TissueCypher® Outperforms Pathologist Diagnoses in Predicting Progression in Patients Diagnosed with Barrett’s Esophagus with Low-Grade Dysplasia

FRIENDSWOOD, Texas–(BUSINESS WIRE)–Castle Biosciences, Inc. (Nasdaq: CSTL), a company that improves health through innovative tests that guide patient care, today announced new study data demonstrating the ability of its TissueCypher test ® for Barrett’s Esophagus to independently predict malignant progression to dysplasia (HGD) and esophageal adenocarcinoma (EAC) in patients with nondysplastic (ND), indefinite, or low Barrett’s esophagus (BE) grade (LGD). The TissueCypher Barrett Esophageal Test is designed to predict the future development of HGD and/or esophageal cancer in patients with EB.

In the study, TissueCypher outperformed the standard of care in predicting malignant progression in a review of surveillance biopsies from 154 BE patients who were independently reviewed by 30 pathologists. Importantly, TissueCypher identified over 40% of patients with LGD who progressed to HGD or EAC who were, on average, downgraded to NDBE by pathologists, and would therefore be missed by the standard of care (due to the variability of pathology diagnoses) .

Details of the study were shared during a podium presentation during Digestive Disease Week (DDW) 2022. The presentation was titled “Barrett’s Objective, Fully Automated Risk Prediction Test Outperforms Pathology in risk stratification of Barrett’s esophagus with low-grade dysplasia”.

Jacques Bergman, MD, Ph.D., corresponding author of the study, leading BE expert and professor of gastroenterology and hepatology at the University Medical Center in Amsterdam, the Netherlands, presented the data. University Medical Center is one of the world’s leading academic medical institutions for the diagnosis and treatment of EB and the prevention of esophageal cancer.

“There is extreme variability among pathologist observers in the diagnosis of EB, and a patient’s plan of care and long-term outcomes can vary significantly depending on which pathologist provides the diagnosis. That’s why the test TissueCypher has the potential to provide substantial value in the management of BE patients,” said Bergman. “As the study shows, TissueCypher can improve risk stratification of patients with BE to more accurately identify those with highest risk of progression to esophageal cancer to ensure that their management plans can be appropriately tailored with early and potentially life-saving interventions.”

The aim of the study was to assess the predictive value of TissueCypher in 154 BE patients with a community diagnosis of LGD, and to compare the performance of the test to an international panel of 15 experts and 15 community general pathologists. In the study, the panel of pathologists identified 63% of patients (susceptibility) who progressed to HGD or EAC. In comparison, TissueCypher identified 71% (sensitivity) of the progressors, and the combination of TissueCypher plus pathology examination identified 80%. Importantly, TissueCypher identified 43% of patients who were downgraded from LGD to NDBE by the pathologist panel, but then progressed to HGD or EAC. Thus, in both measures of this study, TissueCypher outperformed the pathology review (on an average basis for the 30 participating pathologists).

Overall, the study demonstrated that TissueCypher can accurately predict progression to HGD or EAC in BE patients who are initially diagnosed with LGD, outperforming the majority of pathologist diagnoses evaluated in this study. Additionally, TissueCypher test results can provide an objective solution to observer variability, identifying more progressors early and helping to inform management decisions and standardize care plans for patients with EB.

About TissueCypher® Barrett’s esophagus test

The TissueCypher Barrett Esophageal Test is Castle’s precision medicine test designed to predict the future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with esophageal of Barrett (BE). The TissueCypher Barrett Esophagus Test is indicated for use in patients with EB confirmed by endoscopic biopsy that is graded non-dysplastic (NDBE), indefinite for dysplasia (IND) or low-grade dysplasia (LGD) ; its clinical performance has been supported by nine peer-reviewed publications of progressive EB patients with leading clinical centers around the world. The test received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) in March 2022.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company that improves health through innovative tests that guide patient care. The Company aims to transform disease management by putting people first: patients, clinicians, employees and investors.

Castle’s current portfolio includes tests for skin cancers, uveal melanoma, Barrett’s esophagus and mental health issues. Additionally, the Company has active research and development programs for testing in other diseases of high clinical need, including its test in development to predict systemic therapeutic response in patients with moderate to severe psoriasis, atopic dermatitis and related conditions. To learn more, visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, Twitter and Instagram.

DecisionDx-Melanoma, DecisionDx-CMSeqDecisionDx-SCC, myPath Melanoma, DecisionDx DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME, DecisionDx-UMSeqTissueCypher and IDgenetix are registered trademarks of Castle Biosciences, Inc.

Forward-looking statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “sphere of security” created by these sections. These forward-looking statements include, but are not limited to, statements regarding: TissueCypher’s potential to (i) provide substantial value in the management of BE patients and help inform management decisions and standardize care plans, (ii) improve risk stratification of BE patients by more accurately identifying those at highest risk of progression and predicting progression to HGD or EAC in BE patients who are initially diagnosed with LGD, (iii) provide automated and objective risk stratification with clinically impactful sensitivity, (iv) further inform patient management plans with clinically actionable and personalized information that could drive early and potentially life-saving interventions and (v) provide an objective solution to variability observers. The words “may”, “potential”, “could”, “may” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those contained in the forward-looking statements, including, without limitation: the effects of the COVID-19 pandemic on our business and our efforts to address its impact on our business; results and conclusions of subsequent studies or trials may contradict results and conclusions of prior studies or trials, including with respect to the discussion of the TissueCypher® Barrett Esophageal Test in this press release. hurry ; the actual application of our tests may not provide the above benefits to patients; and the risks set forth under “Risk Factors” in our Quarterly Report on Form 10-Q for the three months ended March 31, 2022, and in our other filings with the SEC. Forward-looking statements speak only as of the date they are made, and we assume no obligation to update forward-looking statements except as required by law.

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