Latest news with #TissueCypher
Yahoo
02-05-2025
- Health
- Yahoo
New Data at DDW 2025 Further Demonstrates the TissueCypher® Test's Ability to Identify Patients at Increased Risk for Developing Esophageal Cancer
Additionally, an expert physician panel convened by EndoscopyNow will host a product theater on Sunday, May 4, at 2:45 p.m. Pacific Time, titled, 'The Time is Now: A Clinical Practice Model to Help Prevent Progression from Barrett's to EAC' FRIENDSWOOD, Texas, May 02, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, will share new data on its TissueCypher Barrett's Esophagus test via two posters at the Digestive Disease Week® (DDW 2025) Annual Meeting, being held May 3-6 in San Diego. In addition to the product theater, Castle is collaborating with renowned gastrointestinal (GI) experts and the American Society for Gastrointestinal Endoscopy (ASGE) on several educational sessions highlighting the use of TissueCypher to improve the risk stratification and subsequent management of patients with Barrett's esophagus (BE). 'The compelling new data being presented at DDW 2025 underpins the important role that TissueCypher can play in identifying patients with BE at higher risk for progression to esophageal cancer,' said Emmanuel Gorospe, M.D., MPH, board-certified gastroenterologist and GI medical director at Castle Biosciences. 'By empowering clinicians to move beyond the traditional 'wait and see' approach, we're working to help enable more personalized surveillance and intervention strategies for BE patients that can potentially prevent cancer rather than simply trying to detect it early.' The following posters will be presented at DDW 2025 (all times Pacific Time). Posters will be available on the DDW ePosters site and to conference attendees in the DDW meeting planner and mobile app after 12:01 a.m. on the day of the poster's presentation. 1) Poster Su1466: The Tissue Systems Pathology Test Detected Presence of Missed Neoplasia in a Patient with Non-Dysplastic Barrett's Esophagus Presenter and Lead Author: Philip Woodworth, M.D., Sky Ridge Heartburn and Reflux Treatment Center and Institute of Esophageal and Reflux Surgery Session Type: Poster Session Session Title: Pancreatic and Esophageal Diseases Session #: 7105 Date & Time: Sunday, May 4, 12:30-1:30 p.m. 2) Poster Su1324: The Tissue Systems Pathology Test Provides Risk Stratification for Patients with Barrett's Esophagus Presenter and Senior Author: Charles Randall, M.D., Gastroenterology Research of San Antonio and University of Texas Health Science Center at San Antonio Session Type: Poster Session Session Title: Barrett's Esophagus and Esophagogastric Junction Neoplasia - Biology and Fundamental Mechanisms, Epidemiology, Risk Factors, and Screening Session #: 7085 Session Date & Time: Sunday, May 4, 12:30-1:30 p.m. Visit Castle at DDW 2025For more information on the TissueCypher test and the posters above, please visit Castle at booth 1017; a complete list of Castle's activities at DDW 2025 can be found at Key events include the following: Product Theater The Time is Now: A Clinical Practice Model to Help Prevent Progression from Barrett's to EAC Expert physician panel convened by EndoscopyNow includes: Vivek Kaul, M.D., professor of medicine at University of Rochester Medical Center Harshit Khara, M.D., associate professor of medicine and director of endoscopy at Geisinger Medical Center Jennifer Kolb, M.D., M.S., assistant professor of medicine, Vatche and Tamar Manoukian Division of Digestive Diseases at the David Geffen School of Medicine at UCLA and VA Greater Los Angeles Healthcare System Sri Komanduri, M.D., M.S., associate chief, division of gastroenterology and hepatology, and professor of medicine and surgery at Northwestern Feinberg School of Medicine Location: DDW Theater 1 Date & Time: Sunday, May 4, 2:45-3:30 p.m. AGA Research Forum: Advances in Screening and Risk Stratification in Barrett's Esophagus Presentation title: Clinical utility of tissue systems pathology (TSP-9) risk stratification in patients with and without a family history of Barrett's esophagus and/or esophageal cancer Presenter: Marcia (Mimi) Canto, M.D., MHS, professor of medicine at The Johns Hopkins University School of Medicine Session #: 5270 Date & Time: Tuesday, May 6, 10 a.m. ASGE Theater Talks1) Think BEyond the "Wait and See" paradigm for non-dysplastic Barrett's esophagus Presenter: Dan Lister, M.D., president and co-founder of the American Foregut Society and director of the Arkansas Heartburn Treatment Center Date & Time: Saturday, May 3, 11:30 a.m.-12 p.m. 2) The tissue systems pathology test detected presence of missed neoplasia in a patient with non-dysplastic Barrett's esophagus Presenter: Philip Woodworth, M.D., Sky Ridge Heartburn and Reflux Treatment Center and Institute of Esophageal and Reflux Surgery Date & Time: Monday, May 5, 12:15-12:45 p.m. About Digestive Disease Week® (DDW) Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), the meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at TissueCypher Barrett's Esophagus TestThe 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 16 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. About Castle BiosciencesCastle 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 other diseases with high clinical need, including its test in development to help guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis seeking biologic treatment. To learn more, please visit 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 StatementsThis 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: TissueCypher's ability to (i) play an important role in identifying BE patients at higher risk for progression to esophageal cancer, (ii) empower clinicians and (iii) enable more personalized surveillance and intervention strategies for BE patients that help prevent cancer. The words 'believe,' 'can' 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 obtained in these studies, including with respect to the discussion of our tests in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading 'Risk Factors' in our Annual Report on Form 10-K for the year ended December 31, 2024, 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. Investor Contact:Camilla Zuckeroczuckero@ Media Contact:Allison Marshallamarshall@ Source: Castle Biosciences, in to access your portfolio
Yahoo
28-02-2025
- Business
- Yahoo
Castle Biosciences Inc (CSTL) Q4 2024 Earnings Call Highlights: Record Revenue Growth and ...
Fourth Quarter Revenue: $86.3 million, a 31% increase over Q4 2023. Full Year Revenue 2024: $332.1 million, a 51% increase over 2023. Total Test Report Volume Growth 2024: 36% increase compared to 2023. Cash, Cash Equivalents, and Marketable Securities: $293.1 million as of December 31, 2024. Gross Margin Q4 2024: 76.2% compared to 77.8% in Q4 2023. Full Year Gross Margin 2024: 78.5% compared to 75.4% in 2023. Net Income Q4 2024: $9.6 million compared to a net loss of $2.6 million in Q4 2023. Full Year Net Income 2024: $18.2 million compared to a net loss of $57.5 million in 2023. Diluted Earnings Per Share Q4 2024: $0.32 compared to a diluted loss per share of $0.10 in Q4 2023. Full Year Diluted Earnings Per Share 2024: $0.62 compared to a diluted loss per share of $2.14 in 2023. Adjusted EBITDA Q4 2024: $21.3 million compared to $9.4 million in Q4 2023. Full Year Adjusted EBITDA 2024: $75 million compared to a negative $4.4 million in 2023. Net Cash Provided by Operating Activities 2024: $64.9 million. DecisionDx-Melanoma Test Reports 2024: 36,008, an 8% increase over 2023. DecisionDx-SCC Test Reports 2024: 16,348, a 43% increase over 2023. TissueCypher Test Reports 2024: 20,956, a 130% increase over 2023. Warning! GuruFocus has detected 2 Warning Sign with CSTL. Release Date: February 27, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Castle Biosciences Inc (NASDAQ:CSTL) reported a 51% year-over-year revenue growth, reaching $332.1 million for the full year 2024. The company achieved a 36% increase in total test report volume in 2024 compared to 2023. Castle Biosciences Inc (NASDAQ:CSTL) ended 2024 with $293.1 million in cash, cash equivalents, and marketable investment securities, a $50 million increase over the previous year. The TissueCypher test saw a 130% growth in test report volume in 2024, with positive reception from the gastroenterology community. Castle Biosciences Inc (NASDAQ:CSTL) achieved a net income of $18.2 million for 2024, compared to a net loss of $57.5 million in 2023. The DecisionDx-SCC test faces potential noncoverage by Medicare starting April 24, 2025, which could impact revenue. Gross margin decreased slightly in the fourth quarter of 2024 to 76.2% from 77.8% in the same period of 2023. The company anticipates a decrease in IDgenetix test report volumes and net revenues in 2025 due to market changes. Castle Biosciences Inc (NASDAQ:CSTL) expects typical seasonality to affect the first quarter of 2025, potentially leading to flat or slightly down volumes compared to the fourth quarter of 2024. The company faces challenges in expanding the use of DecisionDx-Melanoma in academic centers due to the absence of guideline inclusion. Q: In our checks, we have noticed that private dermatologists usually prefer DecisionDx-Melanoma, but dermatologists in academic centers are still hesitant to order more broadly before guideline inclusion. Do you agree? How should we think about the opportunity in the absence of guideline updates? A: Derek Maetzold, CEO: The feedback from your interviews seems contrary to the 1,800 new first-time ordering clinicians in 2024. While some clinicians may have settled into a sweet spot, we saw substantial growth in new first-time ordering clinicians. Outside of a few NCCN centers, we don't hear much feedback regarding guideline inclusion affecting personal decisions. Q: When should we expect reimbursement updates for the atopic dermatitis gene expression profile test planned for launch by the end of 2025? A: Derek Maetzold, CEO: Assuming successful validation study results, we aim to launch in late 2025. The reimbursement strategy will be developed over the next several quarters, focusing on patient outcomes and fair reimbursement. Material revenue is not expected until 2028 or 2029. Q: On TissueCypher and getting the New York State Department of Health approval, what percentage of the addressable market does New York State represent? A: Derek Maetzold, CEO: I don't have the exact percentage, but demographically, it should be similar to New York's population percentage of the overall US population. Q: What's the commercial strategy for DecisionDx-SCC while resolving reimbursement issues? Will you continue to offer the test? A: Derek Maetzold, CEO: If we lose coverage, it will be disappointing for patient care. If there's a short-term path to regaining reimbursement, we may continue offering the test. If not, we'll balance shareholder impact and patient needs. We don't plan to remove the test completely. Q: Regarding strategic opportunities with capital allocation, should we consider existing or new verticals? A: Derek Maetzold, CEO: We focus on investing in current commercial efforts and exploring external opportunities. While it's easier to expand within current verticals, we're open to new areas if they offer strong upside. Q: With SCC likely disappearing from the topline, how should we think about adjusted EBITDA for 2025? A: Frank Stokes, CFO: We expect to remain adjusted EBITDA positive for the year, but haven't provided specific guidance on the scale. Q: Is there any residual from non-Medicare payers and private pay on SCC? A: Frank Stokes, CFO: There is not significant private or commercial payment for SCC; it's still very early. Q: How should we model SG&A for 2025? Is the salesforce expenditure increasing? A: Frank Stokes, CFO: We've expanded the TissueCypher salesforce, reflected in Q4 numbers. We'll continue to invest in the salesforce as we see penetration, but no sweeping changes are expected. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
