ADmark® Early Onset Alzheimer's Evaluation

Test Code

93086

CPT Codes
81405, 81406 (x2), 81479<br>Limited Access 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

ADmark® APP DNA Sequencing/Duplication Test, ADmark® PS-1 DNA Sequencing Test, ADmark® PS-2 DNA Sequencing Test

Preferred Specimen

8 mL whole blood collected in EDTA (lavender-top) tube

Minimum Volume

6 mL

Instructions

Special Notes: Athena does not perform this test for individuals under the age of 18.

Stability restrictions: Specimen must arrive in Chantilly Sunday through Wednesday within 24 hours of collection. Athena accepts specimens for this test Monday through Thursday only.

Higher blood volumes ensure adequate DNA quantity, which varies with WBC, specimen condition, and need for confirmatory testing.

Transport Temperature

Room temperature

Specimen Stability

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

Methodology
Next Generation Sequencing • Dosage Analysis

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 U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Varies; Report available: 21-28 days

Reference Range

No sequence variation detected

Clinical Significance

Detects sequence variants in the PS-1, PS-2, and APP genes. Detects duplications in the APP 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.