DPYD genotyping - Clinical Genetic Test - GTR

Genetic Testing Registry

View Advanced Search Options

Classic view of this page

DPYD genotyping

Clinical Genetic Test

offered by

Molecular Genetics Laboratory

GTR Test Accession: GTR000613316.1

PHARMACOGENOMIC

Registered in GTR: 2024-07-19

Last annual review date for the lab: 2024-07-22

At a Glance

Test purpose:

Risk Assessment

Conditions (1):

Fluorouracil response

Genes (1):

DPYD (1p21.3)

Methods (1):

Molecular Genetics - Targeted variant analysis: PCR with allele specific hybridization

Target population:

Patients eligible for treatment with 5-FU derived drugs

Clinical validity:

Not provided

Clinical utility:

Not provided

Ordering Information

Offered by:

Molecular Genetics Laboratory
View lab's website

Test short name:

DPYD

Manufacturer's name:

Elucigene DPYD kit

Specimen Source:

Peripheral (whole) blood

Who can order:

Health Care Provider

Test Order Code:

DPYD

Lab contact:

Marit Skuterud, Staff
marit.skuterud@nygh.on.ca
1-416-756-6444 ext 3500

Contact Policy:

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:

Order URL

Test service:

Clinical Testing/Confirmation of Mutations Identified Previously

Test additional service:

Custom mutation-specific/Carrier testing

Test development:

Manufactured (research use only; not FDA-reviewed)

Informed consent required:

Yes

Pre-test genetic counseling required:

Post-test genetic counseling required:

Recommended fields not provided:

Test strategy

Conditions

Total conditions: 1

Condition/Phenotype	Identifier

Test Targets

Genes

Total genes: 1

Gene	Associated Condition	Germline or Somatic	Allele (Lab-provided)	Variant in NCBI

Methodology

Total methods: 1

Method Category

Test method

Instrument

Targeted variant analysis

PCR with allele specific hybridization

ABI 3500xL

Clinical Information

Test purpose:

Risk Assessment

Target population:

Patients eligible for treatment with 5-FU derived drugs

Variant Interpretation:

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

Will the lab re-contact the ordering physician if variant interpretation changes?
No.

Recommended fields not provided:

Clinical validity, Clinical utility, What is the protocol for interpreting a variation as a VUS?, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report

Technical Information

Test Platform:

None/not applicable

Availability:

Tests performed
Entire test performed in-house

Analytical Validity:

Accuracy, precision, reproducibility: 100%

Assay limitations:

The absence of variants detected by this kit is no guarantee that other variants in the DPYD gene are not present. Rare polymorphisms or variants in the DPYD gene may interfere with the operation of the assay.

Proficiency testing (PT):

Is proficiency testing performed for this test?
Yes

Method used for proficiency testing:
Formal PT program

PT Provider:
GenQA

Recommended fields not provided:

Test Confirmation, Citations to support 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:

Not provided

Additional Information

Reviews:

books

PubMed Clinical Queries

Clinical resources:

Practice guidelines:

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.