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. 2016 Jun 6;8:29–32. doi: 10.1016/j.bdq.2016.05.001

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