What Clongen Laboratories does

Clongen Laboratories, LLC is a privately held, founder-led specialty molecular diagnostics laboratory headquartered in Gaithersburg, Maryland. Founded in 1999 by Dr. Ahmed Kilani, the company operates a 6,000 square-foot CLIA-certified, CAP-accredited facility holding two FDA registrations and clinical laboratory licenses in Maryland, Rhode Island, Pennsylvania, and California. Its core technology is real-time and conventional PCR applied to detection of infectious agents, supplemented by proprietary methods including a Mycoplasma Multiplex PCR Detection Kit (MycoFind) and a pre-enrichment protocol for low-copy tick-borne pathogens such as Borrelia, Babesia, Bartonella, and Mycoplasma species.

The business is organized into three service lines: Clinical Diagnostics Services (240+ molecular assays for clinicians, hospitals, and reference clinical laboratories, with a specialty in tick-borne illness and Lyme disease), Contract Research Services (GLP-compliant lot release and FDA review studies, including sterility testing, LAL bacterial endotoxin testing, mycoplasma testing in biologicals, and clinical trial support for pharma and biotech), and Veterinary Diagnostic Services (100+ assays covering companion animals, livestock, primates, rodents, birds, amphibians, and reptiles). Pricing is quote-based with some published unit prices (e.g., MycoFind kit at $250, LAL GLP at $325 per sample, Mycoplasma PCR at $109 per sample); the company advertises pricing at least 10% below competitors and offers volume discounts.

The go-to-market is sales-led, relying on a direct team reaching clinicians, hospitals, and clinical labs primarily through the company website, PR Newswire releases, toll-free phone (877-CLONGEN), and quote forms. Distribution is exclusively direct; samples are shipped to the Gaithersburg lab. The company is unrelated in name to any other entity and is owned by its founder. A sister company, Clongen Pharma, LLC, is announced for launch in March 2026 to develop cancer therapeutics — a separate entity outside Clongen Laboratories' diagnostic scope. Clongen does not disclose revenue and has no external funding rounds on record.

Name

Clongen Laboratories

Legal name

Clongen Laboratories, LLC

Website

https://clongen.com

Company type

Private

Founded year

1999

Operating status

Operating

Headcount range

1–10 employees

Short description

Clongen Laboratories is a CLIA-certified, CAP-accredited specialty molecular diagnostics lab in Gaithersburg, MD offering 240+ PCR-based tests for clinicians, hospitals, reference labs, biotech CROs, and veterinarians, with a specialty focus on tick-borne and other infectious diseases.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics / Clinical Laboratory Services

NAICS

Medical Laboratories (621511), In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Central Laboratory & Clinical Trial Testing CROs (HLAGAAAE)

akta.pro secondary industry

Release Testing & Batch Certification (QC) (HLAGADAC)

Keywords

• Molecular diagnostics services
• Contract research organization
• Clinical laboratory testing
• PCR detection assays
• Veterinary diagnostic services

Headquarters

HQ city

Gaithersburg

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Supply Chain, Marketing or Sales

Revenue model

1. Clinical Diagnostic Testing Services: Molecular-based assays for detection of common pathogens (bacteria, viruses, fungi, and parasites) offered to clinicians, hospitals, and clinical laboratories. Includes tick testing, STD tests, bloodborne pathogen tests, and over 200 assays for infectious disease detection.
2. Contract Research Services: GLP-compliant studies required for lot release and FDA review for pharmaceutical companies, biotech firms, and research institutions. Includes sterility testing, LAL bacterial endotoxin testing, Mycoplasma testing in biologicals, and custom molecular and cell biology services.
3. Veterinary Diagnostic Services: Over 100 assays to identify diseases or cause of death in animals including dogs, cats, horses, livestock, primates, rodents, birds, amphibians, and reptiles.
4. Test Kit Sales: Sale of MycoFind Mycoplasma PCR Detection Kit (catalog number MF001, Version 1.0) priced at $250.00 per unit for 100 reactions. Ships with overnight ice packs.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Clongen Laboratories is a CLIA-certified, CAP-accredited clinical molecular diagnostics laboratory that performs PCR-based testing for infectious agents in human and animal specimens. The company operates three service divisions: Clinical Diagnostics Services (200+ molecular assays), Contract Research Services (GLP-compliant lot release, sterility, LAL endotoxin, and mycoplasma testing for pharma/biotech), and Veterinary Diagnostic Services (100+ assays across many species), and also sells the MycoFind Mycoplasma PCR Detection Kit as a research product.

Product overview

Clongen Laboratories is a molecular diagnostics laboratory offering three core divisions: Clinical Diagnostics Services, Contract Research Services, and Veterinary Diagnostic Services. The company provides more than 240 molecular-based PCR tests for detection of human pathogens (bacteria, viruses, fungi, parasites), with special expertise in tick-borne illnesses and Lyme disease. For contract research, the company offers GLP-compliant lot release testing including sterility testing, bacterial endotoxin testing (LAL), mycoplasma testing, and mycoplasma elimination services. The company also manufactures the MycoFind™ Mycoplasma PCR Detection Kit as a research use product. All services operate under CLIA certification and CAP accreditation with state licenses in multiple states.

Differentiator

Problem solved

Functional benefit

Brands

• MycoFind: Mycoplasma Multiplex PCR Detection Kit - a test kit product line for detection of Mycoplasma, Acholeplasma and Ureaplasma species in cell cultures
• Clongen Clinical Laboratory

Products and services

• Clinical Diagnostics Services CLIA-certified clinical laboratory offering more than 200 molecular-based PCR assays for detection of bacteria, viruses, fungi, and parasites, with specialty in tick-borne illnesses (including Lyme disease), STD testing, bloodborne pathogen testing, pulmonary disease testing, parasitology, mycology, and virology; serves clinicians, hospitals, and clinical laboratories submitting patient specimens.
• Contract Research Services FDA-compliant contract research organization providing GLP-compliant lot release testing, sterility testing, mycoplasma testing in biologicals per 21CFR 610.30 and 9CFR 113.28, LAL bacterial endotoxin testing, custom molecular and cell biology services, and clinical trial support for pharmaceutical, biotech, and research institution clients.
• Veterinary Diagnostic Services Veterinary diagnostic testing division offering more than 100 molecular assays to identify diseases or determine cause of death across a broad range of animal species including dogs, cats, horses, livestock, primates, rodents, birds, amphibians, and reptiles; serves veterinarians and animal health professionals.
• MycoFind™ Mycoplasma PCR Detection Kit Multiplex PCR detection kit (Catalog MF001, Version 1.0) for amplification of a conserved region of 16S ribosomal DNA of more than 25 Mycoplasma, Acholeplasma, and Ureaplasma species; sold as a research-use product with overnight ice-pack shipping (taq DNA polymerase supplied by user).
• Pre-Enrichment for Detection of Borrelia, Babesia, Bartonella and Mycoplasma Enrichment media service that increases copy number of specific pathogens (Borrelia, Babesia, Bartonella, and Mycoplasma species) prior to PCR detection, with a 10-day incubation period to improve sensitivity for low-copy pathogens; charged at $125 per organism in addition to PCR testing.
• LAL Bacterial Endotoxin Testing Limulus Amoebocyte Lysate (LAL) kinetic chromogenic assay for bacterial endotoxin detection using Associates of Cape Cod reagents, offered in GLP ($325/sample, 2–5 day turnaround, Protocol CB129) and non-GLP ($225/sample, Protocol CB130) formats for pharmaceutical and biotech clients.
• Mycoplasma Testing in Biologicals Comprehensive mycoplasma testing for biologicals including Hoechst staining, multiplex PCR, direct cultivation, and GLP-compliant testing per 21CFR 610.30 and 9CFR 113.28; also offers mycoplasma elimination services for contaminated cell lines (e.g., Mycoplasma Testing by Multiplex PCR Non-GLP at $109/sample, 1–3 day turnaround).
• In Vitro Studies Custom in vitro studies for biotech and biopharmaceutical clients, including drug screening against viral agents in cell culture and molecular assay design.
• Clinical Trial Support Assistance with clinical trials including evaluation of investigational drugs in vitro, vaccine testing, assay optimization, molecular cloning, protein expression, toxicology assays, and immunoassays under GLP/cGMP guidelines for pharmaceutical and biotech sponsors.
• Lyme Tick Panel Highly sensitive real-time PCR test panel for the most common tick-borne infections including Borrelia species, Babesia species, Bartonella species, and Mycoplasma species; intended for clinicians and patients suspecting tick exposure or Lyme disease.
• Zika, Dengue and Chikungunya Virus Detection Real-time PCR-based molecular detection of Zika, Dengue, and Chikungunya virus RNA in human specimens; offered to clinicians and public health testing during outbreak response.

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators10 records

Recent moves8 records

Expansion highlights5 records

Broad incumbents

• Mayo Clinic Laboratories: Major academic reference laboratory with extensive molecular infectious disease menu, used by hospitals and clinicians nationwide. Same broad positioning as Clongen but with substantially deeper test catalog and global reach.
• Quest Diagnostics: National reference lab offering molecular infectious disease testing, including tick-borne and STD panels. Competes on the same clinical diagnostics menu as Clongen but with national logistics, broad payer contracts, and significantly larger scale.
• Laboratory Corporation of America (Labcorp): National clinical reference laboratory with a broad molecular diagnostics and infectious disease menu, plus biopharma central lab services through its drug development arm. Comparable clinical and CRO offerings to Clongen at much larger scale.
• ARUP Laboratories: Large academic reference lab offering 3,000+ tests including molecular infectious disease and esoteric assays. Comparable menu coverage to Clongen but at vastly greater scale, multi-state licensure, and biopharma trial support.
• Charles River Laboratories: Global CRO offering biologics safety testing including mycoplasma, sterility, and endotoxin (LAL) services under GLP. Direct overlap with Clongen's Contract Research Services division serving biopharma lot release, but at much greater scale and global footprint.
• WuXi AppTec: Global CRO providing biologics safety testing including mycoplasma, viral clearance, sterility, and endotoxin services for biopharma lot release. Comparable GLP testing menu to Clongen's Contract Research Services but at global scale across multiple continents.
• Eurofins Scientific: Global bioanalytical and clinical testing network with significant presence in infectious disease molecular diagnostics, biopharma release testing, and veterinary diagnostics. Comparable three-vertical structure to Clongen (clinical/contract research/vet) at vastly larger scale.

Direct peers

• Molecular Testing Labs: Specialty PCR-based infectious disease and STI molecular diagnostics reference lab serving clinicians and hospitals. Comparable scale and go-to-market to Clongen's Clinical Diagnostics Services division, with similar assay menu emphasis.
• Eurofins Viracor BioPharma Services: Specialty infectious disease and immunocompromised molecular diagnostics lab offering PCR-based pathogen detection and biopharma testing services. Directly overlaps Clongen's clinical molecular diagnostics and contract research menus (real-time PCR, mycoplasma, viral load testing).
• IGeneX: Specialty reference laboratory focused on tick-borne disease testing (Lyme, Babesia, Bartonella, etc.) using PCR and immunoassay. Closest comparable to Clongen's Lyme Tick Panel and Pre-Enrichment workflow; both serve clinicians seeking esoteric tick-borne diagnostics.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/clongenlab
• LinkedInlinkedin.com/company/clongen-laboratories-llc

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Clongen Laboratories