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Precision GU
Clinical Genetic Test
Help
offered by
INTEGRATED MEDICAL PROFESSIONALS, PLLC
View lab's test page
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GTR Test Accession: Help GTR000597430.2
CAP
INHERITED DISEASECANCERREPRODUCTIVE HEALTH ... View more
Last updated in GTR: 2022-04-01
View version history
Last annual review date for the lab: 2024-03-18 LinkOut
At a Glance
Test purpose: Help
Predictive; Risk Assessment
Conditions (2): Help
Malignant tumor of prostate; Familial prostate carcinoma
Genes (10): Help
ATM (11q22.3), BRCA1 (17q21.31), BRCA2 (13q13.1), CHEK2 (22q12.1), HOXB13 (17q21.32), ...
Methods (1): Help
Molecular Genetics - Targeted variant analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Individuals diagnosed with Prostate cancer, and individuals with family history …
Clinical validity: Help
Not provided
Clinical utility: Help
Predictive risk information for patient and/or family members
Ordering Information
Offered by: Help
INTEGRATED MEDICAL PROFESSIONALS, PLLC
View lab's test page
Manufacturer's name: Help
TruSight Hereditary Cancer Panel
Specimen Source: Help
Who can order: Help
  • Health Care Provider
Test Order Code: Help
PrecisionGU
CPT codes: Help
**AMA CPT codes notice

Copyright: 2023 American Medical Association. All rights reserved.

Lab contact: Help
Ann Anderson, MD, ABPath, FACP, Lab Director
5162807930
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
Order URL
Test service: Help
Result interpretation
    OrderCode: 88997
Test development: Help
Manufactured (research use only; not FDA-reviewed)
Informed consent required: Help
Yes
Test strategy: Help
All performed in-house.
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Conditions Help
Total conditions: 2
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 10
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)
Illumina NextSeq550Dx
Clinical Information
Test purpose: Help
Predictive; Risk Assessment
Clinical utility: Help
Predictive risk information for patient and/or family members
View citations (1)
  • Prostate Cancer, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology. Mohler JL, et al. J Natl Compr Canc Netw. 2019;17(5):479-505. doi:10.6004/jnccn.2019.0023. PMID: 31085757.

Target population: Help
Individuals diagnosed with Prostate cancer, and individuals with family history of cancer.
View citations (1)
  • Prostate Cancer, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology. Mohler JL, et al. J Natl Compr Canc Netw. 2019;17(5):479-505. doi:10.6004/jnccn.2019.0023. PMID: 31085757.
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
A VUS interpretation contains 3 parts: a. A description of the variant and evidence supporting the VUS description. Select the appropriate quick text based on the ClinVar evidence and fill in the specific details of the variant. b. A description of gene function – use the quick text. c. A … View more

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Not provided.
Sample reports:
Sample Negative Report Help
Sample Negative Report

Sample Positive Report Help
Sample Positive Report

Sample VUS Report Help
Sample VUS Report
Recommended fields not provided:
Clinical validity, 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?
Technical Information
Test Procedure: Help
DNA quantification is assessed using Qubit™ fluorometer and the Qubit ds DNA BR Assay kit (ThermoFisher Q32853). DNA is extracted from blood samples using the chemagic™ Prime Junior and Prepito® DNA extraction methodology. NGS libraries are prepared using the Illumina® DNA Prep for Enrichment, (S) Tagmentation, the TruSight Hereditary Cancer … View more
Test Platform:
Illumina NextSeq550Dx
Test Confirmation: Help
Orthogonal testing performed at another laboratory.
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Discussion: Between the two iterations of NA12872 in this experiment, concordance was identified for 374 SNVs, 6 insertions, and 6 deletions. The sensitivity and specificity of the assay are excellent, as is the accuracy, all with values above 99.99%. The positive predictive value is approximately 91%. This value is somewhat … View more
Assay limitations: Help
Any exons that fail to meet the minimum criterion of 95% nucleotides in the target having a coverage of at least 20X will be listed as an assay limitation for that sample.
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

Description of PT method: Help
Next Generation Sequencing- Germline Test Code- NGS

Description of internal test validation method: Help
Integrated Medical Professionals (IMP) will be performing this assay, called Precision GU™, on clinical samples from P4 Diagnostics consisting of genomic DNA (gDNA) obtained from blood samples. Although the TruSight Hereditary Cancer Panel has probes for 113 genes related to cancer predisposition, as well as a number of SNPs, the … View more
VUS:
Software used to interpret novel variations Help
PierianDx

Laboratory's policy on reporting novel variations Help
An interpretation for a pathogenic or likely pathogenic variant is more individualized. a. If available, a previously written interpretation may be used. This may be an interpretation written by another facility. Such interpretations must be carefully reviewed and amended as appropriate for the disease state of the patient. References, typically … View more
Recommended fields not provided:
Citations to support assay limitations, Citations to support internal test validation method, Citations for Analytical validity, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: Not Applicable
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.