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FDA-approved companion diagnostic

KIT D816V Assay

Qualitative PCR assay that detects the KIT D816V mutation in fresh bone marrow from patients with aggressive systemic mastocytosis to guide diagnosis and treatment decisions.

Lab-developed CDxMethod: PCRSpecimen: Bone marrowBiomarker: KIT D816V
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Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
H140006
Supplements
Manufacturer
ARUP Laboratories, Inc.
Approval date
December 18, 2015
Test specifications
Methodology
PCR
Specimen
Bone marrow
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
KIT D816V
What this test is

KIT D816V Assay is an FDA-authorized, PCR-based humanitarian use device that qualitatively detects the KIT D816V mutation in DNA from fresh bone marrow aspirate in patients with aggressive systemic mastocytosis. By determining KIT D816V mutational status, it helps establish the clonal nature of disease and supports selection of appropriate therapeutic strategies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Aggressive Systemic MastocytosisKITD816VGLEEVEC

Performing lab

ARUP Laboratories, Inc.

ARUP Central Facility (46D0523979)

Founded in 1984, ARUP Laboratories is a leading national reference laboratory and a nonprofit enterprise of the University of Utah Spencer Fox Eccles School of Medicine and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays. In addition, ARUP is a worldwide leader in innovative laboratory research and development, led by the efforts of the ARUP Institute for Research and Innovation in Diagnostic and Precision Medicine™. ARUP is ISO 15189 and CAP accredited. For more information, visit www.aruplab.com.

Order this test

If your organization is connected to Casandra, you can place an electronic order forKIT D816V Assay directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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