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The bone marrow test the FDA lists with imatinib for aggressive systemic mastocytosis, approved as a humanitarian device for a rare disease.
ARUP Laboratories' KIT D816V Assay was approved on 18 December 2015 under a Humanitarian Device Exemption (H140006), the route for devices used in rare conditions, and is listed by the FDA as the companion diagnostic for imatinib in aggressive systemic mastocytosis, tested on bone marrow.
Detects the KIT D816V mutation in bone marrow. Connects to KIT.
| Region | Year | Indication |
|---|---|---|
| US | 2015 | Humanitarian Device Exemption; companion to imatinib in aggressive systemic mastocytosis (bone marrow) |
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Query for this drug: (TITLE:"KIT D816V Assay" OR ABSTRACT:"KIT D816V Assay" OR TITLE:"ARUP Laboratories" OR ABSTRACT:"ARUP Laboratories") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about KIT D816V Assay (ARUP Laboratories), not a curated reading list.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
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