For Measuring Deep Molecular Responses in CML Patients Advances in TKI therapy have driven 5-year survival rates in CML patients to nearly 90%1 and are making treatment-free remission a reality2. To accurately assess treatment response and determine eligibility for cessation, a rapid, accurate and highly sensitive assay for measurement of disease burden is required. The QuantideX® qPCR BCR-ABL IS Kit is the only FDA-cleared assay for ultra-sensitive detection and precise monitoring of BCR-ABL1 transcripts resulting from the Major breakpoints (e13a2, e14a2). With its simple workflow, direct reporting on the IS, and best-in-class clinical sensitivity - 0.002% IS (MR4.7), any molecular laboratory can now assess the deepest molecular responses with unprecedented ease. REDUCED COMPLEXITY • Multi-point standard curve reduces variability and removes need for costly, complex sample exchange • QuantideX® Reporter software automates calculation and reporting of %IS, reducing burden of manual calculations OPTIMIZED WORKFLOW • Multiplexed design amplifies and detects fusion and endogenous control genes in the same reaction • All-inclusive reagent kits sourced and quality controlled together from a single vendor Figure 1: Kit components QUALITY PERFORMANCE • Limit of Detection (LOD) of MR4.7 (0.002% IS) confirmed in clinical human RNA specimens, not cell lines • Armored RNA®-based, IS-calibrated standards provide true RNA quantification American Cancer Society 2 Saußele S, et al. Leukemia (2016) 3

Proven Sensitivity Based on Rigorous Testing Criterion to Assess Complete Molecular Response Table 1: LOD as determined by CLSI EP17-A2 guidelines by testing Human RNA dilutions ranging from MR4.4 to MR6.0 - 60 replicates at each dilution for a total of 1680 data points. 10 of the 28 specimens near LOD that maintained <5% undetected results were used to determine LOD. Minimal Variability Across the Entire Dynamic Range of MR Values Demonstrates the Robustness of the Assay Table 2: Precision was evaluated by using 5 different MR levels composed of 5 unique positive specimens each. Testing spanned...