Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, today announced that it has received its Clinical Laboratory Permit from the New York State Department of Health, including approval for three clinical tests. The receipt of the New York permit allows patients in that state to benefit from the Company’s DecisionDx®-Melanoma, DecisionDx®-UM and DecisionDx®-PRAME molecular diagnostic tests that provide actionable molecular information to inform patient care decisions.
Castle Biosciences’ state-of-the-art laboratory facility in central Phoenix handles all of the Company’s rapidly growing molecular testing and clinical research services, including processing over 13,000 commercial samples a year using their gene expression profiling platform. (Photo courtesy of Castle Biosciences, Inc.)
“We are pleased to obtain our New York Clinical Laboratory Permit, facilitating the process for patients in New York to obtain testing that enables more informed management of their disease,” said Kristen Oelschlager, Castle Biosciences’ Vice President, Clinical Operations. “Successfully completing the rigorous New York State licensure process, which involves laboratory inspection as well as individual test approval, reflects our facility’s high quality standards.”
“We welcome the opportunity to provide our test services to patients and physicians in New York State who have been diagnosed with underserved cancers,” said Derek Maetzold, Castle Biosciences’ President and CEO. “This accreditation is an important milestone for our organization, and is reflective of our commitment to serving patients through the highest quality laboratory operations and assay development.”
Castle Biosciences’ 10,000-square-foot laboratory is accredited by the College of American Pathologists (CAP) and is certified under the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). The laboratory processed over 10,000 commercial samples in 2017 using their gene expression profiling platform.
About Castle Biosciences
Castle Biosciences is a molecular diagnostics company dedicated to helping patients and their physicians make the best possible decisions about their treatment and follow up care 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, DecisionDx®-PRAME and DecisionDx®-UMSeq; 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, DecisionDx-PRAME and DecisionDx-UMSeq are the trademarks of Castle Biosciences, Inc. Any other trademarks are the property of their respective owners.
Contacts
Castle Biosciences, Inc.
Derek Maetzold, 866-788-9007
President and CEO
IR@castlebiosciences.com