On April 27, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported it has signed a definitive agreement to acquire all of the equity of Myriad myPath, LLC (Myriad myPath Laboratory), from Myriad Genetics (Press release, Castle Biosciences, APR 27, 2021, View Source [SID1234578578]). Myriad myPath Laboratory is a CLIA-certified laboratory in Salt Lake City, where the myPath Melanoma 23-gene expression profile (GEP) test was developed and is currently owned and offered. Castle is acquiring Myriad myPath Laboratory for $32.5 million. Castle will finance the acquisition price with cash and cash equivalents on hand. The transaction is expected to close approximately four weeks post signing, at which time Castle will be the successor owner of Myriad myPath Laboratory. The transaction is subject to customary conditions to closing.
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"With the acquisition of Myriad myPath Laboratory, Castle strategically expands its suite of genomic tests for skin cancer and expects to offer the most comprehensive testing solution for difficult-to-diagnose melanocytic lesions"
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myPath Melanoma is 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. Castle currently offers DecisionDx DiffDx-Melanoma, a 35-GEP test designed to characterize difficult-to-diagnose melanocytic lesions. myPath Melanoma is a distinct test, which Castle anticipates will complement its current offerings and enable Castle to provide the most comprehensive molecular testing solution for difficult-to-diagnose melanocytic lesions.
"With the acquisition of Myriad myPath Laboratory, Castle strategically expands its suite of genomic tests for skin cancer and expects to offer the most comprehensive testing solution for difficult-to-diagnose melanocytic lesions," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We believe this acquisition will add incremental value to both myPath Melanoma and DiffDx-Melanoma by leveraging the strengths of these two distinct, validated tests. Thus, through this acquisition, we believe that more patients will receive actionable results more of the time, enabling a more confident diagnosis and clearer treatment path."
DecisionDx DiffDx-Melanoma and myPath Melanoma are both commercially available and will remain available through Castle and Myriad, respectively, throughout the transaction period. As the successor owner, upon closing, Castle will be the sole provider of myPath Melanoma.
National Comprehensive Cancer Network (NCCN) Guidelines Version 2.2021 state that ancillary tests, including GEP tests such as myPath Melanoma and DecisionDx DiffDx-Melanoma, may facilitate interpretation of cases (melanocytic neoplasms of uncertain biologic potential) that are diagnostically uncertain or controversial by histopathology. Additionally, myPath Melanoma is currently covered under a MolDX Local Coverage Determination policy through Noridian Healthcare Solutions, LLC, the Medicare Administrative Contractor that oversees laboratories in both Utah and Arizona.
Company management will host a conference call and webcast to discuss this transaction at 7:30 a.m. Eastern time today.
Conference Call and Webcast Details
A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website (View Source). Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until May 17, 2021.
To access the live conference call via phone, please dial 877-282-2581 from the United States and Canada, or +1 470-495-9479 internationally, at least 10 minutes prior to the start of the call, using the conference ID 8479479.
There will be a brief Question & Answer session following management commentary.
About DecisionDx DiffDx-Melanoma
DecisionDx DiffDx-Melanoma is designed to aid dermatopathologists 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. DecisionDx DiffDx-Melanoma classifies these lesions as: benign (gene expression profile suggestive of benign neoplasm); intermediate-risk (gene expression profile cannot exclude malignancy); or malignant (gene expression profile suggestive of melanoma). Interpreted in the context of other clinical, laboratory and histopathologic information, DecisionDx DiffDx-Melanoma is designed to add diagnostic clarity and confidence for dermatopathologists while helping dermatologists deliver more informed patient management plans.