Fremont, CA, January 30, 2017 – BioGenex, a global leader in molecular pathology, is pleased to announce development of a novel system for quantitative immunohistochemistry (IHC). The system was developed in collaboration with the University of Rochester (NY, USA) and Konica-Minolta Inc. (Tokyo, Japan). The new system is able to accurately quantify the expression of an important breast cancer biomarker, HER2 (Human epidermal growth factor receptor-2) in clinical samples. Quantitative IHC is achieved by combining BioGenex IHC system with Konica-Minolta PID nanoparticles detection system (REF). According to the study presented at the 2016 San Antonio Breast Cancer Symposium (SABCS), the new method is more accurate and shows a broader dynamic range of values when compared with IHC quantitation. When compared to FISH analysis, PID score/cell showed a much better correlation (R2=0.72) as compared to standard IHC (R2=0.41). Moreover, by using BioGenex Xmatrx-Infinity workstation, quantitative IHC can be fully automated with high precision, as demonstrated by Standard deviation (SD) values below 12%. This novel method offers great potential for the quantitative measurement of biomarkers to advance precession medicine for cancer and possible other diseases using tissue and cytology specimen. Further development work is required to bring this technology to molecular pathology laboratory for clinical application.
"Once again we demonstrate our ability to deliver cutting edge technology to solve unmet medical needs years ahead of our competition,” said Dr. Krish Kalra, founder and CEO of BioGenex.
HER2 overexpression in breast cancer is associated with an aggressive clinical course and poor outcome and was the first predictive IHC biomarker approved by the FDA (licensed in 1998). Targeting HER2 overexpression is a remarkably effective therapeutic modality (e.g. trastuzumab/Herceptin), however, inaccuracy of current HER2 testing methods can lead to non-optimal therapy with an estimated economic loss of about $1 billion annually.
About BioGenex: BioGenex designs, develops and commercializes molecular pathology systems for cancer diagnosis, prognosis, precession medicine and life science research. The recent introduction of our cytogenetic FISH workflow solution and miRNA system for characterization of Cancer of Unknown Primary (CUP) and undifferentiated tumors are a game changer and envy of the industry. Our fully-automated molecular pathology workstations are the most advanced system available globally. BioGenex prides itself on delivering cutting edge technology, years ahead of its competition, providing the finest systems for immunohistochemistry (IHC), In Situ hybridization (ISH), FISH, Special stains and in situ PCR. BioGenex unconditionally guarantees performance of its systems and products: antibodies, probes, antigen retrieval, detection systems and histology stains. We are committed to provide quality systems and best in class customer care.