Allomap ~ Testing Approved by FDA !

FDA OK's New Non-Invasive Test for Heart Transplant Rejection

August 27, 2008

Consumer Inquiries: 888-INFO-FDAFDA Clears Test to Help Doctors Manage Heart Transplant Patients. The U.S. Food and Drug Administration today announced it has cleared for marketing a non-invasive test that uses molecular expression techniques to assist doctors in managing heart transplant patients post-surgery for potential organ rejection."AlloMap can help contribute to an appropriate treatment plan by identifying those patients not experiencing post-operative heart transplant rejection," said Daniel G. Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. "It is an example of how advancements in science and technology are leading to new medical care diagnostics."AlloMap measures genetic information contained in the white blood cells (cells of the immune system that defend the body against invading viruses, bacteria or other foreign material) from a patients blood sample.Specifically the test measures gene expression—or how DNA transcribe sits genetic instructions to RNA, the nucleic acid that translates and carries out those instructions—of 20 different genes, resulting in a score that indicates whether a heart transplant patient is unlikely to be rejecting the new organ. Nearly every cell of the body contains a full set of chromosomes and identical genes but only a fraction of these genes are turned on or expressed in any given cell. Gene expression occurs when certain molecular information contained within DNA is transcribed to create molecules known as RNA. These molecules in turn make the proteins that perform most of the critical functions of cells.Following a heart transplant, physicians regularly monitor patients for transplant rejection, a significant risk to patient survival.Rejection occurs when the patients immune system fails to accept the new organ and begins to attack it. Successful heart transplants depend on a balanced immune system response—a response that is suppressed enough to accept the new organ but strong enough to protect the patient from infections.Clinicians often rely on heart biopsy to gauge whether a patient is rejecting the transplanted heart. However, biopsies are difficult to perform and can be risky for the patient.According to the National Heart, Lung and Blood Institute, half of all possible rejections happen during the first six weeks after surgery and 25 percent of patients have signs of possible rejection at least once during the first year following a transplant.XDx Inc. developed AlloMap using blood and biopsy samples and other information collected from heart transplant recipients at nine U.S.heart transplants centers participating in the Cardiac Allograft Rejection Gene expression Observational study (CARGO). CARGO provided data from 153 patients on 300 medical visits at various times after heart transplant study.According to the American Heart Association, there were more than2,000 heart transplants performed in the United States during 2006.AlloMap is the third in vitro diagnostic multivariate index assay(IVDMIA) cleared by the FDA. IVDMIAs are medical devices that combine the values of multiple variables to yield a single, patient-specific result.

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Pulmonary Hypertension ~ Update !

Shortness of Breath...Not Much Fun !
By : Don Jones...8/18/08

I have been an official Pulmonary Hypertension patient now, since July 7, 2008...As I `ve said before, shortness of breath is not much fun. It took Vanderbilt almost two years to diagnose me. It is not that they were not trying, but, pulmonary hypertension is most difficult to diagnose. I have met another PH patient right here in my hometown. He is a pastor at one of our local church`s. He is just 41 year`s old. We have compared notes already. I have joined a group on-line, "Pulmonary Hypertension Association"! Click on the title of this article, it carry you there ! The medical profession does not know a lot about this disease. Dr. Mark Wigger, Heart-Transplant Director, at Vanderbilt University in Nashville, prescribed a drug for my disease called Nitro-Biden, it is a paste that I had to apply to my body one inch every 8 hours. The first couple of days, I thought it might be working, but, alas, it did not. Dr. Wigger has now prescribed a drug called Revatio. Now, Revatio is a derivative of Viagra. Please, no jokes. He started me out on one 20mg. tab. three times a day. He has now put me on 40mg. three times a day ! I`m not positive, but, I believe it might be helping. A few words about Revatio, It is manufactured by the Pfizer pharmaceutical company. Each tablet is a cost of $10.00 ! So, $60.00 per day alone just for one medication. A 30 day supply = $1,800.00 ! Lets just say, that without insurance, I could not pay for this drug. I ordered a book off of the PH web-site > http://www.PHAssociation.org/ <. I have learned that a particular drug may work for a patient, and not for another patient. I have also learned that more women than men get this disease. I am checked monthly for my oxygen levels in my blood, Dr. Slovis my pulmonary Dr. at Vandy, says that if it is more than 50, I am to have a phlebotomy. You ask, what is a phlebotomy ? It is, as in middle ages, you are bled. They draw off a pint of blood monthly. I am learning as I go forward with this disease called "Pulmonary Hypertension"! PH is now referred to as the other high blood pressure, in my terms, it is simply high blood pressure in/of the lungs ! Not too pleasant. With the minimum amount of exertion, I get short of breath. As long, as I`m in-active, I seem perfectly normal. I am not. I am just beginning this trip with PH, as I learn, I will share it with you.