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Myeloid Next Generation Sequencing with Reflex Pathology Interp
Clinical Genetic Test
Help
offered by
Sentara Healthcare Laboratory Services
GTR Test Accession: Help GTR000613387.1
CAP
CANCERHEMATOLOGYIMMUNOLOGY ... View more
Registered in GTR: 2024-09-11
View version history
Last annual review date for the lab: 2024-09-11 LinkOut
At a Glance
Test purpose: Help
Diagnosis; Mutation Confirmation; Predictive; ...
Conditions (3): Help
Acute myeloid leukemia; Myelodysplastic syndrome; Myeloproliferative neoplasm
Genes (69): Help
ABL1 (9q34.12); ALK (2p23.2-23.1); ANKRD26 (10p12.1); ASXL1 (20q11.21); BCL2 (18q21.33) more...
Methods (1): Help
Molecular Genetics - Targeted variant analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Patients with suspected Myeloid Neoplasm
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Sentara Healthcare Laboratory Services
Test short name: Help
Myeloid NGS
Specimen Source: Help
  • Bone marrow
  • Paraffin block
  • Peripheral (whole) blood
Who can order: Help
  • Health Care Provider
  • Licensed Physician
Test Order Code: Help
LAB751
LOINC codes: Help
**LOINC codes notice
CPT codes: Help
**AMA CPT codes notice

Copyright: 2023 American Medical Association. All rights reserved.

Lab contact: Help
David Seidman, PhD, MB(ASCP), Scientific Director
dxseidma@sentara.com
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.
Test development: Help
Manufactured (research use only; not FDA-reviewed)
Informed consent required: Help
Based on applicable state law
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
How to Order, Test strategy
Conditions Help
Total conditions: 3
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 69
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument *
Targeted variant analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose: Help
Diagnosis; Mutation Confirmation; Predictive; Prognostic; Therapeutic management
Target population: Help
Patients with suspected Myeloid Neoplasm
Variant Interpretation:
Will the lab re-contact the ordering physician if variant interpretation changes? Help
No.
Sample reports:
Sample Negative Report Help
Sample Negative Report

Sample Positive Report Help
Sample Positive Report
Recommended fields not provided:
Clinical validity, Clinical utility, What is the protocol for interpreting a variation as a VUS?, Are family members with defined clinical status recruited to assess significance of VUS without charge?, Is research allowed on the sample after clinical testing is complete?
Technical Information
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
The OMAv2 panel was found to have clinical sensitivity to 3.5% allelic frequency for DNA (SNPs/INDELS) and 73 mapped reads (cell lines) or 1% of cells by FISH (FFPE for RNA Fusions variants). Expected allelic frequency acceptability was assessed by direct comparison of OMAv2 results to either previous NGS results … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
College of American Pathologists, CAP

CAP Testing Information Help
Next-Generation Sequencing-Hematologic Malignancies; Next-generation sequencing; NGSHM
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, Citations for Analytical validity, Description of PT method
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
Additional Information

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