On September 16, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to improve treatment decisions, reported that it has received approval from the New York State Department of Health for its proprietary DecisionDx DiffDx-Melanoma gene expression profile (GEP) test (Press release, Castle Biosciences, SEP 16, 2021, View Source [SID1234587840]). DecisionDx DiffDx-Melanoma is designed to provide an objective and comprehensive diagnostic offering to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are proud of the expansion of our New York Clinical Laboratory Permit to include the DecisionDx DiffDx-Melanoma test, as it exemplifies our ongoing commitment to providing high-quality, dermatologic genomic tests that can transform care and improve patients’ lives," said Kristen Oelschlager, chief operating officer of Castle Biosciences. "For patients in New York with ambiguous melanocytic lesions, we believe access to our DecisionDx DiffDx-Melanoma test can provide clarity in the management of their disease for improved overall outcomes."
In May of 2021, Castle acquired myPath Melanoma, a clinically validated GEP test designed to be used as an adjunct to histopathology when the distinction between a benign nevus and a malignant melanoma cannot be made confidently by histopathology alone. Together, myPath Melanoma and DecisionDx DiffDx-Melanoma comprise Castle’s comprehensive diagnostic offering for difficult-to-diagnose melanocytic lesions. Both GEP tests, myPath Melanoma and DiffDx-Melanoma, are designed to provide a comprehensive diagnostic workflow that leverages the strengths of both tests for better patient care.
Castle previously received approvals in the state of New York for its other GEP tests, including DecisionDx-Melanoma, DecisionDx-SCC, DecisionDx-UM and DecisionDx-PRAME, as well as its next generation sequencing panels, DecisionDx-CMSeq and DecisionDx-UMSeq.
In 2020, Castle doubled the footprint of its College of American Pathologists (CAP) accredited, Clinical Laboratory Improvement Amendments (CLIA)-certified primary laboratory facility located in Phoenix. The Company expanded the space to approximately 23,500 square feet by adding a new laboratory facility in close proximity to its primary facility to support growth and provide certain operational redundancy. Earlier this year, Castle further expanded this facility to include approximately 3,600 additional square feet.
About Castle Biosciences’ Comprehensive Diagnostic Offering for Difficult-to-Diagnose Melanocytic Lesions
Castle Biosciences’ comprehensive diagnostic offering leverages the strengths of myPath Melanoma and DecisionDx DiffDx-Melanoma. These gene expression profile tests are designed to provide a highly accurate, objective result to aid dermatopathologists and dermatologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately 2 million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. For these cases, the treatment plan can also be uncertain. Obtaining highly accurate, objective ancillary testing can mean the difference between a path of overtreatment or the risk of undertreatment. Interpreted in the context of other clinical, laboratory and histopathologic information, myPath Melanoma and DecisionDx DiffDx-Melanoma are designed to reduce uncertainty and provide confidence for dermatopathologists and help dermatologists deliver more informed patient management plans.
More information about the test and disease can be found at www.CastleTestInfo.com.