Company History

Ahmed Kilani, Ph.D., President and Laboratory Director: The company was founded by Dr. Ahmed Kilani in 1999 in Mountain View, California. Dr. Kilani registered the company in California and conducted business as a Biotechnology Consulting Firm. Dr. Kilani holds a Bachelor degree in Medical Technology, a Masters in Clinical Science (San Francisco State University) and a Ph.D. in Infectious Diseases and Immunity (University of California at Berkeley, 1999). He is also board certified nationally (American Society of Clinical Pathologists – ASCP) and in California (Clinical Laboratory Scientist – CLS/MT). Dr. Kilani has extensive experience in Microbiology, Virology, Molecular and Cell Biology. The laboratory facility in Gaithersburg, MD was established in 2004. The company consists of two main divisions: Clinical Diagnostics for Infectious Diseases and Contract Research. We hold state and national licenses in laboratory medicine (CLIA-Certified). Dr. Kilani can be contacted at 301-916-0173 (Ext 204) (877-CLONGEN) or by e-mail at akil@clongen.com.

Clinical Diagnostics – An Infectious Disease Specialty

Since its inception, Clongen Labs focused on using rapid detection methods such as PCR, Real Time PCR and DNA sequencing for identification of human and animal pathogens. One of our main strengths is assay development and we have been able to successfully bring online more than 200 assays for the detection of common pathogens (bacteria, viruses, fungi, and parasites – check out our molecular diagnostics test menu.

Contract Research – Lot Release Testing

We operate in accordance with FDA guidelines and offer a long list of studies required for lot release and FDA review under GLP conditions. Our clients receive high quality service and all projects are handled by experienced staff with more than 2 decades of industrial and academic experience. What sets us apart from our competition is our responsiveness to our clients concerns and questions, the high quality service and reporting, competitive pricing and our state of the art laboratory that is open for visits and audits by our clients. We try our best to provide as much information as we can in order to assist our clients in making informed decisions with the choice of studies and technical protocol details. Please visit the In Vitro Studies page for more information on the studies we offer.

Other Services

We offer Microbiology services (microbial identification), Genotyping of mouse tails, custom molecular and cell biology services such as custom cloning, protein expression and purification, western blotting, quantitative real time PCR, cDNA library construction and screening, DNA sequencing under GLP conditions and other custom assay by request.

Mission Statement

The mission of Clongen Laboratories is to improve health worldwide by providing clinical laboratory testing services in the areas of Microbiology, and Molecular Diagnostics of more than 95 human pathogens. We have a special interest in Tick-Borne Illnesses and in particular Lyme Disease. We also have a special interest in orphan diseases and believe that early assessment and comprehensive management of complex chronic disease could save our national health care system billions of dollars each year and improve the health index in the United States and Worldwide. We seek to build and maintain the reputation of highest quality and reliability for the services that we offer and to advance this specialty area of medicine through education, research, and publications.

Service

Clongen Laboratories is directed by medical specialists in Microbiology, Virology, Molecular and Cell Biology. These full-time professionals are available for consultations with clients concerning significance of test results, unusual cases, and other technical matters. We do our best to assist the clinicians in selecting the most suitable tests for their patients and offer detailed explanations of test results and methodologies at no charge.

Quality

At Clongen Laboratories, our goal is to provide our clients with timely, accurate and dependable test results and support services. Based in the Washington, DC metropolitan area, we are licensed by the state of Maryland and the Office of Health Care Quality (OHCQ) – CLIA to provide reference testing for other laboratories nationwide.

Innovation

Clongen Laboratories offers a broad range of specialty Molecular testing procedures for clinicians, hospitals, clinical laboratories and researchers. We can develop customized protocols for clinical trials and any other special project required for investigational drugs, vaccines or other biologicals.

Research

While we have our own Diagnostics Development research projects, we welcome other research projects from external sources and are ready to assist you in developing a protocol and provide free consultation on external projects. Please call the Clongen Laboratory Director for further information.

Clinical Trials

Clongen Clinical Laboratory has available specific resources and capabilities for clinical trials and research projects. Contact the Clongen Laboratory Director for further information.

Turnaround Time

Test turnaround time is the number of days that will usually elapse between the time Clongen receives a specimen and the time the results of that specimen are released. More complex analytical methodologies may require more time. For up-to-date information on individual tests, please call client services at 1-877-256-6436.

Quality Assurance

The primary goal of the Quality Assurance program at Clongen Laboratories is to deliver quality results in a timely fashion to our clients. This program is designed to assess and monitor all aspects of the laboratory, from specimen collection kit construction and delivery through accessioning and specimen validation, assay performance, result reporting, and customer support. The analytical performance of the laboratory is monitored through external and internal programs. External proficiency testing includes participation in programs conducted by the College of American Pathologists. Internal Quality control is monitored by running high standard quality control material with each run, running split samples within our own laboratory, and running split samples with other quality laboratories.

Licenses and Certifications:

All clinical laboratory testing performed at Clongen Laboratories are subject to the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88). Clongen Laboratories maintain current CLIA, Maryland State Licenses, as well as accreditation by The College of American Pathologists.

Clongen CAP Certificate

CAP Number: 8717089

AU-ID: 1685665

CAP Accreditation

Licensing Authority
License Number
Expiration Date
License Image
CLIA Department of Health
21D1032144
10/4/2019
pdf
Maryland
1026
06/30/2018
pdf
State of California MT License
MTA38516
3/21/2018
pdf
Proficiency Testing
API
12/31/2017
pdf
Tax ID Number
51-0505181
Active
National Provider Number (NPI)
1770722100
Active
 Rhode Island State Health Department
LCO00757
12/30/2017
pdf
Pennsylvania State Health Department
033055
8/15/2018
pdf
State of California Department of Public Health
COS00800428
5/29/2018
pdf
State of Florida – Agency for Health Care
Administration – Clinical Lab License
80026846
06/24/2019
pdf

 

Clongen Labs also hold two active FDA registrations:

  • Blood establishment registration – good till May 31, 2018 pdf
  • Human tissues, cells, and cellular and tissue based products (HCT/Ps) – good till 3/31/2017 pdf

Clinical Specialists

Clongen maintains a staff of scientists trained and licensed as clinical laboratory scientists to interpret test results in relation to clinical interventions. We do not offer medical advice but will be more than happy to offer phone consultations and test result interpretation. Please call 877-CLONGEN (256-6436) and ask for Dr. Kilani for assistance.