CNBP DNA Test(DM2)

Test Code
901092


CPT Codes
81187<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


Minimum Volume
6 mL


Instructions
Informed Consent Required.

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.

Shipping Conditions: Room temperature, avoid freezing. Must arrive Monday through Friday.


Transport Temperature
Room temperature


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


Methodology
Repeat Expansion, Southern Blot

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 the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Varies; Report available: 14-28 days


Reference Range
Normal: Less than 177 base pairs


Clinical Significance
Disease(s) tested for: Myotonic dystrophy, Type 2. Detects CCTG repeat expansions in the Zinc Finger Protein 9 (ZNF9) gene.




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.