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Initial Training Slides
- 1. Pyro-Sequencing of Bacteria, Fungal ,Viral
- 3. Agenda • Intro to PathoGenius what do we do • Your objective • Process for implementation • Lesson on Microbiology and Culture test • The ENT Market • Review of Sales Binder • Common objections
- 4. Otitis Media Biofilm Sinus Cavity Biofilm
- 5. PathoGenius • Started by Dr RandyWolcott MD • Based in LubbockTx • Performs Molecular Microbial Diagnostics • DNA extract – Complex & expensive • PCR vs. Next Generation Sequencing • PathoGenius provides the Kits and does the billing • Physician does not buy anything or bill anything • Medicare covers our test and commercial plans reimbursement to PathoGenius is 50% nationwide
- 7. Call Objective • Have the physician move from traditional cultures to using Molecular Diagnostic • “Doc there is a new technology available to identify bacteria and fungus “ We don’t have to grow microbes anymore, all bacteria and fungal organisms have DNA and we can identify them by their DNA. Now you will know the bug and pick the right antibiotic” • Medicine is about “Diagnose and treat” • The more accurate your information the better your treatment decisions • You are only as good as the information you have • DNA sequencing is the “Gold Standard” of Microbial Diagnostics.
- 8. Implementation • Contract • Ship sales Binder and Kits toYou • Initial exploration with your docs • Familiarize yourself with the material • Set up field visits with myself • Field visits , maximize my time, lunches, dinners • Need to hand hold each customer for the first weeks
- 9. How the process works • Doctor takes the sample in Office / Surg center. Sends sample with lab req and patient demos on Monday • Samples overnighted to Lubbock arrivesTues am • Lab processes sample scans lab req and patient insurance info • Pharmacy access info to review type of infection and patient insurance on Tuesday • Doctor receives first Level 1 report from PathoGeniusTuesday afternoon/evening • Friday the Physician / Pharmacist receives the Level 2 report • Pharmacy can send a customize topical Rx to the doc based on the Level 2
- 10. Microbiology
- 12. “The impact of proper specimen management on patient care is enormous” “Specimen selection and collection are the responsibility of the medical staff and not the laboratory”
- 13. American Society for Microbiology Standard: Swab transport, RoomTemperature, 2 hours Current Lab: Swab transport, unknown temp, end of the day. High probability of error from the start.
- 14. Planktonic Bacteria Single Cell Bio Film “Community of Bacteria” Cause of 80% of Infections Cause of ChronicWounds Will not grow in traditional culture Biofilm cells express a radically different phenotype than planktonic bacteria Only Diagnostic tool is Molecular Cause of Acute Infection Will grow in traditional Culture
- 18. Material from an infected elbow prosthesis stained with the Molecular Probes • Seven Surgical Procedures • Over 5 years • Cultures consistently Neg • Case represented a landmark in the diagnosis of chronic bacterial infection in Orthopedic Surgery • PCR identified the infection
- 21. Dr. Caroline Fife Dr. John Steinberg Dr. Chris Attinger Dr. James McGuire Dr. Berrylin Ferguson Dr. Donald Lanza
- 22. Stages of Biofilm Development
- 26. Multiple Strategies are required to succeed against bio-films in chronic wounds Debridement –Is the “Corner Stone” Biocides Systemic Antibiotics Topical Customized Antibiotics
- 27. Diagnose –The physician needs to know what they are up against • The current diagnostic tool for identifying bacteria in the wound used by many physicians is traditional culture Culture – Means to Grow 1800Technology- Louis Pasteur based Microbiology 15 % Accuracy - Less than 5% of known bacteria will readily grow in the lab Culture Result – What they could grow , not what is in the wound biofilm
- 28. DNA Analysis vs.Traditional Cultures 51 Chronic wounds- Parallel Samples 16 S DNA Sequencing Traditional Culture • 46 /51 Staph Identified • 32 / 51 Pseud Identified • 28/51 Staph Identified • 8 / 51 Pseud Identified DNA Sequencing OutperformedTraditional Cultures DNA Sequencing identified 145 Genera – Cultures 14 !
- 29. The Neuropathic Diabetic Foot Ulcer Microbiome Is AssociatedWith Clinical Factors Sue E. Gardner,1 Stephen L. Hillis,2 Kris Heilmann,2 Julia A. Segre,3 and ElizabethA. Grice4 From the 1University of Iowa, College of Nursing, Iowa City, Iowa; the 2University of Iowa, Carver College of Medicine, Iowa City, Iowa; the 3National Institutes of Health, National Human Genome Research Institute Similar to other studies (7,12,36), we found that cultures do not fully represent bacterial diversity as compared with 16S rRNA gene sequencing. Microbial load is widely viewed as the reference standard for determining problematic bioburden in chronic wounds that may not express robust clinical signs (37).We demonstrated for the first time that cultures underrepresent the microbial load of the ulcer as compared with 16S rRNA gene approaches. These findings may have important clinical implications justifying the clinical use of molecular approaches rather than traditional cultures.
- 30. Diagnostic Services – What we deliver Two molecular microbial diagnostic tests are currently used at PathoGenius®. We take your patient's swab, washing, or tissue sample; extract the microbial DNA; and report the microbial analysis to you. Level 1: PCR 24-Hour Rapid Screening Screen 8 Common ENT Bacteria and 1 Fungal Provide Quantitative Bacterial Load Rapid turn around time of approximately 24 hours from the time of sample receipt. Pathogens Identified in Level 1 Staphylococcus (including MRSA) Streptococcus pyogenes (GAS) Haemophilus influenza Moraxella Catarrhalis Pseudomonas Streptococcus pneumonia Streptococcus agalactiae Candida albicans
- 31. Level 2: DNA Microbial Pyro Sequencing Only lab in the country that can provide your patients access to DNA Pyro Sequencing Pyro sequencing matches the DNA from your sample to the entire universe of know bacteria and fungal pathogens Level 2 Report is fax/emailed to you in 5-7 days Level 2 Report includes a table of the pathogens identified and the antibiotics that will cover them. ( Antibiogram)
- 32. Pathogenius DNA Molecular Diagnostics. 12,000 DNA codes on file. Indifferent to time, media and transport issues.
- 37. COST AND COVERAGE OF MOLECULAR DIAGNOSTICSTRADITIONAL CULTURE • MEDICARE PAYS $250 DNA SEQUENCING • MEDICARE PAYS $ 285
- 38. CUSTOMIZED FOR EACH PATEINT TOPICAL RX LIPOGEL BASED DOSED 3X WEEK CONTAINS ANTIBIOFLIM AGENTS ANTIBIOTICS ANTIFUNGALS
- 41. DNA Diagnostic “Must be expensive “ How much will it cost? Private Office If your patients are a Medicare patient, 100% of the cost of your testing will be paid by Medicare. Medicare reimburses $190 for our Level 1 and Level 2 If your patients have private insurance, 50% of Commercial Plans pay for the test. No sample will ever be denied by Patho Genius No Patient will ever go to collection
- 42. Benefits Pathogenius DNA MolecularTesting • Fast Identification of Biofilms and their composition in patients referred to you—Accuracy and Speed. • Gives you the most comprehensive bacterial and fungal and viral commercially available • Eliminates errors and misdiagnosis caused by sample handling: Proper Media,Time, temperature and transport as required by the American Society of Microbiology. • Proven to improve healing times and clinical outcomes
- 43. Questions?
- 44. Lab Requisition