High Resolution (Hi-Res) HER2 Testing for HER2 Equivocal Breast Cancer
Knowing the HER2 (ERBB2) status in newly diagnosed breast cancer is critical for selecting patients predicted to respond to anti-HER2 therapy.
The College of American Pathologists (CAP)/American Society for Clinical Oncology (ASCO) guidelines recommend all newly diagnosed and metastatic breast tumors be evaluated for HER2 positivity by protein-based immunohistochemistry (IHC) and/or chromosome-based fluorescence in situhybridization (FISH) .
In the majority of cases, these tests provide a clearly actionable “positive” or “negative” answer.
However, in an estimated 10- to 20% of breast cancers the tumor’s true HER2 status remains a mystery because both tests are reported as “equivocal.”
“Double equivocal” breast cancer presents a treatment decision dilemma for oncologists and the clinical need for an alternative testing method to deliver unequivocal results.
The Hi-Res HER2 test is designed to meet the needs of oncologists and their patients with “high-risk, HER2 equivocal breast cancer.”
Drawing from over 10 years experience in resolving “double equivocal” breast cancer, the Hi-Res HER2 test was developed by Targeted Genomics and optimized in the PacificDxLaboratory, Irvine CA to provide the answers clinicians and patients are looking for.
Hi-Res HER2 uses DNA microarray to provide:
• Definitive results for HER2 gene status.
• Results from formalin fixed paraffin embedded (FFPE) tissue.
• Fast turn around time
• Testing billable to insurance