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Oncomine™ Dx Target Test – P160045/S035
… from treatment with an FDA-approved drug, ENHERTU (fam-trastuzumab deruxtecan-nxki). In normal tissue, the ERBB2 proteins … if the patient is eligible for treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki). The report is sent to the …
List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)
… (Leica Biosystems) Breast Cancer - Tissue Herceptin (trastuzumab) BLA 103792 ERBB2 (HER2) HER-2 protein … Medicine, Inc.) Breast Cancer - Tissue Herceptin (trastuzumab) BLA 103792 ERBB2 ( HER2 ) ERBB2 ( HER2 ) … Cell Lung Cancer (NSCLC) - Plasma ENHERTU (fam-trastuzumab deruxtecan-nxki) BLA 761139 ERBB2 ERBB2 Activating Mutations …
Guardant360 CDx – P200010/S008
… may benefit from personalized treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki). How does it work? A patient’s blood … who may be eligible for treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki) based on the test results. The …