Neonatal Diabetes Mellitus Evaluation

Test Code
901143


CPT Codes
81403, 81404 (x2), 81406, 81407<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.


Includes
ABCC8 (NDM) DNA Sequencing Test
GCK (NDM) DNA Sequencing Test
INS (NDM) DNA Sequencing Test
IPF1 (NDM) DNA Sequencing Test
KCNJ11 (NDM) DNA Sequencing Test


Preferred Specimen
8 mL whole blood collected in two EDTA (lavender-top) tubes
Pediatric (0-3 years): 2 mL


Minimum Volume
6 mL • Pediatric: 1 mL


Instructions
Informed consent is required.

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

Shipping Conditions: Avoid freezing.
Hemolysis may compromise DNA recovery and integrity after 48 hours

Note: 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.


Transport Temperature
Room temperature


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


Methodology
Sanger Sequencing

Setup Schedule
Set up: Varies; Report available: 28-42 days


Reference Range
No sequence variation detected


Clinical Significance
Detects mutations (including point mutations, deletions, insertions, and rearrangements) in the coding sequences of the genes KCNJ11, ABCC8, INS, GCK, and IPF1




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.