HER-2/NEU, FLUORESCENCE IN SITU HYBRIDIZATION (FISH)

Additional Codes

Software	Test Code
Label Text	FH2N
EPIC	LAB10241

Performing Laboratory

NorDx Laboratories

Useful For

Guiding therapy; patients with HER2 amplification may be candidates for therapies that target the HER2 protein (eg, trastuzumab [Herceptin}, pertuzumab, lapatinib)

Confirming the presence of HER2 amplification in cases with 2+ (low level) HER2 overexpression by IHC

This test is usually ordered in conjunction with a pathology consultation. The pathology professional component will be billed separately by the consulting pathologist.

Method Name

Fluorescence In Situ Hybridization (FISH)

Reference Values

An interpretive report will be issued

Days and Times Test Performed

Tuesday and Thursday

Report Available

2 Days

Specimen Type

H&E Stained Slides and Unstained Slides

Preferred Container

Slide

Specimen Collection and Handling

Cut in sequence:

1. One H&E stained slide

2. Three slides with 4-5 µm thick sections of paraffin embedded tissue

3. An additional slide stained with H&E

Send at ambient temperature.

Alternatively, a block of paraffin embedded tissue may be provided (to be sectioned by NorDx).

Add On Capable

Not Permitted

Advance Beneficiary Notice Requirements

This test, when ordered on Medicare patients, is subject to the National Coverage Determination (NCD) policies. Please verify that the diagnosis code (ICD code) you have chosen demonstrates medical necessity for the test as documented in the physician’s patient record. The CMS web site is available to assist you with this verification. A properly executed Advance Beneficiary Notice (ABN) must be submitted with the specimen if medical necessity is not demonstrated by the ICD code chosen.

CPT Code Information

CPT Code	CPT Description	CPT Disclaimer
88271 x2	Molecular Cytogenetics, DNA Probe, Each (eg: FISH)
88274	Molecular Cytogenetics, DNA Probe, Each (eg: FISH), Interphase In Situ Hybridizaion, Analyze 25-99 Cells

Performing Laboratory Location