Amyotrophic Lateral Sclerosis Advanced Evaluation

Test Code

93068

CPT Codes
81403, 81404, 81405, 81406 (x4), 81479<br /> Limited Access Code<br />

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 an EDTA (lavender-top) tube(s)

Minimum Volume

6 mL

Transport Temperature

Room temperature

Specimen Stability

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

Methodology
Repeat Expansion Detection by Polymerase Chain Reaction, Next Generation Sequencing

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: 21-28 days

Reference Range

See Laboratory Report

Clinical Significance

ALS is characterized by progressive degeneration of upper and lower motor neurons leading to muscle stiffness, fasciculations, and atrophy. This test includes sequencing 16 genes including ALS2, ANG, CHMP2B, DCTN1, FIG4, FUS, OPTN, PFN1, SETX, SIGMAR1, SOD1, SQSTM1, TARDBP, UBQLN2, VAPB, VCP, and C9orf72 repeat expansion test. This test has a sensitivity of 60-70% of familial ALS cases and 15% of sporadic ALS cases.

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.