Castle Biosciences’ Uveal Melanoma Test Receives Positive Medicare Local Coverage Determination and Commercial Insurance Positive Coverage Policies

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.

Derek Maetzold, President and CEO of Castle Biosciences

“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.