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October 12, 2015 - Updated: 01.04.18

FDA-Approved KRAS Tests (CM00027, V2)

Two tests have met the FDA criteria for KRAS genetic testing:

Effective 7/6/2012

Therascreen® KRAS to detect seven somatic mutations in the human KRAS oncogene was developed to aid in the identification of CRC patients for treatment with Erbitux® (cetuximab).

Effective 5/7/2015

Cobas® KRAS to detect mutations in codons 12 and 13 of the KRAS gene was developed to aid in identification of CRC patients for treatment with Erbitux® (cetuximab) or Vectibix® (panitumumab).

To report an FDA approved KRAS, codon 12 and 13 test kit service, please submit the following claim information:

  • Enter CPT code 81275
  • Enter the appropriate DEX=Z-Code™ identifier in the comment/narrative field for the following claim field/types:
    • Loop SV202-7 for Part A or Loop 2400/ SV101 - 7 for the 5010A1 837P for Part B
    • Block 80 for Part A or Box 19 for Part B

Select the appropriate ICD-10-CM diagnosis from the following list:

  • C77.0 - Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck
  • C77.1 - Secondary and unspecified malignant neoplasm of intrathoracic lymph nodes
  • C77.2 - Secondary and unspecified malignant neoplasm of intra - abdominal lymph nodes
  • C77.3 - Secondary and unspecified malignant neoplasm of axilla and upper limb lymph nodes
  • C77.4 - Secondary and unspecified malignant neoplasm of inguinal and lower limb lymph nodes
  • C77.5 - Secondary and unspecified malignant neoplasm of intrapelvic lymph nodes
  • C77.8 - Secondary and unspecified malignant neoplasm of lymph nodes of multiple regions
  • C77.9 - Secondary and unspecified malignant neoplasm of lymph node, unspecified
  • C78.01 - Secondary malignant neoplasm of right lung
  • C78.02 - Secondary malignant neoplasm of left lung
  • C78.1 - Secondary malignant neoplasm of mediastinum
  • C78.2 - Secondary malignant neoplasm of pleura
  • C78.39 - Secondary malignant neoplasm of other respiratory organs
  • C78.4 - Secondary malignant neoplasm of small intestine
  • C78.5 - Secondary malignant neoplasm of large intestine and rectum
  • C78.6 - Secondary malignant neoplasm of retroperitoneum and peritoneum
  • C78.7 - Secondary malignant neoplasm of liver and intrahepatic bile duct
  • C78.80 - Secondary malignant neoplasm of unspecified digestive organ
  • C78.89 - Secondary malignant neoplasm of other digestive organs
  • C79.01 - Secondary malignant neoplasm of right kidney and renal pelvis
  • C79.02 - Secondary malignant neoplasm of left kidney and renal pelvis
  • C79.11 - Secondary malignant neoplasm of bladder
  • C79.19 - Secondary malignant neoplasm of other urinary organs
  • C79.2 - Secondary malignant neoplasm of skin
  • C79.31 - Secondary malignant neoplasm of brain
  • C79.32 - Secondary malignant neoplasm of cerebral meninges
  • C79.49 - Secondary malignant neoplasm of other parts of nervous system
  • C79.51 - Secondary malignant neoplasm of bone
  • C79.52 - Secondary malignant neoplasm of bone marrow
  • C79.61 - Secondary malignant neoplasm of right ovary
  • C79.62 - Secondary malignant neoplasm of left ovary
  • C79.71 - Secondary malignant neoplasm of right adrenal gland
  • C79.72 - Secondary malignant neoplasm of left adrenal gland
  • C79.81 - Secondary malignant neoplasm of breast
  • C79.82 - Secondary malignant neoplasm of genital organs
  • C79.89 - Secondary malignant neoplasm of other specified sites

Note: MolDX will apply NPI to ID editing on FDA approved KRAS kits. All labs that submit claims for a KRAS, codon 12 and 13 test kit Must register the test and confirm the UNMODIFIED use of the kit. Tests may be registered on the DEX Diagnostics Exchange™External Website.

This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.

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