LYMEPOLICYWONK: The CDC, the FDA and Lyme Disease Lab Tests: Two-Tiered Tests, IGeneX, the C6, and the New Culture Test

16th March 2013

Science testtubes etc

The CDC website now states that before the CDC will recommend new tests, “their performance must be demonstrated to be equal to or better than the results of the existing procedure, and they must be FDA approved.” But is FDA approval required for diagnostic tests? No, FDA approval is only required for tests that are marketed to other labs. Single lab tests, like those offered by IGeneX and Advanced Laboratory Services (ALS) do not require FDA approval. Instead, federal law requires that they undergo a rigorous validation process established by the Centers for Medicare and Medicaid Services (CMS) and Clinical Laboratory Improvement Amendments (CLIA). CMS and CLIA require developers to prove that their tests are accurate, precise, sensitive, and specific prior to marketing. Both IGeneX and ALS diagnostic tests are CLIA and CMS approved. Why is the CDC asking for more than compliance with federal regulations?

And, what about its other requirement—that the test must be equal to or better than the existing two-tiered testing procedure recommended by the CDC. Research shows that the current two-tiered testing procedures do more harm than good.  While the testing has few false positives (called “high specificity”), it has many false negatives (or “low sensitivity”). Two-tiered testing misses 44 of every 100 patients who have Lyme disease. Imagine if that were the case with AIDS!  Take a look at the table below from the article “Let’s Tackle the Testing”:

What plan do the CDC and NIH have for the future of testing?  Well, the NIH has invested heavily in the C6 test. The C6 is commercially marketed by two companies, Immunetics and DiaSorin, both of whom have commercial ties with Dr. Wormser, who authored the IDSA guidelines which require positive lab tests for diagnosis.  In addition, Immunetics receives NIH research grants, which fund Dr. Wormser’s research. Dr. Barbara Johnson of the CDC and Dr. Gary Wormser, who authored the IDSA guidelines, have jointly published a number of articles supporting this test, which is FDA approved, but performs no better than the two-tiered strategy.  So, why is the American public funding C6 research?

And, how do tests the CDC is targeting fare?  The IGeneX test is called on in a CDC “warning” issued in February 2005 cautioning against tests that “interpret Western blots using criteria that have not been validated and published in peer-reviewed scientific literature.”  IGeneX test reports specify whether the test results meet the CDC interpretation criteria, which requires 5 of 10 IgG bands. However, other studies were able to increase the sensitivity of the test to 93% or higher by using an interpretation requiring 2 of 5 bands.  So, IGeneX also reports this information.  Why is the CDC ignoring these studies which have a far greater sensitivity?

What about the ALS culture test?  The CDC surveillance criteria list “culture test” as an acceptable test, and culture tests are widely regarded as the “gold standard” of testing.  As noted above, the ALS test has been validated using the CLIA and CMS requirements.  However, it is a relatively new test.  A recently published study of the test demonstrated that it had sufficient sensitivity and specificity, but these findings should be confirmed in additional studies. Why isn’t the government funding this type of research?

It’s time for the CDC and the NIH to abandon the failed two-tiered strategy and stop funding tests like the C6, which do no better.  Patients want diagnostic tests with greater sensitivity so that patients can get diagnosed and treated.  A recent article pegs the number of Lyme tests performed annually at 3.4 million—which translates into a market of roughly $340 million a year.  Not only do these numbers suggest that there is a lot more Lyme around than the CDC or IDSA acknowledge, but they also tell us that commercially vested interests and the researchers they consult with may have a stake in keeping the status quo in lab testing regardless of how bad the tests are. Could monetary considerations have something to do with opposition to new lab tests?

The LYME POLICY WONK blog is written by Lorraine Johnson, JD, MBA, who is the Chief Executive Officer of, formerly CALDA. Contact her at


The American Association for Clinical Chemistry, which is a professional association of over 8,000 members concerned with blood diagnostic tests, has an extensive website describing diagnostic lab test validation requirements.  Interested readers should check it out.

Centers for Disease Control and Prevention, Lyme disease: Two-step Laboratory Testing Process

Centers for Disease Control and Prevention. Notice to Readers: Caution Regarding Testing for Lyme Disease. Mmwr. February 11, 2005 February 11, 2005;54((05)):125.

Engstrom SM, Shoop E, Johnson RC. Immunoblot interpretation criteria for serodiagnosis of early Lyme disease. J. Clin. Microbiol. 33(2), 419–427 (1995).

Kelly, J. Lyme Culture Test Causes Uproar. Medscape (Jan 30, 2013).

Ma B, Christen B, Leung D, Vigo-Pelfrey C. Serodiagnosis of Lyme borreliosis by western immunoblot: reactivity of various significant antibodies against Borrelia burgdorferi. J. Clin. Microbiol. 30(2), 370–376 (1992).

Sapi E, Pabbati N, Datar A, Davies EM, Rattelle A, Kuo BA. Improved culture conditions for the growth and detection of borrelia from human serum. Int J Med Sci. 2013;10(4):362-76.

Shah JS, Du Cruz I, Narciso W, Lo W, Harris NS. Improved clinical sensitivity for detection of antibodies to Borrelia burgdorferi by Western blots prepared from a mixture of two strains of B. burgdorferi, 297 and B31, and interpreted by in-house criteria. European Infect. Dis. 2010;4:56–60.

Stricker RB, Johnson L. Lyme wars: let’s tackle the testing. BMJ. 2007 Nov 17;335(7628):1008.

Related posts:

  1. LYMEPOLICYWONK: New Lyme Disease Culture Test Could be Game Changer
  2. LYMEPOLICYWONK: Embers Monkey Trials Part 4. Lab Tests Fail to Detect Lyme Disease.
  3. NEWS: Lyme culture test causes uproar
  4. NEWS: Clarification on new Lyme culture test
  5. NEWS: Latest info about new Borrelia culture lab test

10 thoughts on “LYMEPOLICYWONK: The CDC, the FDA and Lyme Disease Lab Tests: Two-Tiered Tests, IGeneX, the C6, and the New Culture Test

  1. The lack of accurate lyme testing continues to be both infuriating and very disheartening and discouraging. Until the financial conflicts of interest end, I don’t see anything changing in my lifetime. So very frustrating.

  2. Thank you for this EXCELLENT piece! The graphic w/comparison is better than anything I have seen to get down to brass tacks…. Sharing Sharing Sharing! Great piece!

  3. Who regulates the CDC, is it congress or the executive branch? I think we should write letters or complain to someone about this double standard.

    • The Office of Inspector General of the DHHS or the Government Accounting Office. The Office of Inspector General has been doing some good work as of late but the GAO is probably the most independent organization in the Federal Government and answers only to Congress. The OIG head is a political appointee and also answers to Congress. I encourage you to write to both organizations.

  4. It’s all about money and power. I like to call the CDC the Center for Disease Cover-up and the FDA the Fatal Drug Approvers.

    Proteomics was very promising for the detection of any disease. The first one was Ovacheck and being high risk for ovarian cancer I entered the study back in 2002. In 2007 I wondered what happened to the test so I started researching and found Congressional testimony that doctors at the NIH left to start a new company that competed with the patent holder of Ovacheck and a few other diagnostic tests they had developed. The company eventually went out of business because they couldn’t get their test approved (the FDA said it was going to regulate it as a medical device) which is unfortunate because ovarian cancer is usually found when it is too late.

    In conclusion it isn’t Lyme disease although the Lyme community has done an amazing job in bring about awareness of the conflicts but it is our medical industrial complex that is the problem or cancer industrial complex or fill in the blank. And the patient population pays dearly for their corrupt and greedy behavior. You’re right we all need to be more involved. Also read “Next” by Michael Lewis. The way he describes new technology as having the ability to flatten the business hierarchy is fascinating without the permission or interference of the militant FDA, CDC or the NIH.

    Thank you for this article.

  5. This article would be much more helpful, especially for those new to the field, if it explained some of the tests mentioned: it does not define or give a link to information about the “C6″ test or the ALS test.

  6. I am at lost for words when it comes to the CDC. We are in an epidemic when it comes to Lyme Disease, as many cases get hidden due to the so called two- tiered testing.
    Elisa test was negitive, so years went by for my daughter with symptoms going to her heart, joint, body and now her brain. She will never be the same ever again. For the last 10 yrs since the age of 15, my daughter has suffered. Yes, a Wertern Blot was finally done years later and tested positive for Lyme but will the CDC take care of her now with her body and brain damaged?.
    Francine Roca, Tarpon Springs Fl.

    • I am so sorry for your daughter. It is sad for sure.

      I don’t have Lyme disease and neither does anyone in my family but we are becoming quite active in fighting the corruption in medicine. This is the best place to start because that is what this is all about, corruption and greed.

      I was poisoned by gadolinium based contrasting agents (GBCAs) used for MRIs that have been injected into millions of people but many don’t even know why they are sick. Gadolinium is a toxic metal and I was injected with GE’s product Omniscan 11 times for profit.
      I think of the parents whose children are autistic because, many believe, of the mercury laced vaccinations. I can tell you I would be fit to be tied. How do these parents live with the knowledge that their child was injured by vaccinations and not a single doctor will support them? And then there is surgical mesh. Every single woman that has surgical mesh has 24/7 pain and infections for a product that never should have been used. But we hear nothing of these stories. Johnson and Johnson is responsible.

      Those in the Lyme community in my opinion have done the best job of organizing but we need to bring in more people and we need to understand it is all about corruption and greed.

    • Francine, we are in the same boat here with our two girls. It is shameful how their young lives have been spent in illness, pain, and debility due in part to the CDC’s refusal to come to terms with the enormity of the Lyme epidemic. It’s also shameful how doctors expected them to accept their illnesses with no diagnosis other than psychosomatic disorder. No one suggested further testing, or even Lyme, for that matter. It was a never-ending quest for answers that finally led me to Igenex and their Western blot. I want to do more to stop this madness, but unfortunately most of my time is spent trying to get my girls well. That is the case with so many; they’re too sick to do little more than devote their time and energy to seeking answers to their enormous health issues. This has got to stop!

  7. I get the impression from this article that there are only 2 sources for diagnostic test kits for Lyme Disease. That is misleading. Back in the early 90′s I was selling EIA test kits that had 97% sensitivity and 97% specificity. I can’t imagine why the medical community is going backwards with their testing capabilities. I haven’t worked for the company for many years, but I can attest to the accuracy of their products! Here is the link for the diagnostic kits I used to sell:

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