Diagnostic Testing and Standard Lab Testing

Nagalese Testing

Nagalase in Blood
Test for monitoring efficacy of therapy for cancer and certain viral infections

Nagalase in serum / plasma
The test measures the activity of an enzyme α-N-acetylgalactosaminidase (nagalase) in blood.

Nagalase is an extracellular matrix-degrading enzyme that is secreted by cancerous cells in the process of tumor invasion. It is also an intrinsic component of the envelope protein of various virions, such as HIV and the influenza virus. Thus, it is also secreted from virus-infected cells1,3,4.

Nagalase deglycosylates the vitamin D3-binding protein DBP (also known as Gc-protein). Gc-protein, which contains three sugars, is the precursor for the major macrophage-activating factor (MAF). By complete deglycosylation, Gc-protein can no longer be converted to MAF.

Normally, MAF is produced from the Gc-protein by sequential removal of the galactose and sialic acid without touching the remaining sugar N-acetylgalactosamine.

Macrophage activation for phagocytosis and antigen presentation is the first step in the immune development cascade. Lost precursor activity, therefore, leads to immune suppression.

Increased nagalase activity has been detected in the blood of patients with a wide variety of cancers like cancer of the prostate, breast, colon, lung, esophagus, stomach, liver, pancreas, kidney, bladder, testis, uterus, and ovary, mesothelioma, melanoma, fibrosarcoma, glioblastoma, neuroblastoma, and various leukemias1,3,4. For various types of tumors, various levels of nagalase activity were found7. It appears that the secretory capacity of individual tumor tissue varies among tumor types depending upon tumor size, staging, and the degree of malignancy or invasiveness7. Increased nagalase activity has not been detected in the blood of healthy individuals1.

Nagalase activity is directly proportional to viable tumor burden1,2. Studies correlating nagalase levels with tumor burden suggest that the measurement of this enzyme can diagnose the presence of cancerous lesions below levels detectable by other diagnostic means1. In research studies, nagalase activity decreased to near tumor-free control levels one day after surgical removal of primary tumors from cancer patients, suggesting that the half-life of nagalase is less than 24 hours1,6. The short half-life of nagalase is valuable for prognosis of the disease during various therapies1,5.

Test indications
Nagalase in blood is a sensitive test for monitoring the efficacy of therapy in cancer and certain viral infections, including HIV and recently HSV-1/2. Because of the short half-life of nagalase, the method is suitable for monitoring various types of therapy. The great sensitivity of the test may help the physician / oncologist in obtaining a better understanding of the therapy and to fine-tune the treatment.

NOTE: The values may be affected by certain drugs used in the five days preceding blood draw. Drug use must be indicated on the Questionnaire submitted with the Requisition Form.

Korbelik M, VR Naraparaju, N Yamamoto. The value of serum alpha-N-acetylgalactosaminidase measurement for the assessment of tumour response to radio- and photodynamic therapy. Br J Cancer, 77:1009-1014, 1998.
Reddi AL et al. Serum alpha-N-acetylgalactosaminidase is associated with diagnosis/prognosis of patients with squamous cell carcinoma of the uterine cervix. Cancer Lett, 158:61-64, 2000.
Yamamoto N and M Urade. Pathogenic significance of alpha-N-acetylgalactosaminidase activity found in the hemagglutinin of influenza virus. Microbes Infect, 7:674-681, 2005.
Yamamoto N. Pathogenic significance of alpha-N-acetylgalactosaminidase activity found in the envelope glycoprotein gp160 of human immunodeficiency virus Type I. AIDS Res Hum Retroviruses, 22:262-271, 2006.
Yamamoto N, H Suyama, N Yamamoto. Immunotherapy for prostate cancer with Gc protein-derived macrophage activating factor (GcMAF). Transl Oncol, 1:65-72, 2008.
Yamamoto N et al. Therapeutic efficacy of vitamin D3-binding protein-derived macrophage activating factor for prostate, breast and colon cancers. Cancer Res Proc, 38:31, 1997.
Yamamoto et al. Deglycosylation of serum vitamin D3-binding protein leads to immunosuppression in cancer patients. Cancer Res, 56:2827-2831, 1996.

Neurotransmitter Testing

Orthomolecular Nutrition & Wellness Centers first step is to assess the patients’ neurotransmitter and adrenal hormone biomarkers with a functional laboratory test.

NeuroLab™ from Sanesco provides our patients with 3 primary profiles that measure 6 primary urinary neurotransmitters: Serotonin, GABA, Glutamate, Dopamine, Norepinephrine, and Epinephrine. Salivary adrenal hormones are also measured: 4 timed Cortisols and 2 DHEA. This profile assesses the six neurotransmitters that affect the hypothalamic-pituitary axis (HP) as well as the adrenal hormones cortisol and DHEA. Since the HPA axis initiates an adrenal response, this profile allows the practitioner to assess that response and make therapeutic decisions based on the information. Neurotransmitters are measured from a single urine sample, while cortisol (X4) and DHEA (X2) are measured from four saliva samples, the first taken between 7:00 and 8:00 am and then one every five hours thereafter for the remaining three samples. Orthomolecular Nutrition & Wellness provides a correlation analysis that includes unique clinical decision support and risk management personalized with respect to your patients. Customized functional input is included in each report, as each patient has a unique biochemical make up and variety of lifestyle factors and symptoms. The clinical team is correlating patient lab values to symptoms and severity, medications and dosages, lifestyle factors, medical diagnoses, supplements, and demographics to best analyze these interrelated variables and what this means for you and your patient.

Patient Discovery
When a patient presents one or more symptoms to our practitioner, they are given the appropriate Sanesco test collection kit(s) to establish baseline levels. Each non-invasive urine and/or saliva test provides a convenient, at-home collection method that encourages patient compliance. Urine testing follows an CLIA-approved technology developed by Sanesco’s scientific board . The patient mails the collected sample(s) to Sanesco in a pre-addressed, postage-paid box. Together with the patient’s symptoms, it is logged by Sanesco and forwarded to NeuroLab™ for processing. Test results are sent to Sanesco, whose expert team of multi-disciplinary researchers and clinicians develops a recommended treatment protocol that takes into consideration the patient’s symptoms, the test results and the over 100 self-reported lifestyle, medication, supplementation, medical history factors. A copy of the test results is then forwarded to the practitioner together with Sanesco’s individualized interpretation and educational comments. Whenever requested, Sanesco’s expert team is also available to further interpret test results and assist the practitioner in selecting a viable therapeutic approach. A key advantage of Sanesco’s functional assessment protocol is testing frequency. After an initial baseline is established, it is very important to regularly retest a patient’s neuronal and hormonal responses to measure changes that occur over time. Once therapy is initiated, the patient’s levels begin to shift; retesting allows the restoration of a patient’s health, a period that may last from three to nine months, depending on the individual and the severity of their symptoms. When a patient’s symptoms are relieved and long-term health has been restored, annual or semi-annual testing is conducted to maintain the patient’s state of health and prevent the return of symptoms.

Baseline Laboratory Assessment
Sanesco’s CSM™ process begins with assessment of a patient’s neurotransmitter and adrenal hormone levels with a non invasive lab test. This first step is necessary to begin to fully understand our patient’s neuro-hormonal status. An initial test established a baseline, and helps reveal underlying imbalances that may contribute to the manifestation of symptoms. Unlike traditional test and treat diagnostic models. Our laboratory assessment includes non-invasive serial testing that allows you to monitor changes in neuronal and hormonal responses over time, letting us make adjustments to a patient’s therapeutic protocol to achieve an optimal neuroendocrine balance and effective clinical outcomes.

Retesting for Neuroendocrine Optimization
One of the cornerstones of the CSM™ clinical model is retesting. Monitoring neurotransmitter and hormone levels throughout the rebalancing process is the most effective way of guiding individual therapy. The patient’s current response can be measured against previous results and symptoms, allowing for imbalances to be more adequately addressed. Targeted Nutritional Therapy will be adjusted as results are viewed and compared. With each retest, the patient is moving closer to achieving HPA axis and symptom balance. Example showing the previous and current values are below.http://www.ortholiving.com/images/before-after-results.jpg

What is a neurotransmitter?
The brain makes chemical messengers called neurotransmitters. Neurotransmitters are produced and stored in the brain and are released into action when the brain cells are electronically activated. They are responsible for every thought, mood, pain and pleasure sensation we feel. They control our energy level, our appetite and the foods we crave. Neurotransmitters even regulate how well we sleep as well as our sex drive. Psychological stress and physiological changes can cause neurotransmitter deficiencies or imbalances; likewise, the neurotransmitter deficiency or imbalance can cause psychological changes. Neurotransmitters can be easily measured by specialized noninvasive laboratory testing. Thinking of it this way: it is common to measure thyroid levels before prescribing medication and to test a diabetic’s blood sugar before adjusting the dose of insulin. Therefore, before treating an individual with neurotransmitter imbalances, it is important to identify their specific levels in order to recommend the best therapeutic support. Neurotransmitters and hormones commonly measured are serotonin, dopamine, GABA, nor epinephrine, epinephrine, glutamate, cortisol, DHEA and thyroid. A deficiency of any particular neurotransmitter not only affects neuronal function but also endocrine function anywhere in the body. Our endocrine system is considered primary and critical to all metabolic function. Glands such as the thyroid, the adrenals, the ovaries and the testes all take direction from the brain. There are many conditions that negatively impact hormone levels, and when one hormone is imbalanced, there is a tendency for many other hormones to follow suit. Correction of imbalanced hormones is important but not always sufficient. Correction of imbalanced neurotransmitters, on the other hand, is imperative if clinical progress is to be made. Determining which neurotransmitters are low and which are high should preclude intervention. For instance, combining poor diet with a stressful life-style is a recipe for neurotransmitter imbalances. The types of food we crave (starches, chocolate or sweets)and the time of day we crave them (late afternoon or evening) may characterize specific neurotransmitter deficiencies. In fact, serotonin depletion is one of the most common neurotransmitter imbalances in our culture.

Common symptoms/conditions of serotonin/dopamine imbalances include:
Anxiety and panic attacks
Strong craving for sweets
Difficulty concentrating
Headaches (including migraines)
Low motivation
Chronic pain
Irritability and anger disorders
Seasonal affective disorders
Decreased sex drive

What causes neurotransmitter deficiencies?

Weight Loss / Dieting
Dieting is the most common cause of self-induced neurotransmitter deficiencies. Protein deficient diets may not supply adequate tryptophan, which is necessary for serotonin production. Carbohydrate is necessary to deliver tryptophan to the brain for serotonin production. High protein/low carbohydrate diets are a two-fold problem – there is not enough insulin and too much amino acid competition, which restricts the basic building blocks needed to produce enough neurotransmitters. Studies from major universities, including Harvard, MIT and Oxford, have documented that women on diets significantly deplete their serotonin within three weeks of dieting! This induced serotonin deficiency eventually leads to increased cravings, moodiness and poor motivation, which all contribute to rebound weight gain – the common yet unfortunate consequence of dieting. Diets may also be deficient in B-vitamins and other necessary nutrients. Folic acid, B6, and magnesium are all required in the process of serotonin production. Therefore, it is so important to see a health care professional for your weight loss program where you have the opportunity for neurotransmitter support that can help ensure successful weight loss with a healthy program specifically designed for you.

Certain Medications
Long term use of diet pills, stimulants, pain pills, narcotics and recreational drugs can deplete neurotransmitter stores. Diet pills (like phen-fen , phenteramine) use up large amounts of dopamine and serotonin, which can result in “rebound” appetite control problems, low energy, unstable moods and a sluggish metabolism.

Prolonged Emotional or Physical Stress
The human body is designed to handle sudden, acute or short bouts of stress. Prolonged chronic stress takes its toll on the “fight or flight” stress hormones and neurotransmitters. Eventually, these become depleted and coping becomes more difficult.

Sixty percent of all adults over the age of 40 have some degree of neurotransmitter deficiencies. Aging brain cells make smaller amounts of neurotransmitters. Also, as we get older, the body does not respond as well to them.

Abnormal Sleep
Stressors of all sorts can become chronic and cause adrenal fatigue. Many neurotransmitters are responsible for proper sleep, especially serotonin and are product during REM sleep around 2 to 3 am when serotonin converts to melatonin, the sleep hormone. When serotonin levels are low melatonin level will also be low. Disrupted sleep occurs and fewer neurotransmitters are produced causing a sleepless night.

Heavy Metal Toxicity
Mercury, lead, aluminum, cadmium and arsenic are major neurotoxins. Chemical pesticides, fertilizers, certain cleaning agents, industrial solvents and recreational drugs cause damage to the brain cells and decrease neurotransmitter production.

Any condition ending in “it is,’ such as sinusitis, gastritis or arthritis is an inflammatory condition. Inflammation interferes with the conversion of tryptophan to 5-HTP which is used in the body’s production of serotonin.

Hormonal Imbalance
If hormones are deficient or are off balance, neurotransmitters do not function well. Premenstrual Syndrome (PMS) is a classic example of how low serotonin levels can shift each month. Mood, appetite and sleep can be severely disrupted one or two weeks before the menstrual cycle. Another neurotransmitter imbalance occurs during menopause when dramatic changes in mood, energy, sleep, weight and sexual desire occur.

Genetic Predisposition
Some people are born with a limited ability to make adequate amounts of neurotransmitters. They exhibit deficiency symptoms as children or young adults and often have relatives who suffer from significant mental illnesses. As they age, affected individuals experience even more profound symptoms and debilitation. To learn more about the lab we use for testing go to Sanesco’s website at: http://www.sanescohealth.com/neurolab/ Our practitioners will go over the extensive test results that we receive from the lab to provide a protocol to help balance and optimize your neurotransmitters.

GI Effects Kit

New GI Effects Reporting Enhancements
Genova Diagnostics is pleased to announce innovative reporting enhancements to the GI Effects Comprehensive and GI Effects Microbial Ecology stool profiles.

New Features Include:
A Commensal Balance Infographic – Designed to provide a more precise view of an individual patient’s commensal bacteria (PCR) results relative to a spectrum of healthy and unhealthy commensal patterns. (See video featured below.) It is a composite of two measures:

The Healthy-Pattern Continuum (formerly known as the Diversity Association Index) is a progressive ranking scale based on a Genova proprietary algorithm that differentiates healthy and unhealthy commensal patterns. This algorithm is applied to an individual patient’s GI Effects commensal bacteria (PCR) findings, and produces a numeric result ranging from 0 to 10. It is denoted by the ‘y’ axis of the Commensal Balance infographic.
The Reference Variance Score reflects the total number of an individual patient’s commensal bacteria (PCR) results that are out of reference range. This number ranges from zero to 24, and is denoted by the ‘x’ axis of the Commensal Balance infographic.
Clinical Association Charts – See how patient results compare to commensal bacteria (PCR) and biomarker patterns seen in patients with specific clinical conditions:

Metabolic Syndrome
Chronic Fatigue
Autoimmune dysfunction
Type 2 Diabetes
High Blood Pressure
Mood Disorders
Correlations are now evident between many disease processes and microbial dysbiosis patterns in both gut dysfunction and extra-intestinal disorders.1,2

Heavy Metal Toxicity

Health Consequences of Toxic Exposure
Evidence suggests that chronic toxic element exposure can adversely affect:

Energy levels
Reproductive function
Cancer risk
Neurological development and function
Respiratory, cardiac, hepatic, and immune functions
Cognitive and emotional health
Degenerative conditions
Toxins and Sources of Exposure
Accumulations of element toxins can occur in the human body in response to occupational exposures or to environmental exposures from toxic release in air, soil, or industrial waste systems. These sources include:

Metal refining
Plating and parts manufacturing in aerospace and machine tool industries
Fabrication of nuclear reactor fuel assemblies
Electronics and computer manufacturing
According to the EPA, the US has the largest electronics (including computer) workforce in the world. Exposures to the measured elements can occur in other occupations as ell, including:

Welding and metal shaping
Oil refining
Military or police service (with weapons use)
Handling of disposal of wastes
Manufacturing of pigments and coatings
Petrochemical production
The Comprehensive Urine Elements Profile assesses urinary excretion of toxic elements acquired through chronic or acute exposure. Practitioners can effectively monitor the progress of detoxification regimens and nutrient element status during treatment. All toxic metals are reported as micrograms/g creatinine or as micrograms per 24 hours (if a 24-hour urinespecimen is provided).

The Comprehensive Urine Element Profile measures urinary excretion of nutrient elements and toxic metals, including classic toxins such as lead, mercury, and arsenic. This is an ideal test for patients suspected of toxic element exposure as well as potential nutrient mineral wasting.

ALCAT Food Sensitivity Test

Food allergy is an IgE immune system response that is typically characterized by hives, shortness of breath, upset stomach and in some cases anaphylaxis. The most common food allergies are to nuts, shellfish, wheat and dairy. According to the Food Allergy & Anaphylaxis Network, only about 4% of the United States population has a food allergy. The ALCAT Test does not detect Food Allergy. Food intolerance, on the other hand, is much more common than food allergies and is characterized by digestive disorders, migraines, obesity, chronic fatigue, aching joints, skin disorders and behavioral issues. It has been stated that upwards of 70-80% of the US population has food intolerance. Unfortunately for many, those food intolerance symptoms are often identified as individual problems and treated as such, thus treating the symptoms and not the cause. The ROBOCat II instrument, the basis of The ALCAT Test, is an automated liquid handling system designed to measure white blood cells using the electronic principle of particle counting and sizing (measuring changes in electrical resistance produced by a blood cell suspended in a conductive liquid traversing a small aperture). This method is also referred to as the “Coulter” method, which is used in routine hematological evaluations. It has demonstrated a high degree of correlation with clinical manifestations as confirmed through a rigorous double blind trial. Drs. Peter Fell and Jonathon Brostoff reported an 83.4% correlation with ALCAT test results and double blind oral challenges with foods.

Micronutrient Test Kit

Are You in Control of Your Health, or Is It Controlling You?

Nutritional balance plays a key role in optimal wellness, chronic disease prevention and managing the aging process.
Do you find yourself feeling stressed, tired and maybe a little depressed?
Do you take prescription medicines to alleviate symptoms of certain conditions, but wonder why the condition exists at all?
Do you want to boost your immune system now, to possibly prevent chronic disease later?
SpectraCell’s Micronutrient testing offers the most accurate, scientifically proven method of assessing nutritional deficiencies.
Be Proactive, NOT Reactive
Traditionally, a person waited to go to the doctor at the first signs of a symptom. Today, individuals are looking for way to not only manage illness with personalized treatment plans, but they are also seeking to achieve a higher level of wellness.

Eating a balanced diet, exercising and taking a multivitamin is simply not enough. Each person’s body is unique in its own way. Due to the complexity of the human body, an individualized health

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