Clariti 20/20
GTR Test Accession: Help GTR000591325.2
CANCERINHERITED DISEASEINHERITED DISEASE SUSCEPTIBILITY ... View more
Last updated in GTR: 2021-07-16
Last annual review date for the lab: 2021-07-16 Past due LinkOut
At a Glance
Diagnosis; Predictive; Prognostic
Breast-ovarian cancer, familial, susceptibility to, 1; Breast-ovarian cancer, familial, susceptibility to, 2; Colorectal cancer; ...
APC (5q22.2), ATM (11q22.3), BARD1 (2q35), BMPR1A (10q23.2), BRCA1 (17q21.31), ...
Molecular Genetics - Deletion/duplication analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS); ...
Patient with family history
99.99
Establish or confirm diagnosis; Lifestyle planning; Predictive risk information for patient and/or family members
Ordering Information
Offered by: Help
QDx Pathology Services, Inc.
View lab's website
View lab's test page
Specimen Source: Help
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
  • Physician Assistant
  • Registered Nurse
Test Order Code: Help
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
Fill test requisition form and submit with saliva or buccal swab specimen
Order URL
Test service: Help
Full gene sequencing and del/dup analysis
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Yes
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Conditions Help
Total conditions: 15
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 44
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
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
illumina Miniseq
Clinical Information
Test purpose: Help
Diagnosis; Predictive; Prognostic
Clinical validity: Help
99.99
Target population: Help
Patient with family history
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
We follow ACMG guidelines for providing classification and interpretation of VUS

Will the lab re-contact the ordering physician if variant interpretation changes? Help
.
Recommended fields not provided:
Technical Information
Test Platform:
None/not applicable
Test Confirmation: Help
Positive results are confirmed with Sanger sequencing
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Control samples with over 1000 known variants were used to establish analytical validity. Analytical validity of > 99.99% was achieved.
Assay limitations: Help
<10 ng of purified DNA
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Inter-Laboratory

Description of internal test validation method: Help
Following CLIA guidelines
Recommended fields not provided:
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
Additional Information

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