Vast Majority of Ophthalmologists Treating Uveal Melanoma Use Molecular Testing to Guide Patient Care

Prognostic tumor analysis results directly impact patient care plans

Published in Clinical Ophthalmology

FRIENDSWOOD, Texas--()--Castle Biosciences Inc. today announced the publication of study results that assess current clinical practices for uveal melanoma (UM) and demonstrate the impact of molecular prognostic testing on patient management. The paper, “Current clinical practice: differential management of uveal melanoma in the era of molecular tumor analyses,” was published in the peer-reviewed journal Clinical Ophthalmology.

“Current clinical practice: differential management of uveal melanoma in the era of molecular tumor analyses”

The publication presents results from three studies: a survey of 109 ophthalmologists specializing in the treatment of uveal melanoma conducted in 2012; a follow-up survey of 72 physicians in 2014; and a retrospective medical record review of 195 consecutively tested Medicare patients with UM. Consistent across all three studies, a majority of ophthalmologists treating UM use molecular diagnostic tests to help design risk-appropriate treatment follow-up plans for their patients. Castle Biosciences’ prognostic test for uveal melanoma, DecisionDx-UM, is a molecular diagnostic test that measures the gene expression profile (GEP) of an individual's tumor and classifies the likelihood of metastasis as low risk (Class 1) or high risk (Class 2).

“The ability to better assess risk represents an important shift in the management of uveal melanoma patients,” commented study author Thomas M. Aaberg, Jr., Michigan State University Medical School and Retina Specialists of Michigan. “Since less than 5% of patients have detectable metastatic disease at the time their primary tumor is diagnosed, there is great need for a more accurate tool to assess the risk of metastasis. These results suggest that physicians have widely adopted the new prognostic tools, and have incorporated the results to devise the most appropriate follow-up care plans for patients. Ultimately, we hope to use these tools to design and appropriately enroll patients into clinical trials aimed at prophylactically treating uveal melanoma patients at high risk for metastatic disease.”

Study Details

Based on the results from the Medicare medical records review, 58% of patients undergoing the DecisionDx-UM test had a low risk (GEP Class 1) result and 42% were high risk (GEP Class 2). In cases where documented reference to follow-up systemic surveillance was made, all of the low risk patients underwent a low-intensity plan including liver function tests with or without abdominal ultrasound at a frequency of one or two times per year. In contrast, 100% of the high risk patients were followed with high intensity surveillance, primarily defined as liver function tests and abdominal ultrasound, CT, and/or positron emission tomography (PET) at a frequency of 2 to 4 times per year (P<0.0001 versus Class 1 surveillance).

Ophthalmologist Survey Results

  • 74% of ophthalmologists who participated in the 2012 survey used the information obtained from cytogenetic or GEP analyses to adjust the frequency of metastatic disease surveillance for their patients;
  • For patients at higher risk of metastasis, 15% of doctors offered prophylactic therapy and 23% offered participation in clinical trial of investigational therapy.
  • 79% of respondents who participated in the 2014 survey used the information from cytogenetic or GEP analyses to change their clinical practice, such as adjusting the frequency of metastatic disease surveillance, referral to medical oncology for follow-up, and/or counseling/referral regarding adjuvant treatment or clinical trials.

“These data support the conclusion that molecular analyses, including GEP testing (DecisionDx-UM), have been widely accepted and adopted to support more informed uveal melanoma management decisions. In addition to the impact on patient management, the results from these tests are now used as entry criteria for clinical trials involving adjuvant therapies,” said Derek Maetzold, President and CEO of Castle Biosciences.

The paper can be accessed at http://www.dovepress.com/articles.php?article_id=19386.

About Uveal Melanoma

Although it is rare, uveal melanoma is the most common form of eye cancer in the United States, with about 2,000 diagnoses per year. This form of eye cancer, sometimes referred to as ocular melanoma, may occur in any of the three parts of the uvea. For this reason, it is sometimes referred to as choroidal, ciliary body, or iris melanoma based upon its exact location. The choroid is the most common place for a tumor to develop.

Similar to other melanomas, uveal melanoma begins in cells called melanocytes that help produce the pigments of the skin, hair, and eyes. While most patients are middle-aged with fair skin, uveal melanoma can and has affected people of all complexions and ages.

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 test requires a sample of the patient's tumor that is obtained prior to radiation surgery, the most common therapy used in the treatment of uveal melanoma.

The DecisionDx-UM test is standard of care in the management of uveal melanoma in the majority of ocular oncology practices (125 of the estimated 130 practices as of August, 2014). Additionally the American Joint Committee on Cancer recommends gene expression profile testing for use as the results are “clinically significant.” The American Joint Committee on Cancer (AJCC, version 7, 2010) is the only national organization that reviews uveal melanoma and the DecisionDx-UM test is the only clinically available gene expression profile 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 and prognostics 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 rare cancers including uveal and cutaneous melanoma, thymoma, esophageal and brain cancers. More information can be found at www.castlebiosciences.com.

Contacts

For Castle Biosciences Inc.
Brad Miles, 646-513-3125
Bmiles@bmccommunications.com
or
Amy Bonanno, 646-513-3117
Abonanno@bmccommunications.com