Food and Drug Administration Approval of Laboratory Tests

Abstract

Listen

Translate article

The United States Food and Drug Administration (FDA) recently granted accelerated approval to crizotinib (Xalkori; Pfizer, New York, New York) to treat patients with advanced-stage non–small cell lung cancer (NSCLC) that is positive for anaplastic lymphoma kinase (ALK) fusion genes. Concurrently, the FDA granted accelerated approval for a companion diagnostic test, the Xysis ALK Break Apart FISH Probe Kit (Abbott Molecular, Inc, Chicago, Illinois), designed to detect rearrangements of the ALK gene, which are found in about 5% of patients with NSCLC. Crizotinib comes with ‘‘a hefty price tag’’— $9600 per month, or $115 000 per year; however, ‘‘[w]e are going to be treating patients more effectively and avoiding treatments that don’t work.’’ 1 ‘‘This is the first targeted agent to be developed with an accompanying diagnostic test, said Mace Rothenberg, MD, senior vice president of Pfizer’s Oncology Business Unit.’’ 1 ‘‘‘The Abbott ALK FISH test was developed in conjunction with Pfizer and the clinical trials for crizotinib,’ said Kathryn B. Becker, PhD, director of Abbott Molecular Oncology. ‘It was configured to work specifically in NSCLC patients . . .’’’ 1 (emphasis added). The launch of crizotinib and the companion Abbott ALK FISH test has made FDA-approved laboratory tests a hot topic among pathologists. Food and Drug Administration approval of laboratory tests is new, and raises many questions. How did FDA approval of laboratory tests come about? What laboratory tests, if any, should require FDA approval? What is FDA approval meant to accomplish? What does this change mean to the pathologist? To the patient? Is FDA approval desirable? Political? Inevitable?