News & Events

Insight ALK Screen Technology Clinically Validated

by Insight Genetics
December 30, 2015

The Archives of Pathology and Laboratory Medicine recently published an article by a group from the Department of Pathology and Genomic Medicine at Houston Methodist Hospital who performed a clinical validation of the Insight ALK Screen qPCR assay which is manufactured and distributed globally by QIAGEN as ALK RGQ RT-PCR Kit.

Twenty ALK positive and 23 ALK negative samples were used to validate the ALK qPCR assay against the FDA approved Vysis FISH assay. The ALK RGQ RT-PCR Kit was found to have a 100% clinical specificity (21/21; 95% confidence interval, 83.8%–100%) and 100% clinical sensitivity (15/15; 95% confidence interval, 78%–100%). The assay was 100% accurate (36/36) compared to the FISH assay and demonstrated 100% repeatability and reproducibility.

The article concludes that the high performance of the ALK RGQ RT-PCR Kit, in combination with the ability to screen for EGFR mutations concurrently with aberrant ALK expression, has changed clinical practice at their institution especially when dealing with small amounts of clinical specimens. Utilization of the ALK qPCR assay reduced both results turnaround time and the number of patient samples sent out for costly FISH testing.