Molecular Diagnostic Services

What Molecular Diagnostic Services does

Molecular Diagnostic Services, Inc. (MDS) is a privately held U.S. Contract Research Organization (CRO) founded in 1992 and headquartered in San Diego, California. The company provides a broad portfolio of molecular diagnostics, cellular and molecular biology, toxicology, microbiology, sterility assurance, and biocompatibility testing services to pharmaceutical, biotechnology, medical device companies, and research institutions. Services are delivered under both GLP-compliant protocols for regulatory submissions (recognized by FDA, EPA, OECD, EEC, JMHW, and JMAFF) and non-GLP study formats for discovery-stage research, with confidentiality and direct technical-staff access positioned as core client-facing principles.

The underlying technology platform is a conventional wet-lab stack spanning PCR (endpoint and TaqMan quantitative real-time), flow cytometry and cell sorting, FISH, G-band karyotyping across multiple mammalian species, STR and SNP genotyping, DNA fingerprinting, Ames and mammalian gene mutation assays, chromosome aberration and micronucleus tests, GLP/GMP-grade plasmid DNA production, and GLP-compliant in vivo animal studies. The wholly-owned RRDA division maintains an AAALAC-, USDA-, and NIH-accredited vivarium that supplies toxicology, PK/ADME, vaccine efficacy, immunogenicity, and medical device testing in rabbits and rodents, plus short- and long-term vivarium leasing.

MDS operates as a project-based, quote-priced CRO with no publicly disclosed fee schedules. Go-to-market is direct enterprise engagement — primarily field sales and relationship-driven — supported by a company website (mds-usa.com), downloadable submission forms, a newsletter channel, and facility audit invitations. Revenue is generated through fee-for-service contracts, with the firm employing between 11 and 50 staff and reporting no parent company, venture capital, or private equity affiliations.

Name

Molecular Diagnostic Services

Legal name

Molecular Diagnostic Services, Inc.

Website

https://mds-usa.com

Company type

Private

Founded year

1992

Operating status

Operating

Headcount range

11–50 employees

Short description

Molecular Diagnostic Services is a privately held San Diego-based Contract Research Organization, founded in 1992, providing GLP-compliant molecular diagnostics, toxicology, microbiology, sterility assurance, and biocompatibility testing to pharmaceutical, biotechnology, medical device, and research clients, including in vivo animal studies via its RRDA vivarium division.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Scientific Research and Development Services (5417), Testing Laboratories and Services (541380), Medical Laboratories (621511)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)

akta.pro primary industry

Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC)

akta.pro secondary industries

Bioanalytical & Biomarker CROs (PK/PD/Immunogenicity) (HLAGAAAD), Laboratory Quality & GLP/GCLP Compliance (HLAGAKAK), Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL)

Keywords

• Contract research services
• GLP-compliant testing
• Molecular diagnostics
• Preclinical toxicology
• Biocompatibility testing

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Research Services: MDS operates as a Contract Research Organization providing comprehensive testing services to pharmaceutical, biotechnology, medical device, and research institutions. Revenue is generated through project-based testing contracts for GLP-compliant and non-GLP studies covering molecular diagnostics, toxicology, microbiology, sterility assurance, and biocompatibility services.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Molecular Diagnostic Services, Inc. is an independent Contract Research Organization (CRO) operating since 1992, providing comprehensive cellular and molecular biology, toxicology, microbiology, sterility assurance, and biocompatibility testing services to pharmaceutical, biotechnology, medical device, and research institutions. Services are offered both as GLP-compliant studies for regulatory submission (FDA, EPA, OECD, EEC, JMHW, JMAFF) and non-GLP screening for product research and development. The RRDA division adds an AAALAC/USDA/NIH-accredited vivarium for in vivo toxicology, PK/ADME, vaccine efficacy, and surgical procedures.

Product overview

Molecular Diagnostic Services is an independent Contract Research Organization (CRO) operating since 1992, providing comprehensive cellular and molecular biology, toxicology, microbiology, sterility assurance, and biocompatibility services to pharmaceutical, biotechnology, medical device, and research institutions. The company offers a broad portfolio of testing services designed for both GLP-compliant regulatory submission and non-GLP screening for product research and development. Key service areas include Molecular Diagnostics, Clinical Trial Services, Animal Testing Services (through the RRDA division), Antibody Services, Blood Chemistry, Endocrinology, EPA Services, Genotyping, Hematology, Histology, Cell Bank Qualification, In Vivo and In Vitro Toxicity Studies, Immunogenicity, Immunotoxicology, Microbiology, Mutagenesis, Stem Cell Services, Sterility Testing, Vaccine Testing, and Biostatistical Analysis. The company also provides specialized services such as Flow Cytometry, PCR Services (Endpoint, Q-PCR, Species-Specific), DNA Sequencing, FISH Services, Plasmid DNA Production, Custom Cloning, Transgenic Testing, and Expert Witness Services. Services are available for various species including human, murine, bovine, porcine, equine, avian, and others.

Differentiator

Problem solved

Functional benefit

Products and services

• Molecular Diagnostics Core molecular biology testing services including cellular and molecular biology analysis for pharmaceutical, biotechnology, medical device, and research institutions.
• Clinical Trial Services Clinical trial support services for regulatory-compliant product testing and evaluation.
• Rabbit and Rodent Diagnostic Associates (RRDA) Animal Testing Services Animal testing services offering an AAALAC, USDA, and NIH accredited vivarium with GLP or non-GLP toxicology, PK, ADME, drug efficacy, vaccine efficacy, immunogenicity studies, medical device testing, and surgical procedures for laboratory animals. Also offers vivarium space on short or long-term leases.
• Antibody Services Antibody production and characterization services for research and development applications.
• Blood Chemistry R&D and CLIA-certified Blood Chemistry Blood chemistry testing services for research and development and CLIA-certified clinical diagnostic applications.
• Endocrinology Services Endocrine testing and analysis services.
• EPA Services Environmental Protection Agency-compliant testing services for pesticides and other regulated products.
• Genotyping Services DNA genotyping services including SNP analysis, STR profiling, DNA fingerprinting, and species identification.
• Hematology R&D and CLIA-certified Hematology Hematology testing services for research and CLIA-certified clinical diagnostics.
• Histology R&D and CAP-certified Histology Histological analysis and pathology services including H&E slide preparation and interpretation.
• Cell Bank Qualification Characterization and qualification of cell banks including Master Cell Banks (MCB) and Working Cell Banks (WCB), covering genetic stability, adventitious agent testing, and cell aging characterization.
• In Vivo Toxicity Studies GLP-compliant in vivo toxicity testing for pharmaceuticals, biopharmaceuticals, medical devices, and pesticides.
• In Vitro Toxicity Studies In vitro toxicology testing including genetic toxicity, compound evaluation, and ADME studies.
• Immunogenicity and Immunotoxicology Services Immunogenicity testing to evaluate immune responses to pharmaceutical and biological products, and immunotoxicity assessment for evaluating adverse immune effects of test articles.
• Microbiology Services Microbiological testing including bacterial, fungal, mycoplasma detection and identification, microbial identification via 16S rRNA sequencing, environmental monitoring under 21 CFR 58, endotoxin (LAL) testing, and bioburden determination per USP <61>.
• Mutagenesis Services In vitro and in vivo mutagenesis testing including Ames assay, mammalian gene mutation tests, and chromosomal aberration assays.
• Stem Cell Services Stem cell culture, characterization, differentiation monitoring, and pluripotency evaluation for therapy development, including pluripotency PCR signature, signaling pathway analysis, and phenotypic characterization.
• Sterility Testing Biosafety and pharmacopeial sterility testing of biologics and biopharmaceuticals following USP, JP, EP, ICH, 21 CFR, and FDA Points to Consider guidance, including direct inoculation, membrane filtration, preservative efficacy, and bioburden determination.
• Vaccine Testing Services Characterization and qualification of viral, bacterial, and plasmid DNA vaccines including MCB/WCB characterization, bulk plasmid product release assays, final product release testing, potency, safety, sterility, purity, quantity, identity, endotoxin, DNA sequence analysis, and DNA vaccine modification testing.
• Biostatistical Analysis Statistical analysis services for research and clinical trial data.
• Plasmid DNA Production (R&D and GLP/GMP grade) Production of reagent (R&D) grade and GLP/GMP-grade plasmid DNA from microgram to multi-gram amounts, including cell banking, cloning, transfection, and full QC release testing with stringent purity requirements for low endotoxin, host cell chromosomal DNA, and RNA contamination.
• Expert Witness Services Expert witness testimony services for patent infringement litigation using GLP- and GMP-compliant testing.

Named customers4 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature10 records

Scale indicators1 record

Recent moves2 records

Expansion highlights3 records

Direct peers

• Pharmaron: Integrated CRO with preclinical toxicology, genetic toxicology, molecular biology, and bioanalytical services supporting pharma and biotech drug development. Comparable GLP-compliant service portfolio and similar mid-sized CRO positioning to MDS.
• Pacific BioLabs: California-based preclinical CRO offering GLP-compliant toxicology, biocompatibility, microbiology, and analytical chemistry testing — a close geographic and capability peer to MDS serving the same San Francisco Bay Area and broader US biotech client base.
• Inotiv: Preclinical CRO and contract research organization providing toxicology, pathology, and animal model services with GLP compliance. Competes with MDS's RRDA vivarium capabilities and in vivo toxicology services for the same pharma/biotech study budgets.
• ABC Laboratories: Mid-sized analytical and microbiology testing CRO with GLP-compliant services for pharma, biopharma, and medical device companies. Offers overlapping microbiology, sterility, and analytical testing capabilities that compete with MDS's biosafety service line.
• BioReliance (Merck/Sigma-Aldrich): Specialized biosafety testing and characterization services for biologics, vaccines, and cell therapy products — including sterility, mycoplasma, adventitious agent testing, and cell line authentication — directly mirroring MDS's biosafety/molecular diagnostic service lines.

Broad incumbents

• WuXi AppTec: Global CRO/CDMO with preclinical toxicology, molecular biology, and biologics testing capabilities that overlap MDS's service portfolio. Its scale, integrated discovery-to-manufacturing model, and aggressive pricing pressure small specialized CROs like MDS in pharma outsourcing decisions.
• Charles River Laboratories: Global preclinical CRO offering toxicology, genetic toxicology, molecular biology, and vivarium services that directly overlap MDS's core offerings. A dominant incumbent with vastly greater scale, multi-site capacity, and bundling power that competes for the same pharma/biotech preclinical study budgets.
• Labcorp Drug Development (formerly Covance): Global clinical and preclinical CRO offering toxicology, genetic toxicology, and molecular biology testing at very large scale. Competes with MDS for both large pharma preclinical packages and provides centralized lab alternatives for biotech sponsors.
• Eurofins Scientific: International testing services group with significant molecular biology, microbiology, sterility, and GLP-compliant testing operations. Competes with MDS for biotech testing contracts and offers similar genetic toxicology, vaccine testing, and cell bank characterization services at much larger scale.

Regional players

• NorthEast BioLab: US-based molecular biology and GLP-compliant testing CRO serving pharma and biotech with PCR, sequencing, and cell line characterization services — a regional player offering similar molecular specialty capabilities to MDS but with a different US geography focus.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/molecular-diagnostic-services-inc-

Revenue estimate

Valuation estimate

Number of profiles

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 Molecular Diagnostic Services