This is topic FDA may ban or limit IGENEX testing in forum General Support at LymeNet Flash.


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Posted by Rivendell (Member # 19922) on :
 
http://lymedisease.org/news/lymepolicywonk/fda-and-lyme-tests-is-it-simply-vested-interests-protecting-vested-interests.html?utm_source=FDA+and+Lyme+testing&utm_campaign=FDA+%26+ot her+Aug+news&utm_medium=email

Please read the above.

Senators who were supposed to help improve lyme testing and treatment seem to have gone the other way (including Blumenthal). Is it money...or are they just incredibly stupid?

Anyway, this could seriously hurt getting IGENEX testing.
 
Posted by hermit (Member # 44427) on :
 
I'd prefer to think they are stupid. A side by side comparison of IgeneX and the current Western Blot do not produce the same results - so why not require proving it to the FDA? As I sit and decide to pay for it out of my pocket, the usual and customay cost that the insurance would allow for the test will be less than they are charging currently. The other face of the coin is - IgeneX is making a killing by not being approved and also has no vested need to pay FDA to approve it.

The government needs to be sued for wrongful death or intentional death before anything will get changed.

My grandfather died of mesotheliomia asbestiosis, right on his death certificate. I'm not calling a lawyer to claim my five dollars payout of the class action lawsuit. But the government does not allow the use of asbestos anymore.
 
Posted by steve1906 (Member # 16206) on :
 
The CDC will do anything to put us one step backwards… They may be stupid but, they have the power!

The CDC continues to take us on a long ride to “nowhere”. Actually, it’s worse than that, because big government has the capacity to do big harm. Going nowhere would be better than going in the wrong direction!

 -

Steve
 
Posted by Lymetoo (Member # 743) on :
 
Moving to General Support, as this has been posted several times.
 
Posted by 'Kete-tracker (Member # 17189) on :
 
I think the key line here was (is):
"Recently,the Centers for Disease Control and Prevention (CDC) reviewed a frequently utilized LDT to detect Lyme disease and found ‘serious concerns’ about false-positive results and misdiagnosis."

"frequently utilized"?... as in ELISA? PCR?
Which test are they refering to??

Apparently this Lyme disease test (LDT) is giving "false positives"...
O.K. So how are they verifying that the result should have been negative in some of these cases?? What other "tests" are they using to "confirm"- or not confirm- Lyme? I mean Bi-ZARRE!
 
Posted by Lymetoo (Member # 743) on :
 
They're STUPID.
 
Posted by Rivendell (Member # 19922) on :
 
I keep hoping there is more to this story and that it will work in our favor.

But........
 
Posted by Rivendell (Member # 19922) on :
 
Steve I love the photo!!!!
 


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