Interpretive software IVDs

Intended purpose

“NGSengine is a qualitative in vitro diagnostic software product intended for high-resolution identification of HLA alleles by means of sequencing-based typing (SBT). Specimens are Next-Generation Sequencing (NGS) data files, derived from HLA amplicons, originated from human genomic DNA. NGSengine is non-automated software, intended to inform clinical management as an aid in the diagnosis of HLA gene compatibility between donor and recipient for transplantation purposes (e.g. hematopoietic stem cell transplantation). The intended testing population are both, transplant donors as well as transplant recipients. NGSengine is intended for laboratory professional use in an EFI or ASHI accredited diagnostic laboratory setting, by personnel trained in HLA typing and DNA sequencing.”