FDA Approved CLL Companion Diagnostic Test Coding and Billing Guidelines (M00153, V1)

Effective April 11, 2016, the FDA approved venetoclax (VENCLEXTA^®/AbbVie), a new drug treatment for patients with B-cell chronic lymphocytic leukemia (CLL) with 17p deletion and at least one prior therapy, and a new indication for Vysis CLL FISH Probe Kit, a laboratory test to detect 17p deletion, as a companion diagnostic for venetoclax.

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