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LeukoStrat CDx FLT3 Mutation Assay
Clinical Genetic Test
Help
offered by
Laboratory for Personalized Molecular Medicine
View lab's test page
LinkOut
GTR Test Accession: Help GTR000562156.1
NYS CLEP
CAP
IMMUNOLOGYINHERITED DISEASECANCER ... View more
Registered in GTR: 2018-11-20
View version history
Last annual review date for the lab: 2022-08-02 Past due LinkOut
At a Glance
Test purpose: Help
Drug Response; Predictive; Prognostic
Conditions (1): Help
Acute myeloid leukemia
Genes (2): Help
FLT3 (13q12.2); FLT3 TKD (13q12.2)
Methods (2): Help
Molecular Genetics - Deletion/duplication analysis: PCR with allele specific hybridization; ...
Target population: Help
Patients diagnosed with Acute Myeloid Leukemia
Clinical validity: Help
Assay was shown to be predictive of the efficacy of …
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by: Help
Laboratory for Personalized Molecular Medicine
View lab's website
View lab's test page
Manufacturer's name: Help
LeukoStrat CDx FLT3 Mutation Assay
Specimen Source: Help
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
Test Order Code: Help
FLT3 CDx
View other test codes
CPT codes: Help
**AMA CPT codes notice

Copyright: 2023 American Medical Association. All rights reserved.

Lab contact: Help
Jordan Thornes, BS, Scientific Director
jthornes@invivoscribe.com
8582246630
Contact Policy: Help
Laboratory can only accept contact from health care providers. Patients/families are encouraged to discuss genetic testing options with their health care provider.
How to Order: Help
Fresh peripheral blood or bone marrow. Test Requisition Form on the website must be filled out and sent with the specimen.
Order URL
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
    OrderCode: FLT3 CDx
Test development: Help
FDA-reviewed (has FDA test name)
Informed consent required: Help
Decline to answer
Test strategy: Help
Test upon suspicion of Acute Myeloid Leukemia to prevent treatment delays with FLT3 inhibitors
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 2
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 2
Method Category Help
Test method Help
Instrument *
Deletion/duplication analysis
PCR with allele specific hybridization
Mutation scanning of select exons
PCR with allele specific hybridization
* Instrument: Not provided
Clinical Information
Test purpose: Help
Drug Response; Predictive; Prognostic
Clinical validity: Help
Assay was shown to be predictive of the efficacy of midostaurin in newly diagnosed Acute Myeloid Leukemia patients.
View citations (1)
  • https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160040 N Engl J Med 2017; 377:454-464
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
View citations (1)
  • Stone RM, Mandrekar SJ, Sanford BL, Laumann K, Geyer S, Bloomfield CD, Thiede C, Prior TW, Döhner K, Marcucci G, Lo-Coco F, Klisovic RB, Wei A, Sierra J, Sanz MA, Brandwein JM, de Witte T, Niederwieser D, Appelbaum FR, Medeiros BC, Tallman MS, Krauter J, Schlenk RF, Ganser A, Serve H, Ehninger G, Amadori S, Larson RA, Döhner H. Midostaurin plus Chemotherapy for Acute Myeloid Leukemia with a FLT3 Mutation. N Engl J Med. 2017;377(5):454-464. doi:10.1056/NEJMoa1614359. Epub 2017 Jun 23. PMID: 28644114.

Target population: Help
Patients diagnosed with Acute Myeloid Leukemia
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
Not applicable to this assay type.

Are family members with defined clinical status recruited to assess significance of VUS without charge? Help
Not applicable to this assay type.

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Not provided. Not applicable to this assay type.
Recommended fields not provided:
Are family members with defined clinical status recruited to assess significance of VUS without charge?, Will the lab re-contact the ordering physician if variant interpretation changes?, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report
Technical Information
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Analytical validity was determined by the FDA, see PMA#P160040
View citations (1)
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
VUS:
Software used to interpret novel variations Help
Not applicable to this assay type.

Laboratory's policy on reporting novel variations Help
Not applicable to this assay type.
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: IVD - In Vitro Device.
FDA Review of (Item reviewed): Assay(s)
FDA Regulatory Status: FDA cleared/approved
Application number: P160040
NYS CLEP Approval: Help
Number: 8613
Status: Approved
Additional Information

IMPORTANT NOTE: NIH does not independently verify information submitted to GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.