Frequently Asked Questions

Only a physician, physician’s assistant, or nurse practitioner can order a Castle test.

Castle Biosciences operates clinical laboratories in Phoenix and Pittsburgh. The Company’s laboratories are College of American Pathologists (CAP) accredited and Clinical Laboratory Improvement Amendments (CLIA) certified, reflecting the Company’s commitment to high-quality standards and excellence in patient care. Castle's laboratories are licensed to perform tests throughout the United States.

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).

Castle Biosciences works with all insurance providers, including Medicare, Medicaid, commercial insurers, and the VA, to secure payment for the DecisionDx-UM 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.

Castle began storing residual tissue after DecisionDx-UM testing in mid-2015. If your biopsy was collected after that time, Castle may have residual tumor tissue remaining following your DecisionDx-UM test. If enough residual tissue is remaining, your provider may request that these additional tests be performed on your sample.

Castle’s Clinical Services Team can tell you whether there is residual sample remaining after testing is complete. For inquiries regarding residual sample, call 866-788-9007 and select option #1.