On May 27, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported that it has been selected as the winner of the "Best New Technology Solution – Dermatology" award in the sixth annual MedTech Breakthrough Awards program for its innovative DecisionDx-Melanoma gene expression profile (GEP) test (Press release, Castle Biosciences, MAY 27, 2022, View Source [SID1234615204]). DecisionDx-Melanoma leverages Castle’s advanced technologies to identify the risk of metastasis, recurrence and sentinel lymph node (SLN) positivity for patients diagnosed with invasive cutaneous melanoma. In 2021, Castle was awarded "Best New Technology Solution – Oncology" by MedTech Breakthrough for its DecisionDx-SCC and DecisionDx DiffDx-Melanoma GEP tests, both of which were launched in the second half of 2020.
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The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the innovation, hard work and success in a range of health and medical technology categories. This year’s program attracted more than 3,900 nominations from over 15 different countries throughout the world.
DecisionDx-Melanoma is Castle’s proprietary risk stratification GEP test that is designed to use a patient’s tumor biology to predict individual risk of metastasis or recurrence for patients diagnosed with invasive cutaneous melanoma, a deadly skin cancer, as well as the risk of SLN positivity, independent of traditional staging factors. Unlike traditional treatment plans that are developed using clinical and pathologic factors alone (e.g., a patient’s age, tumor thickness, ulceration, etc.), incorporating the patient’s primary tissue biology can help physicians and patients make more informed disease management decisions aligned with each patient’s unique biologic risk.
"Having an accurate picture of whether melanoma is likely to recur or spread is critical to making the right treatment and disease management decisions, and though risk indicators like clinicopathological factors and patient history are important, they have their limitations," said James Johnson, managing director, MedTech Breakthrough. "Genomic testing can supplement these traditional factors, and Castle’s GEP test has been shown to accurately and independently predict individual risk of recurrence or metastasis, and can provide clinically actionable and personalized information to inform the treatment plan for each patient. Congratulations to the Castle team for being our choice for ‘Best New Technology Solution – Dermatology.’"
In 2021, Castle incorporated two new proprietary, independently validated algorithms into its DecisionDx-Melanoma test: i31-SLNB (designed to predict SLN positivity) and i31-ROR (designed to predict an individual patient’s risk of recurrence). These algorithms combine a patient’s clinical and pathologic risk factors with their DecisionDx-Melanoma class result to provide an Integrated Test Result with precise and personalized risk information specific to each patient, including his/her:
Personalized likelihood of SLN positivity, thus informing consideration of the SLN biopsy surgical procedure.
Personalized, patient-specific risk of recurrence predictions, including five-year outcomes for melanoma-specific survival, distant metastasis-free survival and recurrence-free survival, to give guidance for patient follow-up and treatment intensity decisions.
"The choices that clinicians and patients make immediately after a diagnosis of invasive melanoma can be critical and ultimately determine the outcome of a patient’s disease," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Thus, it was important to us at Castle that our DecisionDx-Melanoma test provided the most precise and personalized information possible to help inform potentially life-changing decisions around the management and treatment of a patient’s cancer. We are thrilled to win this award, recognizing our innovative DecisionDx-Melanoma test that we believe is transforming the management of melanoma and guiding improved patient care."
About DecisionDx-Melanoma
DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma (CM) metastasis or recurrence, as well as the risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 6,300 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. Additionally, Castle has an ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on CM cases. This collaboration has resulted in Castle’s analysis of 5,226 samples (clinically tested through December 31, 2018) in a study to evaluate melanoma-specific survival and overall survival; in this study, patients tested with DecisionDx-Melanoma had better survival rates than untested patients, and the data suggested that DecisionDx-Melanoma can accurately risk-stratify for disease progression to aid in risk-aligned treatment plans for improved patient outcomes and survival. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Additionally, impact on patient management plans for one of every two patients tested has been shown in five multi-center/single-center studies including more than 800 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Through March 31, 2022, DecisionDx-Melanoma has been ordered 97,288 times for patients with cutaneous melanoma.