HOW IT WORKS

PrIMe is based on the Oncomine Comprehensive Assay Plus, which is used for the analysis of 500+ genes associated with targeted and immuno-oncology therapies. This assay detects relevant SNVs, indels, CNVs, gene fusions, splice variants in addition to TMB, PD-L1 and MSI immunotherapy biomarkers, all simultaneously.

This assay is the new evolved version of the original assay with robust performance proven to be effective in large clinical oncology trials such as NCI MATCH.

Sequencing is carried out using the Next Generation Sequencing platform Ion GeneStudio™ S5 PrIME System (Thermo Fisher Scientific). For details on assay performance in SNV, Indel and CNV analysis, please refer to table I.

The accreditation of TMB analysis was done in two phases:

  1. PrIMe’s TMB test was compared in silico with WES (Whole Exome Sequencing). This comparison showed a high correlation between WES and PrIMe.
  2. The PrIMe TMB test was compared with another commercially available test with patient samples, which also showed a high correlation in the determination of TMB.

Table I. Assay performance

Assay performance on reference control

Variant TypeSensitivityPPV
SNV98.51%99.82%
Indel98.41%96.88%

Assay performance on CNV

Variant TypeSensitivityPPV
CNV gain97.1%100%
CNV loss89.4%100%

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