Castle Biosciences’ TissueCypher® Barrett's Esophagus Test Receives 2023 MedTech Breakthrough Award for Artificial Intelligence Innovation

This marks the third consecutive year that Castle has been recognized with a MedTech Breakthrough Award for its innovative testing solutions

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that it has been selected as the winner of the “Best Use of Artificial Intelligence in Healthcare” award in the seventh annual MedTech Breakthrough Awards program for its innovative TissueCypher® Barrett’s Esophagus test. TissueCypher is Castle’s risk-stratification test designed to predict future development of esophageal cancer in patients with Barrett’s esophagus (BE).

BE is a serious complication of gastroesophageal reflux disease (GERD) and a risk factor for the development of esophageal cancer, one of the fastest-growing cancers (by incidence) in the U.S., with a five-year survival rate of less than 20%.¹

“Patients with higher grades of BE generally receive effective interventions, such as ablation therapy, to halt the progression of BE to esophageal cancer,” said Derek Maetzold, president and chief executive officer of Castle Biosciences. “However, the majority of BE patients are graded with lower grades of BE, or as non-dysplastic. On a population basis, these lower-graded patients are predicted to have a low likelihood of developing cancer, but these lower graded patients make up the majority of patients who end up progressing to esophageal cancer. This disconnect shows there is a significant clinical need for personalized, biologically based risk-stratification information to enable improved alignment between risk of progression and use of effective interventions.

"The personalized risk-stratification information provided by TissueCypher was discovered, developed and validated to fill this clinical need, and the harnessing of artificial intelligence was part of the solution. We are incredibly honored to once again be recognized with a MedTech Breakthrough Award for our innovation in testing solutions that guide patient care.”

The TissueCypher test provides clinicians with important information about a patient’s individual risk of progression to esophageal cancer based on advanced analysis of biopsied tissue to guide more informed and risk-aligned management of BE patients.

“Most cancer diagnoses and associated risk-stratification estimates are currently made by pathologists viewing tissue on glass slides via light microscopy. This approach is limited in its ability to evaluate multiple biomarkers and cell types within the tumor system and predict future development of cancer,” said James Johnson, managing director, MedTech Breakthrough. “TissueCypher utilizes artificial intelligence to predict the risk of developing esophageal cancer – one of the world’s most deadly cancers. Congratulations to the Castle team on winning the ‘Best Use of Artificial Intelligence in Healthcare’ award in 2023!”

The mission of the MedTech Breakthrough Awards is to honor excellence and recognize innovation, hard work and success in a range of health and medical technology categories. This year’s program attracted more than 4,000 nominations from over 17 different countries throughout the world.

Castle has previously won two consecutive MedTech Breakthrough Awards: “Best New Technology Solution — Dermatology” in 2022 for its DecisionDx®-Melanoma gene expression profile (GEP) test, and “Best New Technology Solution — Oncology” in 2021 for its DecisionDx®-SCC and DiffDx®-Melanoma GEP tests.

About TissueCypher^® Barrett’s Esophagus Test

The TissueCypher Barrett’s Esophagus test is Castle’s precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE). TissueCypher is indicated for use in patients with endoscopic biopsy confirmed BE that is graded non-dysplastic (ND), indefinite for dysplasia (IND) or low-grade dysplasia (LGD); its clinical performance has been supported by nine peer-reviewed publications of BE progressor patients with leading clinical centers around the world. The TissueCypher Barrett’s Esophagus test is a proprietary Laboratory Developed Test with its own unique CPT PLA code (0108U). Additionally, the test received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) in March 2022 and was recognized by the American Gastroenterological Association (AGA) in their 2022 Clinical Practice Update as a tool that may be used to risk-stratify patients with NDBE.

About Castle Biosciences

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

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

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME, DecisionDx-UMSeq, TissueCypher and IDgenetix are trademarks of Castle Biosciences, Inc.

About MedTech Breakthrough

Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the MedTech Breakthrough Awards program is devoted to honoring excellence and innovation in medical & health technology companies, products, services and people. The MedTech Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough healthcare and medical companies and products in categories that include Patient Experience & Engagement, Health & Fitness, Medical Devices, Clinical Administration, Connected Healthcare, Medical Data, Healthcare Cybersecurity and more. For more information, visit MedTechBreakthrough.com.

¹Esophageal Cancer Action Network, https://ecan.org/facts/; accessed May 12, 2023

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