A New Immune Response Based Lyme Test: Is it Valid?

Medical topics with questions, information and discussion related to Lyme disease and other tick-borne diseases.
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A New Immune Response Based Lyme Test: Is it Valid?

Postby Claudia » Sun 13 Feb 2011 22:52

The name is goofy: "My Lyme Immune I.D.," and the company, NeuroScience, Inc., is questionable...

MY Lyme Immune I.D.

A revolutionary new test method for the assessment of acute and chronic Borrelia burgdorferi (Lyme) specific immune response in patients.

What makes this test different?
The combination of B. burgdorferi (Lyme) specific T cell response and cytokine analysis, in conjunction with standard western blot, evaluates both cellular and humoral immune responses, as well as the inflammatory response. This comprehensive assessment provides the most complete clinical analysis available.

MY Lyme Immune I.D. Comprehensive Assessment (#5652) Includes:

Immune Tolerance Test® (ITT®)
Identifies T cell response specific for B. burgdorferi (Lyme) antigens, even hidden or low levels.
Includes a panel of B. burgdorferi (Lyme) specific antigens that offer early and late stage identification.

Protein mitogens used:

OspC - Early antigen appears shortly after tick bite or transfer of the spirochete
p41 - Early and late antigen that provides mobility to the spirochete
VlsE-1 - Late antigen appears after spirochete infection
p100 - Late stage antigen
DbpA - Essential protein needed for overall virulence

Cytokine Analysis
Analysis of B. burgdorferi (Lyme) antigen specific inflammatory immune response in patients.
Provides guidance for effective intervention protocols.Assessment includes cytokines, chemokines, and immune growth factors:

IL-1β IL-6 IL-10 IL-13 G-CSF MCP-1 TNF-alpha

Western Blot Analysis (IgG and IgM) (Industry standard methodology)


Here's a recent company press release about being the recipient of a Federal Government grant, with additional information about the test:

SOURCE: NeuroScience, Inc. Nov 03, 2010

Pharmasan Labs, Inc. Wins Grant for Novel Immune Tolerance Test (ITT)-Cytokine Platform

OSCEOLA, WI--(Marketwire - November 3, 2010) - Pharmasan Labs, Inc. and NeuroScience, Inc. announce that Pharmasan Labs is the recipient of a $244,479 grant under the highly competitive Qualifying Therapeutic Discovery Project ("QDTP") Program established by the Patient Protection and Affordable Care Act of 2010. The grant was awarded for the company's novel immune testing platform that aims to diagnose clinically relevant immune responses across a spectrum of acute and chronic conditions, thereby facilitating more targeted therapeutic interventions.

The ITT-Cytokine platform can help identify the root cause of chronic conditions, allowing practitioners to provide appropriate therapeutic interventions. As an example, Pharmasan Labs, Inc., in collaboration with NeuroScience, Inc., currently offers MY Lyme Immune I.D.™, which assesses whether an individual has had an immune response to the Lyme disease bacterium Borrelia burgdorferi and whether the infection is currently active.

"While Lyme disease, food sensitivity, and other conditions are often diagnosed using antibody-based methodologies, these traditional detection methods can sometimes yield false-negative results," remarked Mieke Kellermann, President of Pharmasan Labs, Inc. "By assaying for the presence of antigen-specific T cells and elevated cytokine production in response to specific antigens, we are identifying the key drivers of inflammation underlying clinical pathology and symptoms. Therefore, the ITT-Cytokine platform offers a superior diagnostic approach to antibody-based testing."

In the ITT-Cytokine platform, an individual's white blood cells are isolated and cultured in the presence of individual antigens, such as proteins from bacteria or food. If the individual's white blood cells contain T cells (a type of white blood cell) that respond to that antigen, they become activated, leading to both an increase in number as well as heightened production of cytokines (soluble messengers of inflammation).

The QDTP Program funds research that shows significant potential to produce new cost-saving therapies, create U.S. jobs, and increase U.S. competitiveness. The Department of Health and Human Services evaluated each project for its potential to produce new therapies, reduce long-term health care costs, or cure cancer within 30 years.

About Pharmasan Labs, Inc.

Pharmasan Labs, Inc. is an independent, CLIA certified lab (ID #52D0914898) also licensed by the New York State Department of Health (Serial #CQPZ6456). It performs testing in the fields of neurology, immunology, and endocrinology and offers its services through NeuroScience, Inc.

http://www.marketwire.com/press-release ... 346271.htm

NeuroScience, Inc., had some trouble with the FDA a few years back:

Second FDA Warning Letter to NeuroScience, Inc., from 2006:

http://www.casewatch.org/fdawarning/pro ... ence.shtml

And Science Based Medicine recently featured the company in an article on bogus diagnostic tests, concerning other tests that they offer and their company business model of selling both tests and their remedies (nutraceutical supplements), and NeuroScience's relationship with Pharmasan Labs:

Scienced Based Medicine, April 2010

"Bogus Diagnostic Tests"


A Full Service Company

If my friend’s daughter had followed her psychiatrist’s recommendation, she would have sent her saliva and urine samples to a company called NeuroScience, which would have had them tested for certain hormones and neurotransmitters. The psychiatrist would have chosen those tests based on prompting by NeuroScience itself. Here’s what would have happened next:

"Based on the laboratory results, NeuroScience, Inc. works with healthcare providers to develop Targeted Amino Acid Therapy (TAAT™) protocols designed to address the spectrum of neurotransmitter and hormone imbalances. Addressing neurotransmitter and hormone imbalances through TAAT™ can lead to significantly improved patient outcomes for a number of today’s most challenging conditions. Why wait? Get Started with NeuroScience, Inc. today."

NeuroScience will even help providers convince insurance companies to pay for the tests. And there’s no extra waiting time, because NeuroScience sells not only the tests, but the remedies. But it sells them exclusively to practitioners, who are then expected to resell them to their patients for a markup (look here for an example of the report that the practitioner will receive). If all goes according to plan, that sweet deal will last quite a while:

"It is possible to decrease chances of excitatory overload by introducing inhibitory support for one to two weeks prior to the addition of excitatory support. This 1st phase strengthens just the inhibitory system, allowing it to regain control over the excessive excitatory activity during the night. This often leads to improvements in the quality of sleep in many patients. Excitatory support is then introduced in the second phase to enhance excitatory neurotransmission throughout the day, to increase motivation and reduce fatigue.

The second phase of therapy is structured in a way that mimics the body’s natural circadian rhythms. Excitatory neurotransmitter support, if needed, is typically recommended earlier in the day, when the body requires the energetic and cognitive effects of the excitatory transmitters. Likewise, inhibitory support is typically suggested in the latter half of the day, to calm the body and set the stage for sleep.

Even though specific amino acids can change single neurotransmitter levels rapidly, it is difficult to predict when a patient will experience symptomatic improvement. Many report improvement within the first week, whereas others may require several months of continued therapy to note significant changes. It is our experience that 3-6 months is the average amount of time it takes to optimize neurotransmitters overall.

The transition to the final phase of therapy is recommended when the patient has reached their health goals and their neurotransmitter levels have been optimized, as determined through follow-up lab tests. This phase serves as a maintenance phase, whereby the dosing of products is reduced to the minimum level that maintains the symptom resolution. The unfortunate reality of any approach to neurotransmitter imbalances is that the effects of the intervention may not be maintained with discontinuation. Due to ongoing factors that influence neurotransmitter levels, including stress, diet, and genetics, some individuals will require long-term neurotransmitter support. Hence the focus of the third phase is to maintain optimal neurotransmitter levels long-term to offset factors contributing to their imbalance and in the interest of preventing a recurrence of symptoms."

Wow! Not only can “addressing neurotransmitter and hormone imbalances through TAAT™ lead to significantly improved patient outcomes,” it can also lead to significantly improved practitioner incomes! What a company! What doc, squeezed by diminishing 3rd-party reimbursements, wouldn’t be tempted to sign up?

There are only a couple of problems. Hormone levels measured in saliva are almost never legitimate.


NeuroScience also boasts of the legitimacy of its laboratory tests. It outsources these to a convenient “independent” lab, Pharmasan, which seems to be right next door and which shares its founder with NeuroScience:

"Gold Standard Laboratory Testing
NeuroScience, Inc. uses an independent, CLIA certified testing lab that is licensed in every state–including New York, which holds the highest level of qualification standards."


Anyone know any more about this type of immune response and antigen testing for accurately diagnosing Lyme disease, if it is psuedoscience and a misuse of laboratory testing like some of their other offerings, or does it have real diagnostic validity?

Posts: 1448
Joined: Wed 14 Nov 2007 1:19
Location: Connecticut, USA

Re: A New Immune Response Based Lyme Test: Is it Valid?

Postby Claudia » Mon 14 Feb 2011 16:50

From Relative Risk Blog, December 27, 2010

Some notes on evolving diagnostics

BBK07 immunodominant peptides as serodiagnostic markers of Lyme disease.

Clin. Vaccine Immunol. doi:10.1128/CVI.00461-10
22 Dec 2010.
Coleman AS, et al.

With millions of serum samples tested for LD each year, standardization and automation of serological testing are one of the major goals of LD research.

Recombinant and synthetic antigen ELISA kits ease standardization, are amenable to automation, and may improve specificity by concentrating B. burgdorferi-specific epitopes. Among the synthetic antigens previously tested for early LD diagnosis is the OspC-derived peptide pepC10. Highly conserved among Borrelia strains, pepC10 is 10 amino acids in length, and appears to be a target for IgM antibodies during the early infection. The synthetic peptide C6, isolated from a conserved region of the variable membrane protein VlsE, is a target for host IgG, and has been shown to be a sensitive and specific serodiagnostic marker. While purified antigens show great promise, no recombinant or synthetic antigen has demonstrated sufficient sensitivity to replace the current two-tiered approach. Some of the highest sensitivities reported thus far have used several antigens in combination to enhance diagnostic accuracy. However, there remains a need for improvement in sensitivity, especially for detection during the earliest stages of disease. The addition of new immunogenic epitopes could allow these tests to eventually supplant the two-tiered approach, improving both the efficacy and cost of LD testing.

The B. burgdorferi lipoprotein BBK07 was identified as an immunodominant antigen in a study by Barbour et al. We have recently shown that BBK07 is an in vivo-induced surface antigen, which is selectively expressed during mammalian infection and is a promising serodiagnostic marker for LD. We demonstrated that an amino-terminal fragment of BBK07 could be used as a component of effective serodiagnostic marker to detect human LD.

In our current studies we further assessed the sensitivity and specificities of BBK07-based diagnosis using serum samples from North American and European patients with diagnosed LD and several other conditions including syphilis and autoimmune diseases. We also assessed the serodiagnostic abilities of BBK07 using a full-length protein and an overlapping peptide library, identifying the most immunogenic epitopes of BBK07. We demonstrate that serum testing using a combination of peptides was superior to full-length BBK07 protein. Finally, we show that the peptides are able to detect both canine and human LD, even during the early stages of the disease. IgG and IgM ELISAs further show that a cohort of human LD sera failed to recognize VlsE-derived C6 or OspC-derived pepC10 peptides but exclusively reacted with BBK07 peptides attesting their potential use in enhancing diagnostic sensitivity of early LD.

The effectiveness of some B. burgdorferi antigens, including VlsE, OspC, and BmpA, has been reduced by sequence variation in the bacterial population. Our data indicates that BBK07 immunoreactivity is detectable across the B. burgdorferi isolates present in North America, but not in European LD patients. Although the BBK07 gene is highly conserved in B. burgdorferi sensu stricto isolates in United States, the linear plasmid carrying the BBK07 gene or an ortholog thereof is absent in major B. burgdorferi sensu lato strains prevalent in Europe. Therefore, while BBK07 diagnosis is unlikely to be effective in Europe, reactivity to BBK07 or similar antigens absent in other B. burgdorferi sensu lato species could aid physicians or researchers in differentiating between individuals infected with B. burgdorferi or the European strains.

Posted by Relative Risk at 06:33

http://relative-risk.blogspot.com/2010/ ... html#links
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