Castle biosciences presents expanded data supporting use of decisiondx-melanoma test to inform sentinel lymph node biopsy recommendations
Castle biosciences, inc. announced the presentation of data from an expanded, multi-center, prospectively tested patient cohort study supporting clinical use of the decisiondx®-melanoma test to inform discussions and recommendations regarding sentinel lymph node biopsy (slnb), as well as data from a separate multi-center prospective outcomes study. the data supports the clinical use of decisiondx-melanoma test results in combination with clinicopathologic factors to identify patients at low risk of sentinel lymph node (sln) positivity and that t1-t2 patients identified as low risk by the decisiondx-melanoma test had high survival rates. this information can inform patient discussions and recommendations regarding the slnb surgical procedure in line with national melanoma clinical practice guidelines. in the expanded, multi-center prospectively tested patient cohort study: in slnb-assessed patients 65 years of age or older with t1-t2 tumors and a class 1a test result, sln positivity was 2.7%, significantly less than patients with a class 1b-2a (p<0.01) or class 2b result (p<0.0001), and below the 5% threshold at which guidelines do not recommend the procedure. use of the decisiondx-melanoma test to guide slnb decisions in study patients 65 years of age or older with t1-t2 melanoma, shows that slnb surgical procedures could be reduced by 58%. in the multi-center prospective outcomes study: in a prospective cohort with median follow-up of 3.2 years, class 1a patients with t1-t2 melanoma, at three years, had overall survival of 99.4%, distant metastasis-free survival of 98.7% and recurrence-free survival of 96.6%, adding further support that this population can safely avoid the slnb surgical procedure.
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