History and Background Clongen Laboratories

Advanced Clinical Diagnostics, Contract Research and Veterinary Testing services – celebrating 22 years in business.

Founded in 1999 by Dr. Ahmed Kilani, Clongen Laboratories began as a specialized biotechnology consulting practice in Mountain View, California. In 2004, the company expanded to a state-of-the-art laboratory facility in Gaithersburg, Maryland, with a focus on rapid and reliable pathogen detection.

Today, Clongen Laboratories is a CLIA-certified and CAP-accredited specialty laboratory with three core divisions: Clinical Diagnostics for Infectious Diseases, Contract Research and Veterinary Testing.  Our clinical menu includes more than 250 molecular assays using PCR, real-time PCR, and DNA sequencing to identify human and animal pathogens. Our contract research team provides GLP-compliant lot-release testing and customized scientific support aligned with applicable FDA guidelines. In addition, we offer a wide range of cell culture services, microbial identification and other custom assay development services.

Led by Dr. Kilani, we deliver responsive, high-quality laboratory services focused on clear results, sound scientific guidance, and client success.

Why Partner with Us?

• Exceptional Responsiveness: Prompt answers and immediate attention to your concerns.
• Premium Quality & Reporting: Clear, precise, and actionable data.
• Competitive Pricing: High-value laboratory services without compromising quality.
• Transparent Operations: A facility open to client visits and audits.
• Informed Decision Support: Expert guidance on technical protocols and study design.

Specialized Services

• Microbiology: Advanced microbial identification of bacteria, yeast and mold.
• Custom Molecular & Cell Biology:  cell banking services of all types of cell lines, virus banking, Mycoplasma elimination from contaminated cell lines and cell bank generation and a wide range of other services.
• Specialized Assays: GLP-compliant lot release testing and a list of services performed compliance with United States Pharmacopeia and CBER protocols.

Our Purpose & Commitments, Service, Quality & Innovation

Mission Statement

Clongen Laboratories advance health worldwide through precise, dependable clinical testing in microbiology and molecular diagnostics. We are especially committed to improving the detection and understanding of tick-borne illnesses, including Lyme disease, orphan diseases, and other complex conditions. Through combining early assessment, scientific rigor, education, research, and publication, we aim to improve patient outcomes and, strengthen the practice of specialty medicine., and help reduce the long-term burden on healthcare systems.

Service Commitment

Led by full-time specialists in microbiology, virology, molecular biology, and cell biology, our laboratory partners closely with clinicians and research institutions. As an integral part of our service, we provide comprehensive consultative support. We guide clients through test selection, help interpret unusual findings, and clearly explain complex methodologies and results.

Quality

We are committed to delivering timely, accurate, and dependable results supported by responsive client service. Located in the Washington, D.C., metropolitan area, Clongen Laboratories is licensed in Maryland and operates as a CLIA-certified reference laboratory serving clients nationwide.

Innovation

We develop and apply specialized molecular testing procedures for clinicians, hospitals, laboratories, and researchers. Our team also creates customized protocols for clinical trials and other projects involving investigational drugs, vaccines, and biological products., helping partners move complex scientific programs forward with confidence.

Research & Clinical Trial Support

Research

We advance medical science through internal diagnostic-development initiatives and active support for external investigators. Our team provides protocol-development consultations and customized assistance for research projects. To discuss a collaboration, contact the Clongen Laboratory Director.

Clinical Trials

Clongen Laboratories offers dedicated resources, advanced technical capabilities, and adaptable infrastructure to support clinical trials and complex research programs. Contact the Laboratory Director to discuss facility capabilities and partnership opportunities.

Turnaround Time

Turnaround time is measured from specimen receipt to final result release. Standard tests are processed promptly, while complex analytical methods may require additional time. For current assay-specific turnaround times, call us at 1-877-256-6436.

Quality Assurance

Our quality assurance program supports accurate, reliable results across the complete testing lifecycle.

• Pre-Analytical: Collection-kit preparation, delivery, accessioning, and specimen validation.
• Analytical: High-performance assay execution and strict method monitoring.
• Post-Analytical: Secure result reporting and ongoing customer support.

Validation & Controls

• External Validation: Participation in proficiency-testing programs conducted by the College of American Pathologists.
• Internal Controls: Quality-control materials with every batch, internal split-sample testing, and cross-laboratory split-sample validation.

Ready to Discuss Your Project?

Contact Clongen Laboratories to discuss testing needs, research support, clinical-trial services, or a customized laboratory program.