Solid Tumors

Genoptix offers pathologists an advanced tool to assess breast cancer biomarker status of Estrogen Receptor (ER), Progesterone Receptor (PR), HER2, and Ki-67. This imaging-based platform enables you to assess digital whole slide images, perform algorithmic calculations, and determine biomarker status via our easy-to-use, yet secure Report Builder™ website. By collaborating with Genoptix, you can work with a premier provider of Image Analysis by immunohistochemistry (IHC) technology using high quality standards and processes. The Genoptix Report Builder enables you to easily review digital slide images, score regions of interest, and build a customized professional report.

disease state indication(s)
Breast Cancer

clinical use
Predictive, prognostic
Hormone receptor (ER/PR) status determines eligibility for targeted therapies (such as tamoxifen). HER2 status determines eligibilty for targeted therapies (scuch as trastuzumab); HER2 positivity is prognostic for poor outsomes. The Ki-67 proliferation index is also prognostic, with higher values correlating with more aggressive disease and poorer outcomes.

methodology/product platform
Immunohistochemistry (IHC)

specimen type and requirements
Preferred: One (1) formalin-fixed, paraffin-embedded (FFPE) block containing breast tumor with sufficient cells for analysis. Tissue specimens should be fixed in 10% neutral buffered formalin for 6 to 72 hours for ER/PR/HER2/Ki-67 testing.
Acceptable Alternative: At least 3 FFPE tissue sections per marker, cut at 4 µm thickness, plus accompanying H&E stained slide. Slides should be received at Genoptix within 5 weeks of sectioning; date of sectioning must be specified.
Note: Store and ship at room temperature. May use refrigerated cold pack for transport during warmer months, but make sure cold pack is not in direct contact with specimen.

turnaround time
Tech-only (TC): 2 days

cpt code(s)
88360 (x1) Estrogen Receptor (ER)
88360 (x1) Progesterone Receptor (PR)
88360 (x1) HER2
88360 (x1) Ki-67

medicare moldx cpt code
Not applicable

regulatory classification
Refer to individual tests

ordering option
Tech-only (TC)