PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary …
The PATHWAY anti-HER2 (4B5) Antibody assay is a laboratory test designed to detect HER2 protein in patients with breast cancer. If the test shows that a patient’s breast cancer does have...
VENTANA ® anti-HER2/neu (4B5) Rabbit Monoclonal Primary …
HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, VENTANA, one of over 250 optimized pre-diluted reagents for use on the BenchMark IHC/ISH automated slide staining instruments by Roche Diagnostics.
PATHWAY ® anti-HER-2/neu (4B5) Rabbit Monoclonal Primary …
PATHWAY HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, one of over 250 optimized pre-diluted reagents for use on the BenchMark IHC/ISH automated slide staining instruments by Roche Diagnostics.
FDA Expands PATHWAY HER2 (4B5) Test to Include HER2-Ultralow …
6 days ago · The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its prior HER2-low indication. The FDA has expanded the label for the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody.
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal (the “HER2 (4B5) assay”) is directed against the internal domain of the c-erbB-2 oncoprotein (HER2). HER2 oncoprotein was cloned and characterized...
FDA Approves First HER2-Ultralow Companion Diagnostic, …
Jan 31, 2025 · FDA approval of PATHWAY HER2 (4B5) test expands diagnostic capabilities for HER2-ultralow metastatic breast cancer, enabling targeted treatment with trastuzumab deruxtecan.
Roche receives FDA approval for first companion diagnostic to …
The Roche HER2 (4B5) clone achieves consistently high-proficiency assessment scores compared to other clones 9 and demonstrates high concordance with HER2 FISH, 10,11 empowering laboratories to employ the most widely adopted and reliable HER2 IHC …
FDA Approves PATHWAY anti-HER2/neu Rabbit Monoclonal …
Oct 8, 2022 · The PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody was approved by the FDA as a companion diagnostic to help identify patients with HER2-low metastatic breast cancer who may be eligible to receive fam-trastuzumab deruxtecan-nxki.
FDA Approves Roche’s HER2 CDx for BTC Patients | Clinical Lab …
Nov 25, 2024 · The Roche HER2 (4B5) clone achieves consistently high proficiency assessment scores compared to other clones(9) and demonstrates high concordance with HER2 FISH,(10,11) empowering laboratories to employ the most widely adopted and reliable HER2 IHC …
VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody [VENTANA HER2 (4b5)] is intended for the semi-quantitative detection of HER2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic breast and gastric tissue on a VENTANA automated slide staining device.