Study of Castle Biosciences’ Multi-Analyte Test for Esophageal Cancer Published in Gastrointestinal Cancer: Targets and Therapy

Results confirm test’s ability to identify which patients are unlikely to benefit from standard pre-surgical chemoradiation

FRIENDSWOOD, Texas--()--Castle Biosciences, Inc. today announced the publication of the second clinical validation study of its multi-analyte test for esophageal cancer. The DecisionDx-EC test analyzes the localization of three protein biomarkers within a patient’s tumor to classify the cancer as either responsive to or resistant to pre-surgical chemoradiotherapy. The paper, “Prospective prediction of resistance to neoadjuvant therapy in patients with locoregional esophageal adenocarcinoma,” was published in the peer-reviewed journal Gastrointestinal Cancer: Targets and Therapy.

“Neoadjuvant chemotherapy and radiation therapy will achieve no clinical benefits in up to a quarter of patients with esophageal cancer. However, this subset of patients is subject to potential toxicity, along with associated costs”

According to the study, DecisionDx-EC demonstrated strong accuracy and specificity in identifying patients with tumors that are unlikely to respond to standard pre-surgical (neoadjuvant) chemotherapy and radiation.

“Neoadjuvant chemotherapy and radiation therapy will achieve no clinical benefits in up to a quarter of patients with esophageal cancer. However, this subset of patients is subject to potential toxicity, along with associated costs,” commented Kenneth Kesler MD, Professor of Surgery, Thoracic Oncology Program, Indiana University. “The ability to identify resistance may help with selection of alternative chemotherapy agents or treatment strategies.”

Study Highlights

The test, a three-protein biomarker assay, was discovered by researchers at the University of Texas MD Anderson Cancer Center and licensed to Castle Biosciences. Pre-treatment tumor biopsies were used to evaluate resistance (exCTRT) or responsiveness to (non-exCTRT) standard pre-surgical CTRT regimens under CAP-accredited, CLIA-certified laboratory protocols. According to validation studies, the test can reliably differentiate patients who are complete or partial responders to chemoradiotherapy from those who are non-responders. An initial, single center clinical validation study of 167 patients, which was used as a training set for the current validation study, achieved an area under the curve (AUC) of 0.96 and an overall accuracy of 90%.

The second validation study, published today, enrolled 64 patients from two independent institutions, and achieved an AUC of 0.96 and an overall accuracy of 84% for classifying which patients are likely to be highly resistant to pre-surgical chemotherapy treatment for esophageal cancer.

The DecisionDx-EC test uses a predictive algorithm to classify patients as either exCTRT (College of American Pathology Treatment Response Grade 3) or non-exCTRT (College of American Pathology Treatment Response Grade 0, 1, or 2). Compartmental localization of the biomarkers NF-kB, Gli1 and SHH is assessed in pre-treated tumor biopsies to determine a localization index score for each biomarker. This information is then analyzed using the proprietary algorithm to predict exCTRT or non-exCTRT. The test is currently available for health care providers to order through Castle Biosciences.

“Publication of these results is a culmination of our extensive program to analytically and clinically validate a new predictive test for esophageal cancer,” said Derek Maetzold, President and CEO of Castle Biosciences. “DecisionDx-EC fits well within our strategy of developing and commercializing valuable prognostic tests that help physicians to select the most appropriate care for their patients.”

About Esophageal Cancer

The esophagus carries food and liquid from the mouth to the stomach. There are two main types of esophageal cancer: adenocarcinoma and squamous cell carcinoma. The most common form of the disease in the U.S. is adenocarcinoma and is most prevalent in Caucasian men between the ages of 50 and 70. Adenocarcinoma, which is one of the fastest growing cancers in the country, has also been linked to obesity – perhaps related to chronic exposure to stomach acid. According to the National Cancer Institute, about 18,000 Americans were diagnosed with esophageal cancer in 2013.

About Castle Biosciences

Castle Biosciences is a molecular diagnostics and prognostics company dedicated to helping patients and their physicians make the best possible decisions about their treatment and follow-up care based on the individual molecular signature of their tumor. The Company offers tests providing actionable information that improve patient care through advances in cancer staging accuracy and treatment precision in uveal and cutaneous melanoma, esophageal and brain cancers. More information can be found at www.castlebiosciences.com.

Contacts

For Castle Biosciences, Inc.
Brad Miles, 646-513-3125
Bmiles@bmccommunications.com
or
Amy Bonanno, 646-513-3117
Abonanno@bmccommunications.com