bioTheranostics, a bioMérieux company that develops oncology diagnostic tests to support targeted disease management, has published study results related to the clinical validity and the clinical utility of CancerTYPE ID®, its 92-gene molecular classification test to aid in the determination of the origin of a tumor, in the upcoming issue of the Journal of Molecular Diagnostics.
The study, Performance and Clinical Evaluation of the 92-Gene Real-time PCR Assay for Tumor Classification, demonstrates that CancerTYPE ID classifies 30 main tumor types and 54 histological subtypes, covering over 95% of all solid tumors. A database of 2,206 specimens with a median of 62 samples per tumor type allowed for the increase in tissue coverage. The 92-gene classification algorithm demonstrated sensitivities of 87% for the 30 main tumor types and 85% for the 54 histological subtypes.
“Our study featured a 300 consecutive clinical case series in which CancerTYPE ID classified 22 types and 36 different subtypes, which included several rare tumors. This real-world clinical finding shows the importance of having a comprehensive scope of reportable tumor types to resolve differential diagnosis, to avoid the risk of misclassification and for overall clinical applicability,” said Richard Ding, chief executive officer of bioTheranostics.
Additional highlights from the study showed that CancerTYPE ID can discriminate among tumor types that pose diagnostic dilemmas including neuroendocrine subtypes, squamous carcinomas (head and neck versus lung), tumors present in the ovary (ovarian mucinous versus GI tumor), and gynecological tumors (cervical versus ovarian).