Used in conjunction with GeneXpert® technology, Xpert Breast Cancer STRAT4 simplifies breast cancer biomarker assessment through semi-automated sample preparation, automated RNA isolation, reverse transcription, amplification by real-time PCR and detection. The entire process happens within a patented cartridge-based system.
The Need
Breast cancer biomarker ER/PGR/HER2/Ki-67 results need to be dependable and objective
Clinicians need more reliable ER/PGR/HER2/Ki-67 assessment in FFPE tumor tissues.
5% of HER2 IHC results are equivocal based upon guide line recommended classifications.1
Resolving HER2 IHC2+ equivocal results with FISH is challenging.1-4
Technical and observer variability can lead to approximately 20% inaccurate ER and PGR results.
Ki-67 IHC scores deviate due to a lack of standardization.
The Solution
Xpert® Breast Cancer STRAT4 paves the way for a standardized, precise and reliable ER/PGR/HER2/Ki-67 mRNA assessment in less than 2 hours
Xpert Breast Cancer STRAT4 delivers semi-quantitative determination of ER/PGR/HER2/Ki-67 mRNA levels in FFPE invasive breast cancer sections
CYFIP1* reference gene is used for sample normalization
Three controls included in each test
Software report allows for objective and easy result interpretation
External FFPE controls# available for identifying errors, shifts, trends and operator variabilities
The Impact
Xpert Breast Cancer STRAT4 standardizes reproducible ER/PGR/HER2/Ki-67 assessment
Clear and accurate results empower oncologists.
Enables flexibility, simplicity and random access for a streamlined workflow 24/7.
Easy and fast test implementation.