Diagnostics

Genomic and Molecular Services

A WORLD OF DATA DRIVEN INSIGHTS

MOgene delivers precise research and clinical insights for our customers based on decades of experience offering comprehensive, highly customized, and data-driven genomic solutions

Experience the MOgene Difference

MOre Knowledgeable

  • Decades of experience with genomic and molecular testing
  • Specialized in a wide range of complex to routine projects
  • Consultative approach to customer needs
  • More than 150 publication citations

MOre Customized

  • Client specific project management teams focused on effective communication
  • Experienced scientists and bioinformaticians for complex projects
  • Wide range of discovery, development, and sample analysis services

MOre Quality & Safety

  • Robust Quality Management System (QMS)
  • Integrated quality throughout lab workflow
  • CLIA-certified, purpose built BSL-2+ facility
  • GxP Compliance

Molecular Diagnostics

 

MOgene has the expertise to perform and validate diagnostic assays to deliver raw and interpreted data for input into your bioinformatic systems.  We will work with you on your choice of platform and application to launch your panel.

Clinical Genomics
  • Partner with us for the development of NGS validation assay for your clinical bioinformatics software
  • Highly trained scientific team and board-certified Medical Director to support, review, and sign-off clinical reports
Diagnostic Platforms

MOgene has a variety of platforms that can be used for molecular diagnostic panels. We will work with your choice of platform and application to launch your panel.

 
  • Illumina MiSeq and NextSeq Next Generation Sequencing (NGS)
  • QuantStudio™ 12K Flex OpenArray System
  • NanoString nCounter® SPRINT Profiler
  • Droplet Digital™ PCR
Applications
  • Pathogen detection and quantification
  • Genotyping and SNP detection
  • Epigenetics
CLIA certification

 

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Laboratory Developed Tests (LDTs)

 

MOgene supports the continued development of personalized medicine by assisting with a range of LDTs. 

Assay Development
  • Customized assay development for detection of DNA variations to help diagnose a genetic disease
  • Full-service package from feasibility assays to validation, and sample management to report generation for your LDTs
Applications
  • Pathogen detection and quantification
  • Genotyping and SNP detection
  • Epigenetics

Quality and safety

The Quality Commitment From MOgene

Regulatory Services

MOgene has a state-of-the-art CLIA certified facility with an established reputation of complying with relevant national and international GxP compliance regulations.

  • CLIA Regulations 42 CFR Part 493, cGMP compliance per FDA 21 CFR Part 210/211, GLP compliance per FDA 21 CFR Part 58 and Part 11
  • Active CAPA program for process improvement
  • Audit ready for clients with routine internal quality audits
  • Assays validated per ICH/CLSI guidelines
  • CLIA Certified
Quality Management System

MOgene has a robust Quality Management System (QMS) detailed in a Quality Manual that details the quality policy of MOgene along with a set of quality procedures that outline the necessary documented controls and compliance measures to ensure continual quality monitoring and improvement.

 
  • Rigorous sample management process
  • Transparent and routine communications on project timelines and deliverables
  • Complete documentation of standard operating procedures (SOPs) and 100% QC of data
BioSafety

Our Biosafety practices enable us to provide genomics services for early R&D to market release studies for pathogens that require BSL-2+ facilities.

 
  • Higher levels of lab safety for antimicrobial, human, and animal health vaccine development
  • Dedicated BSL-2+ lab and pre-amplification room for your clinical studies
  • Trained personnel to handle all kinds of BSL-2+ level agents
  • UNIDIRECTIONAL workflow 
Security and Data Protection

MOgene considers safety and confidentiality a top priority for our client’s data.

 
  • 24/7/365 temperature and humidity monitoring
  • Individually coded key access to labs
  • Secured access to data files
  • Daily back-up of data

OUR HISTORY SPEAKS FOR ITSELF

 

Supporting Genomic Studies Since 2004
Industry Leading Experienced Team
More Than 150 Citations in Peer-reviewed Journals

CONTACT MOGENE

To contact MOgene or request a quote click the links below