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The US Food and Drug Administration
announced its decision to allow XDx Inc. to sell a test, called AlloMap, which
is intended to aid in the identification of heart transplant recipients who have
a law risk of rejection of the new organ.
The test measures genetic information
contained in a patient’s white blood cells, which are cells that normally help
defend the body against viruses, bacteria, or other harmful material. The cells
can also attack the new organ as a foreign entity. After a patient’s blood sample
is tested in the lab, the results provide information on the risk that a heart
transplant patient will reject the new organ.
AlloMap is an example on how the science of
genetics is changing the practice of medicine, according to the Food and Drug
Administration. The test will save the transplant patients from biopsies to check
for sign of rejection and it represents an alternative non-invasive method to
identify those patients who are more likely to experience postoperative heart
transplant rejection.
Dr. James Yee, chief medical officer of
XDx, Inc., the company located in Brisbane,
Calif., said the test is “non-invasive”
and it requires only a blood sample. The test may prove effective in cases of “silent
rejection,” when there are no evident symptoms that the body will reject the
organ.
According to the FDA, AlloMap gene
expression test is the third in vitro diagnostic multivariate index assay (IVDMIA)
approved by the FDA.
About 2,600 heart transplants are performed
in the United States
each year.
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