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Test ID: FH2MT    
HER2 Amplification, Miscellaneous Tumor, FISH, Tissue

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Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.

This test has been modified from the manufacturerís instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

88291-Cytogenetics and molecular cytogenetics, interpretation and report

88299-Unlisted cytogenetic study (Refer to patient report to apply the appropriate CPT code below in place of this unlisted cytogenetic study CPT code)

 

Standard analysis of D17Z1/HER2: Based on the total number of cells analyzed and 2 probes utilized, MML would recommend the following:

88274-Interphase in situ hybridization with 25 to 99 cells

88271 x 2-Molecular cytogenetics (eg, FISH), each probe

 

Reflex probes adding D17S122/HER2: Based on the total number of cells analyzed and 4 total probes utilized, MML would recommend the following:

88275-Interphase in situ hybridization with 100 to 300 cells

88271 x 4-Molecular cytogenetics (eg, FISH), each probe

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
51129SpecimenN/A
51130Specimen IDN/A
51131Source31208-2
51132Order DateN/A
CG566Reason for Referral42349-1
51134FixativeIn Process
51135Method49549-9
51136Result31150-6
51137Interpretation69965-2
51138Amendment31150-6
51139Reviewed byN/A
51140Release DateN/A