OncoAlly™ Solid Tumor Analysis
Clinical Genetic Test
Help
offered by
GTR Test Accession: Help GTR000603515.1
Last updated in GTR: 2022-11-09
Last annual review date for the lab: 2024-01-30 LinkOut
At a Glance
Diagnosis; Prognostic; Therapeutic management
Solid tumor
ABL1 (9q34.12), ABL2 (1q25.2), ABRAXAS1 (4q21.23), ACVR1 (2q24.1), AJUBA (14q11.2), ...
Molecular Genetics - Deletion/duplication analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS); ...
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Ordering Information
Offered by: Help
Specimen Source: Help
Who can order: Help
  • Health Care Provider
Test Order Code: Help
CPT codes: Help
**AMA CPT codes notice
Lab contact: Help
Christine Stanley, PhD, FACMG, Medical Director
christine.stanley@variantyx.com
+1 617-209-2090
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
Informed consent required: Help
Yes
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 433
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)
Mutation scanning of select exons
Next-Generation (NGS)/Massively parallel sequencing (MPS)
RNA analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose: Help
Diagnosis; Prognostic; Therapeutic management
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
Variants are classified using in-house developed procedures, including the review of applicable functional studies. Benign and likely benign variants are not reported. Pathogenic, likely pathogenic and variants of uncertain clinical significance are reported. Variants of unknown significance (VUS) may be detected in the patient's tumor. Reported VUS may not have … View more

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Not provided.
Recommended fields not provided:
Technical Information
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
The sensitivity for single nucleotide variants and small insertions and deletions less than 50 base pairs is greater than 0.97 and 0.95 respectively. Specificity for single nucleotide variants and small insertions and deletions less than 50 base pairs is greater than 0.999. The sensitivity and specificity for copy number variant … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Intra-Laboratory
VUS:
Software used to interpret novel variations Help
Claudia for Genomics™ platform
Recommended fields not provided:
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.