoholism 3 $272,137
MH (NIMH) National Institute of Mental Health 1 $950,372

FOA / NOFO routes

Opportunity number prefixes: PA = Parent Announcement (broad, omnibus, multiple ICs), PAR = Parent with Special Review, PAS = Parent with set-aside funds, RFA = Request for Applications (targeted, single-IC, fixed budget). Status unknown means the pipeline has not verified whether the FOA is currently posting awards; the SBIR omnibus has been in reauthorization gap during this window. See the glossary for full definitions.

OpportunityStatusRecords
PA-22-176 unknown 131
PA-21-259 unknown 79
PA-23-230 unknown 78
PA-24-245 unknown 26
PA-23-232 unknown 18
PA-21-262 unknown 14
PA-22-178 unknown 13
PA-24-247 unknown 12
PAS-22-196 unknown 8
PA-19-272 unknown 8
PA-20-260 unknown 8
PA-20-272 unknown 7
PAS-22-197 unknown 6
PAS-19-316 unknown 4
RFA-DA-22-023 unknown 3
RFA-CA-21-001 unknown 3
RFA-DA-23-021 unknown 3
PAR-24-131 expired 3
PA-21-345 unknown 3
PAR-22-073 unknown 3
PA-22-177 unknown 2
RFA-CA-23-034 unknown 2
RFA-MD-23-003 unknown 2
RFA-DK-21-021 unknown 2
RFA-CA-20-033 unknown 2
PAR-21-225 unknown 2
PA-20-265 unknown 2
RFA-HL-23-008 unknown 1
PA-24-246 unknown 1
PA-25-212 unknown 1
PA-18-574 unknown 1
RFA-DA-24-018 unknown 1
RFA-MD-22-004 unknown 1
PAR-21-247 unknown 1
PA-20-047 unknown 1
RFA-CA-22-025 unknown 1

Comparable funded projects

ApplIDFYICTitleOrganizationAmount
10983353 2025 TR A cross-species preclinical platform to enhance the translation of new medicines CURI BIO INC $1,149,771
11010813 2025 AI Improving availability of ImmunoPET via automation of radio-synthesis and quality control of antibody-based HIV imaging PET tracers on a single platform. TRACE-ABILITY, INC. $1,000,000
11013882 2025 AI IND-enabling development of MM010, a PEG-specific intervention that blocks allergic response and restores repeated dosing for select PEGylated medicines impacted by anti-PEG antibody MUCOMMUNE, LLC $291,458
11026444 2025 AI Non-Clinical Pharmacology of CX-01 CERAMEDIX HOLDING, LLC $992,960
11039937 2025 AI Development of ultra-efficient antibodies for single cell mapping applications EPICYPHER, INC. $1,004,302
11043284 2025 HL An in vitro diagnostic assay for the early and accurate detection of platelet-activating antibodies associated with Heparin-inducedThrombocytopenia RETHAM TECHNOLOGIES, INC. $1,154,002
11043387 2025 AI Multiplexed Assay for Point-of-Care UTI Diagnosis (ID/AMR) NANOPATHDX, INC. $964,943
11043396 2025 HD Automated microfluidic device for blood analysis in neonates SERSENSE, INC. $774,788

Review panels that have appeared on these records

Panel names use NIH's Center for Scientific Review (CSR) format: a 2-4 letter study-section code plus a meeting-cycle number in parentheses (e.g. ISB (12) = Instrumentation and Systems Development, cycle 12). SBIR/STTR review groups are temporary, meeting-specific bodies. The names below describe panels that have appeared on the cited funded-project records, not where future applications get assigned. NIH assigns panels at the time of submission based on the application content.

Limitations

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