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Introduction Michael T. Parra MD Medical Director, PAS

Introduction Michael T. Parra MD Medical Director, PAS. PROBLEM – National Concern. 60 Million Americans suffer from allergies 40% of children – 30% of adults 90% of asthma is triggered by allergies Allergies increased 50% since 1997 Testing is traumatic and treatment is time consuming.

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Introduction Michael T. Parra MD Medical Director, PAS

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  1. Introduction Michael T. Parra MD Medical Director, PAS

  2. PROBLEM – National Concern • 60 Million Americans suffer from allergies • 40% of children – 30% of adults • 90% of asthma is triggered by allergies • Allergies increased 50% since 1997 • Testing is traumatic and treatment is time consuming

  3. RESULT – Mask Symptoms • Approximately 95% of patients go untreated! • Americans spent $17.5 Billion in 2010* ($18B in 2015) • antihistamines, decongestants, inhalers, steroids • pills, eye drops, nasal sprays • Still suffer dreaded trips to the ER • Asthma attacks during sporting events, etc. * Schaffer F. National Impact of Allergies. Academy of Allergy and Asthma in Primary Care. http://www.aaapc.us/wp-content/uploads/2013/01/National-Impact-of-Allergies.pdf (Retrieved April 8 2015)

  4. PROBLEM – Why? (Standard Testing) • Scratch Tests • Painful – 40-50 skin pricks • Limited - only 40-50 allergens • Time consuming – 20-25 minutes • 30% false positive results • Subjective – Observation alone • Non-measurable as a repeatable test

  5. PROBLEM – Why? (Standard Testing) • Intradermal Shots • Potential risks – insert food & other allergens • Subjective – Observation only • Non-measurable

  6. PROBLEM – Why? (Standard Testing) • Food Challenge • Potential risks – insert concentrated amount of food • Tragic Result • Alastair Watson – Children’s Hospital of AL – 07/30/17

  7. PROBLEM – Why? (Standard Treatment) • Weekly shots (SCIT) • Time consuming • (missed school & work) • Children are afraid of shots • Titrate up 6-9 months to reach the maintenance level • Do not feel better for at least 9 months, 84% drop out rate

  8. PROBLEM – Why? (Standard Treatment) • Sublingual drops (SLIT) • Hold under tongue for two minutes – forget to do • Unpleasant taste • Compliance 60%

  9. NO NEW DEVELOPMENTS IN ALLERGY TESTING AND TREATMENT PROTOCOLS IN USA FOR 20 YEARS …UNTIL NOW!

  10. SOLUTION – NEW IN-OFFICE TEST & TREATMENT PROGRAM • Now you can test and treat your allergy patients in your office! • No longer need to refer over 95% of allergy patients to allergists • As simple as 1…2…3

  11. STEP ONE – NEW TEST • Finger-prick blood test – 120 allergens • (compared to 40-50 with scratch tests) • Unique Next-Generation Microarray Chip Assay Most advanced – FDA cleared technology • Simply drop 4 drops on specialized paper • Airborne, environment & food • 50 Allergen non-inhalant panel • Foods, insects, latex, penicillin • 70 Allergen environmental inhalant panel • Animals, fungi, grass, insects, molds, trees, weeds

  12. FINGER-PRICK BLOOD TEST Sensitivity and Specificity Results • Allergy tests correctly scored 20 positive and negative serum specimens for a total of 1,160 analytes for 100% sensitivity and 100% specificity for the inhalant allergens. • Allergy tests correctly scored 20 positive and negative serum specimens for a total of 660 analytes for 100% sensitivity and 100% specificity for the non-inhalant allergens.

  13. FINGER-PRICK BLOOD TEST • Studies – Asthma & Food • Study of 215 children (1-14yrs) using ImmunoCAP Rapid testing demonstrated effective (88.4-97.6%) correct identification of allergic sensitization in children with recurrent asthma. • Prospective food allergy study of this technology demonstrating the importance of quantitative IgE measurements in 100 children, referred for food allergy evaluation tested for IgE to egg, milk, peanut, soy, wheat, and fish after dx of food allergy established on hx and food challenge. Results showed greater than 95% of food allergies were correctly identified, and could predict clinical reactivity (positive food challenges) with greater than 95% certainty. Diaz-Vazquez C, et al. Accuracy of ImmunoCAP(R) rapid in the diagnosis of allergic sensitization in children between 1 and 14 years with recurrent wheezing: the IReNE study. Pediatric Allergy Immunol 2009;20:601-9. Sampson HA. Utility of food specific IgE concentrations in predicting symptomatic food allergy. J Allergy ClinImmunol 2001;107:891-6.

  14. STEP ONE – NEW TEST • Finger-Prick Blood Test • Safe, Fast & Easy • Four Drops of Blood • Measurable results • Comprehensive • 120 Allergens vs 40-50 with Scratch Test • Eliminates need for Food Challenge – Safe!

  15. Non-Inhalant and Environmental Allergens Acremonium, Alder, Alfalfa Pollen, Alternaria, Aspergillus, Auareobasidum, Australian Pine, Bahia grass, Bald cypress, Bayberry (wax myrtle), Bermuda grass, Birch White, Box Elder, California Live Oak, Candida Albicans, Cat Hair, Cattle Hair, Cedar Red, Cedar Mountain, Cladosporium, Cocklebur, Cockroach Mix, Cottonwood, Curvularia, Dog Hair, Drechslera, Elm American, Elm Chinese, English planain, Epicoccum, Fusarium, Horse Hair, Johnson Grass, June Grass, Juniper, Kochia, Lamb's Quarters, Maple Pollen, Mite Farinae, Mite Pteronyssinus, Mouse Hair, MucorPlumbeus, Mugwort, Olive Russian, Pecan Pollen, Perennial Ryegrass, PhomaHerbarum, Queen Palm, Rough Pigweed, Russian Thistle, Pine White, Poplar White, Privet, Queen Palm, Ragweed False, Ragweed Western, Red Birch, Red Mulberry, Red Oak, Rough Marsh Elder, Sagebrush, Shagbark Hickory, Sheep Sorrel, Short Ragweed, Sycamore American, Tall Ragweed, Timothy Grass, Virginia Live Oak, Walnut Black Pollen, White Ash, White Oak, Willow Black

  16. Food Allergens Almond, Apple, Banana, Barley, Beef, Brazil Nut, Buckwheat, Casein, Carrot, Celery, Chicken, Clam, Cod Fish, Corn, Crab, Egg White, Egg Yolk, Flounder, Garlic, Green Pea, Halibut, Lobster, Milk, Mustard Seed, Oat, Oyster, Peach, Peanut, Pork, Rye, Salmon, Sesame Seed, Shrimp, Soybean, Strawberry, Tomato, Tuna, Walnut, Wheat, Yeast

  17. STEP TWO – PRESCRIBE • Write prescription for customized serum • Compounding pharmacy • Mixes unique allergen serum, based • on finger stick non-food allergen results

  18. STEP THREE – TOOTHPASTE • Oral Mucosal Immunotherapy (OMIT) • Serum is mixed in OMIT base to create prescribed toothpaste • Patient returns quarterly for checkup and receive next 90-day supply

  19. STEP THREE – NEW TOOTHPASTE • Safe - Natural • More effective than SCIT (shots) or SLIT (sublingual drops) • Begin at maintenance level (vs. titrate up 6-9 months) • Patients feel better – faster • Increase compliance

  20. BENEFITS – To Practice • Solve a national concern • Provide testing & treatment in office • Measurable Results • Natural, safe, effective regimen specifically designed for non-food allergies • New revenue: • Quarterly office visits • Admin fee with Treatment

  21. BENEFITS – To Patient • Not Scary/Quick - Prick finger • Safe – Drop blood on card for testing • Effective – Natural therapy • Simple – Brush teeth for 2 min • Tastes good • Berry or Mint flavor

  22. BENEFITS – To Parents/Patients • Save Time • No weekly trips to allergist • No missed work or school • Save Money • Gas, parking fees, time • No copays ($20-$50 per visit) • Easy & sustainable treatment • Brush teeth daily for 2 minutes

  23. SUMMARY • Unique Microarray Chip Assay (Test) • Drop 4 Drops of blood on card (safe/quick) • 120 Allergens (vs 40-50 with scratch testing) • Measurable results (from test to test) • Prescribe • Unique serum per patient • Toothpaste • Most effective delivery system (start at maintenance level vs. titrating up 6-9 months like with shots) • Saves money ($120 for shots vs. $105)

  24. RESULT • Replace or enhance out-dated: • Scratch test • Intradermal test • Food Challenge • Replace weekly shots (time consuming) • Replace sublingual drops (unpleasant taste) • Treat 95% of patients in office! (currently untreated) • Feel better – sooner • Compliant – completion of regimen

  25. LEARN MORE… • Is this safe? • Does it work? • For more information, go to: www.PediatricAllergySolutions.com

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