The EpiSwitch OBD29 test diagnoses malignant melanoma from non-melanoma patients of both sexes over the age of 30.
Validation Trial
OBD has completed its first clinical trial for the test in July 2011 with an initiative from an Australian company.
A total of 53 melanoma and 33 control samples (mostly Basal Cell Carcinoma and Squamous Cell Carcinoma) were used for the trial. The test looks at chromosome conformations in 12 gene loci, including those of BRAF and p16, to differentiate the two groups. It is indicated for male or female patients over 30 years of age considered to be at risk of melanoma skin cancer. Patients with a positive result would undergo biopsy to confirm the diagnosis.
An elaborative trial design was set up to produce a robust test that will tolerate any sample, biological, operator, technical and replicate variations.
Performance Characteristics
The test performance and data analysis of the read-out was developed and validated on extensive data points incorporating both biological and technical variations, with highly robust performance across the full spectrum of the samples provided.
Sensitivity 97% (95% CI=91-99%)
Specificity 96% (95% CI=87-99%)
Proportion Correct 97% (95% CI=92-99%)
Positive Predictive Value 97% (95% CI=91-99%)
Negative Predictive Value 96% (95% CI=87-99%)
The EpiSwitchTM melanoma diagnostic test offers a unique contribution to the comprehensive, effective, non-invasive and cost-controlled diagnosis of Malignant Melanoma from Basal and Squamous Cell Carcinoma.
