Special Instructions

A signed informed consent in the patient's medical record is required. The consent should not be sent to the laboratory. The link to the Genetic Testing Consent Form is provided as a convenience for the providers and genetic counselors within the order.

MRL Ordering Instructions

MN Statute:  Obtain and retain genetic testing informed consent in your patient's chart.

Test Includes

The assay tests for the following genes and star alleles: CYP2B6*9, CYP2C19*2, CYP2C19*3, CYP2C19*4, CYP2C19*5, CYP2C19*6, CYP2C19*8, CYP2C19*17, CYP2C9*2, CYP2C9*3, CYP2C9*5, CYP2C9*6, CYP2C9*8, CYP2C9*11, CYP2D6*2 (*34), CYP2D6*2 (*39), CYP2D6*3, CYP2D6*4, CYP2D6*6, CYP2D6*10, CYP2D6*17, CYP2D6*41, CYP3A5*3, DPYD D949V, DPYD*2A, DPYD*13, SLCO1B1*5, TPMT*2, TPMT*3B, TPMT*3C, TPMT*4, UGT1A1*80 as well as provides the information of the CYP2D6 copy number.  The Go4PGx PDF based report includes additional diplotype-phenotype information as well as gene-phenotype-drug recommendations based on CPIC guidelines.

Turnaround Time

Testing is performed Mon-Fri; results are reported within 7-10 days.

Use

Pharmacogenomic (PGx) testing is performed at the MHealth Fairview Molecular Diagnostic Laboratory. It uses targeted genotyping technology to evaluate the presence of DNA variants tht affect the metabolism of certain medications, Whole blood and buccal swab samples are acceptable DNA sources for PGx testing.

Specimen Type

Blood (ACD or EDTA) (preferred)
or Buccal swab of cheek.

Collection Containers

Yellow (ACD, Solution A) tube available from laboratory
Alternate Containers: Purple (EDTA), Yellow (ACD, Solution B) tube available from laboratory
Buccal swab: Genotek OraCollect-DX (OCD-100) buccal swab

Collection Volume

Blood ACD or EDTA: 10 mL (preferred)


OR


Two Genotek OraCollect-DX (OCD-100) buccal swabs

Minimum Collection Volume

Blood ACD or EDTA: 3 mL


OR


One OraCollect buccal swab

Specimen Preparation

Do not process. Store at room temperature.

Unacceptable Conditions

Blood samples tested in hematology using automated instrumentation not accepted. DNA extracted at a non-CLIA certified (or equivalent) lab.

Shipping Instructions

Ship at room temperature.

Stability (from collection to initiation)

5 days at room temperature.

Containers

Yellow (ACD, Solution A) Tube, available from laboratory

Alternate Containers

Purple (EDTA)

Yellow (ACD, Solution B) Tube, available from laboratory

Buccal Swab

Reference Interval

By report.

CPT Disclaimer

The Current Procedural Terminology (CPT) Codes published in the M Health Fairview Test Directory are based on American Medical Association (AMA) guidelines and are provided for informational purposes only. CPT codes are provided only as guidance to assist clients with billing. CPT coding is the responsibility of the billing party. M Health Fairview Laboratories does not assume responsibility for billing errors due to reliance on the CPT codes listed in this Test Directory. Charges may vary due to reflexing, susceptibilities, specimen source, patient age, methodology requirements, etc..

Patient Price Inquiries

Requester Contact Information
Patient and UMP/FV Care Team Fairview Consumer Line at 612-672-1048
MRL Outreach Client DEPT-MRL-CLIENT-MANAGEMENT@Fairview.org
Research research@fairview.org

CPT Codes

CPTQtyHC HospitalPR ClinicNote
81418130081418018141801HC PGX DRUG METABOLISM VERSION 1 6+ PANEL
G04521971G045201G045201HC MOLECULAR INTERP PF

Methodology

SNP Genotyping of selected drug-metabolizing enzymes using Fluidigm BioMark HD and Life Technologies TaqMan®

MRL Test Build

Test Name Component Required Description Type LOINC
LAB8161     Pharmacogenomics Profile Orderable  
  SPT_1097 Y Specimen type: Prompt  
  SRC_1000 Y Specimen source: Prompt  
  1230003559   Results Molecular Result  
  1230005210   Signout Location if Remote Result 90119-9
  1238000018   PGX Variants Result  
  1238000019   About the PGX test Result  
  1238000030   Methodology Result  
  1238000040   Limitations Result  
  1238000050   Disclaimer Result  
  1238000060   Comments Result  

Contact

For questions regarding the test code Interface Map, please contact DEPT-LAB-CLIENT-INTERFACE@fairview.org
Ordering

Special Instructions

A signed informed consent in the patient's medical record is required. The consent should not be sent to the laboratory. The link to the Genetic Testing Consent Form is provided as a convenience for the providers and genetic counselors within the order.

MRL Ordering Instructions

MN Statute:  Obtain and retain genetic testing informed consent in your patient's chart.

Test Includes

The assay tests for the following genes and star alleles: CYP2B6*9, CYP2C19*2, CYP2C19*3, CYP2C19*4, CYP2C19*5, CYP2C19*6, CYP2C19*8, CYP2C19*17, CYP2C9*2, CYP2C9*3, CYP2C9*5, CYP2C9*6, CYP2C9*8, CYP2C9*11, CYP2D6*2 (*34), CYP2D6*2 (*39), CYP2D6*3, CYP2D6*4, CYP2D6*6, CYP2D6*10, CYP2D6*17, CYP2D6*41, CYP3A5*3, DPYD D949V, DPYD*2A, DPYD*13, SLCO1B1*5, TPMT*2, TPMT*3B, TPMT*3C, TPMT*4, UGT1A1*80 as well as provides the information of the CYP2D6 copy number.  The Go4PGx PDF based report includes additional diplotype-phenotype information as well as gene-phenotype-drug recommendations based on CPIC guidelines.

Turnaround Time

Testing is performed Mon-Fri; results are reported within 7-10 days.

Use

Pharmacogenomic (PGx) testing is performed at the MHealth Fairview Molecular Diagnostic Laboratory. It uses targeted genotyping technology to evaluate the presence of DNA variants tht affect the metabolism of certain medications, Whole blood and buccal swab samples are acceptable DNA sources for PGx testing.

Collection & Processing

Specimen Type

Blood (ACD or EDTA) (preferred)
or Buccal swab of cheek.

Collection Containers

Yellow (ACD, Solution A) tube available from laboratory
Alternate Containers: Purple (EDTA), Yellow (ACD, Solution B) tube available from laboratory
Buccal swab: Genotek OraCollect-DX (OCD-100) buccal swab

Collection Volume

Blood ACD or EDTA: 10 mL (preferred)


OR


Two Genotek OraCollect-DX (OCD-100) buccal swabs

Minimum Collection Volume

Blood ACD or EDTA: 3 mL


OR


One OraCollect buccal swab

Specimen Preparation

Do not process. Store at room temperature.

Unacceptable Conditions

Blood samples tested in hematology using automated instrumentation not accepted. DNA extracted at a non-CLIA certified (or equivalent) lab.

Shipping Instructions

Ship at room temperature.

Stability (from collection to initiation)

5 days at room temperature.

Containers

Containers

Yellow (ACD, Solution A) Tube, available from laboratory

Alternate Containers

Purple (EDTA)

Yellow (ACD, Solution B) Tube, available from laboratory

Buccal Swab

Result Interpretation

Reference Interval

By report.

Administrative

CPT Disclaimer

The Current Procedural Terminology (CPT) Codes published in the M Health Fairview Test Directory are based on American Medical Association (AMA) guidelines and are provided for informational purposes only. CPT codes are provided only as guidance to assist clients with billing. CPT coding is the responsibility of the billing party. M Health Fairview Laboratories does not assume responsibility for billing errors due to reliance on the CPT codes listed in this Test Directory. Charges may vary due to reflexing, susceptibilities, specimen source, patient age, methodology requirements, etc..

Patient Price Inquiries

Requester Contact Information
Patient and UMP/FV Care Team Fairview Consumer Line at 612-672-1048
MRL Outreach Client DEPT-MRL-CLIENT-MANAGEMENT@Fairview.org
Research research@fairview.org

CPT Codes

CPTQtyHC HospitalPR ClinicNote
81418130081418018141801HC PGX DRUG METABOLISM VERSION 1 6+ PANEL
G04521971G045201G045201HC MOLECULAR INTERP PF

Methodology

SNP Genotyping of selected drug-metabolizing enzymes using Fluidigm BioMark HD and Life Technologies TaqMan®

Interface Mapping

MRL Test Build

Test Name Component Required Description Type LOINC
LAB8161     Pharmacogenomics Profile Orderable  
  SPT_1097 Y Specimen type: Prompt  
  SRC_1000 Y Specimen source: Prompt  
  1230003559   Results Molecular Result  
  1230005210   Signout Location if Remote Result 90119-9
  1238000018   PGX Variants Result  
  1238000019   About the PGX test Result  
  1238000030   Methodology Result  
  1238000040   Limitations Result  
  1238000050   Disclaimer Result  
  1238000060   Comments Result  

Contact

For questions regarding the test code Interface Map, please contact DEPT-LAB-CLIENT-INTERFACE@fairview.org
Private Details