Home » menu of tests

Breast Cancer Testing - HER2 (FISH): OncoCEE-BR™

FISH: Fluorescence In Situ Hybridization - this test uses fluorescent probes to look at the number of HER2 gene copies in a tumor cell. Our test reviews a ratio of HER2 to Chromosome 17.  If the ratio is greater than 2.2, then the sample is considered "amplified" for HER2 expression.

Approximately 20-25 percent of breast cancers have an amplification of the HER2/neu gene or overexpression of its protein product. This receptor is normally stimulated by a growth factor which causes the cell to divide; in the absence of the growth factor, the cell will normally stop growing. Overexpression of this receptor in breast cancer is associated with increased disease recurrence and worse prognosis. Trastuzumab (Herceptin), a monoclonal antibody to HER2, has improved the 5 year disease free survival of stage 1–3 HER2+ breast cancers to about 87% (overall survival 95%).

*Source http://www.ncbi.nlm.nih.gov/pubmed/19204209

 

 

HER2 (FISH) Details  Deta

HER2 OncoCEE-BRTM

The detection of circulating tumor cells (CTC) in the peripheral blood followed by genetic analysis of HER-2 and amplification by FISH

 

 

Test Number

BR-101

 

 

Test Name Aliases

Her-2 Test

Breast Test

Herceptin Test

 

 

Methodology

Comprehensive analysis to include CTC enumeration by ICC/CEETM; amplification of genes for HER2 by FISH;

 

CEETM – Cell Extraction and Enrichment

ICC- Immunocytochemical

FISH- fluorescent in situ hybridization

 

 

Specimen Requirements

Peripheral Blood- 2 CEE-SureTM   tubes (10mL each) is optimal

 

 

Turn Around Time

5-7 days from sample received into the laboratory to sample reported

 

 

Sample Prep for Shipment
  1. Sample Collection- Draw sufficient blood or bone marrow aspirate to fill CEE-SureTM  collection tubes.  Gently invert each tube 5 times.  Label the tubes with the date of draw. Include patient identifiers or affix bar code label.
  2. Packaging- Place tubes into the designated biohazard container.  Place the tube & container within the shipping mailer kit.  The temperature gel packs are on the bottom and one on top.  Place the patient requisition/billing information/clinical data on top of the lid and then close the mailer.
  3. Shipping the sample- Place the mailer within the FedEx bag.  Contact FedEx (800-GoFedEx or 800-463-3339) to schedule a pickup.

 

 

Comments

*This test does not provide information about the primary site of the tumor.

 

*This test does not predict whether patients with positive results will have better clinical outcomes if switched to alternative treatment regiments.

 

*The HER2 OncoCEE-BR™ test has not been FDA approved.  It is a Laboratory Developed Test (LDT).  Biocept is a certified CLIA laboratory and accredited by CAP.

 

 

Specimen Retention

Specimens are retained until the final result is processed. 

 

 

 

 

Customer Service

T: 888.332.7729
F: 877.300.1761

 

CustomerService@biocept.com