Lyme Disease Support Network

Igenex testing, what's the deal?


And I would highly caution anyone seeing a doctor who contends that the standard CDC protocol is a perfectly sufficient diagnostic metric for Lyme. Of the 3 bands looked at for IgM Western blots, band 41 is widely cross-reactive, 39 is cross-reactive among all spirochetes, and only band 23 (Outer surface protein C/OspC) is Borrelia-specific. Outer surface proteins B and C, two of the most widely studied Lyme antigens, are completely excluded. Further complicating matters is that fact that OspC is a widely variable protein, so much so that the literature groups strains by their “OspC type.” Almost all labs use strain B31 as the source of their antigens for ELISA and Western blot tests, which is an OspC type A strain. The problem is that OspC types B, I, K, and to a lesser extent H, are also widely prevalent and proven to cause infection (source 1, table 1). Antibody cross-reactivity studies have shown devastatingly low levels of cross-reactivity between OspC type A and the other types (source 2, table S3), especially K, which is the most common type in the Northeast (includes strain 297). This means that by the CDC protocol, if you are infected with an OspC type K strain, your band 23 that would have made you CDC positive could come back negative, and you might go untreated.

I am all for skepticism regarding the LLMDs and specialty labs, but as someone with a biology degree and several years of molecular biology/microbiology research experience, some of the “science” I have seen from the conventional doctors and government agencies regarding Lyme is borderline disgraceful, and is at a minimum a violation of basic scientific thought and logic.


  1. Brisson D, Baxamusa N, Schwartz I, Wormser GP (2011) Biodiversity of Borrelia burgdorferi Strains in Tissues of Lyme Disease Patients. PLoS ONE 6(8):
    e22926. doi:10.1371/journal.pone.0022926
  2. Baum E, Randall AZ, Zeller M, Barbour AG (2013) Inferring Epitopes of a Polymorphic Antigen Amidst Broadly Cross-Reactive Antibodies Using Protein
    Microarrays: A Study of OspC Proteins of Borrelia burgdorferi. PLoS ONE 8(6): e67445. doi:10.1371/journal.pone.0067445


31-OspA and 34-OspB

In the 1996 serology conference (I was there and along with my colleague Willy Bugrdorfer who was one of the primary presenters. There was agreement that the use of OspA and OspB (31-and 34-kDa) bands did not significantly add to the sensitivity or the specificity of the IgG Western blot (The western blot is what Igenex does - its a technique not a specific test), as these bands may develop only late in disease and other diagnostic bands would already be present when OspA and OspB antibodies appeared.

The concern was that the elimination of these bands (OspA and OspB) from the diagnostic criteria might result in excluding some cases of Lyme disease.

WeThe conference reviewed the data for all patients who had positive ELISAs and immunoblot assays for Lyme disease from 1 September 1992 to 31 December 1993 in order to assess whether any patients considered to have Lyme disease by the previously used criteria would now be considered negative according to these new recommendations.Of the 136 patients who were evaluated for suspected Lyme disease during that time period, 50 were considered to have Lyme disease. Of these 50, 4 patients would not have met Western blot criteria for the diagnosis of Lyme disease by the new recommendations. Quite the opposite effect actually. But that is left out in "independent testing. Granted 136 patients is on the low end of what would be considered a strong statistical base

The numbers a better for the current method The recommendations by the CDC/ASTPHLD are based on data by Dressler et al., who prospectively evaluated 225 case and control subjects.
They concluded that the following bands were considered helpful in the diagnosis of Lyme disease: 18, 21, 28, 30, 39, 41, 45, 58, 66, and 93 kDa. The reported sensitivity and specificity of the IgG blot after first weeks of infection were 83 and 95%, respectively. In the world of serology those are significant numbers. (and no where close to 65%.

There was another interesting thing brought out in the conference and interestingly enough brought up by Eileen Hilton, james Devoti and Sunlil Sood from Long Island Jewish Medical Center who were proposing the addition of 31-OspA and 34-OspB and that was that Currently, the most common problem in diagnosing Lyme is the over diagnosis of Lyme disease, and the development of standardized criteria for the serological diagnosis of Lyme disease is a welcome improvement.

I’m not saying that there isn’t room for evaluating the whole serological basis of Lyme diagnoses, but then serology has NEVER been an absolute measure of anything.

My problem with “specialty labs” is not necessarily the data they produce, My problem is LLMDs and their use of the data. Pouring antibiotics into folks based on the data is the problem. Is malpractice (if not criminal) pure and simple. Herxing for example, they say is a good thing when it is body reacting to poison and trying to right itself. Its a very serious situation.

According to Serological Testing I have measles, mumps, chicken pox, and polio and even Hong Kong flu. Some of those things I have had some I have not, but I have been exposed to all and will have positive bands if a blot is done. Doesn’t mean I need treated for any of them.

What these guys fail to do is understand is that serology simply is determining whether or not the immune system has responded to a stimuli. That response varies, so there is a lot more to diagnosing a condition than just a “blood test”

Huge differences in antibody responses of patients with Lyme borreliosis have been noted; European investigators have reported IgG bands of 22, 41, and 60 kDa in patients with meningitis and 13, 18, 21, 23, 30, 39, 60, 73, and 94 kDa in later stages of infection. Patients in the United States, while similar in their IgM responses (21 and 41 kDa), showed reactivity to greater numbers of spirochetal polypeptides including,
in addition to those above, the 28-, 31-, 34-, 45-, 58-, 66-, and 74-kDa proteins. In other studies from the United States, 71% of 80 patients with arthritis had strong IgG reactivity with OspA (31 kDa) or OspB (34 kDa) or both and have never been exposed to Lyme.

Antibiotics can treat active infections effectively. They can’t treat an infection that has run its course and the immune system has handled in some manner already.

So all of that to say IGENEX, so what. There is a huge reason they provide only Data not diagnoses. but the biggest problem is patients are not being properly treated as a result. Lyme when not treated EARLY can lead horrible disease OUTCOME and permanent Damage. Its is incorrectly called chronic lyme Disease 9only my the “Lyme Literate” The real problem is “Post-treatment Lyme Disease Syndrome” (PTLDS). That varies by the individual and needs treated for what is going on, not what caused it. Lyme has already done its damage. Keep in mind Lyme Spirochetes are gram-negative, motile, spiral bacteria that are antibiotic resistent. The more antibiotics you give them the stronger they get and the less able the body is to fight them.

So yes a good doctor will treat SYPMTOMs not a lab test. If that happens to be reactive Arthritis (the most common outcome) FMS, or other rheumatological symptoms, thats what needs treated. The best one can hope for from “testing” is confirmation that “yup,something is going on…”



Wow, you were a colleague of Dr. Willy Burgdorfer. Another moderator went fishing with him. I guess you would both know that Dr. Willy Burgdorfer stated–
'The controversy in Lyme disease research is a shameful affair. And I say that because the whole thing is politically tainted. Money goes to people who have, for the past 30 years, produced the same thing—nothing. There are lots of physicians around who wouldn’t touch a Lyme disease patient. They tell the nurse, “You tell the guy to get out of here. I don’t want to see him.” That is shameful. So [this] shame includes physicians who don’t even have the courage to tell a patient, “You have Lyme disease and I don’t know anything about it."
OspA and OspB (31-and 34-kDa) bands Were taking out of the Western blot due to greed over a failed Lyme vaccine.

In the early 90’s, Allen Steere described Lyme Disease as a disease that affects the brain causing a mass amount of systemic issues.
CDC decided to make a vaccine for Lyme Disease. 1992 Allen Steere decided to go to Europe and change the entire definition of Lyme Disease. In order to promote the new Lyme vaccine. CDC officers U, Yale, Corixa and Imugen all own patents.
Dearborn conference in 1994, Steere and others claimed Chronic Lyme no longer exist a new definition was made. This is just a part of the hidden truth about a 75 billion dollar disease called Lyme.


Understand that vaccines are most frequently not immunization but rather a treatment. (A common misunderstanding about “vaccines” The original patent in this area was from Ribi immunochem an independent research/development Montana company that interestingly enough is/was right across the street from the CDC Rocky Mountain Laboratory (RML is is best known as the “Tick Lab” around here. It was prolly one of the most successful projects to ever come out of the labs.

Recombinant vaccines didn’t do much for Lyme because Allen Steere was right in one respect . The problem isn’t Lyme as most people fully recover(about 90%) but rather the damage to both the body and immune system Lyme causes in the other 10%. That damage isn’t disease but rather the result of a disease that in some measure that group has recovered from. The Lymies have never distinguished the difference between active “Lyme Infection” and post infection syndromes. Its an important distinction wwhich has lead to unwarranted and unfounded attacks on Alan Steere and Barbara Johnson.

Recombinant vaccines pioneered at RML and Willy’s work have done more for treatment of multiple diseases than any single approach in recent years. Other “names” for them include “Gene Therapy,” Immunotherapy and “biologic Medications” Multiple forms of cancer (especially childhood cancers), HIV, most Recently Ebola Diseases once thought non treatable are now treatable. Death rates from childhood cancers have dropped from 80% to less than 20% in the past few years along with some forms of prostate, breast cancer and Multiple Myeloma. Millions of Arthritis patients now have a life as a result. The field is FINALLy emerging after nearly 70 years going back to of all things Rocky Mountain Spotted Fever research.

OspA and OspB (31-and 34-kDa) bands were not taken out of the Western blot due to greed over a failed Lyme vaccine. quite the opposite in fact. Willy and others understood that by including them, fewer patients would be treated. OspA and OspB (31-and 34-kDa) bands indicate (as near as anyone can tell) advanced disease damage including them in the “Western Blot” which is a diagnostic INDICATOR (not a pass fail test) would in the way things work preclude treatment for many who had negative OspA and OspB (31-and 34-kDa) bands.

It doesn’t mean the bands shouldn’t be done and the data isn’t important, it just means that they should NOT be a part of a screening/diagnostic protocol looking for active (and highly treatable) disease.

Here’s the problem as I see it. You are correct the disease is political. It hasn’t become that way because of the CDC, but rather by patients who are demanding treatment/cure. The whole process then falls into the hands of borderline charlatans who meet that demand with unproven/often dangerous treatments who take advantage of these folks. The basis of all of this is "we know what we are doing and the medical/pharmacology industries don’t and don’t want to. There is a long list of these diseases/conditions.

On a personal Note Lymrix is perfect example of disease politics gone arwy. It was designed as a three-dose medicine, studies showed the vaccine was 49 to 68 percent effective at preventing Lyme disease with two injections. After the third and final injection, that number jumped to 76 to 92 percent effective. The studies were done by multiple independent sources who had no financial stake in the thing.

In 1999, a class action lawsuit was filed against the drug company by 121 people who had received the vaccine and had developed arthritis. They claimed the vaccine caused harmful side effects and that the pharmaceutical company was hiding the evidence.

Around the same time, an infamous study in the journal Lancet connected another type of vaccine with autism. Today, that Lancet autism study has been retracted and proven false, but it helped fuel an anti-vaccine movement that still persists

In April of 2002, the company announced that sales for LYMErix had fallen from 1.5 million doses in 1999 to about 10,000 expected for that year. That was despite the fact that cases of Lyme diseases were on the rise. The company stopped producing and selling the vaccine that year.

After the company pulled the vaccine, the U.S. Food and Drug Administration (FDA) conducted several additional tests to verify or refute the lawsuit’s claims. They were unable to replicate the adverse events and side effects that opponents of the vaccine reported in the lawsuit and elsewhere.

The company settled the class action suit based on economic concerns for a product showing poor performance in the market. The final agreement included $1 million in legal fees but provided no financial compensation to the supposed vaccine victims.

Despite it still being approved and licensed in the United States and despite studies to refute the claims of side effects, Glaxo SmithKline has never reintroduced LYMErix.

It had nothing to do with The Dearborne conference, definitions, or the like. and everything to do with activism.