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ResearchDx

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Irvine, California, US

About ResearchDx

ResearchDx is the leading Contract Diagnostics Organization for the Clinical Laboratory, Pharmaceutical and Diagnostic Industries. We build diagnostic assays for a multitude of applications, including Biomarker Discovery, Laboratory Developed Testing (LDT’s), and in vitro Diagnostic Devices (IVD’s).... Show more »

ResearchDx is the leading Contract Diagnostics Organization for the Clinical Laboratory, Pharmaceutical and Diagnostic Industries. We build diagnostic assays for a multitude of applications, including Biomarker Discovery, Laboratory Developed Testing (LDT’s), and in vitro Diagnostic Devices (IVD’s).

ResearchDx was founded on the core principles and expertise that help biopharmaceutical companies create, develop, accelerate and manufacture their companion diagnostic products. As the premier Contract Diagnostics Organization, ResearchDx has established integrated, turn-key, flexible services that are focused on our customer’s objectives. We manage the entire diagnostic development process – from initial assay concept and discovery all the way through clinical research to regulatory approval.

We perform a wide array of diagnostic testing in our CAP/CLIA accredited and GxP compliant facility, and our experts provide consulting services to the Clinical Laboratory and In Vitro Diagnostic industries. We are one of few companies to have successfully assisted clients with multiple NGS 510 (k) and PMA FDA regulatory submission and approvals, while also maintaining a leadership position in providing services to leading clinical laboratories and Bio-Pharma industries.

Publications

  • Kim SK, Sims CL, Wozniak SE, Drude SH, Whitson D, Shaw RW, Antibiotic Resistance in Bacteria: Novel Metalloenzyme Inhibitors. Chemical Biology and Drug Design. 2009; 74: 343-348.
  • Kovaleva N, Cotter PD: Somatic/gonadal mosaicism for structural autosomal rearrangements: Female predominance among carriers of gonadal mosaicism for unbalanced rearrangements. Mol. Cytogenet. 9: 8, 2016
  • Zehentner BK, Hartman L, Johnson KR, Stephenson CF, Chapman DB, de Baca ME. Wells DA, Loken MR, Tritorahardjo B, Gunn SR, Lim L. Array-based karyotyping in plasma cell neoplasia after plasma cell enrichment increases detection of genomic aberrations. Am J Clin Pathol. 2012 Oct;138(4)579-89.
  • Awad MM, Oxnard GR, Jackman DM, Savukoski DO, Hall D, Shivdasani P, Heng JC, Dahlberg SE, Jänne PA, Verma S, Christensen J, Hammerman PS, Sholl LM: MET Exon 14 Mutations in Non-Small- Cell Lung Cancer Are Associated With Advanced Age and Stage-Dependent MET Genomic Amplification and c-Met Overexpression. J Clin Oncol. 2016 Mar 1;34(7):721-30
  • Phin S, Babu D, Moore MW, Cotter PD: Fluorescence in situ hybridization (FISH)-based companion diagnostics in oncology. Trends Cancer Res. 10: 93-102, 2014.
  • Moore MW, Babu D, Cotter PD: Companion diagnostics and personalized medicine: a review of molecular diagnostic applications. Curr. Topics Genet. 5: 23-30, 2012. 96.
  • Cotter PD, Babu D, Moore MW: A new paradigm for personalized medicine and companion diagnostics: the Contract Diagnostics Organization. Open Conf. Proc. J. 3: 52-58, 2012. 97.
  • Phin S, Moore MW, Cotter PD: Genomic rearrangements of PTEN in prostate cancer. Front. Oncol. 3: 240, 2013.
  • Moore MW, Babu D, Cotter PD: Challenges in the co-development of companion diagnostics. Personalized Med. 9: 485-496, 2012.
  • Gunn S, Reveles X, Weldon K, Barrera A, Ishaque M, Taylor D, mcCaskill C, Kim J, Shah R, Mohammed M, Barry T, Kaiser B, Patnaik A, Tolcher A. Molecular cytogenetics as a clinical test for prognostic and predictive biomarkers in newly diagnosed ovarian cancer. J Ovarian Res. 2013 Jan 4;6(1):2
  • Gunn, Shelly, I-Tien Yeh, Irina Lytvak, Budi Tirtorahardjo, Natasha Dzidic, Soheila Zadeh, Jaeweon Kim, Chris Mccaskill, Lony Lim, Mercedes Gorre, and Mansoor Monhammed. “Clinical Array- based Karyotyping of Breast Cancer with Equivocal HER2 Status Resolves Gene Copy Number and Reveals Chromosome 17 Complexity." BMC Cancer 10.1 (2010):6-2
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Certifications & Qualifications

CLIA/CAP

Diversity Certificates

Small business

Our Services (49)


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Array CGH

Microarray-Based Comparative Genomic Hybridization
Price on request
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Clinical Biomarkers

Price on request
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Medical Device Clinical Trials

Price on request
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Companion Diagnostic Development

Price on request

ResearchDx has unparalleled experience in developing custom diagnostic assays for your discovery, pre-clinical, and clinical studies. We are one of few companies to have successfully assisted clients with multiple NGS 510 (k) and PMA FDA regulatory submission and approvals. Our team of molecular and cellular biologists provides... Show more »

ResearchDx has unparalleled experience in developing custom diagnostic assays for your discovery, pre-clinical, and clinical studies. We are one of few companies to have successfully assisted clients with multiple NGS 510 (k) and PMA FDA regulatory submission and approvals. Our team of molecular and cellular biologists provides tailored assay development services to customers worldwide, including diagnostic, biotechnology, and pharmaceutical companies as well as academic researchers. We are experienced in assay development and validation at all stages of the process, from concept and discovery through to final validation, and can support your assay development needs from any point along the way. Our teams are highly skilled in an array of technologies including DNA sequencing (Sanger and Next-Gen technologies), gene expression (Microarray, fluid array technologies Digital and Quantitative PCR), genotyping (SNPs and gross chromosomal abnormalities), flow cytometry, and ELISA. Whether your project includes testing one or ten thousand samples, we are equipped with multiple platforms to reliably meet your needs.

PRE-CLINICAL DEVELOPMENT

ResearchDx can utilize several screening technologies to power your pre-clinical development program. While we are happy to customize any approach to our client’s needs. Popular options for establishing a biological baseline include:

Customized evaluation of enzyme activity and inhibition
Inhibitor screening and validation
Drug compound detection
Investigations on reversibility of enzyme inhibition
Substrate profiling analyzing selectivity of enzymes and other proteins
NGS panel, exome, and whole Genome analysis
Transcriptome analysis
Flow Cytometry, Multiplex ELIZA and Mass-Spec screening.
Multiplex QPCR panels
DNA Sequencing
LDT (LABORATORY DEVELOPED TEST DEVELOPMENT)

Regulatory authorities are increasingly requesting that diagnostic studies be conducted under the more stringent CLIA regulations. Through our subsidiary, Pacific Diagnostics, we can design and clinically validate custom assays specific for a clinical study, in less than a third of the time of our competitors, and at under half the cost. We’ve even pioneered technologies, developing a four-color RET/PDGFR?/KIT/CC4 FISH probe.

KIT DESIGN AND COMMERCIALIZATION:

Through our Custom Diagnostics division, we offer flexible kit and reagent manufacturing to meet your business need. Services include:

Reagents: We can manufacture reagents under GMP conditions and provide certificates of analysis where required. Typically our reagents are used for specific pre-clinical and clinical diagnostic studies, although our customers have found many other unique and interesting uses.

Sample Collection Kits: We can provide a GMP/GLP environment for the manufacture and distribution of your specialized sample collection kits to meet your needs.

Custom Diagnostic Kits: We will ensure a safe GMP/GLP environment for the manufacture and distribution of your specialized diagnostic assays.

Product Manufacturing: Custom Diagnostics can be an Original Equipment Manufacturer of reagents, kit components, or entire diagnostic assays.

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Affymetrix GeneChip Workstation Illumina MiSeq Illumina NextSeq 500 sequencing system Applied Biosystems 7900HT Fast Real-Time PCR System Ion Torrent Personal Genome Machine (PGM) Rotor-Gene 6000 ABI 3730XL Agilent Microarray Show 8 more tags Show less

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Premarket Approval Application

Price on request

Complete outsourcing of 510(k), PMA development, analystical and clinical validations, submissions and approvals
510(k), PMA documentation preparation, Submissions, Review and Revisions
FDA Pre-Submission (PRE-IDE) process
Special 510k (Device Modification)
Abbreviated 510k Submissions
Substantial Equivalence (SE)... Show more »

Complete outsourcing of 510(k), PMA development, analystical and clinical validations, submissions and approvals
510(k), PMA documentation preparation, Submissions, Review and Revisions
FDA Pre-Submission (PRE-IDE) process
Special 510k (Device Modification)
Abbreviated 510k Submissions
Substantial Equivalence (SE) Comparison
510(k) Summary Statement
FDA Labeling
Indications for Use
510k Device Description
Performance Compliance 21 CFR 807.87 D
Class III Certification and Summary (for Class III only)
Final Certification and Disclosure Statement for 510k notifications with Clinical Studies
510k Kit Certification
Software Documentation
Third Party Review by Accredited Persons (AP)
Expedited Review

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510(k) PMA

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CLIA Certification

Clinical Laboratory Improvement Amendements certification
Price on request

CLINICAL LABORATORY CONSULTING (CLIA)
ResearchDx has earned a reputation as the premier provider of CLIA accreditation laboratory consulting services, having provided guidance for many industry-leading CLIA laboratories. We can provide complete turnkey Clinical Laboratory startup services, or work with established companies to... Show more »

CLINICAL LABORATORY CONSULTING (CLIA)
ResearchDx has earned a reputation as the premier provider of CLIA accreditation laboratory consulting services, having provided guidance for many industry-leading CLIA laboratories. We can provide complete turnkey Clinical Laboratory startup services, or work with established companies to seamlessly integrate only the components needed for your current framework.

OUR CLINICAL CONSULTING SERVICES INCLUDE:
CLIA licensure applications and changes
CAP and ISO15189 Accreditation licensure applications and changes
State-specific (CA, NY, FL etc) licensure applications
Provision of contracted Laboratory Directors, and Clinical and Technical Consultants
Evaluation of laboratory director, clinical / technical consultant, and personnel qualifications
Mock CLIA and accreditation inspections, and GAP analysis
Responses to CLIA standard and condition level deficiencies
Responses to CAP and ISO15189 audits
CLIA compliant Quality Management System.
Provision of standard laboratory SOP’s
Provision of logs for reagent inventory, temperature, QC and patient testing
Guidence and review of Requisitions and Reports
General guidance for CPT coding
Enrollment in proficiency testing

OUR TURN KEY CLIA CERTIFICATION SERVICES INCLUDE:
CLIA and Accreditation Compliant Quality Management System
Electronic Document Control Sytem
Assistance with all requried clinical laboratory forms and templates
Expert guidance on technical SOP content
Assistance with initial assay validation and verification
Initial onsite audit, Progress visits, pre-inspection mock audit
Inspection day guidance and assistance
Post inspection deficiency correction
Interim Laboratory Director as needed.
Post licensure / accreditation quality management review and follow-up

INTERNATIONAL LICENSURE AND ACCEDITATION
ResearchDx has extensive experience in navigating international companies through the United States Clinical Laboratory Improvement Amendments (CLIA) international certification process, ISO15189 and College of Pathology (CAP) international accreditation process (where required).
Many pharmaceutical company clinical trials are requiring these internationally recognized standards, and the process is slightly different for international laboratories.

At ReasearchDx, we are proud to uphold the standards of the federal government and use Good Laboratory Practices throughout the entire process. This ensures that our results are as accurate as possible without sacrificing speed, and promotes our commitment to our clients and their patients. We can provide complete support for comprehensive startup services, or work with our clients’ existing systems and integrate only the components needed for licensure and accreditation.

VIRTUAL CLINICAL LABORATORY:
Host your assay in our clinical laboratory. Custom and esoteric assays are our specialty!

Our virtual clinical laboratory services include:
A fully CLIA licensed and CAP accredited Clinical Laboratory
A dedicated state of the art Laboratory formation system
Access to state o the art equipment and facilities.
Dedicated laboratory space
A team of Experienced California licensed, and CLIA qualified laboratory technologists.
Extensive Bioinformatic capabilities
Dedicated phone tree, and client services
Customized reporting options available
Flexible billing

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CLIA CAP ISO15189 Joint Commission

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Clinical Validation of In Vitro Diagnostics/Companion Diagnostics

Price on request

ResearchDx has unparalleled experience in developing custom diagnostic assays for your discovery, pre-clinical, and clinical studies. We are one of few companies to have successfully assisted clients with multiple NGS 510 (k) and PMA FDA regulatory submission and approval, while also maintaining a leadership position in providing... Show more »

ResearchDx has unparalleled experience in developing custom diagnostic assays for your discovery, pre-clinical, and clinical studies. We are one of few companies to have successfully assisted clients with multiple NGS 510 (k) and PMA FDA regulatory submission and approval, while also maintaining a leadership position in providing clinical validation services to leading clinical laboratories (CLIA, CAP, ISO15189) and Bio-Pharma industries. Our team of molecular and cellular biologists provides tailored assay development services to customers worldwide, including diagnostic, biotechnology, and pharmaceutical companies as well as academic researchers. We are experienced in assay development and validation at all stages of the process, from concept and discovery through to final validation, and can support your assay development needs from any point along the way. Our teams are highly skilled in an array of technologies including DNA sequencing (Sanger and Next-Gen technologies), gene expression (Microarray, fluid array technologies Digital and Quantitative PCR), genotyping (SNPs and gross chromosomal abnormalities), flow cytometry, and ELISA. Whether your project includes testing one or ten thousand samples, we are equipped with multiple platforms to reliably meet your needs.

PRE-CLINICAL DEVELOPMENT

ResearchDx can utilize several screening technologies to power your pre-clinical development program. While we are happy to customize any approach to our client’s needs. Popular options for establishing a biological baseline include:

Customized evaluation of enzyme activity and inhibition
Inhibitor screening and validation
Drug compound detection
Investigations on reversibility of enzyme inhibition
Substrate profiling analyzing selectivity of enzymes and other proteins
NGS panel, exome, and whole Genome analysis
Transcriptome analysis
Flow Cytometry, Multiplex ELIZA and Mass-Spec screening.
Multiplex QPCR panels
DNA Sequencing
LDT (LABORATORY DEVELOPED TEST DEVELOPMENT)

Regulatory authorities are increasingly requesting that diagnostic studies be conducted under the more stringent CLIA regulations. Through our subsidiary, Pacific Diagnostics, we can design and clinically validate custom assays specific for a clinical study, in less than a third of the time of our competitors, and at under half the cost. We’ve even pioneered technologies, developing a four-color RET/PDGFR?/KIT/CC4 FISH probe.

KIT DESIGN AND COMMERCIALIZATION:

Through our Custom Diagnostics division, we offer flexible kit and reagent manufacturing to meet your business need. Services include:

Reagents: We can manufacture reagents under GMP conditions and provide certificates of analysis where required. Typically our reagents are used for specific pre-clinical and clinical diagnostic studies, although our customers have found many other unique and interesting uses.

Sample Collection Kits: We can provide a GMP/GLP environment for the manufacture and distribution of your specialized sample collection kits to meet your needs.

Custom Diagnostic Kits: We will ensure a safe GMP/GLP environment for the manufacture and distribution of your specialized diagnostic assays.

Product Manufacturing: Custom Diagnostics can be an Original Equipment Manufacturer of reagents, kit components, or entire diagnostic assays.

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CLIA CAP ISO15189 GLP GxP

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Regulatory Affairs Consulting

Price on request

Complete outsourcing of 510(k), PMA development, analystical and clinical validations, submissions and approvals
510(k), PMA documentation preparation, Submissions, Review and Revisions
FDA Pre-Submission (PRE-IDE) process
Special 510k (Device Modification)
Abbreviated 510k Submissions
Substantial Equivalence (SE)... Show more »

Complete outsourcing of 510(k), PMA development, analystical and clinical validations, submissions and approvals
510(k), PMA documentation preparation, Submissions, Review and Revisions
FDA Pre-Submission (PRE-IDE) process
Special 510k (Device Modification)
Abbreviated 510k Submissions
Substantial Equivalence (SE) Comparison
510(k) Summary Statement
FDA Labeling
Indications for Use
510k Device Description
Performance Compliance 21 CFR 807.87 D
Class III Certification and Summary (for Class III only)
Final Certification and Disclosure Statement for 510k notifications with Clinical Studies
510k Kit Certification
Software Documentation
Third Party Review by Accredited Persons (AP)
Expedited Review

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Next Generation Sequencing (NGS)

Price on request

Illumina and IonTorrent: Custom Panels, Exome, Genome. CLIA, GLP and research services available.

Illumina and IonTorrent: Custom Panels, Exome, Genome. CLIA, GLP and research services available.

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Illumina HiSeq 2500 sequencing system Illumina MiSeq Illumina NextSeq 500 sequencing system Ion Torrent Personal Genome Machine (PGM) Amplicons Exome sequencing RNA-Seq Hybrid Capture NGS Panels Copy Number Show 10 more tags Show less

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Agilent DNA Microarray

Price on request
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SNP Microarray

Single nucleotide polymorphism microarray
Price on request
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Affymetrix Microarray

Price on request
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qRT-PCR

Quantitative reverse transcription polymerase chain reaction
Price on request

We provide custom PCR, QPCT, RTPCR diagnostic services. Our instrumentation includes ABI 7900, ABI QuantStudio, and Qiagen RotorGene. Custom assay development is a specialty. We can perform the assays to Research, GxP, CLIA and FDA regulation as required.

We provide custom PCR, QPCT, RTPCR diagnostic services. Our instrumentation includes ABI 7900, ABI QuantStudio, and Qiagen RotorGene. Custom assay development is a specialty. We can perform the assays to Research, GxP, CLIA and FDA regulation as required.

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Custom Microarrays

Price on request

We provide a complete list of Microarray assay diagnostic services. Affymetrix and Agilent arrays, SNP, CGH analysis, and custom array design and development

We provide a complete list of Microarray assay diagnostic services. Affymetrix and Agilent arrays, SNP, CGH analysis, and custom array design and development

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RT-PCR

Reverse transcription polymerase chain reaction
Price on request

We provide custom PCR, QPCT, RTPCR diagnostic services. Our instrumentation includes ABI 7900, ABI QuantStudio, and Qiagen RotorGene. Custom assay development is a specialty. We can perform the assays to Research, GxP, CLIA and FDA regulation as required.

We provide custom PCR, QPCT, RTPCR diagnostic services. Our instrumentation includes ABI 7900, ABI QuantStudio, and Qiagen RotorGene. Custom assay development is a specialty. We can perform the assays to Research, GxP, CLIA and FDA regulation as required.

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Biomarker Discovery

Price on request

ResearchDx offers a wide array of DNA, RNA, and protein based approaches. We maintain multiple technology platforms in-house, including:

Cytogenetics: Somatic and germline
Immunophenotyping including Flow cytometry
ELISA design, devlopment, and screening
Cytokine analysis
PCR and Q-PCR based Molecular diagnostics
FISH:... Show more »

ResearchDx offers a wide array of DNA, RNA, and protein based approaches. We maintain multiple technology platforms in-house, including:

Cytogenetics: Somatic and germline
Immunophenotyping including Flow cytometry
ELISA design, devlopment, and screening
Cytokine analysis
PCR and Q-PCR based Molecular diagnostics
FISH: Commercial and Custom probes available.
Microarray characterization: Affymetrix and Agilent arrays.
Gene sequence analysis
Gene expression analysis
Next-Gen Sequencing: Custom and commercial panels, exome and genome analysis. Analysis from fixed tissues and difficult specimens is a specialty.
We can customs design an assay for almost any application. Please contact us about your specific requirements.

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Custom Manufacturing

Price on request

Reagents: We can manufacture reagents under GMP conditions, and provide certificates of analysis where required. Typically our reagents are used for specific pre-clinical and clinical diagnostic studies, although our customers have found many other unique and interesting uses.
Sample Collection Kits: We can provide a... Show more »

Reagents: We can manufacture reagents under GMP conditions, and provide certificates of analysis where required. Typically our reagents are used for specific pre-clinical and clinical diagnostic studies, although our customers have found many other unique and interesting uses.
Sample Collection Kits: We can provide a CLIA-approved GMP/GLP environment for the manufacture and distribution of your specialized sample collection kit needs. Great for clinical trials where critical reagents need to be formulated, assembled and shipped to clinical sites.

Custom Diagnostic Kits:We can provide a GMP/GLP environment for the manufacture and distribution of your specialized diagnostic assays. Great for 510(k)/PMA studies where diagnostics needs to be assembled and shipped to multiple external sites.

Product Manufacturing: Custom Diagnostics can OEM manufacture reagents, kit components, or entire diagnostic assays.

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Phase IV Clinical Trials

Price on request
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Phase III Clinical Trials

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Phase II Clinical Trials

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Phase I Clinical Trials

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Clinical Trial Management

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Biomarker Analysis

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Analytical Validation

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Analytical Chemistry Services

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Clinical Research

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Clinical Chemistry

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Nucleic Acid Analysis

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Clinical Trials, Consulting, and Management

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Pharmacology & Toxicology

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Medical Devices & Diagnostics

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Formulation Services

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Clinical Validation Services

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DNA Microarrays

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Regulatory Affairs Services

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Clinical Laboratory Services

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Antibody/Antigen Detection Based Testing

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Biomarkers

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Biochemistry & Molecular Biology

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PCR

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Manufacturing Services

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DNA Sequencing

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Project Management

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Biology

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DNA Services

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Genotyping Services

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Genotyping Services

Genotyping Services

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Nucleic Acid Services

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Chemistry and Materials

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Bioanalysis

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