Genetic Tests Cause Changes in Diagnostics
A "new wave" of genetic or protein tests has begun to "remake the diagnostics business, both for the technology they use and the way they are developed and sold," the New York Times reports. In the past, diagnostic tests were considered the "low-profit, poor cousin of prescription drugs," but the new tests "are emerging as high-profit products" marketed directly to patients and physicians, rather than to laboratories, according to the Times.
Tests currently available or under development can detect cancer early, monitor heart transplants and determine which medications will most benefit patients with cancer, AIDS and heart disease. In addition, the new tests "could help pave the way to personalized medicine," the Times reports.
However, FDA has raised concerns about regulation of the new tests, which in most cases do not require agency approval. According to FDA, some of the new tests might "legally be considered medical devices and require agency approval" as a result, the Times reports.
Randy Scott -- co-founder and CEO of Genomic Health, which offers a test to determine which medications will most benefit patients with cancer -- said, "I'm not sure we could exist at all if we were required up front to have FDA approval" because the cost of the process could make the development of new tests uneconomical (Pollack, New York Times, 4/13).