BD Diagnostic Systems Announces FDA 510(k) Clearance Of The BD Viper(TM) System

BALTIMORE, Jan. 9 /PRNewswire-FirstCall/ -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company), today announced FDA 510(k) clearance and immediate market launch of the BD Viper System(TM) for in vitro infectious disease molecular diagnostic testing.

The BD Viper System is a novel, patented approach to laboratory automation using an industrial class of robotics known as Selective Compliance Assembly Robot Arm (SCARA). This classification indicates that the robot is multi-jointed (4-axis), similar to the human arm.

The BD Viper System automates previously manual and semi-automated steps of the market-leading BD ProbeTec(TM) System. The BD ProbeTec ET System, first marketed in 1998, is the only commercially available real-time DNA amplification assay for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae. Incubations, amplification and detection all occur on the BD Viper System, with repetitive pipetting labor delegated to the robot. The SCARA robotic approach delivers an extremely robust instrument by eliminating all pumps, syringes and reagent tubing, commonly thought of as the “Achilles’ heel” of traditional laboratory equipment regarding maintenance and reliability.

The high throughput of the BD Viper System also helps address the critical shortage of technologists in laboratories. By minimizing hands-on-time, the technologist can take advantage of “load and go” workflow, letting the robot do the processing work.

The system sets new standards for processing accuracy, precision, speed, quality, instrument reliability and efficiency.

“The automation of the BD Viper System allows the clinical laboratory to process several hundred more samples per day with no increase to our staff,” states Jill MacAfee, CLS, MBA, Director of Laboratory Services and Clinical Trials for Planned Parenthood Mar Monte, San Jose, CA.

The BD Viper System uses the proven chemistry of Strand Displacement Amplification (SDA) that has been embraced by over 1,100 laboratories worldwide, making SDA a leading technology in the area of amplified testing for chlamydia and gonorrhea. The isothermal, real-time amplification and detection offered by SDA has greatly simplified complex molecular testing making this technology more accessible to clinical laboratories. Early and accurate diagnosis of chlamydia and gonorrhea lead to more effective treatment as well as reduce the potential for the further spread of infection. Left undetected and untreated in women, chlamydia can lead to infertility, tubal pregnancy and debilitating pelvic pain.

About BD

BD is a medical technology company that serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. BD manufactures and sells a broad range of medical supplies, devices, laboratory equipment and diagnostic products. To learn more about BD, please visit http://www.bd.com.

BD Diagnostics

CONTACT: Barbara Kalavik of BD Public Relations, +1-201-847-4209,Barbara_Kalavik@bd.com

Web site: http://www.bd.com/

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