Xpert® Breast Cancer STRAT4 Standardized breast cancer ER/PGR/HER2/Ki-67 mRNA biomarker assessment in less than two hours In Vitro Diagnostic Medical Device Not available in all countries . Not available in the United States .

Xpert Breast Cancer STRAT4 ® Used in conjunction with GeneXpert® technology, Xpert® Breast Cancer STRAT4 simplifies breast cancer biomarker assessment through semiautomated sample preparation, automated RNA isolation, reverse transcription, amplification by realtime PCR and detection. The entire process happens within a patented cartridge-based system. Breast cancer biomarker ER/PGR/HER2/Ki-67 results need to be dependable and objective 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 • Clinicians need more...

Performance Xpert Breast Cancer STRAT4 results are highly concordant with ER/PGR/Ki-67 IHC and IHC/FISH (HER2)7 Xpert Breast Cancer STRAT4 vs. IHC PPA NPA OPA Positivity detection cut-offs of Xpert Breast Cancer STRAT4 for ER/PGR/HER2 correlate with those in ASCO-CAP, St. Gallen Consensus and ESMO Guidelines.1,5,8,9 Software delivers binary test results and normalized gene expression scores: • ESR1 positive correlates with IHC results > 1% ER positive cells • PGR positive correlates with IHC results > 1% PGR positive cells • ERBB2 positive correlates with HER2 IHC 3+ and IHC 2+/FISH amplified...

Workflow Xpert® Breast Cancer STRAT4 is easy to perform and provides results in less than 2 hours with minimal hands-on time One H&E stained FFPE section is used to confirm invasive tumor area. This area is removed (scraped) from an unstained 4 μm section and placed into a lysis tube. Add FFPE lysis reagents, add Proteinase K and heat for 30 min at 80°C. Add ethanol and vortex. Insert cartridge and start test (run time 75 minutes). Ordering Information CATALOG NUMBER Xpert FFPE Lysis Kit ® Xpert® Breast Cancer STRAT4 (10 tests) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....