Monogenic Diabetes (MODY) 4-Gene Evaluation (8800)

Test Code

38238

CPT Codes
81404, 81405 (x2), 81406 (x2), 81479<br>**RESTRICTED CLIENT CODE**

Physician Attestation of Informed Consent

This germline genetic test requires physician attestation that patient consent has been received if ordering medical facility is located in AK, DE, FL, GA, IA, MA, MN, NV, NJ, NY, OR, SD or VT or test is performed in MA.

Preferred Specimen

8 mL whole blood collected in two EDTA (lavender-top) tubes
Pediatric volume: 2 mL whole blood

Minimum Volume

Adult: 6 mL • Pediatric: 1 mL

Instructions

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

Higher blood volumes ensure adequate DNA quantity, which varies with WBC, specimen condition, and need for confirmatory testing. Patients, 0-3 years may have higher WBC, yielding more DNA per mL of blood.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 10 days
Refrigerated: 10 days
Frozen: Unacceptable

Methodology
Sanger Sequencing • Multiplex Ligation-dependent Probe Amplification (MLPA)

FDA Status
This test was developed and its analytical performance characteristics have been determined by Athena Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Report available: 14-28 days

Clinical Significance

Permits the sequence analysis of the four genes GCK, HNF1A, HNF1B, and HNF4A that are frequently mutated in MODY.

The CPT Codes provided in this document 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 payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.