Castle Biosciences announces the results of the study DecisionDx-CE multi-analyte test for cancer of the esophagus

Castle Biosciences announces the results of the study DecisionDx-CE multi-analyte test for cancer of the esophagus -

Castle Biosciences Inc. announced today the study results of its multi-analyte test DecisionDx owner-EC, which is designed to identify esophageal cancer patients are likely to respond or not to respond standard preoperative chemoradiation therapy. The results were discussed at a poster presentation at 50 ^e Annual Meeting of the American Society of Clinical Oncology (ASCO). The data demonstrate the biomarker test's ability to accurately identify two types of patients: those who are likely to respond to a pre-surgical therapy chemoradiation (CTRT) and should continue to receive the standard treatment; and those unlikely to respond to CTRT and could instead move quickly to surgery or other more effective therapies.

"One of the challenges in esophageal cancer treatment is to know that, although some patients have an excellent response to standard pre-surgical chemoradiation, up to 30 percent of patients not respond to this therapy, "said Dr. Sunil Badve, MD, FRCPath, professor of pathology and laboratory medicine at the medical school of the University of Indiana, and co-author of the study. "The toxicities associated with chemoradiation therapy are important and can significantly reduce the quality of life of a patient while delaying surgery and the use of potentially more effective therapies. We could use the results of the multi-analyte test for better identify patients who are likely to respond, while avoiding highly toxic therapies in patients for whom they are unlikely to be effective. "

Results of the study on cancer esophagus

DecisionDx the CE-test analyzes the location of three protein biomarkers, NF-kB, Gli1 and SHH, to classify tumors could have a complete response (pathCR) or likely to have extreme resistance to CTRT (exCTRT). The test was performed on paraffin embedded formalin fixed at (FFPE) tissue esophageal adenocarcinoma.

This independent multi-center study of 65 patients with locoregional esophageal adenocarcinoma was the second validation study for DecisionDx-CE test. In this group of patients, multi-analyte test predicts patients who would experience exCTRT with a specificity of 95%, demonstrating a positive predictive value (PPV) of 83% and negative predictive value (NPV) of 77%.

Importantly, the results also found that the test can accurately predict which patients will experience a complete response to therapy before surgery, and will likely see no benefit. The EC-DecisionDx test predicts pathCR with a specificity of 87%, PPV 42% and NPV of 89%. This aspect of the test has been optimized to ensure that the potential CTRT stakeholders will not be outsourced.

Rectal Adenocarcinoma Results

Castle Biosciences also presented initial data from a study of its newly developed rectal cancer (RC) test in samples FFPE 10 patients with rectal adenocarcinoma (RC). Using the same biomarkers as test CE multi-analyte, the RC test was able to predict exCTRT and pathCR with an overall accuracy of 80%, a specificity of 100%, 100% PPV, and NPV of 71% . Extended Validation of biomarkers RC test is currently underway.