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October 12, 2015 - Updated: 01.04.18

FDA-Approved BRAF Tests (CM00029, V2)

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

Effective 09/07/2012

cobas® 4800 BRAF V600 to detect the presence of a mutation in the BRAF gene in melanoma cells and determine if a patient is eligible for Zelboraf™ (vemurafenib), a treatment indicated for a melanoma that cannot be surgically excised or has spread in the body

Effective 5/29/13

ThxID™ BRAF V600/K to detect the BRAF V600E and V600K mutations in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar®] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist™].

To report an FDA approved BRAF V600 test kit service, please submit the following claim information:

  • CPT 81210 Enter DEX Z-Code™ identifier in the comment/narrative field for the following claim field/types:
  • Line SV202.7 for Part A or Loop 2400 or SV101 - 7 for the 5010A1 837P for Part B
  • Submit theDEX Z - Code™ Identifier on an attachment to the claim form for paper claim (Form locator 80 for Part A or Box 19 for Part B)

Select appropriate ICD-10-CM codes:

  • C43.0 - Malignant melanoma of lip
  • C43.11 - Malignant melanoma of right eyelid, including canthus
  • C43.12 - Malignant melanoma of left eyelid, including canthus
  • C43.21 - Malignant melanoma of right ear and external auricular canal
  • C43.22 - Malignant melanoma of left ear and external auricular canal
  • C43.31 - Malignant melanoma of nose
  • C43.39 - Malignant melanoma of other parts of face
  • C43.4 - Malignant melanoma of scalp and neck
  • C43.51 - Malignant melanoma of anal skin
  • C43.52 - Malignant melanoma of skin of breast
  • C43.59 - Malignant melanoma of other part of trunk
  • C43.61 - Malignant melanoma of right upper limb, including shoulder
  • C43.62 - Malignant melanoma of left upper limb, including shoulder
  • C43.71 - Malignant melanoma of right lower limb, including hip
  • C43.72 - Malignant melanoma of left lower limb, including hip
  • C43.8 - Malignant melanoma of overlapping sites of skin
  • C43.9 - Malignant melanoma of skin, unspecified
  • C79.2 - Secondary malignant neoplasm of skin
  • D03.0 - Melanoma in situ of lip
  • D03.11 - Melanoma in situ of right eyelid, including canthus
  • D03.12 - Melanoma in situ of left eyelid, including canthus
  • D03.21 - Melanoma in situ of right ear and external auricular canal
  • D03.22 - Melanoma in situ of left ear and external auricular canal
  • D03.39 - Melanoma in situ of other parts of face
  • D03.4 - Melanoma in situ of scalp and neck
  • D03.51 - Melanoma in situ of anal skin
  • D03.52 - Melanoma in situ of breast (skin) (soft tissue)
  • D03.59 - Melanoma in situ of other part of trunk
  • D03.61 - Melanoma in situ of right upper limb, including shoulder
  • D03.62 - Melanoma in situ of left upper limb, including shoulder
  • D03.71 - Melanoma in situ of right lower limb, including hip
  • D03.72 - Melanoma in situ of left lower limb, including hip
  • D03.8 - Melanoma in situ of other sites
  • D03.9 - Melanoma in situ, unspecified

NOTE: MolDX will apply NPI to ID editing on FDA approved BRAF kits. All labs that submit claims for a BRAF V600 test kit MUST register the test and confirm the UNMODIFIED use of the kit. Tests may be registered on theDEX 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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