TECHNICAL FIELD

The following disclosure relates generally to the use of DNA profiles to therapeutic treatment with allergens.

BACKGROUND

Immunotherapy (IT) is recognized as one of the most curative treatment for allergies. By exposing the immune system to slowly increasing concentrations of immunomodulators such as an allergen or antigen, it will eventually stabilize and regain control the portion that is hypersensitive to the allergen or antigen. In general, immunotherapy is the “treatment of disease by inducing, enhancing, or suppressing an immune response.” Immunotherapies designed to elicit or amplify an immune response are classified as activation immunotherapies, while immunotherapies that reduce or suppress are classified as suppression immunotherapies. The active agents of immunotherapy are collectively called immunomodulators. They are a diverse array of recombinant, synthetic and natural preparations, often cytokines.

Immunotherapy involved in the treatment of allergies is a type of suppression immunotherapy, often termed desensitization or hypo-sensitization. This is compared with allergy treatments such as antihistamines or corticosteroids which treat only the symptoms of allergic disease. Immunotherapy is the only available treatment that can modify the natural course of the allergies, by reducing sensitivity to the immunomodulators such as antigens or allergens. An antigen and an allergen can both cause one's immune system to respond. An allergen is an antigen, but not all antigens are allergens. An antigen is any substance that is capable of causing one's immune system to produce antibodies. They are typically organic, or living, produced proteins. An allergen is any antigen that causes an allergic reaction. A nonallergen antigen could be a bacteria, virus, parasite, or fungus that causes an infection. This could also be something else that causes antibody immune system response, like toxins, chemicals, tissue cells involved in transplants or blood cells from a blood transfusion. An allergen is an environmentally produced substance that causes an allergic reaction, although the substance may not be harmful. Allergens cause no reactions in some individuals, while possibly causing a hypersensitive reaction in others. Common allergens include such things as pollen, plants, smoke, feathers, perfumes, dust mites, toxic mold, food, drugs, animal dander, and insect bites and stings.

The exact mechanisms of how IT works are not fully understood, but they involve shifting a patient's immune response from a predominantly “allergic” T-lymphocyte response to a “non-allergic” T-lymphocyte response.

Current accepted processes for performing allergy immunotherapy include injecting immunomodulator matter in the form of antigen material into patient subjects. This is referred to as subcutaneous immunotherapy (SCIT), requiring a patient to visit a doctor's office for weekly injections. It's is very expensive and time-consuming. A second technique, sublingual immunotherapy (SLIT), involves the application of allergy extracts (antigens), and allergens placed into a pill form and swallowed by the patient or disposed in “allergy drops” which are placed under the tongue for the allergens/antigens to be absorbed into the oral mucosa. Transdermal patches may have been used without much success and mostly were used for patch testing to see if a patient reacts to various chemicals or allergens.

Of the people who start traditional subcutaneous injected immunotherapy (SCIT), 90% fail to complete their therapy due to needle fatigue and not being able to see a doctor in their office once or more per week for several years. Further, doctors charge for every one of those visits. Further, doctors trained to give injections for allergies are concentrated in high population and upper middle class places. People in rural areas and people who do not live in upper middle class areas cannot get to an allergist for shots. Consider an inner city kid having to ride public transportation and pay a high copay just to get a high risk injection if an alternative therapy were available!

Allergies are also linked to depression and suicide and are among the top ten reasons for missed work and lost productivity. Lastly, allergies and asthma result in billions of dollars in lost productivity and healthcare costs among the 90% of allergy patients that either never get immunotherapy or receive failed immunotherapy delivered under its current administration methods.

The determination of what type of allergies an individual is susceptible to can be determined based on a number of different techniques. The conventional technique is to use what is referred to as a “prick” test. This test involves disposing on a plurality of small needles the drop of allergen at a specified dose and “pricking” the skin of the individual with each of the needles in a predetermined pattern. Since the pattern map with the allergens, a later observation of the treated area on the skin of the individual will feel which allergens caused a symptomatic response, i.e., typically a swelling localized around the particular prick. By defining which of the pricks have a localized response, and the level of that response, a determination can be made as to what allergens a particular individual is susceptible to.

Another test that is being used more frequently is that associated with a blood test for allergens. Allergy blood tests detect and measure the amount of allergen-specific antibodies in the blood of an individual. When an individual comes into contact with an allergy trigger, known as an allergen, their body makes antibodies against it. These antibodies tell cells in their body to release certain chemicals and these chemicals are what cause allergy symptoms. The allergy blood tests usually screen for at least 10 common allergy triggers, including dust, pet dander, trees, grasses, weeds, and molds related to the locale in which an individual lives. These blood tests are also particularly helpful in diagnosing food allergies.

These allergy blood tests are sometimes referred to as immunoassay tests and include Enzyme-linked immunosorbent assay (ELISA, or EIA) and Radioallergosorbent test (RAST). The ELISA test measures the amount of allergen-specific antibodies in the individual's blood and the RAST test looks for specific allergen-related anti-bodies in order to identify an individual's allergy triggers. These blood tests can also check white blood cell counts, including a count of a type of white cell called the eosinophil.

Another area is that associated with Pharmacogenetics, which is basically an area involved with determining how one's genes respond to certain medications. This provides for determining the right drug for the right patient at the right dosage. This typically involves a DNA test. This DNA test allows the treating physician to prescribe medication that best suits a particular individual's DNA structure. The advancement of genetic research has led to far greater understanding of the importance of genetic disease and a demand for pharmacogenetics testing companies. Personalized medicine uses genetic information, lifestyle behavior, and other risk factors to tailor medical decisions and treatments to individual patients. Thus, a pharmacogenetics testing lab provides knowledge that helps physicians prescribing drug regimen the greater probability of a positive outcome. This is basically involved to some extent with predicting drug-drug interactions. Pharmacogenetics involves variation in genes involved in drug metabolism with a particular emphasis on improving drug safety. The use of pharmacogenetic testing provides the opportunity to improve prescribing safety and efficacy. For example, the drug Plavix blocks platelet reception and is the second best-selling prescription drug in the world; however, it is known to warrant different responses among patients. Certain studies have linked the gene CYP2C 19 to those who cannot normally metabolize Plavix. With knowledge of the presence of this gene, treatment regimen can prevent use of this drug.

SUMMARY

In one embodiment, a therapeutic treatment kit includes a container for holding a plurality of compartmentalized therapeutic dispensers is provided. The therapeutic treatment kit comprising each of the therapeutic dispensers including a plurality of vials of antigens, and a plurality of containers of supplements disposed in compartments, each of the compartments labeled with the name of the supplement. A compartment is also provided for containing applicators or the antigens, such that an individual can extract the antigen from the vial in a single dose; and para instructions associated with a therapeutic program for utilizing the vials of antigens and the supplements in accordance with a therapeutic program that is predefined. The construction of the kit, including the dosages of the antigen, the types of antigens and the supplements all associated with a particular therapeutic program.

