Clongen Laboratories


Clongen Laboratories is a leading provider of clinical diagnostic services, contract research, and veterinary testing, with a focus on molecular diagnostics for infectious diseases, tick-borne illnesses, and other pathogens. Founded in 1999 and based in Gaithersburg, Maryland, the company is CLIA-certified and operates in accordance with FDA guidelines, offering over 250 assays and custom protocols for clinical trials and research. Committed to scientific excellence, quality, and innovation, Clongen supports healthcare providers, researchers, and the pharmaceutical industry with reliable, high-quality testing and research services.

Industries

Biotechnology
Health Diagnostics
Veterinary
Biotechnology Research

Nr. of Employees

small (1-50)

Clongen Laboratories

Gaithersburg, Maryland, United States, North America


Products

Mycoplasma PCR detection kit

PCR-based kit for detection of mycoplasma contamination in cell lines and biological materials.

Clinical specimen collection kits and standardized test order forms

Packaged specimen collection kits and standardized clinical test order forms to support sample submission and accessioning for diagnostic testing.

Babesia species (9 different species)

Molecular detection test covering 9 different Babesia species.

Babesia species (excludes B. duncani)

Individual laboratory test for Babesia species excluding B. duncani.

Bartonella species

Individual laboratory test for Bartonella species.

Bartonella species (20 different species)

Molecular detection test covering 20 different Bartonella species.

View All Products

Services

Laboratory testing services for human infectious diseases using molecular and microbiology methods, providing an extensive assay menu and specimen collection support with typical 1–3 day turnaround for many tests.

GLP-aligned contract research services including sterility, endotoxin (LAL), microbial identification, mycoplasma testing, and custom protocol development to support investigational products and regulatory submissions.

Diagnostic testing and consultation for a wide range of animal species with an expanded veterinary assay menu and species-specific testing guidance.

Expertise Areas

  • Molecular diagnostics
  • Comprehensive clinical microbiology (bacteriology, mycology, parasitology, virology)
  • Pulmonary and respiratory pathogen diagnostics
  • Sexually transmitted infection diagnostics
  • Show More (6)

Key Technologies

  • Real-time PCR (qPCR)
  • Conventional PCR
  • Multiplex PCR panels
  • Next-generation sequencing (NGS) and NGS bioinformatics
  • Show More (4)

News & Updates

Clongen Laboratories, LLC, celebrates 20 years of service since its first laboratory operation in 2004, establishing a reputation for quality in infectious disease diagnostics and research.

Offering highly sensitive real-time PCR tests for tick-borne infections, with rapid turnaround times to aid in diagnosis and treatment.

Providing extensive testing and elimination services for mycoplasma in cell lines, in compliance with USP and FDA regulations.

Enrichment media to increase pathogen copy number and improve test sensitivity, especially for tissue colonizers.

Received formal registration from the Department of Health and Human Services as a blood and product processing facility, operating in compliance with GLP and FDA guidelines.

Celebrating two decades of service and growth in infectious disease diagnostics and research.


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