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Foundation Medicine's Stock Rises on Approval of Test as New ADLT

NEW YORK (GenomeWeb) – Foundation Medicine's stock rose today following an announcement that its FoundationOne CDx test was approved by the Centers for Medicare and Medicaid Services (CMS) as a new Advanced Diagnostic Laboratory Test (ADLT).

CMS classified FoundationOne CDx as an ADLT under the Protecting Access to Medicare Act (PAMA), a move that Foundation Medicine had said it was expecting.

For a nine-month period starting July 1, CMS will reimburse FoundationOne CDx at a rate of $3,500 per test, in accordance with PAMA and as described by Healthcare Common Procedure Coding System billing code 0037U. During that period, the company will collect and assess private payer rates under PAMA.

Late last year, the US Food and Drug Administration approved FoundationOne CDx for all solid tumors, and as a companion diagnostic for five tumor types. CMS concurrently issued a preliminary national coverage determination for the test, which was later finalized.

In Monday trading on the Nasdaq, Foundation Medicine's shares closed up 7 percent at $87.00.