FDA Use of HIVE for Regulatory Evaluations

 

The FDA then uses the hexagon module of HIVE to perform the alignment and variant calling analyses & to verify the life sciences safety & efficacy claims.

Biological Sample Mapping

Quality Controls

Census of Genomic Sequences

Alignment Hexagon

Classification MC-RLDA

Issues

Mislabelling, missing data, wrong formats

Sequencing issues

Contaminations and wrong experiments

Missing resistance, pathogens

Incomplete diagnostics panels

HIVE Features

BioSample & Biocompute FDA standards

Automated deep QC protocols

Inegrated taxonomy identification

Sensitivity & performance

Multivariant pathway diagnostics