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FRIENDSWOOD, Texas--(BUSINESS WIRE)--Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, today announced the publication of results from a study evaluating the clinical impact of its gene expression profile (GEP) test DecisionDx®-Melanoma. The test uses tumor biology to provide an individual risk of recurrence in cutaneous (skin) melanoma patients. The paper titled, “Impact of a 31-gene Expression Profiling Test for Cutaneous Melanoma on Dermatologists’ Clinical Management Decisions,” was recently published in the Journal of Drugs in Dermatology. In the study, researchers found that the DecisionDx-Melanoma test had a significant and risk-appropriate impact on management decisions for patients with melanoma, while remaining within the context of established guidelines. These data were previously presented at the Society for Melanoma Research 2016 Congress, which was held in Boston, MA from November 6–9, 2016. In the study, 169 physicians were presented with clinical validity evidence for the DecisionDx-Melanoma test showing prognostic accuracy in prospectively planned multicenter studies. The physicians were then provided with descriptions of six clinical vignettes for cutaneous melanoma (CM) patients representing those commonly evaluated in high-volume dermatology practices. The respondents were asked how a Class 1 (low-risk) and Class 2 (high-risk) test result, in addition to traditional clinicopathologic features, would affect their clinical recommendations. Respondents were also asked to provide the Breslow thickness (ranging from 0.7-1.5mm in 0.1mm increments) at which they would change management with and without the information provided by the DecisionDx-Melanoma test. “It is critical that management and follow-up recommendations for patients with cutaneous melanoma are tailored to individual risk, yet current staging methods are often unable to precisely stratify different risk groups that may have markedly different outcomes,” noted study co-author Darrell Rigel, M.D., M.S., Clinical Professor at New York University School of Medicine. “These results demonstrate that information on tumor biology can impact clinical decisions in a significant, risk-appropriate manner.” The publication may be accessed at: http://jddonline.com/articles/dermatology/S1545961617P0428X/1 The DecisionDx-Melanoma test uses tumor biology to provide a prediction of individual risk of melanoma recurrence beyond traditional factors. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multi-center studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in three independent, prospective studies including 510 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included 1200 patients, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Clinical impact has been demonstrated in a multi-center and single-center study showing that test results add additional patient-specific prognostic information to complement traditional staging tools. More information about the test and disease can be found at www.SkinMelanoma.com. Castle Biosciences is a molecular diagnostics company dedicated to helping patients and their physicians make the best possible treatment and follow-up care decisions based on the individual molecular signature of their tumor. The Company currently offers tests for patients with cutaneous melanoma (DecisionDx®-Melanoma; www.SkinMelanoma.com) and uveal melanoma (DecisionDx®-UM and DecisionDx®-PRAME; www.MyUvealMelanoma.com), with development programs in other underserved cancers. Castle Biosciences is based in Friendswood, TX (Houston), and has laboratory operations in Phoenix, AZ. More information can be found at www.CastleBiosciences.com. DecisionDx-UM, DecisionDx-Melanoma and DecisionDx-PRAME are the trademarks of Castle Biosciences, Inc. Any other trademarks are the property of their respective owners.


FRIENDSWOOD, Texas--(BUSINESS WIRE)--Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, today announced three important milestones in improving access to DecisionDx®-UM, the standard of care prognostic tool for patients with uveal melanoma (UM), an aggressive form of eye cancer. Palmetto GBA, the administrator of the MolDX® program that assesses molecular diagnostic technologies on behalf of the Centers for Medicare and Medicaid Services (CMS), issued a final local coverage determination (LCD) for the DecisionDx-UM test effective July 10, 2017. Medicare beneficiaries will now have improved access to the DecisionDx-UM test to help determine prognosis (metastatic potential) in patients diagnosed with uveal melanoma. The LCD provides for coverage of the DecisionDx-UM test to determine metastatic risk for the management of newly diagnosed uveal melanoma, and to guide surveillance and referral to medical oncology for those patients. Additionally, the DecisionDx-UM test has obtained a positive coverage policy with fourteen Blue Cross Blue Shield (BCBS) insurance plans, including California, Florida, New Jersey, North Carolina, Michigan, Massachusetts, Washington, Oregon, Alabama, Arizona, Louisiana, Utah, Idaho, and Alaska. The DecisionDx-UM test has also obtained a positive coverage policy with Aetna as of July 1, 2017. “These coverage decisions mark important progress toward broadening patient access to the DecisionDx-UM test. We are pleased that 57 million Medicare recipients and more than 58 million insurance members affiliated with the BCBS and Aetna commercial plans will now have improved access to the DecisionDx-UM test, which is standard of care for those who are diagnosed with uveal melanoma,” said Derek Maetzold, President and CEO of Castle Biosciences. “Since most patients present with local disease and no evidence of metastases, using the DecisionDx-UM test is the most accurate way to identify the approximately 50% of patients with uveal melanoma who are at high risk of developing distant metastasis.” DecisionDx-UM is the only prognostic test for uveal melanoma that has been clinically validated for accuracy in multiple prospective and retrospective multicenter and single-center studies.1-6 According to a 446-patient study conducted by the Collaborative Ocular Oncology Group (COOG), the DecisionDx-UM test is clinically and statistically superior to all other prognostic factors in predicting metastatic risk, including clinical and pathologic factors, as well as chromosome 3 testing.1 These results are comparable to previous and subsequent single-center and multicenter prospective and retrospective studies.2-6 Two published clinical utility studies have shown clinically significant impact on patient management.7,8 About DecisionDx-UM The DecisionDx-UM test measures the gene expression profile (GEP), or molecular signature, of an individual’s tumor and identifies with high accuracy the likelihood of metastasis. The DecisionDx-UM test is standard of care in the management of uveal melanoma in the majority of ocular oncology practices. Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) has included gene expression profiling for identification of Class 1 and 2 as a prognostic factor recommended for clinical care. The AJCC is the only national organization that reviews uveal melanoma and the DecisionDx-UM test is the only clinically available GEP test for use in the U.S. The test has been validated in multiple prospective and retrospective studies. More information about the test and disease can be found at www.MyUvealMelanoma.com. About Castle Biosciences Castle Biosciences is a molecular diagnostics company dedicated to helping patients and their physicians make the best possible treatment and follow-up care decisions based on the individual molecular signature of their tumor. The Company currently offers tests for patients with cutaneous melanoma (DecisionDx®-Melanoma; www.SkinMelanoma.com) and uveal melanoma (DecisionDx®-UM and DecisionDx®-PRAME; www.MyUvealMelanoma.com), with development programs in other underserved cancers. Castle Biosciences is based in Friendswood, TX (Houston), and has laboratory operations in Phoenix, AZ. More information can be found at www.CastleBiosciences.com. DecisionDx-Melanoma, DecisionDx-UM and DecisionDx-PRAME are the trademarks of Castle Biosciences, Inc. Any other trademarks are the property of their respective owners. 1. Onken MD, Worley LA, Char DH, et al. Collaborative Ocular Oncology Group report number 1: Prospective validation of a multi-gene prognostic assay in uveal melanoma. Ophthalmology 2012;119:1596-603. 2. Onken MD, Worley LA, Tuscan MD, et al. An accurate, clinically feasible multi-gene expression assay for predicting metastasis in uveal melanoma. J Mol Diagn 2010;12:461-7. 3. Chappell MC, Char DH, Cole TB, et al. Uveal melanoma: Molecular pattern, clinical features, and radiation response. Am J Ophthalm 2012;154:227-32.e2. 4. Correa ZM & Augsburger JJ. Sufficiency of FNAB aspirates of posterior uveal melanoma for cytologic versus GEP classification in 159 patients, and relative prognostic significance of these classifications. Graefes Arch Clin Exp Ophthalmol 2014;252:131-5. 5. Demirci H, Ozkurt ZG, Slimani N, et al. Gene expression profiling test of uveal melanoma: prognostic validation. In American Society of Ophthalmic Plastic & Reconstructive Surgery Fall Scientific Symposium. 2015: Las Vegas, NV. 6. Correa ZM & Augsburger JJ. Independent prognostic significance of gene expression profile class and largest basal diameter of posterior uveal melanomas. Am J Ophthalmol 2016;162:20-7e1. 7. Aaberg TM, Cook RW, Oelschlager KM, et al. Current clinical practice: differential management of uveal melanoma in the era of molecular tumor analyses. Clin Ophthalm 2014;8:2449-60. 8. Plasseraud KM, Cook RW, Tsai T, et al. Clinical performance and management outcomes with the DecisionDx-UM gene expression profile test in a prospective multicenter study. J Oncology 2016; doi:10.1155/2016/53257622016.


FRIENDSWOOD, Texas--(BUSINESS WIRE)--Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, today announced the publication of a study confirming the robust, reproducible performance characteristics of the DecisionDx®-UM test, the standard of care prognostic tool for patients with uveal melanoma (UM), an aggressive form of eye cancer. The paper, titled “Gene Expression Profiling in Uveal Melanoma: Technical Reliability and Correlation of Molecular Class with Pathologic Characteristics,” was published online this week in the journal Diagnostic Pathology. The study evaluated performance metrics of the 15-gene expression profile (GEP) test in Castle’s CLIA-certified laboratory setting, including concordance of test results from samples subjected to repeat testing, description of technical success, and correlation of results with pathologic variables. These metrics are especially important factors in validating the accuracy of UM molecular tests since most UM patients receive eye-sparing radiotherapy, thus limiting the amount of available tissue. “Molecular testing in uveal melanoma is performed on limited and precious samples, so high technical success and reliability are critical,” said Federico Monzon, M.D., Chief Medical Officer of Castle Biosciences and study author. “The DecisionDx-UM test is currently used in approximately 80% of UM patients in the U.S. as part of their diagnostic workup. The consistent robust performance of the GEP test, as evidenced by this study, supports the continued use and adoption of the assay in clinical practice to better inform patient management decisions.” The publication is open access and may be found at: http://rdcu.be/uLs4. DecisionDx-UM is the only prognostic test for uveal melanoma that has been clinically validated for accuracy in multiple prospective and retrospective multicenter and single-center studies.1-6 According to a 446-patient study conducted by the Collaborative Ocular Oncology Group, the DecisionDx-UM test is clinically and statistically superior to all other prognostic factors in predicting metastatic risk, including clinical and pathologic factors, as well as chromosome 3 testing.1 These results are comparable to previous and subsequent single-center and multicenter prospective and retrospective studies.2-6 Two published clinical utility studies have shown clinically significant impact on patient management.7,8 The DecisionDx-UM test measures the gene expression profile (GEP), or molecular signature, of an individual’s tumor and identifies with high accuracy the likelihood of metastasis. The DecisionDx-UM test is standard of care in the management of uveal melanoma in the majority of ocular oncology practices (more than 130 specialists ordered the test in 2016). Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) has included gene expression profiling for identification of Class 1 and 2 as a prognostic factor recommended for clinical care. The AJCC is the only national organization that reviews uveal melanoma and the DecisionDx-UM test is the only clinically available GEP test for use in the U.S. The test has been validated in multiple prospective and retrospective studies. It is estimated that nearly 8 in 10 diagnosed patients in the U.S. receive DecisionDx-UM as part of their diagnostic workup. More information about the test and disease can be found at www.MyUvealMelanoma.com. Castle Biosciences is a molecular diagnostics company dedicated to helping patients and their physicians make the best possible treatment and follow-up care decisions based on the individual molecular signature of their tumor. The Company currently offers tests for patients with cutaneous melanoma (DecisionDx®-Melanoma; www.SkinMelanoma.com) and uveal melanoma (DecisionDx®-UM and DecisionDx®-PRAME; www.MyUvealMelanoma.com), with development programs in other underserved cancers. Castle Biosciences is based in Friendswood, TX (Houston), and has laboratory operations in Phoenix, AZ. More information can be found at www.CastleBiosciences.com. DecisionDx-Melanoma, DecisionDx-UM and DecisionDx-PRAME are the trademarks of Castle Biosciences, Inc. Any other trademarks are the property of their respective owners.


CHICAGO--(BUSINESS WIRE)--Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, today announced that three abstracts detailing results from studies of DecisionDx®-Melanoma were presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, IL from June 2-6. Presentations included an interim analysis of a prospective, multicenter registry study, test performance in Stage III cutaneous (skin) melanoma patients and an analysis of test performance in patients with melanoma of the head and neck. The molecular diagnostic test uses tumor biology to provide an individual risk of recurrence in cutaneous melanoma patients. In the abstract, “Interim Analysis of Survival Outcomes in a Prospective Multicenter Cohort Evaluating a Prognostic 31-Gene Expression Profile (GEP) Test for Melanoma” (Abstract #9573), outcome results from 322 patients with Stage I-III cutaneous melanoma who received DecisionDx-Melanoma testing were discussed. The DecisionDx-Melanoma test was performed to determine molecular class for each patient, with a Class 1 result indicating low 5-year risk of metastasis and a Class 2 result indicating high risk. Endpoints of recurrence-free survival (RFS), distant metastasis-free survival (DMFS) and overall survival (OS) were assessed using Kaplan-Meier and Cox regression analyses. The abstract reports an interim analysis at year 3 of an anticipated 5-year prospective, multicenter registry study. Median follow-up time for this analysis was 1.5 years for event-free patients. “This prospective, multicenter study adds to the growing body of evidence that the DecisionDx-Melanoma test produces consistent, clinically meaningful results,” noted study co-investigator Eddy C. Hsueh, M.D., Professor and Director, Division of Surgical Oncology, St. Louis University Hospital. “The alignment of these results with previous studies shows that the DecisionDx-Melanoma test provides accurate, independent prognostic information across multiple practice settings.” “It is important to identify early stage patients with melanoma who are at an increased risk of recurrence so that appropriate surveillance can be provided,” commented study co-investigator Kelly M. McMasters, M.D., Ph.D., Chair of the Department of Surgery, University of Louisville. “The results from this interim analysis confirming the association of the DecisionDx-Melanoma class with patient outcome align with my experience in clinical practice showing that assessing tumor biology can provide important, clinically impactful prognostic information.” In the abstract, “Performance of a Prognostic 31-Gene Expression Profile Test in Stage III Cutaneous Melanoma Subjects” (Abstract #9578), results from 207 patients with Stage III cutaneous melanoma were reported. Cox Multivariate Regression Analysis for DMFS in All Stage III Patients “The results from this study demonstrate that the DecisionDx-Melanoma test is an accurate predictor of distant metastasis and survival for patients with Stage IIIA melanoma, which could potentially have significant clinical impact by identifying those Stage IIIA patients who would benefit from adjuvant therapies,” commented lead study investigator Martin D. Fleming, M.D., FACS, Chief of Surgical Oncology and Associate Professor of Surgery at University of Tennessee Health Science Center. “Additionally, the performance of the GEP test in the group of patients who underwent completion lymph node dissection, suggests that the test may be valuable in guiding use of the CLND procedure.” In the abstract, “Performance of a 31-gene expression profile (GEP) test for metastatic risk prediction in cutaneous melanomas (CM) of the head & neck” (Abstract #9576), results from 157 patients with cutaneous melanoma of the head and neck region were reported. Primary endpoints of the study were RFS, DMFS, and MSS. Survival rates by SLN status include clinically node-negative patients. “The results of these three studies presented at the ASCO meeting provide new, confirmatory data that our DecisionDx-Melanoma test demonstrates consistent accuracy across different patient cohorts, providing reliable prognostic information,” added Federico A. Monzon, M.D., FCAP, Chief Medical Officer of Castle Biosciences of Castle Biosciences. “Clinicians across the U.S. are now relying on the DecisionDx-Melanoma test to provide individualized and accurate prognostic information to assess risk of recurrence and plan follow-up care.” The posters may be accessed on Castle Biosciences’ website. The DecisionDx-Melanoma test uses tumor biology to provide a prediction of individual risk of melanoma recurrence beyond traditional factors. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multicenter studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in three independent, prospective studies including 510 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included 1200 patients, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Clinical impact has been demonstrated in a multicenter and single-center study showing that test results add additional patient-specific prognostic information to complement traditional staging tools. More information about the test and disease can be found at www.SkinMelanoma.com. Castle Biosciences is a molecular diagnostics company dedicated to helping patients and their physicians make the best possible treatment and follow-up care decisions based on the individual molecular signature of their tumor. The Company currently offers tests for patients with cutaneous melanoma (DecisionDx®-Melanoma; www.SkinMelanoma.com) and uveal melanoma (DecisionDx®-UM and DecisionDx®-PRAME; www.MyUvealMelanoma.com), with development programs in other underserved cancers. Castle Biosciences is based in Friendswood, TX (Houston), and has laboratory operations in Phoenix, AZ. More information can be found at www.CastleBiosciences.com. DecisionDx-UM, DecisionDx-Melanoma and DecisionDx-PRAME are the trademarks of Castle Biosciences, Inc. Any other trademarks are the property of their respective owners.


Proceeds from the credit facility are being used to provide additional working capital as Castle accelerates marketing support and new product development to further help patients and their physicians make the best possible treatment and follow-up care decisions based on the molecular signatures of their tumors. "Oxford is pleased to provide financing to Castle Biosciences, which has developed and clinically validated prognostic tests enabling improved treatment decisions and outcomes for patients with uveal and cutaneous melanomas" said Christopher A. Herr, senior managing director at Oxford Finance. "We look forward to supporting the Company's continued growth and development of new tests for other underserved cancers." "Silicon Valley Bank is pleased to continue its longstanding relationship with Castle Biosciences in support of its development efforts and commercial growth endeavors," said Anthony Flores, director of Silicon Valley Bank's Southwest Biopharma and Diagnostics practice. "Our goal remains to bring the right financing, connections and services to bear for Castle as they work to improve diagnostic outcomes, and ultimately the broader treatment paradigm for cancer patients." "Castle Biosciences is focused on delivering high value tests to improve cancer treatment. This expanded capital facility will be used to accelerate growth of our cutaneous melanoma test, DecisionDx®-Melanoma, and support our near-term pipeline," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Through this relationship with Oxford and Silicon Valley Bank we will be able to expand the reach of our innovative molecular diagnostic tests, and help more physicians and patients make improved disease management decisions." Oxford Finance is a specialty finance firm providing senior secured loans to public and private life sciences and healthcare services companies worldwide. For over 20 years, Oxford has delivered flexible financing solutions to its clients, enabling these companies to maximize their equity by leveraging their assets. Oxford has originated over $4 billion in loans, with credit facilities ranging from $5 million to $100 million. Oxford is headquartered in Alexandria, Virginia, with additional offices in San Diego, California; Palo Alto, California and the greater Boston area. For more information, visit oxfordfinance.com. For more than 30 years, Silicon Valley Bank (SVB) has helped innovative companies and their investors move bold ideas forward, fast. SVB provides targeted financial services and expertise through its offices in innovation centers around the world. With commercial, international and private banking services, SVB helps address the unique needs of innovators. Learn more at svb.com. ©2017 SVB Financial Group. All rights reserved. Silicon Valley Bank is the California bank subsidiary of SVB Financial Group. Silicon Valley Bank is a member of the FDIC and the Federal Reserve System. Castle Biosciences is a molecular diagnostics company dedicated to helping patients and their physicians make the best possible treatment and follow-up care decisions based on the individual molecular signature of their tumor. The Company currently offers tests for patients with cutaneous melanoma  (DecisionDx®-Melanoma; www.SkinMelanoma.com)and uveal melanoma (DecisionDx®-UM and DecisionDx®-PRAME; www.MyUvealMelanoma.com), with development programs in other underserved cancers. Castle Biosciences is based in Friendswood, TX (Houston), and has laboratory operations in Phoenix, AZ. More information can be found at CastleBiosciences.com. DecisionDx-Melanoma, DecisionDx-UM and DecisionDx-PRAME are the trademarks of Castle Biosciences, Inc. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/oxford-finance-and-silicon-valley-bank-close-20-million-credit-facility-with-castle-biosciences-300454483.html


News Article | November 22, 2016
Site: www.businesswire.com

FRIENDSWOOD, Texas--(BUSINESS WIRE)--Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, today announced that Derek Maetzold, President and CEO, will be presenting at the Piper Jaffray 28th Annual Healthcare Conference on Tuesday, November 29th, 2016 at 4:50 p.m. EST in New York. About Castle Biosciences Castle Biosciences is a molecular diagnostics company dedicated to helping patients and their physicians make the best possible decisions about


The invention as disclosed herein in encompasses a method for predicting the risk of metastasis of a primary cutaneous melanoma tumor, the method encompassing measuring the gene-expression levels of at least eight genes selected from a specific gene set in a sample taken from the primary cutaneous melanoma tumor; determining a gene-expression profile signature from the gene expression levels of the at least eight genes; comparing the gene-expression profile to the gene-expression profile of a predictive training set; and providing an indication as to whether the primary cutaneous melanoma tumor is a certain class of metastasis or treatment risk when the gene expression profile indicates that expression levels of at least eight genes are altered in a predictive manner as compared to the gene expression profile of the predictive training set.


Patent
Castle Biosciences | Date: 2014-02-28

The invention as disclosed herein in encompasses a method for predicting the risk of metastasis of a primary cutaneous melanoma tumor, the method encompassing measuring the gene-expression levels of at least eight genes selected from a specific gene set in a sample taken from the primary cutaneous melanoma tumor; determining a gene-expression profile signature from the gene expression levels of the at least eight genes; comparing the gene-expression profile to the gene-expression profile of a predictive training set; and providing an indication as to whether the primary cutaneous melanoma tumor is a certain class of metastasis or treatment risk when the gene expression profile indicates that expression levels of at least eight genes are altered in a predictive manner as compared to the gene expression profile of the predictive training set.


Patent
Indiana University and Castle Biosciences | Date: 2013-06-22

Biomarkers are provided for detecting, diagnosing and prognosing thymic cancer in individuals having or suspected of having thymic cancer. In addition, kits are provided for measuring expression levels or the presence of the biomarkers associated with thymic cancer for detecting, diagnosing and prognosing thymic cancer. Furthermore, methods are provided for detecting, diagnosing and prognosing thymic cancer in individuals having or suspected of having thymic cancer via the biomarkers.


The invention as disclosed herein in encompasses a method for predicting the risk of metastasis of a primary cutaneous melanoma tumor, the method encompassing measuring the gene-expression levels of at least eight genes selected from a specific gene set in a sample taken from the primary cutaneous melanoma tumor; determining a gene-expression profile signature from the gene expression levels of the at least eight genes; comparing the gene-expression profile to the gene-expression profile of a predictive training set; and providing an indication as to whether the primary cutaneous melanoma tumor is a certain class of metastasis or treatment risk when the gene expression profile indicates that expression levels of at least eight genes are altered in a predictive manner as compared to the gene expression profile of the predictive training set.

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