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)
Colorectal Cancer (CRC)

clinical use
Predictive
Mutations in codons 12 and 13 of the KRAS gene are found in ~40% of colorectal cancers. Pathogenic KRAS and NRAS mutations predict a lack of response to anti-EGFR antibody therapies such as cetuximab and panitumumab.

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.
DO NOT FREEZE.

turnaround time
Global (TC & PC): 7 days

cpt code(s)
81275 (x1)

medicare moldx cpt code
Not applicable

regulatory classification
FDA approved/cleared

ordering option
Global (TC & PC)