By developing a classifier then analyzing 12,000 methylation haplotypes across 1200 clinical samples collected over 10 years, PanSeer has demonstrated very high sensitivity at over 90% in four of five tumor tissue types, including colorectal, esophageal, lung and liver cancers.
In addition the specificity is over 95%, performed on a blinded test set.
With same-day sample-to-sequencer workflow, an automation-friendly workflow, and efficient yet sophisticated bioinformatics, the PanSeer assay has the power to detect cancer up to a full four years before conventional diagnosis.
You can access a PanSeer Technical Note here (PDF).
Data Driven - The classifier was derived from analysis of over a thousand clinical samples from the Taizhou Longitudinal Study
Very high Sensitivity and Specificity – PanSeer does not have the high false-positives nor false-negatives that plague other assays
A new type of analyte – Methylation haplotype analysis from cell-free DNA may open up new diagnostic opportunities outside of cancer
The Receiver Operator Characteristic curve relates sensitivity to specificity, and a computed area under curve (AUC) value in the figure above shows values well above 0.9
Current approved test technology for colorectal cancer (CRC) suffers from either low compliance (with the 'gold standard' colonscopy) or low accuracy (sensitivity and specificity of stool- or blood-based tests). Low sensitivity results in frequent false-positives, where the errant test result drives many unnecessary colonoscopies, and low specificity results in missed cancers that could have been detected much earlier.
Using 20,000 methylation haplotypes to generate a ColonES classifier across over 1200 clinical samples, the ColonES assay has very high sensitivity at over 97% in Stage I CRC, with a specificity of 99%.
Advanced adenoma are precancerous lesions, of which it is estimated that 85%-90% if not removed will progress into CRC. The specificity for advanced adenoma samples with the ColonES assay is 91%.
Covariate analysis shows high sensitivity regardless of tumor size, tumor location, or gender.
ColonES Sensitivity Stg II-IV
ColonES Sensitivity Stg I
ColonES Sensitivity Pre-Stg I
Specificity (healthy individuals)
You can access a ColonES Product Sheet (PDF) here.
Discover The Future
At the leading edge of biology and assay technology, Singlera Genomics uses a new biomarker type called ctmDNA (circulating tumor methylated DNA) to peer into the future.