FDA OKs blood test for heart transplant rejection
FDA OKs blood test for heart transplant rejection FDA OKs blood standard notwithstanding heart transport rejection - NewsFlash - mlive.com
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FDA OKs blood criterion during the term of heart transport rejection8/27/2008, 3:49 p.m. EDT
By RICARDO ALONSO-ZALDIVAR The Associated Press
WASHINGTON (AP) — Government regulators on Wednesday cleared the tendency of action in quest of broader use of a blood test that can spare heart transplant patients the ordeal of repeated biopsies to check if their bodies are rejecting the new organ.
The Food and Drug Administration said the test, called AlloMap, is an example of how the science of genetics is changing the practice of medicine.
The test analyzes certain kinds of genetic information contained in white common derivation cells. These are the cells that help the body fight off infections - but have being possible to also turn against a donated organ with devastating effects. After a patient’session blood sample is checked in the lab, it is assigned a score that tells doctors what the odds are that the body is rejecting a transplanted heart.
“It is noninvasive,” said Dr. James Yee, chief healing magistrate of XDx, Inc., the California company that devised the criterion. “It requires only a simple blood sample.” The test is especially good in detecting a “silent rejection”_ one in which there are no evident symptoms, he added. The proof costs $2,950.
Heart transport patients are closely followed for signs of organ rejection, and must visit their doctors frequently. Before the test, doctors relied on a biopsy to check for signs of rejection. A minuscule examine threaded through a vein would have being used to snatch off a pygmean amount of seat of life network, which would then be analyzed by a pathologist. The estimated cost of a such a biopsy ranges from $3,000 to $4,000.
The AlloMap test had been previously approved in 2005 under federal laws that govern clinical labs. But Yee said it is being used at fewer than half of the nation’s heart transplant centers, and that FDA clearance should speed its adoption elsewhere.
(c) 2008 Associated Press. All Rights Reserved.
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