TissueCypher Barrett’s Esophagus Assay

TissueCypher Barrett’s Esophagus Assay

Your doctor has recommended the TissueCypher® test to help determine what treatment is best for your Barrett’s esophagus. The test determines how far the condition has advanced and therefore how much risk you face for developing cancer of the esophagus.
Let’s learn the basics about Barrett’s esophagus, how the TissueCypher® test works, and the health insurance coverage and other financial assistance you can expect on completing the test.

What Is Barrett’s Esophagus?

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, it can damage the cells that line the esophagus. Barrett’s esophagus affects more than 3.3 million adults in the United States1 and it is the primary cause of cancer of the esophagus. This often fatal disease can be prevented if the unhealthy cells are found and treated before they turn into cancer. Barrett’s esophagus develops slowly in stages (grades), each one more serious than the next.

What Are The Different Grades Of Barrett’s Esophagus And How Is The Condition Treated?

Medical societies – organizations of professionals in medical specialties – offer guidelines to their members about the most appropriate treatments for certain diseases. Here is what medical societies dealing with the digestive system say about treating the different grades of Barrett’s esophagus.

Grade or Level of Disease

GRADE 1 -Intestinal Metaplasia (IM) (Metaplasia: A change in body tissue or cells from one type into another, often from normal tissue to abnormal or diseased tissue.)
The normal lining of the esophagus has been injured, and the tissue looks more like the redlining of the intestines instead of the normal pink lining of the esophagus.
People who have intestinal metaplasia are at low risk for Barrett’s esophagus progressing (getting worse). However, some people have other factors that place them at greater risk than the general population, and they may be considered for some form of Barrett’s esophagus treatment.2,3
GRADE 2 -Low-grade Dysplasia (LGD) (Dysplasia: The abnormal growth or development of cells in body tissues, bones, or organs.)
The tissue cells are larger than the cells in intestinal metaplasia, and the cell pattern is abnormal.
Recent data suggests that when lowgrade dysplasia has been verified, simply monitoring the disease through regular examination is not effective in preventing progression to cancer.4 It is better to take action and remove the disease.
GRADE 3 -High-grade Dysplasia (HGD)
The tissue cells are very disorganized, large and multi-layered. This is the most severe form of Barrett’s esophagus.
This grade of disease poses the greatest risk. Society guidelines say that patients with high-grade dysplasia should have some form of therapy to destroy the disease and reduce the risk of progression to cancer.2,3

What Is The TissueCypher Barrett’s Esophagus Assay?

The TissueCypher® Barrett’s Esophagus Assay is the first test of its kind that can predict the risk that your Barrett’s esophagus disease will worsen and progress to cancer of the esophagus. Barrett’s esophagus is first detected in a procedure called endoscopy, in which a doctor uses a flexible tube (endoscope) fitted with lenses and a light source to examine the esophagus lining. During the procedure, the doctor may remove a sample of tissue for further study (biopsy) to determine whether disease is present and how serious it is.
The TissueCypher® assay is for people with Barrett’s esophagus who have had one or more endoscopy procedures with biopsy. The assay analyzes the biopsies to produce a risk score from zero to 10, where zero is the lowest risk and 10 is the highest risk for developing cancer of the esophagus. Most important, the estimate of cancer risk applies to you specifically; no other test has that capability.

When Is A TissueCypher Test Ordered And What Are Its Potential Benefits?

The TissueCypher® Barrett’s Esophagus Assay can be used after you have an endoscopy with biopsy that has been confirmed to contain Barrett’s esophagus through examination by a pathologist – a doctor who interprets changes caused by disease in cells and tissues. The test results are reported directly to your doctor about 14 days after Cernostics receives your tissue samples..
The Cernostics TissueCypher® test: • Can be performed on existing biopsies taken during previous endoscopies; a repeat biopsy is NOT necessary. • Identifies patients at high risk of progression to cancer of the esophagus within five years after biopsy. • Helps detect existing high-risk disease or cancer that might have been missed by standard monitoring by way of regular endoscopy. • Identifies patients at very low risk of progressing to esophageal cancer within five years after biopsy, providing information to help choose the best strategy for monitoring disease progress. • Is more effective at predicting risk than more traditional approaches that rely on visual tissue examination alone. • Increases confidence that treatment decisions are tailored to each individual patient, leading to more personalized and precise care.

WILL MY INSURANCE COVER THIS TEST?

In most cases, yes. The TissueCypher® Barrett’s Esophagus Assay uses medical testing procedures commonly covered by health insurance providers, including Medicare. Cernostics will bill Medicare or private health insurance on your behalf, or may arrange for your care provider’s clinical laboratory to bill your insurance company for the test.

REFERENCES 1. Study provides first estimate of US population affected by Barrett’s esophagus. Science Daily [webpage]. www.sciencedaily.com/ releases/2005/12/051202084834.htm. Published December 2, 2015. Accessed March 1, 2016. 2. ASGE Standards of Practice Committee. The role of endoscopy in Barrett’s esophagus and other premalignant conditions of the esophagus. Gastrointest Endosc. 2012 Dec;76(6):1087-94. 3. American Gastroenterological Association Medical Position Statement on the Management of Barrett’s Esophagus. Gastroenterology. 1 March 2011 (volume 140 issue 3 Pages 1084-1091 DOI: 10.1053/j. gastro.2011.01.030). 4. Phoa K, van Vilsteren FI, Weusten BM, et al. Radiofrequency Ablation vs Endoscopic Surveillance for Patients With Barrett Esophagus and Low-Grade Dysplasia: A Randomized Clinical Trial. JAMA. 2014;311(12):12091217. doi:10.1001/jama.2014.2511.