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» LymeNet Flash » Questions and Discussion » Medical Questions » FDA to Regulate Tests for Lyme Disease

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Author Topic: FDA to Regulate Tests for Lyme Disease
beck
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FDA to regulate tests for Lyme Disease, other illnesses

Not good.

Here is the link to the article:

http://www.bostonglobe.com/lifestyle/health-wellness/2014/07/31/fda-plans-regulate-diagnostic-tests-now-exempt-from-oversight/7u7yqVsHaBjOTFW4y0RJwL/story.html
Posts: 91 | From USA | Registered: Apr 2014  |  IP: Logged | Report this post to a Moderator
Razzle
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Nooooooooooooooo!!!!!!!!!!!!!!! [shake]

Is this going to mean tests through 23andme.com will go away?

--------------------
-Razzle
Lyme IgM IGeneX Pos. 18+++, 23-25+, 30++, 31+, 34++, 39 IND, 83-93 IND; IgG IGeneX Neg. 30+, 39 IND; Mayo/CDC Pos. IgM 23+, 39+; IgG Mayo/CDC Neg. band 41+; Bart. (clinical dx; Fry Labs neg. for all coinfections), sx >30 yrs.
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beck
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23andme.com already no longer offers the health-related genetic reports because of this. [Frown]
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surprise
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Of course, they are SO SCARED! Getting some legislation through finally, and what do you know...

--------------------
Lyme positive PCR blood, and
positive Bartonella henselae Igenex, 2011.
low positive Fry biofilm test, 2012.
Update 7/16- After extensive treatments,
doing okay!
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Catgirl
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If you want to help, at least go here and sign this one now. There is literally no time to waste. Stuff like this has a domino effect.

Once they regulate the testing, all your other tests ordered by your lyme doc might possibly be on the block next (see Razzle's post in activism to save lyme testing).

It's possible that if they regulate one, lyme or genome, they will regulate more. WE CANNOT LET THEM REGULATE ANY OF THESE TESTS.

Suppose they regulate lyme tests next (THEY ARE TRYING TO DO THIS RIGHT NOW), or co infections. Then if/when you get a negative test (lyme, co infections, etc), you may then no longer get your meds covered by insurance. We HAVE to stop this yesterday.

This is how they do this stuff. They start with one test, then they progress onto the others. They would love nothing more than to cut all lyme docs ability to treat off with a test loophole. And insurance companies would love it too.

Run don't walk to sign this one. Razzle posted this on saving the lyme test in Activism.

http://flash.lymenet.org/scripts/ultimatebb.cgi?ubb=get_topic;f=8;t=003142;p=0

[ 07-31-2014, 07:16 PM: Message edited by: Catgirl ]

--------------------
--Keep an open mind about everything. Also, remember to visit ACTIVISM (we can change things together).
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miyamotoi
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This is specifically targeting getting ALS and IGeneX. There is a group of Senators pressing the FDA to release new guidance which could stimulate them to do to ALS and IGeneX what they did to 23andMe.
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susank
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This nuts.
Speaking of - whatever happened to ALS vs CDC?

--------------------
Pos.Bb culture 2012
Labcorp - no bands ever
Igenex - Neg. 4 times
With overall bands:
IGM 18,28,41,66 IND: 23-25,34,39
IGG 41,58 IND: 39
Bart H IGG 40
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Judie
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Here's a list of FDA approved tests for Lyme if anyone is curious:

http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?start_search=1&search_term=LSR&approval_date_from=&approval_date_to=04/17/2014&sort=approvaldatedesc&pagenum=10

Here's an article in Medscape. I found the comments most interesting because only medical professionals are allowed to comment.

http://www.medscape.com/viewarticle/823840
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Tincup
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Paul Auwaerter- Hopkins IDiot duck- IDSA Guideline editor and spokesman for IDSA- and winner of Lyme Disease Hall of Shame award for two decades running....

Has recently been put on the FDA Panel. Ah HA!

Yes, this situation for our labs is serious. There are some plans in the works to address it. If you all could, please be aware this is happening and be ready to take action IF it is needed.

The way to increase profits for the standard labs that the IDiots have patents on and CDC recommends (in cahoots) is to shut down the other labs (competition).

The last figures I saw from Maryland, for example, the use of standard tests were down and a huge financial loss was being felt by those standing to profit.

And miyamotoi- you cause me a lot of anxiety!!

[lol]

(In case you didn't see the news article in medical section, please do.)

Judie- That is a list I DO need and want. Research these days is so tiring and help is much appreciated. I'll take it to the folks working on this situation.

--------------------
www.TreatTheBite.com
www.DrJonesKids.org
www.MarylandLyme.org
www.LymeDoc.org
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Tincup
Honored Contributor (10K+ posts)
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Judie, just saw it. Excellent! Thanks!!!

--------------------
www.TreatTheBite.com
www.DrJonesKids.org
www.MarylandLyme.org
www.LymeDoc.org
Posts: 20353 | From The Moon | Registered: Jun 2004  |  IP: Logged | Report this post to a Moderator
   

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