Becton, Dickinson and Company · NYSE:BDX
Becton, Dickinson and — Technical Presentation (August 2017)
28 slides from Becton, Dickinson and's technical presentation, August 2017
Slide 1: BD MAX Extended Enteric Bacterial Panel (xEBP)
BD MAX™ Extended Enteric Bacterial Panel (xEBP)
Slide 2: Table of Contents
TABLE OF CONTENTS ① Introduction ② Product Overview ③ Benefits of the BD Solution ④ Summary
Slide 3: Why Focus on Enteric Testing?
WHY FOCUS ON ENTERIC TESTING?
Slide 4: Typical workflow with conventional methods
Typical workflow with conventional methods Campy agar Salmonella/Shigella Agar 25o incubator • 42o incubation • 35o incubation • Used for Yesinia testing only • Microaerophilic • Multiple types • 48hr read • 24hr read • 72hr hold • 48hr hold • QC requirements • High false positives H2S+ 42o incubato
Slide 5: Typical workflow with conventional methods
Typical workflow with conventional methods Campy agar Salmonella/Shigella Agar 25o incubator • 42o incubation • 35o incubation • Used for Yesinia testing only • Microaerophilic • Multiple types • 48hr read • 24hr read • 72hr hold • 48hr hold • QC requirements • High false positives H2S+ 42o incubato
Slide 6: The true cost of culture
THE TRUE COST OF CULTURE3 64% of negative stool cultures required some testing beyond the primary media. Due to low positivity rate, the cost of finding ONE positive = $427 5 technologists were monitored for time and supplies needed to work up 206 stool cultures Cost = $2137.30, 5 positives were ide
Slide 7: Product Overview
Product Overview
Slide 8: BD MAX Extended Enteric Bacterial Option: We give you a choice
BD MAX™ EXTENDED ENTERIC BACTERIAL OPTION… FULL BACTERIAL COVERAGE WHEN NEEDED BD MAX Extended Enteric Routine Bacterial Option • Routine use with the Enteric Bacterial Panel virtually Yersinia eliminates need for culture or conventional tests to enterocolitica screen for bacterial pathogens ETEC Ve
Slide 9: Why test for these organisms?
WHY TEST FOR THESE ORGANISMS? • ETEC4,5 – Leading cause of “travelers’ diarrhea” – High risk regions: Asia, Middle East, Africa, Mexico, Central and South America – Becoming recognized as an important source of foodborne illness in the U.S. – Frequently resistant to common antibiotics • Vibrio spp.⁴
Slide 10: Why test for these organisms?
WHY TEST FOR THESE ORGANISMS? Yersinia enterocolitica7 Ingestion of “chitterlings”, made from pig intestines: common in several countries and certain regions of the U.S. • CDC reports 170,000 illnesses per year in the U.S. • Occurs most often in young children Plesiomonas shigelloides8 • Associated
Slide 11: Why not Aeromonas?
Why not Aeromonas? 9 The genus Aeromonas is commonly found in aquatic environments, being isolated from rivers, lakes, ponds, seawater (estuaries), drinking water, groundwater, wastewater and sewage. The exact incidence of Aeromonas infections on a global basis is unknown. Aeromonas is not a reporta
Slide 12: BD MAX Extended Enteric Bacterial Solution – Configuration
THE BD MAX EXTENDED ENTERIC BACTERIAL SOLUTION – CONFIGURATION Enteric Bacterial Panel (existing) • Salmonella spp. • Shigella spp. • Campylobacter spp. • Shiga-toxin producing E. coli Extended Enteric Bacterial Panel • Plesiomonas shigelloides • Vibrio (V. vulnificus, V. parahaemolyticus, and V. ch
Slide 13: Prospective Performance
THE BD MAX EXTENDED ENTERIC BACTERIAL SOLUTION – PROSPECTIVE PERFORMANCE Vibrio P. shigelloides Y. enterocolitica ETEC Specimen Type PPA NPA PPA NPA PPA NPA PPA NPA Unpreserved No data 99.8% No data 99.9% No data 100% 100% 99.9% Prospective Cary-Blair 100% 99.6% No data 99.9% No data 99.9% 100% 99.8
Slide 14: Retrospective Performance
THE BD MAX EXTENDED ENTERIC BACTERIAL SOLUTION – RETROSPECTIVE PERFORMANCE Vibrio P. shigelloides Y. enterocolitica ETEC Specimen Type PPA NPA PPA NPA PPA NPA PPA NPA Unpreserved 100% 97.8% 100% 97.9% 100% 100% 90% 96.3% Retrospective Cary-Blair 100% 100% 100% 100% No data No data 100% 100% Retrospe
Slide 15: Packaging and Labelling: Kit Contents
THE BD MAX EXTENDED ENTERIC BACTERIAL SOLUTION – PACKAGING AND LABELLING Kit Contents Assay Kit DOES NOT contain Sample Buffer xEBP Package Insert Tubes, Strips, Extraction 24 xEBP Master Mix snap-in Reagents tubes • 2 blue-top pouches of xEBP Assay CANNOT 12 each run alone • xEBP MM snap-in tube xE
Slide 16: Specimen Transport
THE BD MAX EXTENDED ENTERIC BACTERIAL SOLUTION – SPECIMEN TRANSPORT Specimens: • Unpreserved liquid or soft stool samples • Transfer liquid or soft stool samples to a dry, clean container. Avoid contamination with water or urine. • Preserved stool samples in Cary-Blair transport media • Transfer liq
Slide 17: Enteric Bacterial and Extended Enteric Bacterial Sample Prep
Enteric Bacterial and Extended Enteric Bacterial Sample Prep • Vortex unformed stool or Cary-Blair sample • Insert a 10 μL disposable inoculation loop into stool sample • Transfer properly loaded loop into the corresponding Sample Buffer Tube • Roll the loop between fingers to release the specimen f
Slide 18: BD MAX Enteric Run Set Up
THE BD MAX ENTERIC RUN SET UP Load rack, align Extraction, EBP MM and xEBP MM tubes according to designated colors • Rack with blue line is not a necessity…there will be no other place to put the xEBP MM except in the open spot (snap-4)once EBP reagents are loaded into the positions that are color c
Slide 19: BD MAX Enteric Hands On/Total Time
THE BD MAX ENTERIC HANDS ON/TOTAL TIME • From loop collection device to end of PCR BD MAX™ xEBP (including EBP) • HOT & TTR from R&D testing • Inoculating loop of stool, transferring sample to SBT, vortexing Manual steps • Run setup • All steps performed at room temperature Hands-on-time • 22 minute
Slide 20: Reimbursement (U.S.)
Reimbursement (U.S.) as of 5/2017 Number of Applicable Reimbursement Targets Panel Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (e.g., Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, Giardia), includes 6-10 EBP/xEBP $300 x 1 multiplex reverse tr
Slide 21: Results are reported for each target individually
THE BD MAX ENTERIC RUN SET UP Results are reported for each target ASSAY RESULT REPORTED INTERPRETATION OF RESULT Plesio POS Plesiomonas shigelloides DNA detected individually Plesio NEG Plesio UNR Plesiomonas shigelloides DNA detected Unresolved – inhibitory specimen or reagent failure; no • UNR re
Slide 22: Benefits of the Enteric Solution
Benefits of the Enteric Solution
Slide 23: BD MAX System provides a simple and efficient way to run molecular assays
THE BD MAX™ SYSTEM PROVIDES A SIMPLE AND EFFICIENT WAY TO RUN MOLECULAR ASSAYS
Slide 24: Optimize workflow to improve patient care
OPTIMIZE WORKFLOW TO IMPROVE PATIENT CARE TESTING FLEXIBILITY • Runs 1–24 samples and different assays at the same time10 • Tests a wide range of sample types11 STAFF PRODUCTIVITY THROUGH AUTOMATION11 • Offers simple implementation and standardized workflow OPPORTUNITY TO REDUCE TOTAL COST13 • Enabl
Slide 25: The BD MAX Enteric Solution
THE BD MAX ENTERIC SOLUTION Efficiency: BD MAX Enteric panels provide more accurate13 13 and faster 14 results (over conventional methods) for the 14 diagnosis of infectious gastroenteritis Versatility: Our focused syndromic approach offers clinicians the ability to order tests based on patient hist
Slide 26: BD MAX Enteric Solutions: targeted, clinically relevant results
BD MAX Enteric Solutions…targeted, clinically relevant results in an automated, cost effective platform Focused Panels designed for comprehensive pathogen detection allow for full flexibility based on clinical needs BD MAX System provides full automation with broad IVD and OSR molecular menu options
Slide 27: References
REFERENCES 1. WHO Fact Sheet, APRIL 2013. http://www.who.int/mediacentre/factsheets/fs330 2. CDC 2016. http://www.cdc.gov/foodsafety/foodborne-germs 3. Beal et al; May 2013 ASM 4. Mayo Clinic Symptoms and Causes of Travelers’ Diarrhea; October 2016 5. CDC 2014. http://www.cdc.gov/ecoli/etec 6. CDC 2
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