Solid Tumors

The Therascreen® KRAS RGQ PCR Kit is a real-time qualitative PCR assay used on the Roto-Gene® Q MDx instrument for the detection of seven somatic mutations in codons 12 and 13 (exon 2) of the human KRAS oncogene, using DNA extracted from formalin-fixed, paraffin-embedded (FFPE) tissue.

disease state indication(s)
Non-Small Cell Lung Cancer (NSCLC)

clinical use
Predictive, Prognostic
KRAS is mutated in 25% of North American lung cancer patients. It lies downstream of EGFR in the signal transduction pathway, and activating KRAS mutations confer primary resistance to EGFR TKIs. Independent of therapy, mutated KRAS is prognostic for poor survival compared to wild-type KRAS.

methodology/product platform
Polymerase chain reaction (PCR)

specimen type and requirements
Preferred: One (1) or two (2) formalin-fixed, paraffin-embedded (FFPE) blocks containing tumor tissue from most recent surgery or biopsy.
Acceptable Alternative: Seven (7) unstained slides at 2×5 µm thickness, plus accompanying H&E slide.
Unacceptable: Specimens preserved in alternative (non-formalin) fixatives, decalcified specimens, fresh or frozen tissue.
Note: Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen.

turnaround time
Global (TC & PC): 7 days

cpt code(s)
81275 (x1)

medicare moldx cpt code
Not applicable

regulatory classification
Laboratory developed test (LDT)

ordering option
Global (TC & PC)