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The University of Utah's nonprofit national reference laboratory, which holds an FDA humanitarian approval for a KIT D816V test.
ARUP Laboratories describes itself as a national academic reference laboratory and a nonprofit enterprise of the University of Utah and its Department of Pathology. Its KIT D816V Assay was approved in December 2015 under a Humanitarian Device Exemption and is listed by the FDA as the companion diagnostic for imatinib in aggressive systemic mastocytosis.
The bone marrow test the FDA lists with imatinib for aggressive systemic mastocytosis, approved as a humanitarian device for a rare disease.
Shares KIT D816V Assay (ARUP Laboratories), Systemic mastocytosis.
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