retraction or edge artifacts are not recommended and might be a criteria for sample exclusion for performing or interpreting the HER2 assay. [18] This means that a reliable interpretation of IHC ...

IHC uses a scoring system of 0 to 3 to designate ... Alternate methods of pathologic assessment and interpretation of HER2 testing are being assessed in an effort to improve accuracy.

Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...

Komen advocacy organization. HER2-ultralow is defined as immunohistochemistry (IHC) 0 with membrane staining. T-DXd, an antibody-drug conjugate now approved for multiple tumor types, gained ...

Roche has secured a new FDA approval for its first companion diagnostic test aimed at identifying breast cancer patients with ...

human epidermal growth factor receptor 2 (HER2)-low (immunohistochemistry [IHC] 1+ or IHC 2+/in situ hybridization [ISH]-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer ...

The FDA has approved a companion diagnostic to determine if patients with HR-positive, HER2-ultralow metastatic breast cancer are eligible for T-DXd treatment.

HER2 interpretation in breast cancer is evolving. With the introduction of HER2-low and now HER2-ultralow classifications, Roche continues to lead in HER2 diagnostics, helping to expand patient ...

Assessment of HER2 is recommended in every newly diagnosed case of breast cancer. Immunohistochemistry ... to establish the methods and criteria of interpretation to improve the selection of ...

The drug is now cleared for use in adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining ...