Frequently Asked Questions
Only a physician, physician assistant, or nurse practitioner can order a TissueCypher test.
Castle Biosciences works with all insurance providers, including Medicare, Medicaid, commercial insurers, and the VA, to secure payment for your TissueCypher test. Castle will submit your insurance claim and manage the insurance billing process on your behalf. The company also offers an industry-leading Patient Assistance Program with the belief that quality care should not depend on financial considerations.
You can get more information about insurance coverage, claims processing and financial assistance by calling 866-788-9007 and selecting option #3.
The TissueCypher test can be used after you have had an endoscopy with biopsies that have been confirmed by a pathologist to contain Barrett’s esophagus. Test results are reported directly to your healthcare provider approximately 18 to 20 business days from the date your sample is received by Castle Biosciences.
TissueCypher provides increased confidence that treatment decisions are tailored to each individual patient, leading to more personalized and precise care. The TissueCypher test is designed to:
- Be performed on existing biopsies taken during previous endoscopies; a repeat biopsy is NOT necessary.
- Identify patients at high risk of progression to esophageal cancer within five years of biopsy.
- Help detect existing high-risk disease or cancer that might have been missed by standard endoscopic surveillance.
- Identify patients who have a very low risk of progressing to cancer within five years of biopsy, providing additional information to help optimize surveillance strategy.
Additionally, the test has been shown to outperform predictions based on standard pathology alone.
The TissueCypher Barrett’s Esophagus test is the first test of its kind that predicts your risk for developing esophageal cancer if you have Barrett’s esophagus. It is intended for people with Barrett’s esophagus who have had an endoscopy procedure with biopsies. The test analyzes the biopsies taken during your endoscopy to produce a risk score that ranges from 0-10, with 0 being the lowest risk and 10 being the highest risk for developing more serious esophageal disease or cancer. Importantly, the test provides personalized information that can predict your chances for developing cancer.
Barrett's esophagus is a condition in which healthy cells in the esophagus turn into unhealthy cells. The esophagus is the tube that carries food from the mouth to the stomach. When acid from the stomach comes up into the esophagus (called Gastroesophageal Reflux Disease, or GERD), it can damage the cells that line the esophagus. In some people, Barrett's esophagus can become more serious and develop into cancer. While very serious, esophageal cancer can be prevented if the unhealthy cells found in high-risk Barrett's esophagus patients are treated before they turn into cancer.
This type of testing is an emerging, fast-growing field, so your doctor may not be aware of all of the tests that are now available to guide disease management decisions. If your doctor is interested in more information beyond our test descriptions on this website, please refer them to Castle Biosciences’ customer service (at 412-920-3050 or email).
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.