Castle Biosciences Announces Inclusion of DecisionDx-UM Prognostic Test in New NCCN Guidelines for Uveal Melanoma

New consensus recommendations include test class result to guide risk-appropriate surveillance plans

FRIENDSWOOD, Texas--()--Castle Biosciences, Inc., today announced that the National Comprehensive Cancer Network (NCCN) has included the DecisionDx®-UM gene expression profile (GEP) test class results in their new clinical practice guidelines for uveal melanoma. These recommendations, released on March 15, 2018, are the first-ever NCCN guidelines for uveal melanoma, and their publication is an important milestone in the care of patients with this rare eye cancer.

The new guidelines recognize the important role of genetic testing in determining risk of distant metastasis. Information from this testing is important to guide risk-appropriate surveillance imaging and follow-up, as well as clinical trial eligibility. As many as 50% of patients with uveal melanoma will experience distant metastasis, usually to the liver. Therefore the accurate identification of patients at low risk of metastasis who can be safely followed with a less intensive surveillance regimen, and those with a high risk of progression who can benefit from a more intensive surveillance plan to identify early disease progression is critical to improve health outcomes.

The NCCN guidelines recognize that the frequency of surveillance imaging and follow-up should reflect the metastatic risk associated with the patient’s primary eye tumor, and recommend different surveillance regimens for patients with low-, medium-, and high-risk tumors. The inclusion of the DecisionDx-UM class results and recommended imaging protocols for each group are as follows:

  • Class 1A (low risk): consider surveillance imaging
  • Class 1B (medium risk): consider surveillance imaging every 6-12 months for 10 years; then as needed
  • Class 2 (high risk): consider surveillance imaging every 3-6 months for 5 years, then 6-12 months for 10 years; then as needed

“The new NCCN consensus recommendations for uveal melanoma reflect current standard of care by including risk-appropriate surveillance imaging based on results from the DecisionDx-UM gene expression profile test,” said Federico Monzon, MD, FCAP, Chief Medical Officer at Castle Biosciences. “The guidelines are important to help advance patient care, including access to surveillance imaging based on an individual’s risk of metastasis.”

DecisionDx-UM is the only prognostic test for uveal melanoma that has been validated in prospective, multi-center studies.1,2 In addition the DecisionDx-UM test result has been shown to be a superior predictor of metastasis compared to chromosome 3 status, mutational status, American Joint Committee on Cancer (AJCC) stage, and cell type, as demonstrated in multiple studies.1-6

The new NCCN recommendations for surveillance imaging based on metastatic risk align with current clinical practice for the management of uveal melanoma as demonstrated in two multi-center DecisionDx-UM clinical utility studies. Results from the studies showed that Class 1 patients receive a less intensive surveillance schedule than Class 2 patients, who are screened every 3-6 months.2,7

The new uveal melanoma NCCN guidelines (v1.2018) can be found at www.nccn.org

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 GEP testing for the identification of Class 1 and 2 as a prognostic factor recommended for clinical care. In 2018, NCCN published guidelines on uveal melanoma that include the DecisionDx-UM test results of Class 1A, 1B and 2B as prognostic factors to guide clinical care. The test has been validated in multiple prospective and retrospective studies. It is estimated that nearly 7 in 10 patients diagnosed with uveal melanoma in the U.S. receive the DecisionDx-UM test as part of their diagnostic workup. 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 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.

References

1. Onken MD, 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. Plasseraud KM, 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

3. Decatur CL, et al. Driver mutations in uveal melanoma: associations with gene expression profile and patient outcomes. JAMA Ophthalmol 2016;134:728-33.

4. Walter SD, et al. Prognostic implications of tumor diameter in association with gene expression profile for uveal melanoma. JAMA Ophthalmol 2016;134:734-40.

5. Correa ZM and JJ Augsburger. Independent prognostic significance of gene expression profile class and largest basal diameter of posterior uveal melanomas. Am J Ophthalmol 2016;162:20-7.e1.

6. Chappell MC, et al. Uveal melanoma: molecular pattern, clinical features, and radiation response. Am J Ophthalmol 2012;154:227-32.e2.

7. Aaberg TM, et al. Current clinical practice: differential management of uveal melanoma in the era of molecular tumor analyses. Clin Ophthalmol 2014;8:2449-60.

Contacts

Castle Biosciences, Inc.
Derek Maetzold, 866-788-9007
President and CEO
IR@castlebiosciences.com

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Contacts

Castle Biosciences, Inc.
Derek Maetzold, 866-788-9007
President and CEO
IR@castlebiosciences.com