Available Stat

No

Performing Lab

Medical Genomics - Molecular Diagnostics

Performed

Once per week, or as needed

Methodology

Fluorescent PCR, retriction enzyme digestion, capillary electrophoresis, peak integration to determine mutant-to-normal ITD ratios.

Reported

Routine cases reported within 10-14 days. Expedited cases will be reported within 7 days upon request.

Additional Information

FLT3 is a receptor tyrosine kinase expressed on the surface of many types of hematopoietic stem and progenitor cells. It is mutated in approximately one-third of AML patients. Internal tandem in frame duplications (ITD) within its cytoplasmic domain lead to its constitutive activation. ITD mutations represent the most common type of FLT3 mutations and occur in approximately 23% of adult AML cases. Another FLT3 mutation, termed D835, consists of an amino acid substitution in the FLT3 kinase domain and is found in approximately 12% of AML cases. Cytogenetically normal AML without the FLT3-ITD mutation constitutes a more favorable outcome than cytogenetically normal AML with a FLT3-ITD mutation.   

This test will determine the presence or absence of the FLT3 ITD and D835 mutations. In addition, it will report the ratio of mutant to normal ITD alleles, which can be used as a guide for the combination treatment of FLT3-positive AML with chemotherapy and the multikinase inhibitor midostaurin.

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.
 

Reflex Testing

An interpretation of this test by a laboratory physician will automatically be performed and billed for separately.

Synonyms

  • FLT-3
  • fms-related tyrosine kinase 3
  • fetal liver kinase-2
  • FLT3-ITD
  • FLT3-D835

Sample Type

Blood, bone marrow aspirate, FFPE sections

Collect

Lavender top (EDTA)

Amount to Collect

See Preferred Volume

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

Minimum 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

Remarks

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

Stability (from collection to initiation)

Room temperature 3 days, refrigerated 1 week, frozen unacceptable.

Test Code

FLT3

Test Group

AML molecular markers

Performing Lab

Medical Genomics - Molecular Diagnostics

Specimen Preparation

Do not freeze blood or bone marrow samples. Ship to CB as soon as possible.

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

Minimum 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

Stability (from collection to initiation)

Room temperature 3 days, refrigerated 1 week, frozen unacceptable.

Reference Interval

Negative

Additional Information

FLT3 is a receptor tyrosine kinase expressed on the surface of many types of hematopoietic stem and progenitor cells. It is mutated in approximately one-third of AML patients. Internal tandem in frame duplications (ITD) within its cytoplasmic domain lead to its constitutive activation. ITD mutations represent the most common type of FLT3 mutations and occur in approximately 23% of adult AML cases. Another FLT3 mutation, termed D835, consists of an amino acid substitution in the FLT3 kinase domain and is found in approximately 12% of AML cases. Cytogenetically normal AML without the FLT3-ITD mutation constitutes a more favorable outcome than cytogenetically normal AML with a FLT3-ITD mutation.   

This test will determine the presence or absence of the FLT3 ITD and D835 mutations. In addition, it will report the ratio of mutant to normal ITD alleles, which can be used as a guide for the combination treatment of FLT3-positive AML with chemotherapy and the multikinase inhibitor midostaurin.

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 Codes

81245, 81246

LDT or Modified FDA

Yes

Available Stat

No

Test Code

FLT3

Test Group

AML molecular markers

Performing Lab

Medical Genomics - Molecular Diagnostics

Performed

Once per week, or as needed

Methodology

Fluorescent PCR, retriction enzyme digestion, capillary electrophoresis, peak integration to determine mutant-to-normal ITD ratios.

Remarks

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

Collect

Lavender top (EDTA)

Amount to Collect

See Preferred Volume

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

Minimum 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

Specimen Preparation

Do not freeze blood or bone marrow samples. Ship to CB as soon as possible.

Reference Interval

Negative

Synonyms

  • FLT-3
  • fms-related tyrosine kinase 3
  • fetal liver kinase-2
  • FLT3-ITD
  • FLT3-D835

Stability (from collection to initiation)

Room temperature 3 days, refrigerated 1 week, frozen unacceptable.

Reported

Routine cases reported within 10-14 days. Expedited cases will be reported within 7 days upon request.

Reflex Testing

An interpretation of this test by a laboratory physician will automatically be performed and billed for separately.

Additional Information

FLT3 is a receptor tyrosine kinase expressed on the surface of many types of hematopoietic stem and progenitor cells. It is mutated in approximately one-third of AML patients. Internal tandem in frame duplications (ITD) within its cytoplasmic domain lead to its constitutive activation. ITD mutations represent the most common type of FLT3 mutations and occur in approximately 23% of adult AML cases. Another FLT3 mutation, termed D835, consists of an amino acid substitution in the FLT3 kinase domain and is found in approximately 12% of AML cases. Cytogenetically normal AML without the FLT3-ITD mutation constitutes a more favorable outcome than cytogenetically normal AML with a FLT3-ITD mutation.   

This test will determine the presence or absence of the FLT3 ITD and D835 mutations. In addition, it will report the ratio of mutant to normal ITD alleles, which can be used as a guide for the combination treatment of FLT3-positive AML with chemotherapy and the multikinase inhibitor midostaurin.

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 Codes

81245, 81246

LDT or Modified FDA

Yes
Ordering

Available Stat

No

Performing Lab

Medical Genomics - Molecular Diagnostics

Performed

Once per week, or as needed

Methodology

Fluorescent PCR, retriction enzyme digestion, capillary electrophoresis, peak integration to determine mutant-to-normal ITD ratios.

Reported

Routine cases reported within 10-14 days. Expedited cases will be reported within 7 days upon request.

Additional Information

FLT3 is a receptor tyrosine kinase expressed on the surface of many types of hematopoietic stem and progenitor cells. It is mutated in approximately one-third of AML patients. Internal tandem in frame duplications (ITD) within its cytoplasmic domain lead to its constitutive activation. ITD mutations represent the most common type of FLT3 mutations and occur in approximately 23% of adult AML cases. Another FLT3 mutation, termed D835, consists of an amino acid substitution in the FLT3 kinase domain and is found in approximately 12% of AML cases. Cytogenetically normal AML without the FLT3-ITD mutation constitutes a more favorable outcome than cytogenetically normal AML with a FLT3-ITD mutation.   

This test will determine the presence or absence of the FLT3 ITD and D835 mutations. In addition, it will report the ratio of mutant to normal ITD alleles, which can be used as a guide for the combination treatment of FLT3-positive AML with chemotherapy and the multikinase inhibitor midostaurin.

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.
 

Reflex Testing

An interpretation of this test by a laboratory physician will automatically be performed and billed for separately.

Synonyms

  • FLT-3
  • fms-related tyrosine kinase 3
  • fetal liver kinase-2
  • FLT3-ITD
  • FLT3-D835
Collection

Sample Type

Blood, bone marrow aspirate, FFPE sections

Collect

Lavender top (EDTA)

Amount to Collect

See Preferred Volume

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

Minimum 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

Remarks

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

Stability (from collection to initiation)

Room temperature 3 days, refrigerated 1 week, frozen unacceptable.
Processing

Test Code

FLT3

Test Group

AML molecular markers

Performing Lab

Medical Genomics - Molecular Diagnostics

Specimen Preparation

Do not freeze blood or bone marrow samples. Ship to CB as soon as possible.

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

Minimum 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

Stability (from collection to initiation)

Room temperature 3 days, refrigerated 1 week, frozen unacceptable.
Result Interpretation

Reference Interval

Negative

Additional Information

FLT3 is a receptor tyrosine kinase expressed on the surface of many types of hematopoietic stem and progenitor cells. It is mutated in approximately one-third of AML patients. Internal tandem in frame duplications (ITD) within its cytoplasmic domain lead to its constitutive activation. ITD mutations represent the most common type of FLT3 mutations and occur in approximately 23% of adult AML cases. Another FLT3 mutation, termed D835, consists of an amino acid substitution in the FLT3 kinase domain and is found in approximately 12% of AML cases. Cytogenetically normal AML without the FLT3-ITD mutation constitutes a more favorable outcome than cytogenetically normal AML with a FLT3-ITD mutation.   

This test will determine the presence or absence of the FLT3 ITD and D835 mutations. In addition, it will report the ratio of mutant to normal ITD alleles, which can be used as a guide for the combination treatment of FLT3-positive AML with chemotherapy and the multikinase inhibitor midostaurin.

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.
 
Administrative

CPT Codes

81245, 81246

LDT or Modified FDA

Yes
Complete View

Available Stat

No

Test Code

FLT3

Test Group

AML molecular markers

Performing Lab

Medical Genomics - Molecular Diagnostics

Performed

Once per week, or as needed

Methodology

Fluorescent PCR, retriction enzyme digestion, capillary electrophoresis, peak integration to determine mutant-to-normal ITD ratios.

Remarks

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

Collect

Lavender top (EDTA)

Amount to Collect

See Preferred Volume

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

Minimum 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

Specimen Preparation

Do not freeze blood or bone marrow samples. Ship to CB as soon as possible.

Reference Interval

Negative

Synonyms

  • FLT-3
  • fms-related tyrosine kinase 3
  • fetal liver kinase-2
  • FLT3-ITD
  • FLT3-D835

Stability (from collection to initiation)

Room temperature 3 days, refrigerated 1 week, frozen unacceptable.

Reported

Routine cases reported within 10-14 days. Expedited cases will be reported within 7 days upon request.

Reflex Testing

An interpretation of this test by a laboratory physician will automatically be performed and billed for separately.

Additional Information

FLT3 is a receptor tyrosine kinase expressed on the surface of many types of hematopoietic stem and progenitor cells. It is mutated in approximately one-third of AML patients. Internal tandem in frame duplications (ITD) within its cytoplasmic domain lead to its constitutive activation. ITD mutations represent the most common type of FLT3 mutations and occur in approximately 23% of adult AML cases. Another FLT3 mutation, termed D835, consists of an amino acid substitution in the FLT3 kinase domain and is found in approximately 12% of AML cases. Cytogenetically normal AML without the FLT3-ITD mutation constitutes a more favorable outcome than cytogenetically normal AML with a FLT3-ITD mutation.   

This test will determine the presence or absence of the FLT3 ITD and D835 mutations. In addition, it will report the ratio of mutant to normal ITD alleles, which can be used as a guide for the combination treatment of FLT3-positive AML with chemotherapy and the multikinase inhibitor midostaurin.

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 Codes

81245, 81246

LDT or Modified FDA

Yes