Startup profile for Pearl Diagnostics: what they do, why they are interesting, stage (series a), industries, and links to our funding articles. Part of the Venture Capital Tracker startup directory.

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

Competitive landscape

Edge: Regulatory milestones on a Hopkins science base — commercial bet is GTM execution, not basic science risk.

  • Culture-based fungal panels incumbent

    Standard of care; Pearl pitches noninvasive alternative.

  • Other molecular fungal tests direct

    Competing cleared diagnostics.

Industries

Biotech & Life Sciences Healthtech

Related funding articles

Venture Capital Tracker pieces that cover Pearl Diagnostics's financing or category context.

FAQs about Pearl Diagnostics

Practical answers founders, operators, and investors typically search for.

Noninvasive fungal infection diagnostics — FDA-cleared lead product entering U.S. sales.
Baltimore, Maryland — Johns Hopkins spinout.
$11.2M Series A (Mar 2026) per SEC filing reported by Technical.ly.
Grant-to-Series-A Hopkins diagnostics path with real regulatory clearance, not a science stub.
Series A; launching commercial sales.
Syndicate not fully mapped in VCT directory; TEDCO-class Maryland capital typical at earlier stages.

Last updated: 2026-07-29