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Personalized progression risk assessment with TissueCypher
TissueCypher is an AI-driven precision medicine test that predicts the risk of progression to cancer in patients with Barrett’s esophagus. The test has the power to improve the standard of care for Barrett’s esophagus patients, many of whom are misclassified by traditional risk assessment.
Limitations of traditional risk assessment for Barrett’s esophagus
Clinicians use a combination of factors to predict the risk of progression to esophageal cancer, which informs how Barrett’s esophagus is treated and managed. Historically, each patient’s risk has been assessed based on their grade of dysplasia (or degree of abnormal cell growth) in addition to endoscopic and clinical features.
Dysplasia is classified as high-grade, low-grade or indefinite, while those with no dysplasia are non-dysplastic. Patients with high-grade dysplasia can immediately be flagged for treatment because they have a clear elevated risk of progression to cancer. However, appropriate care becomes less clear for individuals with less advanced dysplasia or no dysplasia at all.
On the whole, patients with non-dysplastic Barrett’s esophagus are at low risk of progression to cancer, but true risk varies individually and some are actually at high risk. Because this group is so large compared to patients with dysplastic Barrett’s esophagus, half of the patients who progress to cancer every year were initially diagnosed as non-dysplastic.
Low-grade dysplasia is also an unreliable predictor of risk. In fact, studies suggest the progression rate to cancer over time was essentially the same between patients graded as non-dysplastic and those with low-grade dysplasia (Critchley-Thorne et al., 2016; Critchley-Thorne et al., 2017; Davison et al., 2020; Frei et al., 2020; Frei et al., 2021).
The limitations of dysplasia grading as a predictor of progression have a real impact on patient care. Many truly high-risk patients do not receive the intervention they need, while truly low-risk patients undergo unnecessary surveillance endoscopies and experience needless anxiety about developing cancer. To improve patient care, additional risk stratification tools are needed that look at precancerous changes that are not traditionally accounted for.
50% of progressors are initially diagnosed as non dysplastic
TissueCypher reveals hidden progression risk
Standard biopsy analysis methods used for dysplasia grading of Barrett's esophagus tissue have a limited ability to evaluate molecular, cellular and morphological signatures of progression risk.
Through an AI-driven spatialomics approach TissueCypher has made it possible to assess these signatures in biopsies obtained during routine Barrett’s esophagus screening. The molecular signatures identified by TissueCypher are powerful independent predictors of progression risk, and often precede the development of dysplasia, allowing for earlier identification, treatment, and management of truly high-risk Barrett’s esophagus patients.
Assessing progression risk with TissueCypher
Clinicians use TissueCypher to predict the risk of esophageal cancer development in patients with Barrett’s esophagus when the risk of progression to cancer is unclear using traditional risk assessment.
After extracting cellular, molecular, and morphologic information from a patient’s tissue biopsy, TissueCypher provides a risk score from 0 to 10, a risk class (low, intermediate, and high), and a five-year probability of progression to high-grade dysplasia (abnormal cell growth) or cancer. These results can integrate with clinical guidelines and can be used in conjunction with traditional dysplasia-based grading to improve patient care.
Translating risk into action
TissueCypher risk can be used in conjunction with traditional dysplasia-based grading to inform patient care. A low-risk TissueCypher score for a patient with non-dysplastic Barrett’s esophagus reduces their five-year risk of progression to high-grade dysplasia or cancer from 3% to 1.45%, providing confidence to follow the guideline recommendations of surveillance every three years. A high-risk TissueCypher score for a patient with non-dysplastic Barrett’s esophagus increases their five-year risk of progression to high-grade dysplasia or cancer from 3% to 16%, which could inform immediate treatment or frequent surveillance (every 6-12 months), once prevalent disease has been ruled out.
High-risk TissueCypher class
- For non-dysplastic Barrett’s esophagus patients, progression risk with a high-risk TissueCypher score is 18-fold higher than patients scoring low-risk (Iyer et al., 2022).
Patients with a high-risk TissueCypher score are at significant risk of progression. Clinicians may consider treatment even if a patient is non-dysplastic with no other concerning risk factors.
Low-risk TissueCypher class
- Low-grade dysplasia patients are 2.5 times less likely to progress than traditional dysplasia-grading predicts (Iyer et al., 2022).
Patients who are classified as low-risk with TissueCypher are at a reduced risk of progression to cancer. Clinicians may consider extending surveillance intervals for patients with non-dysplastic Barrett’s esophagus and continued frequent surveillance instead of treatment for low-grade dysplasia patients.
