On October 28, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a company applying innovative diagnostics to inform disease management decisions and improve patient outcomes, reported that the DecisionDx-Melanoma integrated test result (ITR) now includes i31-GEP for Risk of Recurrence (i31-ROR) (Press release, Castle Biosciences, OCT 28, 2021, View Source [SID1234592136]). Designed to improve the precision of treatment plans for better patient care, the i31-ROR predicts patient-specific five-year outcomes for melanoma-specific survival (MSS), distant metastasis-free survival (DMFS) and recurrence-free survival (RFS).
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DecisionDx-Melanoma is a gene expression profile (GEP) test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples.
Earlier this year, Castle launched the ITR for DecisionDx-Melanoma, which included i31-GEP Sentinel Lymph Node Biopsy (i31-SLNB). i31-SLNB is an independently validated algorithm that integrates clinicopathologic features with the 31-GEP score. i31-SLNB is designed to provide a more precise and personalized prediction of sentinel lymph node (SLN) positivity to guide discussions and recommendations, within current risk-based guidelines, for the SLN biopsy (SLNB) surgical procedure.
Castle has now completed independent validation of a new, separate algorithm, i31-ROR, that integrates DecisionDx-Melanoma’s 31-GEP score with the specific Breslow thickness, mitotic rate, SLN status, ulceration status and location (head and neck, extremities, trunk) of the individual patient’s tumor. The additional endpoints of RFS and DMFS, which are not currently provided by the American Joint Committee on Cancer Eighth Edition (AJCC8) staging system, are anticipated to be helpful when determining appropriate treatment pathways for each patient’s disease. The new upgraded ITR now provides both this new i31-ROR result as well as the i31-SLNB, in addition to the traditional class designation obtained with DecisionDx-Melanoma.
"Clinicians and patients look to our tests to provide clinically actionable information that better informs cancer management decisions, such as intensity of surveillance and follow-up frequency," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "And we are committed to continually reviewing this process to improve patient care, as evidenced by the introduction of our new i31-GEP for Risk of Recurrence test result.
"With this additional information, DecisionDx-Melanoma results are not only designed to provide a more precise, personalized likelihood of SLN positivity, but now also include a more individualized risk assessment, rather than an average, population-based risk estimate, that we believe can help personalize patient management decisions and overall risk assessments beyond standard melanoma staging."
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 metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. 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. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 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 DecisionDx-Melanoma test result.
Through June 30, 2021, DecisionDx-Melanoma has been ordered 78,277 times for use in patients with cutaneous melanoma. More information about the test and disease can be found at www.CastleTestInfo.com.