Skip to main content
Premium Trial:

Request an Annual Quote

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.


The Scan

Pig Organ Transplants Considered

The Wall Street Journal reports that the US Food and Drug Administration may soon allow clinical trials that involve transplanting pig organs into humans.

'Poo-Bank' Proposal

Harvard Medical School researchers suggest people should bank stool samples when they are young to transplant when they later develop age-related diseases.

Spurred to Develop Again

New Scientist reports that researchers may have uncovered why about 60 percent of in vitro fertilization embryos stop developing.

Science Papers Examine Breast Milk Cell Populations, Cerebral Cortex Cellular Diversity, Micronesia Population History

In Science this week: unique cell populations found within breast milk, 100 transcriptionally distinct cell populations uncovered in the cerebral cortex, and more.