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FLT3 Mutations, Qualitative PCR

Item Value
Approval req'd? No
Available Stat? No
Utilization Guidelines Tests with long turn-around times (i.e., Molecular based tests and Microarrays) should only be requested on an inpatient if the result is going to affect the inpatient management. If the patient will likely be discharged before the result will be available, the test should be requested after discharge. (NOTE: UCSF Medical Center is not reimbursed for inpatient testing).

An exception to the above may be appropriate if there is a possibility the patient will not survive to be discharged and the information is important for diagnosis and/or family decisions/management (e.g., recurrence risk).
Test code FLT3
Test group AML molecular markers
Performed by Medical Genomics - Molecular Diagnostics
In House Availability Run 1st and 3rd Tuesday of every month, day shift only
Method Fluorescent PCR with analysis by restriction enzyme digestion and capillary electrophoresis
Collection Instructions Avoid hemolysis. Due to stability issues these samples should only be collected at UCSF Monday through noon Friday.

Do not collect sample in heparin. Keep sample refrigerated for overnight or longer storage.

For UCSF Samples (from remote sites) Click here for sample collection instructions

For NON-UCSF Samples Click here for Requisition form & Account set-up instructions. Note we only do institutional billing.
Container type Lavender top (EDTA)
Amount to Collect
Blood 5 mL
Bone marrow aspirate 3 mL
FFPE 10 micron sections x5 on uncharged, unstained, glass slides plus one H&E stained section
Sample type Blood, bone marrow aspirate, FFPE sections
Preferred volume
Blood 5 mL
Bone marrow aspirate 3 mL
FFPE 10 micron sections x5 on uncharged, unstained, glass slides plus one H&E stained section
Min. Volume
Blood 2 mL
Bone marrow aspirate 3 mL
FFPE 10 micron sections x3 on uncharged, unstained, glass slides plus one H&E stained section
Processing notes Do not freeze blood or bone marrow samples. Ship to CB as soon as possible.
Normal range Negative
Synonyms FLT-3; fms-related tyrosine kinase 3; fetal liver kinase-2; FLT3-ITD; FLT3-D835
Stability Room temperature 3 days, refrigerated 1 week, frozen unacceptable.
Turn around times 10-14 days
Additional information An interpretation of this test by a laboratory physician will automatically be performed and billed for separately.

The mutation status of FLT3 has prognostic significance for AML patients with a normal karyotype. FLT3 activating are among the most prevalent genetic lesions in AML. The most common mutation, internal tandem duplication, (FLT3-ITD), is found in approximately 25% of adult AML patients. The second most common FLT3 activating mutation occurs in the activation loop of the tyrosine kinase domain, primarily at codon Asp835 (FLT3-D835), occuring in 5% to 10% of AML cases.

Prognosis of cytogenetically normal AML with FLT3-ITD (exon 14 and 15) is significantly inferior compared to cytogenetically normal AML without the mutation when treated with current standard chemotherapy. While the prognostic significance of FLT3-D835 mutations (exon 20) remains controversial, these mutations appear to worsen disease free survival.

A negative result does not rule out the presence of FLT3 mutations at a level below the sensitivity of this assay. This assay cannot distinguish between mutations at codons p.Asp835 or p.Ile836. In addition, this assay cannot detect internal tandem duplications that occur outside of the JM domain. This test is not intended to detect minimal residual disease.

This test was developed and its performance characteristics determined by the UCSF Clinical Laboratories. It has not been cleared or approved by the Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing.
CPT coding 81245, 81479
LDT or Mod FDA? Yes
Last Updated 4/15/2014 10:27:14 AM
Entry Number 1477
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