Transcript


Maimonides, the 13th century physician and scholar is believed to have said, “anything that can be treated by diet should be treated by diet.” Yet each of us is a unique individual. Hence, diets must be personalized. Personalizing the diet with the Alcat Test: the state of the art testing for food sensitivities.

Roger Deutsch CEO and Founder:

How often does a physician have a patient coming in year after year and the patient presents with high blood pressure, a condition of overweight or obesity, other risk factors for serious diseases, like poor blood sugar control? How often does that healthcare practitioner say to the patient, "You really need to make some changes in your life. You need to exercise more. You need to eat better," and nothing happens?

Well, we can provide that support to the healthcare practitioner to perform the testing and find out what foods and chemicals and so forth need to be avoided and which are safe, but also to guide and support that patient in the implementation of changes in their diet and lifestyle through our counselors, both inside Cell Science Systems and at our sister company, PreviMedica.

Dr. Campbell M.D., Medical Advisor:

There are only two ways to identify a food intolerance. First, an oral challenge, and this should be double blinded because expectations can influence the outcome. Each challenge should be separated in time by three days to mitigate carryover from the previous challenge. The second is an immune cell challenge, such as the Alcat test that involves presenting the food substance directly to the patient's live, peripheral immune cells to determine if they provoke a response.

The first method is the gold standard, but it would take months or even possibly years to apply to all the dietary substances and would be highly cost prohibitive. The Alcat test can be performed conveniently with a blood draw at a nominal cost, and it gives nearly the same result as the oral challenge.

Narrator:

In the next few minutes, we will explain the Alcat test, its rationale, and how it determines cellular reactions to foods and other potential toxic substances that people are exposed to every day. The reaction that it identifies appears to be the primary causes of what we call food chemical sensitivities or intolerances.

Test results are unique to each individual and are used to personalize an individual diet. The Alcat test looks at how one's immune cells respond to a vast array of foods or other substances under conditions designed to mimic what happens in real life.

Immune cells, when activated, produce both free radicals and inflammatory substances that can cause tissue damage and premature aging. Food sensitivities have been associated with many conditions, including migraine, rashes, overweight, arthritis, fatigue, respiratory, GI disorders, and many others.

Dr. Wright D.O., Medical Advisory Board:

Other food sensitivity tests measure antibodies against food. Antibodies, except in the case of IgE-mediated classical food allergy are protective. That is they do not themselves produce symptoms, but they help rid the body of excess antigen. Thus, the body produces IgG antibodies to foods that are ingested regularly. That's normal. In general, these IgG antibodies do not produce inflammation.

The Alcat test, however, uses a live, cellular, biological response test. That detects the triggers of inflammation.

Classical food allergy on the other hand is quite different. It involves a different immune reaction mediated by IgE antibodies and, by definition, provokes a rapid onset of symptoms.

Since classical food allergy symptoms typically occur quickly after exposure, identification of the offending food is usually obvious. On the other hand, symptoms of food intolerance or sensitivity tend to be delayed, less acute, subtle, and are usually associated with more chronic conditions. All of this makes it difficult to identify the offending food or substance, which is why the Alcat test is so useful.

Dr. Campbell M.D., Medical Advisor:

There are various reasons why one may have a delayed reaction to even healthful foods. Firstly, plant based foods contain natural toxins to protect themselves from pests. Normally, the body can deal with these toxins. Digested food products are carried through the circulation to the liver where naturally occurring toxins can be neutralized.

But if the toxin level is too great, or if we lack the necessary enzyme to remove them, they may pass into the general circulation. Inflammation is helpful in the face of infection or injury but may prove damaging if it becomes chronic, where they activate the immune system, thereby triggering inflammation.

Secondly, the body may also overreact to other naturally occurring or artificial chemicals that are added to foods, such as artificial colorings, flavorings, preservatives, and emulsifiers. A chemical itself, even if not toxic, may produce a non-immunologically mediated reaction. For example, tyramine in chocolate can trigger a migraine.

Thirdly, it is also possible that some food protein fragments called peptides may cause an adverse reaction via a non-allergic yet immunological pathway. Here, Dr. Alessio Fasano from Harvard University shows how gluten causes activation of granulocytes in the intestinal lining of experimental animals following contact with gluten.

Dr. Fasano Harvard University:

What you see here is the cross section of this core of the villus. This black stuff here are the capillaries. These green dots that you will see a little bit better are the soldiers, neutrophils. They are particularly treated in these transgenic animals with a fruit fly gene that makes them to be fluorescent.

So what you're going to see now is on the left, these are the villi of a mouse that has been exposed to another protein, BSA. This is a mouse that has been gavaged with gluten. This is pretty much what you're going to see there. See how many of the soldiers are stuck on the wall of the capillaries here and then eventually start to move out and get out and get into the external part, what we call the lamina propria, while this guy here, they keep traveling, and they stay in the lumen.

In the animals that were exposed to gluten, gluten is attracting the soldiers outside of the capillary. They start to really get on the battlefield where gluten and god knows, again, what else is sitting in there because it's been absorbed through this breach in the barrier, while these guys, they keep going. Again, who is close by may see that. Even if you're not that close, you see the mess that is happening here. This is all due to the simple difference that here you have bovine serum albumin, and here you have gluten. That's all.

Narrator:

The blood sample is received in the laboratory via an expedited courier while the cells are still viable. The patient's data and requested tests are entered into our secure laboratory information system. All patient blood samples are barcoded for traceability, identification, and tracking throughout the testing process.

Each patient's cellular profile is unique. Therefore, we first perform a preliminary test to determine cell number and distribution. Once verified, the white blood cells and plasma are then isolated from the whole blood. Next, the patient's white blood cells and plasma mixture is introduced to the individual test substances.

Test substances are prepared from organic, raw material following strict preparation protocols and quality assurance guidelines. Our manufacturing division is an FDA registered medical device establishment and is also ISO EN 13485 certified as a medical device manufacturer. Cell Science Systems Lab is certified and licensed by the U.S. government.

To prepare the test items, a precise quantity of the test substance is delivered into a well in the test cassette, and then the entire cassette is put through a drying process. The dispensing system is accurate within a one percent range. There are 55 wells arrayed in the specifically designed cassette.

Over 470 substances can be analyzed by the Alcat test. This may seem like a lot, but considering a fast food hamburger contains approximately 70 different ingredients, this is not excessive testing.

Different substances, such as foods, additives, colorings, environmental chemicals, medicinal herbs, functional foods, commonly used drugs, and molds can go into each test well to allow for a variety of configuration. The entire process occurs in our ISO 7 certified controlled environment room to avoid possible contamination.

The test substance is bound to the bottom of the well, as can easily be seen in the food coloring's cassette. A robotic system is used to pipette the patient's white cells and plasma suspension into each well. The robotic pipettes have an error factor of less than one percent. We now have proportionate quantities of the patient's sample cells and plasma added into each well containing different test substances.

Dr. Dittmar Ph.D., Laboratory Director:

The test is patient specific. Certain wells are used as control wells. What's different about the control wells is that they do not contain a test substance, just buffer. The controls are used to obtain a baseline cellular distribution curve for each patient. That is to see what the immune cell distribution looks like without exposure to any test substance.

Narrator:

Next, the entire cassette is incubated at body temperature. The cassettes are gently rotated during the incubation to promote thorough interaction of the cells with the test substance.

Following incubation, the tests are placed into an instrument that will analyze the white blood cells in each well. Once inside the instrument, a precise volume of neutral buffer, possessing defined electrical conductivity properties. is dispensed into the well. A histogram, the volume distribution curve, is then created for each sample.

Leti Eberly IT Director:

Our laboratory processes are highly automated and coordinated with each patient's barcode using our customized information management system. All operations from instrumentation health to quality control testing to data integrity verification are constantly monitored in real time and displayed on screen throughout the laboratory. These systems are HIPAA compliant and provide validation and traceability that all of our processes and procedures are performed according to protocol.

Samy Puccio Vice President of Manufacturing:

The instrument employs the electric sensing zone method of particle sizing to create a size/volume distribution curve, or histogram, for each sample. This method of determining the cell volume and count is the international standard for the automated analysis of cells.

Simply put, as the blood cell flows through a sensing zone, the resistance will change in proportion to the cell's content. The system's processor will capture the change and express it as a pulse where its amplitude is directly proportional to the cell's volume.

The electronic circuitry of the instrument is also able to count all of the cells within the various size ranges and creates the size distribution curve or histogram. This instrument is designed by our own team of expert engineers and manufactured in our ISO certified and FDA registered facility. Our reagents and instruments have been cleared by the European Union and various other health ministries around the world.

The histogram is a size and frequency distribution curve. The y-axis shows the number of cells. The x-axis shows the size/volume of the various cell types.

Now that the testing is complete, the systems will compare the baseline distribution average from the control wells against the test substance distribution. The area change between the two graph depicts the altered cells in that particular test sample.

The concept here is that regardless of the pathway, be it immunologic or non-immunologic, the cells will show a reaction if that test substance activates the cells, thereby indicating potential harmfulness of that substance to the patient.

Researchers at Yale School of Medicine have confirmed that the cellular changes identified through the Alcat test correlate with the process of degranulation of various white blood cell types wherein chemical mediators and free radicals are released.

Dr. Campbell M.D., Medical Advisor:

These chemical mediators and free radicals are triggers for a variety of inflammatory responses, which may lead to a number of diseases, including: cardiovascular diseases; diabetes; neurological disorders, including Alzheimer's disease and multiple sclerosis; pulmonary diseases, including asthma and COPD; rheumatoid arthritis; kidney diseases, such as renal failure and glomerulonephritis; and eye disorders, including macular degeneration and cataract formation.

As each sample test curve is plotted against the baseline, a mathematical algorithm determines quantitatively the difference between the distributions in populations of each white blood cell type and variant. A cellular response is indicative of a positive reaction.

Amy Pierczarka Director of Nutritional Consultation:

Test results are evaluated and then formatted into an easy to read and easy to interpret, color coded report. For each test substance, cellular responses are categorized according to degree of reactivity: severely reactive, moderately reactive, mildly reactive, or non-reactive.

Many factors can impact these results. Some contributors would be the frequency of exposure, overall detoxification ability, the presence of cofactors which may vary according to the season, and also intestinal permeability could be an issue. With increased intestinal permeability, this could be the result of one or a combination of factors, such as stress, certain medications, infection, and the gut microbiome.

Whereas any cellular reaction may be significant, it's more likely that a stronger cellular reaction will be associated with a clinical response. From here, your healthcare provider or an Alcat nutritional consultant can advise you with regard to what foods to avoid, what foods to consume, and how to build a varied, nutritious eating pattern.

Roger Deutsch CEO and Founder:

We're very concerned about our responsibility to the environment. So we make a special effort to recycle almost all the plastics that are used in the test, which means we recycle upwards of a quarter of a million plastic cassettes that are used in the testing each year.

The test we provide is unique. Towards that end, we design our instruments in order to perform that testing. We design our test to perform and provide the information that we feel is most relevant for identifying very complicated issues that have to do with how the organism, how the human being responds to their environment. That's critical.

I think it's very important to understand that this is a tool that can be very powerfully used by healthcare practitioners to help people overcome symptoms which don't respond to other therapies or other approaches. About 70% of illness can be prevented merely by changes in lifestyle, which includes diet. By managing stress and exercising and eating a proper diet, which would be a healthful diet but also a diet which is constructed according to the unique characteristics of each individual's biochemical and genetic makeup, I think that we can really avoid a lot of the chronic disease that we see flourishing in our society.

Considering that we spend upwards of $2 trillion a year on healthcare and so many of these problems can be prevented through simple measures that are healthy, we can then reallocate that effort and those funds for perhaps greater prevention and other things and improve the quality of life and social programs that there's no shortage of needs to fulfill.

Narrator:

Cell Science Systems remains dedicated to improving the health of individuals through prevention and enhancement of health outcomes and greater efficiency in the healthcare system. Programs can also be tailored for groups.

Cell Science Systems also offers lifestyle genetic testing, digestive disease tests, as well as other tests aimed at prevention of chronic illness. Please see details at www.alcat.com and www.previmedica.com.