Diagnostics

Genomic and Molecular Services

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

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