The BD Viper™ System with XTR™ Technology

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

Molecular labs encounter a diverse set of challenges

Economic Constraints

Decentralized Testing

Unreliable Results

By design, the BD Viper™ System provides a cost-effective solution ideal for an economically-constrained environment

Minimized Waste &

Economic Benefits

Unequivocal Results

Optimized Productivity

• Requirements to do more with less

• Limitations on skilled workforce

• Budgetary constraints

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

The BD Viper™ eliminates the equivocal zone found in other FDA cleared assays – delivering confidence in results

Source: Package insert for BD CT/GC Qx assays

NO EQUIVOCAL ZONE

Reducing the need for retesting

Cutoff of ≥125 MaxRFU Cutoff of ≥125 MaxRFU

The Gen-Probe® Aptima® CT/GC have equivocal zones for both CT and GC that require retesting

Data from Aptima Combo 2® Package Insert

• 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

Relative Light Units (RLU)

The BD Viper™ focuses on productivity, decreasing required hands on time and overall unproductive time

Source: Internal studies

The BD Viper™ maximizes productivity, decreasing required hands on time and overall unproductive time

Source: Internal studies

*

SimulationBD Viper

XTRGen-Probe

TIGRIS

Cycle Time* 3:24:00 6:06:00

Hands-On Manual Labor Time** 0:24:00 0:54:00

Simulated time includes time to release results* 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)

“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

Testimonial – Economic Benefits

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

Standardized Workflow

Most Sample Types

Workstation Consolidation

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

Pre-Aliquot

Post-Aliquot

Pre-Aliquot

Post-Aliquot

BD Qx

Abbott Real Time

Gen-Probe Aptima

Roche Cobas

Hologic PreservCyt BD SurePath

CT/GC Assays

Swab Urine Liquid Based Cytology Media

EndocervicalMale

Urethral VaginalMale Neat

Male Transport

Female Neat

Female Transport

“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

TIGRIS

The BD Viper™ System has 5 FDA-cleared STD assays and is able to efficiently run tests based on your unique requirements

Time

# o

f Ru

ns

Viper XTR

Roche 4800

Abbott m2000

1

2

Minimal pre- & post-analytical hands-on time frees up valuable lab professional time

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

Instrument development considered the customer’s needs throughout the design of the product

*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 01 2009

*

“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.

Testimonials: Efficiency Gains

“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.

The BD Viper™ System design works to minimize Unreliable Results

• Uncertainty surrounding the accuracy of results

• Disruptive repeat testing

No Equivocal

Zone

Extraction Process Control

Total System

Integrity®

Control Over Workflow Process: Reassure consistency of performance during testing and every single test

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

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.

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

Unlike the competition, the BD Viper™ assays provide a definitive yes or no answer for positive or negative results

Source: Package inserts for Gen-Probe and BD CT/GC Qx assays

BD CT/GC Qx Assay Gen-Probe Assay

“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

Testimonials: High Quality Results

“I have no doubt we’re putting out high quality results”

DAVID BANKERT, YORK HOSPITAL LABORATORY, YORK, PA

Our solutions lead the market in addressing the challenges within your laboratory

Why Choose the BD Viper™ System?

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.