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ProvSeq 523
Clinical Genetic Test
Help
offered by
Providence St. Joseph Health Molecular Genomics Laboratory
GTR Test Accession: Help GTR000556857.5
CAP
Last updated in GTR: 2020-01-09
View version history
Last annual review date for the lab: 2024-06-14 LinkOut
At a Glance
Test purpose: Help
Diagnosis; Drug Response; Predictive; ...
Conditions (1): Help
Solid tumor
Genes (523): Help
ABL1 (9q34.12); ABL2 (1q25.2); ABRAXAS1 (4q21.23); ACVR1 (2q24.1); ACVR1B (12q13.13) more...
Methods (1): Help
Molecular Genetics - Sequence analysis of the entire coding region: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Patients with advanced solid tumors.
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Providence St. Joseph Health Molecular Genomics Laboratory
View lab's website
Test short name: Help
ProvSeq
Manufacturer's name: Help
Illumina TruSight Oncology 500
Specimen Source: Help
Who can order: Help
  • Health Care Provider
Test Order Code: Help
LAB24400
Test development: Help
Test developed by laboratory but exempt from FDA oversight (eg. NYS CLEP approved, offered within a hospital or clinic)
Informed consent required: Help
No
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
How to Order, Lab contact for this test, Contact policy, Test strategy
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 523
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Illumina NovaSeq 6000
Clinical Information
Test purpose: Help
Diagnosis; Drug Response; Predictive; Prognostic; Recurrence; Therapeutic management
Target population: Help
Patients with advanced solid tumors.
Recommended fields not provided:
Clinical validity, Clinical utility, What is the protocol for interpreting a variation as a VUS?, 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
In clinical samples, this test has been shown to detect >95% of Single Nucleotide Polymorphisms within the reportable range at allelic frequencies of 5%. The limit of detection for the method to accurately call insertions and deletions is 10% allelic frequency. The limit of detection for gene copy number amplification … 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
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, Citations for Analytical validity, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
Additional Information
Consumer resources:

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.