26399 Cell-Free DNA KRAS 12, 13, 61, 146, Blood (KRASD)

​CRC, Colorectal cancer, EGFR, Epidermal growth factor receptor, Cell free DNA, cfDNA, cell-free DNA, circulating tumor DNA, liquid biopsy, KRAS WT, KRAS codon 12, KRAS codon 13, KRAS codon 61, KRAS codon 146, Circulating tumor cells, KRAS, RAS

​CRC, Colorectal cancer, EGFR, Epidermal growth factor receptor, Cell free DNA, cfDNA, cell-free DNA, circulating tumor DNA, liquid biopsy, KRAS WT, KRAS codon 12, KRAS codon 13, KRAS codon 61, KRAS codon 146, Circulating tumor cells, KRAS, RAS

As an alternative to invasive tissue biopsies for the determination of KRAS 12, 13, 61,146 (G12A, G12C, G12D, G12R, G12S, G12V, G13D, Q61K, Q61L, Q61R, Q61H, and A146T) mutation status

Selection of patients with colorectal cancer who are most likely to benefit from epidermal growth factor receptor (EGFR)-targeted therapies

GENETICS TEST INFORMATION:This test evaluates cell-free DNA (cfDNA) in the peripheral blood for the presence of KRAS mutations at codons 12, 13, 61, and 146 (G12A, G12C, G12D, G12R, G12S, G12V, G13D, Q61K, Q61L, Q61R, Q61H, and A146T) in patients with colorectal cancer and can be used to assess eligibility for targeted therapies.

This test is not validated for serial monitoring of patients with cancer. This test is also not intended as a screening test to identify cancer.

HIGHLIGHTS:This test provides rapid detection of KRAS mutations in colorectal cancer patients as an alternative for KRAS analysis of tissue.

Current data suggests that the efficacy of epidermal growth factor receptor (EGFR)-targeted therapy in colorectal cancer patients is limited to patients whose tumors do not harbor mutations in the KRAS gene.

​SHIPPING INSTRUCTIONS:

1. Samples should be transported at ambient temperature or refrigerated (4 degrees C).

2. Samples are viable for 7 days in the Streck Black/Tan Top Tube Kit (T715).

Additional Information: Only blood collected in Streck Cell-Free DNA BCT tubes will be accepted for analysis. Whole blood will be processed to produce platelet-poor plasma before cfDNA isolation.

Patients with a negative test result may still harbor a KRAS mutation. Mutation testing of a tissue specimen for KRAS mutations should be considered for patients with who have a negative result with this test.

The limit of detection of this assay for the detection of KRAS mutations is influenced by the amount of cell-free DNA (cfDNA) in the blood. This is a biological variable that cannot be controlled.

This assay was designed to detect mutations in KRAS codons 12, 13, 61, and 146 (G12A, G12C, G12D, G12R, G12S, G12V, G13D, Q61K, Q61L, Q61R, Q61H, and A146T).

This test has not been clinically validated for use as a tool to monitor response to therapy or for early detection of tumors.

This test cannot differentiate between somatic and germline alterations. 

​An interpretive report will be provided.