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DecisionDx-Melanoma for precise melanoma management

Gene expression profile test leverages the activity of 31 genes for precise risk assessment of melanomas

PHYSICIANS RELY ON PATIENT CLINICAL DATA AND TUMOR PATHOLOGY FEATURES to predict the course of melanoma management in individual patients. But melanomas are unwieldy, recurring and progressing in the face of careful prognoses and management decisions. DecisionDx-Melanoma targets precise risk assessments for melanomas for physician and patient peace of mind.

DecisionDx-Melanoma is a gene expression profile (gep) test that assesses the risk of recurrence of melanoma for patients diagnosed with early-stage melanoma, says Derek Maetzold, ceo of Castle Biosciences, the DecisionDx-Melanoma prognostics vendor.

According to Maetzold, DecisionDx-Melanoma uses patient tumor biology to predict the 5-year risk of cutaneous melanoma metastasis or recurrence independent of traditional staging factors. The test, which also predicts metastasis to the sentinel lymph node, is designed for patients with a stage I, ii or iii invasive melanoma diagnosis.

How it works

DecisionDx-Melanoma works by measuring gene activity in the patient for 31 genes correlating with the progression of the melanoma. DecisionDx-Melanoma classifies melanoma results using these traditional classdesignations:

• Class 1a: The lowest risk of recurrence/ metastasis within five years

• Class 1b/2a: An increased risk of recurrence/ metastasis within five years

• Class 2b: The highest risk of recurrence/ metastasis within five years

Patterns in the gene expressions in skin tumors serve as powerful indicators of skin biology and whether a confirmed tumor is likely to remain inert or grow aggressively, according to Maetzold. “We believe that assessing these gene expression patterns could help us improve the risk predictions that physicians make whenincorporated with other tools at hand,” he says.

DecisionDx-Melanoma in practice

J. Michael Guenther, m.d., is a surgical oncologist at St. Elizabeth Edgewood Hospital in Englewood, Kentucky. Guenther practices oncology for pancreatic, stomach, breast and skin cancers, mainly focusing on melanomas and breast cancers.

Guenther sees patients with various stages of melanomas that may require surgical intervention. It can be challenging to categorize individual skin tumors in stages I through iv due to factors such as tumor depth, location and the likelihood of spread or return.

Before adopting the DecisionDx- Melanoma test, Guenther weighed the patient’s available clinical data such as age, sun exposure and whether they use sunscreen. He considered the pathological features of the tumor, such as ulceration and the depth of invasion of the tumor into the skin. He read the family medical history relative to cancer.

His assessment process has changed since then.

“When I see a new patient presenting with a confirmed melanoma, I order DecisionDx- Melanoma,” Guenther says. The test uses a small biopsy available from the original melanoma that the physician used to diagnose it. Guenther considers the test results and whether the tumor’s gene expression suggests a high or low risk of recurrence or spread. He looks at the usual clinical and pathological information as well and combines the data to synthesize an overall risk level for the patient.

The test mitigates more than risk; it also releases patient anxiety surrounding their diagnosis. According to Guenther, patients are often convinced that their melanoma will return. If DecisionDx-Melanoma confirms a high risk of recurrence, Guenther offers intensive follow-up. “When patients hear that, they’re less frightened and relieved to know that their physician will be consistently checking in on them,” Guenther says.

According to Guenther, when the test confirms a low risk, it’s life-altering for patients to know that their melanoma is unlikely to spread or recur.

“Either way, most patients want me to use DecisionDx-Melanoma when they hear about how it works. They are incredibly grateful to have appropriate management as a result,” he says.

Guenther claims professional benefits from the prognostic tool. “After I learned about DecisionDx- Melanoma,” he says, “I laid awake staring at the ceiling, wondering if I’d given incorrect recommendations for patient management before the test’s development. DecisionDx-Melanoma is so incredibly valuable. Since melanoma is such a heterogeneous disease, the test truly helps me decide what to do!”

When asked about his favorite feature in the test, Guenther claims its accuracy. “When you see a low- risk result, it means that there is a 99.6% chance at five years that a patient won’t have melanoma again,” Guenther says. Castle Biosciences’ Maetzold says that there have been studies of DecisionDx-Melanoma in 6,000 patient samples.

Castle Biosciences DecisionDx- Melanoma is a medical test billed to the patient’s insurance provider, Medicare and the u.s. Department of Veterans Affairs. Castle Biosciences sponsors a patient assistance program. For more information, visit castletestinfo.com and look for the section on DecisionDx-Melanoma.