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RightMed Comprehensive Test with Gene Report
Clinical Genetic Test
Help
offered by
OneOme, LLC
GTR Test Accession: Help GTR000569929.5
NYS CLEP
CAP
PHARMACOGENOMICINHERITED DISEASE
Last updated in GTR: 2023-06-26
View version history
Last annual review date for the lab: 2024-04-05 LinkOut
At a Glance
Test purpose: Help
Drug Response; Therapeutic management
Conditions (2): Help
Drug metabolism or response; Susceptibility to severe cutaneous adverse reaction
Genes (25): Help
COMT (22q11.21); CYP1A2 (15q24.1); CYP2C19 (10q23.33); CYP2C9 (10q23.33); CYP2D6 (22q13.2) more...
Methods (2): Help
Molecular Genetics - Deletion/duplication analysis: Quantitative PCR (qPCR); ...
Target population: Help
Not provided
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
OneOme, LLC
View lab's website
Test short name: Help
RM-COMP
Specimen Source: Help
Who can order: Help
  • Health Care Provider
  • Licensed Dentist
  • Licensed Physician
  • Nurse Practitioner
  • Physician Assistant
  • Registered Nurse
Test Order Code: Help
RM-COMP
Lab contact: Help
Marissa Rausch, MS, M(ASCP), Staff
marissarausch@oneome.com
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
Authorized healthcare providers with a valid NPI number can order directly from www.oneome.com.
Order URL
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
    OrderCode: RM-COMP
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Based on applicable state law
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Test strategy
Conditions Help
Total conditions: 2
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 25
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
Quantitative PCR (qPCR)
Other
Targeted variant analysis
PCR with allele specific hybridization
Douglas Scientific IntelliQube qPCR platform
Clinical Information
Test purpose: Help
Drug Response; Therapeutic management
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
Only clinically actionable variants are included in the RightMed test and therefore there are no VUS. Novel haplotypes are confirmed with bi-directional sanger sequencing prior to reporting.

Are family members with defined clinical status recruited to assess significance of VUS without charge? Help
No.

Will the lab re-contact the ordering physician if variant interpretation changes? Help
No. As a matter of practice, OneOme will routinely update its pharmacogenomic database as new information becomes available to the scientific community. As a result of these updates, drug binning and annotations found on the RightMed pharmacogenomic test report is dependent on the date of generation and/or the database version used … View more
Recommended fields not provided:
Clinical validity, Clinical utility, Target population, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report
Technical Information
Test Procedure: Help
SNP genotyping by real-time PCR and CYP2D6 copy number analysis by qPCR.
Test Confirmation: Help
Novel alleles are confirmed by bi-directional Sanger sequencing or high-resolution typing (HLAs only).
Test Comments: Help
The RightMed Gene Test interrogates the following variants: rs28371706 NM_000106.5:c.320C>T rs1065852 NM_000106.5:c.100C>T rs1135840 NM_000106.5:c.1457G>C rs16947 NM_000106.5:c.886C>T rs3892097 NM_000106.5:c.506-1G>A rs769258 NM_000106.5:c.31G>A rs5030862 NM_000106.5:c.124G>A rs201377835 NM_000106.5:c.181-1G>C rs5030867 NM_000106.5:c.971A>C hCV32407220 NM_000106.5:c.1411_1412insTGCCCACTG rs5030656 NM_000106.5:c.841_843delAAG rs35742686 NM_000106.5:c.775delA rs72549353 NM_000106.5:c.765_768delAACT rs5030655 NM_000106.5:c.454delT rs774671100 NM_000106.5:c.137_138insT rs1080985 NM_000106.5:c.-1584C>G rs59421388 NM_000106.5:c.1012G>A rs28371725 NM_000106.5:c.985+39G>A rs72549346 NM_000106.5:c.1088_1089insGT rs5030865 NM_000106.5:c.505G>[A,T] rs267608319 NM_000106.5:c.1319G>A … View more
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
The test does not detect all known and unknown variations in the gene(s) tested, nor does absence of a detectable variant (designated as *1 for genes encoding drug metabolizing enzymes) rule out the presence of other, non-detected variants. As with other common SNP genotyping techniques, these assays cannot differentiate between … 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
College of American Pathologists, CAP
VUS:
Software used to interpret novel variations Help
N/A

Laboratory's policy on reporting novel variations Help
Only clinically actionable variants are included in the RightMed test.
Recommended fields not provided:
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
Category: FDA exercises enforcement discretion
NYS CLEP Approval: Help
Number: 9226
Status: Approved
Additional Information
Consumer resources:

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.