Regulated Sequencing


For critical regulatory submissions, selecting a reliable supplier with extensive sequencing experience is the key. NeoGenomics also known as SeqWright Genomic Services provides a wide-range of technical experience, dedicated project management, fast turnaround times with a focus on quality results – with the drive to provide data of value to our customers. 
 

Services Include:

  • Assay transfer and verification
  • Assay development and validation
  • Extraction of nucleic acids from tissues (e.g. FFPE, fresh frozen), blood, buccal swabs, viral and bacterial cultures
  • PCR or RT-PCR
  • 4x bidirectional sequencing
  • Data QC using Phred scoring
  • Variant reporting
  • Variant confirmation using orthologous methods
  • Standardized and custom bioinformatics methods
  • Submission-ready reports
  • Various data delivery methods

NGS Services Available

  • Assay development and validation
  • Detection of low frequency variants
  • Detection of variant populations

Applications include:

  • Comparator testing for diagnostic and companion diagnostic submissions
  • Sequence confirmation of gene delivery vectors
  • Characterization and confirmation of transgenic cell banks
  • Microbial and Fungal ID
  • Viral typing and subtyping

Assays are performed at our CLIA certified facility under general principals of GLP. Our Quality Management System includes the following:

  • Document control of SOPs
  • Written and approved study protocols and control strategies
  • Continuous training and competency assessments
  • Equipment / software qualifications and calibrations
  • Customer complaints system
  • Incident management systems (e.g. CAPA, OOS, discrepancies)
  • Testing documentation for full sample traceability
  • Internal audits performed by QA

NeoGenomics' takes great pride in our experience in, and our understanding of, the scientific and regulatory requirements necessary for the reporting of GxP sequencing data. We encourage all potential clients to schedule an on-site audit to inspect our Quality Management System.

Regulated Sequencing Data Sheet Regulated Sequencing Data Sheet