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
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?