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Frequently Asked Questions
The goal of the TissueCypher test is to predict your personalized risk of progressing to high-grade dysplasia or esophageal cancer. Knowing this potential risk helps your physician gauge how aggressively to treat your Barrett’s esophagus. Your TissueCypher test result includes a risk score and a five-year probability of progression to high-grade dysplasia or esophageal cancer. For example, a risk score of 8.0 has an associated five-year probability of progression of 27%. This means that during the clinical validation studies, 27% of patients with a risk score of 8.0 progressed to high-grade dysplasia or esophageal cancer within five years. Knowing your personalized risk enables your physician to make risk-aligned adjustments to your care plan.
TissueCypher has been in clinical use since 2016 and has been validated in five clinical validation studies using one of the largest sets of BE progressors ever assembled.
The majority of people tested with TissueCypher receive a low-risk score, which is expected because most Barrett’s esophagus patients don’t progress to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC). A high-risk score gives your healthcare provider an opportunity to align your treatment to your predicted risk of progression, to escalate care and intervene early.
TissueCypher provides a risk score and probability of development of high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) within five years. In a recent study by the Mayo Clinic, TissueCypher was shown to independently predict increased risk of progression to HGD/EAC and was also shown to be a stronger predictor of progression than other traditional risk factors like age, sex, segment length, and even expert pathology. Multiple published studies have shown that TissueCypher has a higher positive predictive value than these traditional risk factors, e.g., patients who receive a TissueCypher high-risk score progress at a higher rate than patients with confirmed low-grade dysplasia.
The DecisionDx-SCC genomic test measures the biological activity of specific genes in your tumor that tell how likely it is for your tumor to spread or metastasize. The DecisionDx-SCC test identifies the risk of squamous cell tumors spreading better than traditional measures alone. It is intended to be used in patients with an SCC diagnosis and the presence of one or more traditional risk factors.
Your healthcare provider can use your test results, in combination with other information and procedures, to personalize your treatment and follow-up care. For example, if your tumor is low (Class 1), routine treatment options may be a reasonable choice, avoiding unnecessary treatments and frequent follow-up unless they become necessary later. Conversely, if your test results identify your tumor as moderate or high biological risk (Class 2A or 2B) perhaps a more aggressive approach to treatment.
If you wish to have the DecisionDx-SCC test, please discuss it with your healthcare provider. Only a healthcare provider (physician, physician assistants, or nurse practitioner) can order this test.
Castle Biosciences works with all insurance providers, including Medicare, Medicaid, commercial insurers, and the VA, to secure payment for the DecisionDx-SCC test. Castle will submit insurance claims and manage the insurance billing process on behalf of patients. The company also sponsors an industry-leading Patient Assistance program with the belief that quality care should not depend on financial considerations. For more information about insurance coverage, claims processing and financial assistance call 866-788-9007 and select option #3.
Please call our customer service staff at 866-788-9007 or email.