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Hereditary Cancer Panel
Clinical Genetic Test
Help
offered by
NxGen MDx
GTR Test Accession: Help GTR000570024.1
CAP
INHERITED DISEASECANCERINHERITED DISEASE SUSCEPTIBILITY ... View more
Registered in GTR: 2020-01-16
View version history
Last annual review date for the lab: 2024-07-15 LinkOut
At a Glance
Test purpose: Help
Screening
Conditions (32): Help
Hereditary cancer-predisposing syndrome; Breast cancer, susceptibility to; Breast-ovarian cancer, familial, susceptibility to, 1 more...
Genes (32): Help
APC (5q22.2); ATM (11q22.3); BARD1 (2q35); BMPR1A (10q23.2); BRCA1 (17q21.31) more...
Methods (3): Help
Molecular Genetics - Deletion/duplication analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS); ...
Target population: Help
Not provided
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
NxGen MDx
View lab's website
Who can order: Help
  • Health Care Provider
Test Order Code: Help
HCP
Contact Policy: Help
Post-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
Informed consent required: Help
Decline to answer
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
How to Order, Specimen source, Lab contact for this test, Test strategy, Test development
Conditions Help
Total conditions: 32
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 32
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 3
Method Category Help
Test method Help
Instrument *
Deletion/duplication analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Sequence analysis of select exons
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose: Help
Screening
Recommended fields not provided:
Clinical validity, Clinical utility, Target population, 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?, 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
This test is designed and validated to detect >99% of described pathogenic variants in the 32 genes represented on the panel. Targeted regions of the APC, ATM, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDH1, CDK4, CDKN2A, CHECK2, DICER1, EPCAM, FANCC, GREM1, MLH1, MSH2, MSH6, MRE11, MUTYH, NBN, PALB2, PMS2, POLD1, POLE, … 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
Not provided
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.