Castle Biosciences Announces New York State Department of Health Approval of Its TissueCypher® Barrett’s Esophagus Test
With this approval, all of the tests in Castle’s dermatology, gastroenterology and ophthalmology portfolios, as well as its clinical laboratories in
“We are proud of the expansion of our New York Clinical Laboratory Permit to include our TissueCypher test,” said Kristen Oelschlager, chief operating officer of Castle Biosciences. “We believe this shift from conditional to full approval by the NYSDOH exemplifies Castle’s commitment to providing high-quality, molecular tests that can guide informed care decisions and improve patients’ lives.”
“Successful completion of the rigorous
With access to TissueCypher, clinicians have a prognostic tool designed to risk stratify the estimated
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). The TissueCypher Barrett’s Esophagus test is indicated for use in patients with endoscopic biopsy confirmed BE that is graded non-dysplastic (NDBE), indefinite for dysplasia (IND) or low-grade dysplasia (LGD); its clinical performance has been supported by 14 peer-reviewed publications of BE progressor 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. Learn more at www.CastleBiosciences.com.
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, Barrett’s esophagus, mental health conditions and uveal melanoma. Additionally, the Company has active research and development programs for tests in these and other diseases with high clinical need, including its test in development for use in patients diagnosed with moderate-to-severe atopic dermatitis who are seeking systemic treatment. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, X and Instagram.
DecisionDx-Melanoma, DecisionDx-CMSeq, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are 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 “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: the ability of Castle’s tests to guide informed care decisions and improve patients’ lives; Castle’s ability to ensure that all patients with BE in
- National Institute of Diabetes and Digestive and Kidney Diseases. Last Reviewed August 2024. Accessed December 12, 2024. https://www.niddk.nih.gov/health-information/digestive-diseases/barretts-esophagus/definition-facts.
- Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024;74(1):12-49. doi:10.3322/caac.21820. https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21820; accessed 11/5/24
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Investor Contact:
Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact:
amarshall@castlebiosciences.com
Source: Castle Biosciences Inc.