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The BD Viper™ System with XTR™ Technology

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Presentation on theme: "The BD Viper™ System with XTR™ Technology"— Presentation transcript:

1 The BD Viper™ System with XTR™ Technology
Script: - Viper XTR continues BD’s legacy of high performing solutions that improve patient care The Viper XTR is the best solution for your evolving molecular testing needs For: Dedicated medium (12M + tests) to very high volume STD Molecular testing system Goal of presentation: Illustrate how the Viper XTR can solve a diverse set of issues/concerns within your laboratory

2 Introducing the BD Viper™ System with XTR™ Technology
Designed to meet the challenges faced by today’s laboratory Paired with our FDA cleared assays, BD Viper provides a comprehensive STI solution for your laboratory The Viper XTR was designed with the customer in mind, by researching needs and devising optimal solutions to address the concerns of those who will use the instrument all day everyday Transition: Let’s review the aforementioned challenges one at a time

3 Molecular labs encounter a diverse set of challenges
Economic Constraints Decentralized Testing Molecular testing is changing at a rapid pace, presenting a clear need for molecular solutions Concerns in your laboratory, both internal and external, present issues that require tailored solutions #1 Economics: a) labor shortage of qualified techs b) budgets – do more with less resources #2: Need for platform consolidation – too many instruments with too few tests, with separate maintenance, agreements, tests, and support #3 Inefficiencies: Unable to minimize non-productive time and unrealized walk away freedom #4 : Reliability: a) instrument up time, b) lack of need to retest results c) confidence in results, the first time Note: Gain consensus here and pay particular focus on the customer’s communicated needs (if the same, similar, or slightly different). Spend more time omn their concerns and our matched solutions Unreliable Results

4 Optimized Productivity Minimized Waste & Economic Benefits
By design, the BD Viper™ System provides a cost-effective solution ideal for an economically-constrained environment Requirements to do more with less Limitations on skilled workforce Budgetary constraints Unequivocal Results Intro: All under economic constraints Budget pressures To do more with less funding as well as personnel Limited supply of technicians: Cannot pay for them Hard to find Viper Solutions: Minimized waste – reagents, standardization, 1st run efficiency – heating step, limited repeat testing True automation - free up tech time, limit # of techs required Optimized Productivity Minimized Waste & Economic Benefits

5 Minimizing waste is one way the BD Viper™ solution delivers economic benefits
Improving Economic Value – both personnel and non-personnel costs No refrigeration required No reagent preparation Single unit, ready-to-use reagents Mixed batch capability

6 Reducing the need for retesting
The BD Viper™ eliminates the equivocal zone found in other FDA cleared assays – delivering confidence in results NO EQUIVOCAL ZONE Reducing the need for retesting Cutoff of ≥125 MaxRFU Cutoff of ≥125 MaxRFU Source: Package insert for BD CT/GC Qx assays

7 Relative Light Units (RLU)
The Gen-Probe® Aptima® CT/GC have equivocal zones for both CT and GC that require retesting Relative Light Units (RLU) Result can be either: Positive Negative Indeterminate/Equivocal Initial equivocal and invalid test results should be retested Could cause delays, increased costs and potential false positives Data from Aptima Combo 2® Package Insert

8 The BD Viper™ focuses on productivity, decreasing required hands on time and overall unproductive time Source: Internal studies

9 The BD Viper™ maximizes productivity, decreasing required hands on time and overall unproductive time * * Total cycle time: Time to perform testing on the volume of specimens; this includes all manual and automated pre-analytical (laboratory accessioning is not included), analytical and post-analytical activities (time ends when consumables and specimens have been removed from the instrument, and specimens have been disposed of or prepared for storage) ** Hands-on Manual labor time: The daily amount of time that lab personnel must devote to physically performing testing; this includes pre-analytical, analytical and post-analytical manual labor (it does not include maintenance activities) Source: Internal studies

10 Testimonial – Economic Benefits
“The BD Viper™ System with XTR™ Technology is all about automation and freeing up labor. It has improved our productivity with less staffing. Today, we’re running about 24,000 CT/GC tests a year with one-half FTE.” MICHAEL LOEFFELHOLZ, PhD, UNIVERSITY OF TEXAS MEDICAL BRANCH, GALVESTON, TX Feedback from a user

11 Workstation Consolidation Standardized Workflow
The BD Viper™ System provides an opportunity to consolidate testing requirements as well as service/technical points of contact Multiple workstations for testing requirements Multiple technologies & points of contact Most Sample Types Workstation Consolidation Standardized Workflow

12 A wide variety of specimen types increases the flexibility of sample collection
The BD Viper™ System leads the CT/GC market in sample type availability “It was important that the CT/GC assays were FDA cleared for both SurePath and ThinPrep collections. With the Viper, it’s easier to validate these tests because of the FDA clearance. We are looking at adding HSV testing because it is FDA cleared on the Viper” GARY GEMAR, INCYTE PATHOLOGY, SPOKANE VALLEY, WA

13 The BD Viper™ System has 5 FDA-cleared STD assays and is able to efficiently run tests based on your unique requirements TIGRIS Trich CT/GC 2 Abbott m2000 CT/GC only # of Runs 1 Roche 4800 CT/GC Only Viper XTR CT/GC, Trich & HSV 1 &2 Time

14 Minimal pre- & post-analytical hands-on time frees up valuable lab professional time
Instrument development considered the customer’s needs throughout the design of the product Pre-analytical time for 4 runs 1 Hour (15 minutes/run) FTE per shift (for 4 runs) 13% Post-analytical time for 4 runs 40 minutes (10 minutes/run) Pre & post-analytical hands-on time per run 25 minutes Tech time/results 4.9 seconds * *Data in table from Felder, Robin A. et. al “Process Evaluation of a Fully Automated Molecular Diagnostics System.” Journal of the Association for Laboratory Automation, October

15 Testimonials: Efficiency Gains
“Since we brought testing in house, we are totally in control of turnaround time. Not only are we bringing in more revenue, we are also getting results out a day or two faster.” GARY GEMAR, INCYTE PATHOLOGY, SPOKANE VALLEY, WA. “With the acquisition of our second Viper system, BD provided LEAN consultation and workflow analysis. We were able to design a more efficient process that made it very easy to get up and running smoothly.” PAUL LEPHART, PhD, DETROIT MEDICAL CENTER UNIVERSITY LABORATORIES, DETROIT, MI.

16 Extraction Process Control Total System Integrity®
The BD Viper™ System design works to minimize Unreliable Results Uncertainty surrounding the accuracy of results Disruptive repeat testing Extraction Process Control Total System Integrity® No Equivocal Zone

17 Control Over Workflow Process: Reassure consistency of performance during testing and every single test The BD Viper™ System ensures control throughout the test run The BD Viper System utilizes a special oligonucleotide labeled with a different dye to confirm the validity of our proprietary BD FOXTM DNA extraction process. EC fluorescence is monitored and an automated algorithm is applied to both the EC and target-specific signals to report specimen results as positive, negative, or EC failure. This assures the results you report are high quality and reduces the costs and issues associated with inappropriate treatment and retesting. BD Qx technology 96 samples, 100% control A positive and negative control (per plate) are tested simultaneously with all samples. Every single sample reaction has a process control to monitor performance of individual tests. Gen-Probe TIGRIS example for 100 samples Control bracketing. The system tests a control set and then tests sequentially 100 samples. This is happening across 4 hours and through 20 different testing processes. At the end the system tests a new set of controls. If successful then releases the results. There is not a single control to reassure system performance across 4 hours of testing. Source: Package inserts for Gen-Probe and BD CT/GC Qx assays

18 Assurity Linc™: Dependability and remote service capabilities deliver high reliability and minimize downtime

19 Unlike the competition, the BD Viper™ assays provide a definitive yes or no answer for positive or negative results BD CT/GC Qx Assay Gen-Probe Assay Source: Package inserts for Gen-Probe and BD CT/GC Qx assays

20 Testimonials: High Quality Results
“We’ve not had any evidence of lab contamination since moving the testing to the Viper … and it really contributes to peace of mind” MICHAEL LOEFFELHOLZ, PhD, UNIVERSITY OF TEXAS MEDICAL BRANCH, GALVESTON, TX “I have no doubt we’re putting out high quality results” DAVID BANKERT, YORK HOSPITAL LABORATORY, YORK, PA

21 Why Choose the BD Viper™ System?
Our solutions lead the market in addressing the challenges within your laboratory With a BD partnership, you can depend upon the following: Unparalleled service and support A commitment to continuing education and to your laboratory’s success Continued customer driven development of instruments & assays

22 BD: A Trusted Partner with a Long History of Innovation and Stewardship
Since 1897, BD has been a leading force in innovating medical devices, equipment and diagnostic products. Our purpose is Helping all people live healthy lives, and we do so by developing and manufacturing medical devices, instrument systems and reagents that combat many of the world’s pressing diseases. For more than a century, BD has earned customers’ trust by effectively and efficiently developing and manufacturing high quality products that meet their needs. When you use a product with the BD name on it, you are using a product you can trust.

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