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  7. Pearl Diagnostics, Inc
Pearl Diagnostics, Inc logo

Pearl Diagnostics, Inc

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Baltimore, MD 21205
410-801-7983
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At a glance

Employee size
2-10
Organization type
Privately Held
Headquarters
Baltimore, MD
Founded
2014

About

Born from a Johns Hopkins University spinout founded in 2014, Pearl Diagnostics develops in vitro diagnostic assays that help clinicians detect lung infections through microbial extracellular vesicles. The Baltimore company’s MycoMEIA Aspergillus Assay is its signature achievement: a non-invasive urine test that delivers results in about three hours and received FDA 510(k) clearance in 2025. Pearl Diagnostics is woman-owned and operates under an ISO 13485 quality system.

Capabilities and markets

Products

Manufacturing processes

Service offerings

Economic activities

End markets served

Directory supply chains

Classification

NAICS codes

Certifications and registrations

Certifications

  • FDA 510(k) clearance for MycoMEIA Aspergillus Assay

  • CE Mark for MycoMEIA Aspergillus Assay

  • ISO 13485

  • Financial Conflict of Interest Policy under 42 CFR Part 50 Subpart F

    Compliance program

  • U.S. Small Business Administration Women-Owned Small Business (WOSB)

    Registration

Ownership and small business status

  • Woman-owned

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  • ScreenHER logoScreenHERFounded by Purdue-trained mechanical engineer and medtech commercialization leader Jennifer Estep, ScreenHER is a women’s health diagnostics company focused on making earlier cervical cancer detection more accessible. Its first platform application, UriCerve™, is being developed for rapid, non-invasive use at the point of care so clinicians can make decisions during the same visit. UriCerve™ remains under development and is not approved for clinical use.
  • Novel Microdevices, Inc logoNovel Microdevices, IncBaltimore-based Novel Microdevices develops portable, sample-to-answer molecular diagnostic systems built around disposable microfluidic cartridges. Its battery-powered Novel Dx platform is designed to deliver lab-quality PCR results in about 15 minutes, including testing for respiratory infections and other diseases at the point of care. The company is establishing a GMP-compliant pilot manufacturing facility at its Baltimore headquarters to scale cartridge production.BALTIMORE, MD
More manufacturers in Maryland

Contact information

Website

pearldx.com

Emails

  • info@pearldx.com

Phone numbers

  • 410-801-7983

Social

Locations

Pearl Diagnostics, Inc location map for 1812 ASHLAND AVE G17

1812 Ashland Ave G17

Baltimore, MD 21205

Baltimore City

Get directions
Pearl Diagnostics, Inc location map for 1812 ASHLAND AVE

1812 Ashland Ave

Baltimore, MD 21205

Baltimore City

Get directions
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Directory source

Source
pearldx.com
Updated
Aug 2026