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PrimBio Cancer HotSpot Panel
Clinical Genetic Test
Help
offered by
PrimBio Research Institute
GTR Test Accession: Help GTR000561701.1
CANCERINHERITED DISEASEHEMATOLOGY ... View more
Last updated in GTR: 2018-09-10
View version history
Last annual review date for the lab: 2023-07-07 LinkOut
At a Glance
Test purpose: Help
Screening
Conditions (60): Help
Chronic myelogenous leukemia, BCR-ABL1 positive; Acute lymphoid leukemia; Acute promyelocytic leukemia; ...
Genes (50): Help
ABL1 (9q34.12), AKT1 (14q32.33), ALK (2p23.2-23.1), APC (5q22.2), ATM (11q22.3), ...
Methods (1): Help
Molecular Genetics - Targeted variant analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
This panel is used to determine the genetic information (somatic …
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
PrimBio Research Institute
View lab's website
Test Order Code: Help
6231
Contact Policy: Help
Post-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
Pre-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: 60
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 50
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)
* Instrument: Not provided
Clinical Information
Test purpose: Help
Screening
Target population: Help
This panel is used to determine the genetic information (somatic mutations) of a specific cancer or tumor, so that a physician, genetic counselor, or other health provider can offer the optimal treatment plan for a cancer patient.The variants detected in this assay are associated with many known cancers including breast, … View more
Recommended fields not provided:
Clinical validity, Clinical utility, 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
The limit of detection is 3.5% allele frequency at 500X coverage and 5% allele frequency at 200X coverage. This technology cannot reliably detect mutations at coverage below 200X. Confirmation of actionable mutations should be performed by Sanger sequencing.
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
No
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, Citations for Analytical validity, PT Provider, 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.