We Do First What Others Do Later
Over a decade ago, Dr. Yaziji developed the first quality control program for ERBB2 (HER2) testing, in which he simultaneously (in real time) correlates between the tumor histologic characteristics (tumor grade, nuclear score), HER2 protein status by immunohistochemistry and HER2 gene status by FISH. Following the publication of testing of ~3000 breast cancers using this approach (Yaziji H, et al. JAMA 2004), Dr. Yaziji has personally evaluated close to 15,000 breast cancers as part of this program. Thirteen years later, the ASCO/CAP task force finally adopted components of Dr. Yaziji’s QC program in their most recent HER2 guidelines recommendations.
Another example is Vitro’s clinical validation to ~2000 stage II colon cancer specimens for MMR testing by immunohistochemistry. As part of the QUASAR clinical trial (UK),Vitro tested the entire cohort of colon cancer specimens for MLH1 and MSH2 protein testing, and established a superb correlation between MMR protein deficiency and better clinical outcome. This validation was performed prior to the approval of the Oncotype DX colon cancer assay by the Food and Drugs Administration (FDA).
In addition,Vitro played a key role in several clinical trials as part of pre-FDA approval of various IHC and FISH assays that since then were approved by the FDA and are utilized by all anatomic pathology reference labs in the USA.