Clinical Summary

Findings from this study demonstrate that TissueCypher has the potential to significantly improve the quality of clinical care decisions for BE management, enabling risk aligned care decisions that may lead to better patient health outcomes. This study provides support for TissueCypher's ability to:

• Optimize adherence to clinical guidelines
• Improve accuracy of patient risk assessment
• Increase appropriate recommendations for endoscopic eradication therapy (EET)

Studies have shown that in practice, clinician adherence to society guidelines is limited.1 This is largely because BE is a disease state with risk factors that are often incongruent, and diagnosis and treatment plans rely on subjectivity of pathologic analysis.

This study aimed to evaluate the impact of TissueCypher on adherence to guidelines as well as the accuracy of risk-aligned management decisions that lead to improved patient health outcomes.

Board-certified gastroenterologists or GI surgeons (n=259) were assigned to three groups: Control, Intervention 1, Intervention 2, and were asked to evaluate Clinical Performance and Value (CPV) vignettes, which are realistic simulations of patient cases in which physicians proceeded through domains of a clinical encounter and made management decisions. The simulated patients represented typical Barrett’s patients with a range of clinical factors and TissueCypher risk results. Next, the physicians in the Intervention 1 and 2 group received education on TissueCypher testing after which all three groups were asked to evaluate a new set of CPVs. The quality of the management decisions that were made by the physicians were scored based on adherence to society guidelines by two trained, expert physicians working independently, and any disagreement was adjudicated by a third physician.

• The clinicians that chose to order TissueCypher were significantly better at identifying the risk of progression to HDS/EAC (Figure 1) – 89.6% for test "adopters" vs. 22.2% for "non-adopters" (p<0.001).
• 85% of TissueCypher adopters appropriately ordered EET given the risk of progression, compared to only 32.9% of non-adopters (p<0.001).
• When physicians were given the option to order the test in Intervention 2, it was ordered on 21.9% of cases, with no significant difference in ordering by case type, variant, specialty, practice type or practice setting. This is consistent with the average adoption rate of 25% for new diagnostic technologies².

• Before TissueCypher was introduced, no significant difference was found for the percent appropriate diagnosis and treatment plans (DxTx) across each arm of the study.
• Following incorporation of TissueCypher , Intervention 1 showed a significant difference-in-difference improvement of +4.2% (p=0.021) across all variants.
• The most dramatic increase in performance was seen for simulated patients with low clinical risk who received a TissueCypher high-risk result. Physicians more accurately assessed the risk of disease progression, showing a difference-in-difference score of +65.7 (p<0.001).
• For cases requiring annual endoscopic surveillance, significant improvement was found in adherence for Intervention 1, with a difference-in-difference of +18.5% (p=0.019). 

Evidence-based diagnosis + treatment guideline adherence by study arm for all cases

^aP-values for all within-round comparisons between study arms and within-arm comparisons between rounds were calculated using x2 analyses; difference-in-difference P-values were calculated using regression analyses. Physicians in Intervention 1 were given the results of the TSP-9 test and physicians in Intervention 2 had the ability to optionally order the TSP-9 test.