Department of Health and Human Services, through National Institutes of Health, awarded Pearl Diagnostics, Inc. of Baltimore, MD $1,976,387 under the STTR program (Phase I), with work starting 2025-07-24 and running to 2028-06-30. It is the only SBIR or STTR award to Pearl Diagnostics, Inc. in the last two years. Each figure links to the federal record.
The award
| Recipient | Pearl Diagnostics, Inc. (Baltimore, MD) |
|---|---|
| Awarding agency | Department of Health and Human Services |
| Awarding office | National Institutes of Health |
| Phase | Phase I |
| Amount obligated | $1,976,387 |
| Period of performance starts | 2025-07-24 |
| Period of performance ends | 2028-06-30 |
| Award number | SB1AI186689 (grant, CFDA 93.855) |
| Assistance listing | 93.855, Allergy and Infectious Diseases Research |
| Place of performance | Baltimore, Baltimore (City) County, MD |
| Signed | 2025-07-23 |
| Recipient registry id (UEI) | N9CGVFYJM1B5 |
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What it is for
A point of care urine test to aid diagnosis of aspergillosis - invasive aspergillosis (ia) was recently named by the who as an infection causing “critical” threats to public health, with unmet needs in both diagnostics a
Funding actions on this award
| Date | Action | Modification | Amount |
|---|---|---|---|
| 2026-09-01 | Revision | 001 | $0 |
| 2026-06-30 | Continuation | 000 | $977,071 |
| 2025-07-23 | New | 000 | $999,316 |
A point of care urine test to aid diagnosis of aspergillosis - invasive aspergillosis (ia) was recently named by the who as an infection causing “critical” threats to public health, with unmet needs in both diagnostics and therapeutics. Leveraging novel discoveries supporting patent-protected and proprietary technology that enables identification of microbial antigens in urine, pearl diagnostics (pearldx) has developed the first urine assay for ia, formatted as a high-volume enzyme immunoassay (eia) that is ce marked and under review for clearance at the FDA. Pearldx has also developed a lateral flow device (lfd) that will enable easier, point of care (poc) testing in small hospital labs and clinics. Using support from prior Phase I and ii STTR grants, we characterized heterogeneous urinary antigens, and developed methods to combine glycan-specific antibodies and eliminate biologic interferents in urine. Like the eia, the lfd currently demonstrates 90% sensitivity and specificity, improving on performance of the current blood-based commercial assay and exceeding FDA PRE-510K agreed upon metrics for regulatory clearance. To enable use at poc, we now enter the last stage of optimization, which is focused on eliminating the need for a lab to perform sample processing. This commercial readiness pilot proposal supports final integration and clinical testing for FDA clearance of the ...
From the federal award record.
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Pearl Diagnostics, Inc.'s Form D filing
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Get the free SnapshotWhere this comes from
The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs set aside part of federal research budgets for small companies. Agencies award them in phases: Phase I tests whether an idea is feasible, Phase II funds development, and Phase III is follow-on work paid for outside the set-aside. STTR awards also require a research institution as a partner.
Every figure on this page is taken from the award's own federal record, linked beside it, as it stood when the page was built: the recipient, its address, the awarding agency and office, the amount obligated so far, the dates and the description. Phase and program are shown as the award's own description states them. The amount can grow later if the agency adds funding to the same award.