{"id":797843,"date":"2025-01-06T07:03:42","date_gmt":"2025-01-06T12:03:42","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/castle-biosciences-announces-new-york-state-department-of-health-approval-of-its-tissuecypher-barretts-esophagus-test\/"},"modified":"2025-01-06T07:03:42","modified_gmt":"2025-01-06T12:03:42","slug":"castle-biosciences-announces-new-york-state-department-of-health-approval-of-its-tissuecypher-barretts-esophagus-test","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/castle-biosciences-announces-new-york-state-department-of-health-approval-of-its-tissuecypher-barretts-esophagus-test\/","title":{"rendered":"Castle Biosciences Announces New York State Department of Health Approval of Its TissueCypher\u00ae Barrett\u2019s Esophagus Test"},"content":{"rendered":"

<\/p>\n

Castle Biosciences Announces New York State Department of Health Approval of Its TissueCypher\u00ae Barrett\u2019s Esophagus Test<\/b><\/p>\n

With this approval, all of the tests in Castle\u2019s dermatology, gastroenterology and ophthalmology portfolios, as well as its clinical laboratories in Phoenix and Pittsburgh, are now approved by the state of New York<\/i><\/p>\n

FRIENDSWOOD, Texas–(BUSINESS WIRE<\/a>)–
\nCastle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that it has received assay approval from the New York State Department of Health (NYSDOH) for its TissueCypher Barrett\u2019s Esophagus test. TissueCypher is the first AI-driven precision medicine test designed to predict a patient\u2019s individual risk of progression from Barrett\u2019s esophagus (BE) to esophageal cancer.<\/p>\n

\n\u201cWe are proud of the expansion of our New York Clinical Laboratory Permit to include our TissueCypher test,\u201d said Kristen Oelschlager, chief operating officer of Castle Biosciences. \u201cWe believe this shift from conditional to full approval by the NYSDOH exemplifies Castle\u2019s commitment to providing high-quality, molecular tests that can guide informed care decisions and improve patients\u2019 lives.\u201d<\/p>\n

\n\u201cSuccessful completion of the rigorous New York state assay review process for TissueCypher, which involves a meticulous review of a test\u2019s analytical validity, clinical validity and clinical utility, is an important step toward ensuring all patients with BE in the United States have access to our test,\u201d added Derek Maetzold, president and chief executive officer of Castle Biosciences.<\/p>\n

\nWith access to TissueCypher, clinicians have a prognostic tool designed to risk stratify the estimated 5% of adults in the United States with BE.1 <\/sup>Chronic acid reflux from the stomach causes changes to the molecular and cellular features of the esophagus which can result in BE, the only known precursor condition to esophageal cancer. Esophageal cancer is one of the fastest-growing cancers (by incidence) in the United States and one of the deadliest, with a five-year survival rate of just 22%.2 <\/sup>TissueCypher analyzes cancer-associated biomarkers and spatial biology features to identify a molecular signature of BE progression that can precede visible tissue chances in a patient\u2019s esophagus. By providing a patient\u2019s individual risk of progression from BE to esophageal cancer, TissueCypher helps to inform a risk-aligned surveillance approach or earlier interventions that can help prevent the development of cancer.<\/p>\n

About TissueCypher Barrett\u2019s Esophagus Test<\/b><\/p>\n

\nThe TissueCypher Barrett\u2019s Esophagus test is Castle\u2019s precision medicine test designed to predict future development of high-grade dysplasia (HGD) and\/or esophageal cancer in patients with Barrett\u2019s esophagus (BE). The TissueCypher Barrett\u2019s 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<\/a>.<\/p>\n

About Castle Biosciences<\/b><\/p>\n

\nCastle 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.<\/p>\n

\nCastle\u2019s current portfolio consists of tests for skin cancers, Barrett\u2019s 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<\/a> and connect with us on LinkedIn<\/a>, Facebook<\/a>, X<\/a> and Instagram<\/a>.<\/p>\n

\nDecisionDx-Melanoma, DecisionDx-CMSeq<\/i>, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq<\/i> are trademarks of Castle Biosciences, Inc.<\/p>\n

Forward-Looking Statements<\/b><\/p>\n

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 \u201csafe harbor\u201d created by those sections. These forward-looking statements include, but are not limited to, statements concerning: the ability of Castle\u2019s tests to guide informed care decisions and improve patients\u2019 lives; Castle\u2019s ability to ensure that all patients with BE in the United States have access to TissueCypher; the ability of the TissueCypher test to inform a risk-aligned surveillance approach or earlier interventions to help prevent the development of cancer. The words \u201ccan,\u201d \u201cwould\u201d and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these 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 that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results shown in this study, including with respect to the discussion of TissueCypher in this press release; actual application of our TissueCypher test may not provide the aforementioned benefits to patients; and the risks set forth under the heading \u201cRisk Factors\u201d in our Annual Report on Form 10-K for the year ended December 31, 2023 and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.<\/i><\/p>\n

    \n
  1. \nNational 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<\/a>.<\/p>\n<\/li>\n
  2. \nSiegel 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<\/a>; accessed 11\/5\/24<\/p>\n<\/li>\n<\/ol>\n

    \n\u00a0<\/p>\n

    \"\"<\/p>\n

    View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20250106714830\/en\/<\/a><\/span><\/p>\n

    Investor Contact:
    \n<\/b>
    Camilla Zuckero
    \n
    czuckero@castlebiosciences.com<\/a><\/p>\n

    Media Contact:
    \n<\/b>
    Allison Marshall
    \n
    amarshall@castlebiosciences.com<\/a><\/p>\n

    KEYWORDS:<\/b> New York Pennsylvania Arizona Texas United States North America<\/p>\n

    INDUSTRY KEYWORDS:<\/b> Technology Medical Devices Medical Supplies Health Technology Biotechnology Biometrics Health Artificial Intelligence Oncology<\/p>\n

    MEDIA:<\/b><\/p>\n\n\n\n\n
    Logo<\/b><\/font><\/td>\n<\/tr>\n
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    <\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

    Castle Biosciences Announces New York State Department of Health Approval of Its TissueCypher\u00ae Barrett\u2019s Esophagus Test With this approval, all of the tests in Castle\u2019s dermatology, gastroenterology and ophthalmology portfolios, as well as its clinical laboratories in Phoenix and Pittsburgh, are now approved by the state of New York FRIENDSWOOD, Texas–(BUSINESS WIRE)– Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that it has received assay approval from the New York State Department of Health (NYSDOH) for its TissueCypher Barrett\u2019s Esophagus test. TissueCypher is the first AI-driven precision medicine test designed to predict a patient\u2019s individual risk of progression from Barrett\u2019s esophagus (BE) to esophageal cancer. \u201cWe are proud of the … <\/p>\n

    Continue reading “Castle Biosciences Announces New York State Department of Health Approval of Its TissueCypher\u00ae Barrett\u2019s Esophagus Test”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-797843","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nCastle Biosciences Announces New York State Department of Health Approval of Its TissueCypher\u00ae Barrett\u2019s Esophagus Test - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/castle-biosciences-announces-new-york-state-department-of-health-approval-of-its-tissuecypher-barretts-esophagus-test\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Castle Biosciences Announces New York State Department of Health Approval of Its TissueCypher\u00ae Barrett\u2019s Esophagus Test - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Castle Biosciences Announces New York State Department of Health Approval of Its TissueCypher\u00ae Barrett\u2019s Esophagus Test With this approval, all of the tests in Castle\u2019s dermatology, gastroenterology and ophthalmology portfolios, as well as its clinical laboratories in Phoenix and Pittsburgh, are now approved by the state of New York FRIENDSWOOD, Texas–(BUSINESS WIRE)– Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that it has received assay approval from the New York State Department of Health (NYSDOH) for its TissueCypher Barrett\u2019s Esophagus test. TissueCypher is the first AI-driven precision medicine test designed to predict a patient\u2019s individual risk of progression from Barrett\u2019s esophagus (BE) to esophageal cancer. \u201cWe are proud of the … Continue reading "Castle Biosciences Announces New York State Department of Health Approval of Its TissueCypher\u00ae Barrett\u2019s Esophagus Test"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/castle-biosciences-announces-new-york-state-department-of-health-approval-of-its-tissuecypher-barretts-esophagus-test\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-01-06T12:03:42+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20250106714830r1&sid=flmnd&distro=nx&lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/castle-biosciences-announces-new-york-state-department-of-health-approval-of-its-tissuecypher-barretts-esophagus-test\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/castle-biosciences-announces-new-york-state-department-of-health-approval-of-its-tissuecypher-barretts-esophagus-test\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Castle Biosciences Announces New York State Department of Health Approval of Its TissueCypher\u00ae Barrett\u2019s Esophagus Test\",\"datePublished\":\"2025-01-06T12:03:42+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/castle-biosciences-announces-new-york-state-department-of-health-approval-of-its-tissuecypher-barretts-esophagus-test\\\/\"},\"wordCount\":1063,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/castle-biosciences-announces-new-york-state-department-of-health-approval-of-its-tissuecypher-barretts-esophagus-test\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&sty=20250106714830r1&sid=flmnd&distro=nx&lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/castle-biosciences-announces-new-york-state-department-of-health-approval-of-its-tissuecypher-barretts-esophagus-test\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/castle-biosciences-announces-new-york-state-department-of-health-approval-of-its-tissuecypher-barretts-esophagus-test\\\/\",\"name\":\"Castle Biosciences Announces New York State Department of Health Approval of Its TissueCypher\u00ae Barrett\u2019s Esophagus Test - 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(Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that it has received assay approval from the New York State Department of Health (NYSDOH) for its TissueCypher Barrett\u2019s Esophagus test. TissueCypher is the first AI-driven precision medicine test designed to predict a patient\u2019s individual risk of progression from Barrett\u2019s esophagus (BE) to esophageal cancer. \u201cWe are proud of the … Continue reading \"Castle Biosciences Announces New York State Department of Health Approval of Its TissueCypher\u00ae Barrett\u2019s Esophagus Test\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/castle-biosciences-announces-new-york-state-department-of-health-approval-of-its-tissuecypher-barretts-esophagus-test\/","og_site_name":"Market Newsdesk","article_published_time":"2025-01-06T12:03:42+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20250106714830r1&sid=flmnd&distro=nx&lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/castle-biosciences-announces-new-york-state-department-of-health-approval-of-its-tissuecypher-barretts-esophagus-test\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/castle-biosciences-announces-new-york-state-department-of-health-approval-of-its-tissuecypher-barretts-esophagus-test\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Castle Biosciences Announces New York State Department of Health Approval of Its TissueCypher\u00ae Barrett\u2019s Esophagus Test","datePublished":"2025-01-06T12:03:42+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/castle-biosciences-announces-new-york-state-department-of-health-approval-of-its-tissuecypher-barretts-esophagus-test\/"},"wordCount":1063,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/castle-biosciences-announces-new-york-state-department-of-health-approval-of-its-tissuecypher-barretts-esophagus-test\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20250106714830r1&sid=flmnd&distro=nx&lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/castle-biosciences-announces-new-york-state-department-of-health-approval-of-its-tissuecypher-barretts-esophagus-test\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/castle-biosciences-announces-new-york-state-department-of-health-approval-of-its-tissuecypher-barretts-esophagus-test\/","name":"Castle Biosciences Announces New York State Department of Health Approval of Its TissueCypher\u00ae Barrett\u2019s Esophagus Test - 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