Monogenic Diabetes (MODY) Five Gene Evaluation (GCK,HNF1A,HNF1B,HNF4A,IPF1)

• Test Details
• Technical Information
• CPT Coding
• Specimen Requirements
• Shipping Considerations

Test Details

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Test code:	885
Type of disorder:	Diabetes
Disease(s) tested for:	Maturity-Onset Diabetes of Young (MODY)
Genes Included:	GCK, HNF4A, IPF1, HNF1A, HNF1B
Tests included:	GCK (MODY2) DNA Sequencing and Deletion Test HNF4A (MODY1) DNA Sequencing and Deletion Test IPF1 (MODY4) DNA Sequencing Test TCF1 (MODY3) DNA Sequencing and Deletion Test TCF2 (MODY5) DNA Sequencing and Deletion Test
Informed Consent Required:	This test requires physician attestation that patient consent has been received

Technical Information

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Clinical Significance:	Detects deletions in the HNF4A, GCK, HNF1A, HNF1B genes and mutations in the HNF4A, GCK, HNF1A, HNF1B and IPF1 Typical Presentation: Non-ketotic hyperglycemia in non-obese individuals of any age Indications for testing: Non-ketotic insulin-sensitive hyperglycemia in individuals of any age; Family history of diabetes
Methodology:	Sanger Sequencing, Multiplex Ligation-dependent Probe Amplification (MLPA)
Reference Range:	No sequence variation or deletion detected

CPT Coding

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The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

CPT:	81404(2), 81405(2), 81406(2), 81479(1)

Specimen Requirements

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Please label each specimen tube with two forms of patient identification. These forms of identification must also appear on the requisition form.

Specimen Type:	Whole blood
Specimen Stability:	Room temperature: 10 days, Refrigerated: 10 days, Frozen: Unacceptable
Specimen Requirements:	8 mL (6 mL minimum) whole blood collected in two (lavender-top) EDTA tubes. Pediatric (0-3 years): 2 mL (1 mL minimum)
Instructions:	Higher blood volumes ensure adequate DNA quantity, which varies with WBC, specimen condition, and need for confirmatory testing. Patients, 0-3 years have higher WBC, yielding more DNA per mL of blood

Shipping Considerations

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Transport Temperature:	Room temperature
Set-up/Analytic Time:	14-28 days