Startup profile · funding coverage
Pearl Diagnostics startup funding profile
Johns Hopkins spinout commercializing noninvasive urine assays for lung infections (Aspergillus, Pseudomonas).
Stage
series a
Status
private
Coverage
full
Overview
Pearl Diagnostics develops noninvasive in vitro diagnostics for lung infections by detecting microbial extracellular vesicles in urine. Spun out of Johns Hopkins University in 2014, the company received FDA 510(k) clearance for its MycoMEIA Aspergillus assay in August 2025 and closed an $11.2M Series A in March 2026 (SEC filing) to commercialize in the U.S., with CE approval enabling EU sales.
Why Pearl Diagnostics is interesting
Rare Baltimore diagnostics commercialization: FDA 510(k) clearance for MycoMEIA Aspergillus assay (Aug 2025) plus $11.2M Series A (Mar 2026, SEC filing) to launch U.S. sales — EV-based lung infection detection, not another generic PCR panel.
Product & use cases
Noninvasive diagnostic for fungal infections — moving from regulatory clearance to U.S. and European commercial launch.
- Clinical fungal infection detection without invasive sampling
- Hospital and lab diagnostic workflows post-FDA clearance
Key facts
- Johns Hopkins spinout (2014); HQ Baltimore
- FDA 510(k) clearance: MycoMEIA Aspergillus assay (Aug 2025)
- Series A (Mar 2026): $11.2M per SEC filing (Technical.ly coverage)
- CEO Eric Gornstein joined for commercialization push
Fundraising history
Series A
2026-03 $11.2MSource: https://technical.ly/entrepreneurship/pearl-diagnostics-raises-series-a-maryland-money-moves/
Competitive landscape
Edge: Regulatory milestones on a Hopkins science base — commercial bet is GTM execution, not basic science risk.
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Culture-based fungal panels incumbent
Standard of care; Pearl pitches noninvasive alternative.
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Other molecular fungal tests direct
Competing cleared diagnostics.
Industries
Related funding articles
Venture Capital Tracker pieces that cover Pearl Diagnostics's financing or category context.
FAQs about Pearl Diagnostics
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Last updated: 2026-07-29