surprise
Frequent Contributor (1K+ posts)
Member # 34987
posted
Florida Lyme disease organization:
We regret to announce that there are two recent developments that will further hamper patient’s ability to obtain more reliable Lyme testing.
First, effective August 11, 2014, Labcorp will no longer run a stand alone Western Blot. They will only run a Western Blot if there is an equivocal or positive ELISA (this is known as a Western Blot reflex).
The ELISA test has been broadly criticized as unreliable, missing ½ of actual tests. While the CDC’s criteria for a positive Western Blot is likewise insensitive, requiring a total of 7 positive bands (2 IgM Bands and 5 IgG bands compared to a single IgM and IgG band in China), doctors often consider any positive bands in conjunction with a clinical presentation.
The second issue involves what are known as laboratory developed tests, or LDTs, including Lyme tests performed by iGeneX and Advanced Labs. As long as LDTs are designed, manufactured, and used within a single laboratory, they historically could be sold without US Food and Drug Administration (FDA) approval. The FDA recently announced that it intends to regulate many of the LDTs.
In response to the announcement that the FDA will draft guidance in 60 days to regulate LDTs, the American Clinical Laboratory Association (ACLA) urged the agency to exercise caution, and expressed concern that another layer of regulation could stifle diagnostic innovation and ultimately jeopardize patient access to timely and effective treatments.
“Laboratories have been regulated for decades by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) and by state law,” said Alan Mertz, President of ACLA. “Under the CLIA framework, a thorough and detailed regulatory process, we’ve seen an explosion of innovation in laboratory diagnostics that has allowed labs to diagnose and measure disease with an accuracy and precision never before possible. This has changed how the medical world views and treats everything from rare diseases to infectious disease to cancer.”
The two changes noted above do not help patients, but rather protect those with vested, financial interests in tests that are highly unreliable and insensitive, particularly for areas where there are more diverse strains such as the Southeast.
What can you do? Here are a few suggestions:
1. Contact Labcorp to complain about the change at 800-845-6167.
2. Advise doctors of the change so that they can order stand alone Western Blot tests from iGeneX (www.iGeneX.com), Stony Brook (http://medicine.stonybrookmedicine.edu/system/files/LYME%20TEST%20REQUEST%20FORM.pdf, checking the box to list CDC non-specific bands) or Quest (test code 8593 CPT Code 86617).
3. Contact your state politicians to complain about the lack of access to reliable diagnostic tests.
-------------------- Lyme positive PCR blood, and positive Bartonella henselae Igenex, 2011. low positive Fry biofilm test, 2012. Update 7/16- After extensive treatments, doing okay! Posts: 2518 | From USA | Registered: Nov 2011
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Razzle
Frequent Contributor (1K+ posts)
Member # 30398
It seems after reading the articles above, it would be in the company's best interest to get approved. I would think it would reduce some of the controversy over testing.
Posts: 29 | From 42.782745, -71.280301 | Registered: Apr 2014
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surprise
Frequent Contributor (1K+ posts)
Member # 34987
posted
Because Igenex doesn't have a patent producing money linked to the government?
Sarcasm aside, here is a point of interest: (copied)
'Quest testing leaves out the 2 most specific bands: #31 & #34. These bands are SO SPECIFIC to Lyme, the first human Lyme vaccine was made from #31, and the 2nd from #34!! These very important bands are NOT REPORTED in standard commercial Lyme tests!
Laboratories that use FDA approved kits are RESRICTED from reporting all of these bands, as they must abide by the rules of the manufacturer. These rules are set up in accordance with the CDC's surveillance criteria, and inrease the risk of false negative results.'
-------------------- Lyme positive PCR blood, and positive Bartonella henselae Igenex, 2011. low positive Fry biofilm test, 2012. Update 7/16- After extensive treatments, doing okay! Posts: 2518 | From USA | Registered: Nov 2011
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poppy
Frequent Contributor (1K+ posts)
Member # 5355
posted
Only those that sell test kits to be done by other labs are required to get FDA approval. Or at least that is the way it is been in the past. Thanks to a lot of yammering by ignorant journalists and others, now FDA is apparently going to get into tests done strictly by one lab, which is ridiculous. They do not have the personnel nor is it useful to regulate a field that has been so innovative. This is going to cause more harm than good.
Posts: 2888 | From USA | Registered: Mar 2004
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Rumigirl
Frequent Contributor (1K+ posts)
Member # 15091
posted
quote:Originally posted by poppy: Only those that sell test kits to be done by other labs are required to get FDA approval. Or at least that is the way it is been in the past. Thanks to a lot of yammering by ignorant journalists and others, now FDA is apparently going to get into tests done strictly by one lab, which is ridiculous. They do not have the personnel nor is it useful to regulate a field that has been so innovative. This is going to cause more harm than good.
That's the understatement of the year!! This is huge, and we do need to fight this NOW. They are tightening the noose tighter and tighter.
Blumenthal and Elizabeth Warren are behind this, too. Blumenthal should know better, but maybe doesn't (from his run ins with the IDSA when he was governor of CT).
Warren is clearly misinformed, as I believe she has good intentions. Sorry, I didn't mean to get political, only to say that those two were surprising in this regard. And that we have to educate our congress people.
Posts: 3771 | From around | Registered: Mar 2008
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surprise
Frequent Contributor (1K+ posts)
Member # 34987
posted
Bump up.
-------------------- Lyme positive PCR blood, and positive Bartonella henselae Igenex, 2011. low positive Fry biofilm test, 2012. Update 7/16- After extensive treatments, doing okay! Posts: 2518 | From USA | Registered: Nov 2011
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posted
This is serious - am wondering how we're supposed to be organizing around this issue, as in petition coming, or instructions to call? Anyone know?
Posts: 13116 | From San Francisco | Registered: May 2006
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Catgirl
Frequent Contributor (5K+ posts)
Member # 31149
posted
There are dots people need to connect here. LabCorp is the first to jump on this band wagon, and this is just the first step. It's bigger than just labcorp's new policy though. It's really about standardizing lyme tests, which means that they will only approve the labs they like, the ones with a limited ability to identify the lyme bands.
If they standardize the lyme test and it shows negative guess what? The insurance company can also try to deny you coverage. No kidding, it's that serious.
This is all about idsa clones wanting to shut down lyme treatment for anyone who doesn't fall under their old pitiful guidelines for lyme. They want to be right and probably cover their a---- as well.
These idiots are doing their best to squash lyme treatment, lyme docs, and lyme patients, and it all starts with this test.
IT IS ABSOLUTELY CRUCIAL EVERYONE SIGNS THIS. You only have this chance to oppose it right now. If it passes, good luck to you and yours (you'll need it).
Here is an excerpt from Razzle's link: "Many tests essential to lyme patients' health would no longer be available."
-------------------- --Keep an open mind about everything. Also, remember to visit ACTIVISM (we can change things together). Posts: 5418 | From earth | Registered: Mar 2011
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-------------------- --Lymetutu-- Opinions, not medical advice! Posts: 96223 | From Texas | Registered: Feb 2001
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Razzle
Frequent Contributor (1K+ posts)
Member # 30398
posted
This is not just about Lyme tests. ALL tests developed by private labs which have not gone through the FDA approval process will be affected.
This essentially will destroy the innovation in medical testing, and increase the cost of tests.
Rare diseases would be heavily impacted, as no lab is going to seek FDA approval for tests only needed by a "rare" few individuals.
The problem is, if you actually have the rare disease, it is not rare in your case! This is the downfall of "evidence based medicine." It cannot deal with anything outside the scope and limitations of "common diseases happen commonly."
Ok, stepping down off my soapbox...
Please, please go to my thread in Activism and sign the petition about this issue:
posted
Signed it
Posts: 5 | From Connecticut | Registered: Jul 2014
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Catgirl
Frequent Contributor (5K+ posts)
Member # 31149
posted
Right on Kim!
-------------------- --Keep an open mind about everything. Also, remember to visit ACTIVISM (we can change things together). Posts: 5418 | From earth | Registered: Mar 2011
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