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FDA clears test for mastocytosis diagnosis (Read 8416 times)
peter
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FDA clears test for mastocytosis diagnosis
05/26/12 at 17:35:24
 
http://medicalxpress.com/news/2012-05-fda-mastocytosis-diagnosis.html
May 22, 2012 in Medical research

The Food and Drug Administration has approved a new test to help physicians diagnose a group of rare cell disorders. The test, or assay, was developed by an expert at Virginia Commonwealth University in the field of mast cells.
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Buster
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Re: FDA clears test for mastocytosis diagnosis
Reply #1 - 06/01/12 at 06:18:09
 
Does anyone know if there is any difference between this new tryptase test and the one(s) currently being used?
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Lisa
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Re: FDA clears test for mastocytosis diagnosis
Reply #2 - 06/02/12 at 16:24:00
 
Lawrence Schwartz, M.D., Ph.D., chair of the Division of Rheumatology, Allergy and Immunology and the Charles and Evelyn Thomas Professor of Medicine at VCU, has spent more than 30 years researching mast cells. These cells are vital to the inflammatory process within the body and may play protective roles in wound healing and fighting infections.
"When a mast cell is triggered, it releases several strong chemicals into the body, including histamine and tryptase. Histamine causes itching, swelling, wheezing and sneezing and other signs and symptoms of allergic reactions," said Schwartz.
Mastocytosis, a group of rare chronic disorders found in both children and adults, is caused by the presence of too many of these mast cells in the body. If there are too many mast cells, the increased burden of chemicals released from these cells can cause several symptoms that range in intensity from mild to severe.
Because mast cells play a role in allergic reactions, the symptoms of mastocytosis are often similar to an allergic reaction. However, mastocytosis (I suspect this is a typo, that it should say ANAPHYLAXIS ) may occur spontaneously rather than be triggered by an allergen.
The FDA has cleared ImmunoCAP Tryptase, a new diagnostic assay, to measure the level of tryptase in the blood as an aid in the diagnosis of systematic mastocytosis. A persistently elevated baseline level of tryptase is an indication of possible mastocytosis.
"A physician cannot diagnose systematic mastocytosis based only on a physical examination. The FDA approval of the tryptase assay will provide doctors with an additional diagnostic tool," said Schwartz.
VCU first licensed the assay in 1993 to Pharmacia, now named Thermo Fisher Scientific Inc. The assay has one FDA-approved application – helping to diagnose mastocytosis – and several potential applications, including the diagnosis of systemic anaphylaxis, the prediction of increased risk for future episodes of severe anaphylaxis and use by medical examiners to evaluate cause of death.
"When somebody dies without a clear cause, by measuring postmortem tryptase levels, an increased level of tryptase provides support for an anaphylactic event near the time of death," said Schwartz.
Provided by Virginia Commonwealth University  



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Peter, it looks to me as though this is the very same test, however, a renewal of this test through another commercial assay and the FDA giving it's approval of it through a new commercial assay.   But I believe it's the same test as it was before.

Lisa
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peter
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Re: FDA clears test for mastocytosis diagnosis
Reply #3 - 06/02/12 at 17:35:17
 
hi Buster and lisa it is the same tryptase but it comes back in 4hr
that is not a typo lisa i have symptoms similar to allergic reactions without going into anaphylaxis

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Re: FDA clears test for mastocytosis diagnosis
Reply #4 - 06/02/12 at 21:22:51
 
Yes, I think it means that, in mastocytosis, anaphylaxis can be triggered without allergens.
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Lisa
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Re: FDA clears test for mastocytosis diagnosis
Reply #5 - 06/05/12 at 03:55:44
 
Interesting about the exam coming back in 4 hours!!  Thatīs excellent!!



As to the typo, Peter, the typo is indicating that mastocytosis can be triggered spontaneously and thatīs not so.  Mastocytosis is a genetic defect of the MC and itīs not triggered.  The reactions are triggered and they can be done spontaneously, which is why I think the typo was supposed to say "anaphylaxis can be triggered spontaneously"  and not "mastocytosis can be triggered spontaneously"



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peter
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Re: FDA clears test for mastocytosis diagnosis
Reply #6 - 06/08/12 at 11:47:26
 
[The symptoms] of mastocytosis are often similar to an allergic reaction. However, mastocytosis  may occur spontaneously rather than be triggered by an allergen.
Yes lisa maybe it should have [ However in mastocytosis]
the confistion is Whtch masto are thay talking about
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Lisa
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Re: FDA clears test for mastocytosis diagnosis
Reply #7 - 06/08/12 at 14:11:32
 
Peter, as you and I once argued about the connection between mast cell disorders and other diseases, you've seen the connections they are making in the research and you are correct - there is a genetic connection suspected and researchers are now trying to prove this.  From Dr. Molderings' research, in his paper, Immunogenetics, there is indeed a connection and that even MCAS is proved to have a genetic defect.  So, even though they have not yet fully proven that non-clonal MCAS is indeed non-clonal, they do know that there is some kind of genetic defect on the MCs of those patients.   Therefore, it only goes to follow that regardless of it being SM or MMAS or MCAS, they are all within the same family of genetic defects.   What they don't know is whether these are seperate forms due to different defects upon the MCs or if these are pre-SM forms only much more slower growing, etc.

This is why there is such confusion for there are so very many similarities amongst the patients that it's hard to deny that there can be two totally seperate disease entities, and yet, they find themselves totally puzzled as to why in the "non-clonal MCAS" patient they can't find any firm evidence of the clonal form.   It makes no sense to them that you have patients who can be going through constant anaphylaxis and typical masto symptoms and yet they can't find raised anything and yet you can have these patients who have aggressive masto and are dying from the disease where only months before nobody even the  patient had a clue they were sick!  How can they explain patients who die from aggressive SM but until the day they died nobody knew they had masto!  


Yet, in saying all of this, to answer your question, I rather suspect they are speaking about SM in this article.  


Lisa
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peter
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Re: FDA clears test for mastocytosis diagnosis
Reply #8 - 06/08/12 at 17:12:21
 
hi lisa looks like we need to have another argument
The CONFUSION is geting biger
My ider in my case is DURRING clonal MCA the merture mast cells invaded the bone marrow then started to grow to drifenrent things
sum people with SM do not have mast cell activation but sum do
I nolonger have MCA now just SM BUT I DID HAVE BOTH

I think every sick person has sum mast cell activation

this one is a bit confusion
http://emedicine.medscape.com/article/202030-overview
Hypereosinophilic Syndrome
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peter
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Re: FDA clears test for mastocytosis diagnosis
Reply #9 - 06/08/12 at 20:56:13
 
Interestingly, a significant proportion of ASM patients have a long history of an underlying and frequently misdiagnosed MIS, which can precede by years the onset of C-findings.
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