Sequence analysis offers an important tool for molecular characterization of infectious micro-organisms. It provides high-resolution information about the nucleotide composition and deduced translated proteins, from which important virological features such as genotype, mixed infection, and evolving resistance profile, can be deduced.
DDL offers GLP-compliant sequencing. All processes are performed according to standard operation procedures, using proprietary primers for each target sequence. The sequence is analysed by bidirectional sequencing using sufficient redundancy, resulting in very high guaranteed accuracy (>99,9%).
Our services comprise DNA sequence analysis according to specific project protocols based on SOPs including all procedures from sample reception to data reporting. We generate high-quality data reports which can be incorporated into regulatory files for FDA and EMEA submissions
Technology
- Sequence analysis of PCR-amplified DNA or cDNA, using ABI Big Dye terminator chemistry
- Analysed on state-of-the-art ABI sequencing units
Project and Data Management
- Comprehensive GLP compliant project documentation according to FDA guidelines
- Each project is guided by a designated project leader
- Dedicated project templates and interpretations using ABI SeqscapeTM software
- Complete audit trails
- Archiving of all study materials and data for at least one year or as agreed
Reporting
- Nucleotide (IUPAC/FASTA coding) and deduced amino acid (including mixed codons) sequences
- Reporting compliant with FDA or EMEA submission requirements
- FDA-compatible formats available
- Tailor-made reports available, such as database searches (BLAST), comparisons to reference sequences, multisequence/pairwise alignments, phylogenetic analyses, mutation mapping from baseline to end-of-treatment
Phylogenetic analysis
- Determination of relatedness between different sequences
- For outbreak management and epidemiological studies
