Table 2.
Currently available PCR methods (FDA approved) for FFPE tissue determination of KRAS mutation status. LoD, Limit of Detection http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm.
Features | Therascreen (Qiagen) | Cobas (Roche) | Idylla (Biocartis) |
---|---|---|---|
Starting material | DNA | DNA | FFPE section |
Coverage | Codons 12 and 13 | Codons 12, 13, 61 | Codons 12, 13, 59, 61, 117, 146 |
Analytical Sensitivity (LoD) | <5% | <5% | 5% |
Neoplastic cell% limit | 10% | 10% | NA |
Duration of test | <8 h | <8 h | 2 h |
Reagents | Liquid | Liquid | Cassette |
Results | Manual | Automated | Automated |