For more information, contact
Tom Gardner (317) 841-8014 x101
tom.gardner@RNDGroup.com

The RND Group’s client, Gen-Probe Inc., receives FDA approval for automated PROCLEIX® TIGRIS® System to Test Donated Blood with the PROCLEIX ULTRIO® Assay.

INDIANAPOLIS, IN – The RND Group’s client, Gen-Probe Inc., receives FDA Approval for its Automated PROCLEIX® TIGRIS® System to test Donated blood with the PROCLEIX ULTRIO® Assay. The PROCLEIX TIGRIS system was approved with the PROCLEIX ULTRIO assay to screen donated blood, plasma, organs and tissue for HIV-1 and hepatitis C Virus (HCV) in individual blood donations or in pools of up to 16 blood samples. The system and assay also detect hepatitis B Virus (HBV) in blood donations that are HBV-positive based on traditional serology tests for HBV surface antigen and core antibodies. In March of 2007, the FDA approved another Gen-Probe test, the PROCLEIX WNV (West Nile Virus) assay, to screen donated on the TIGRIS system .

The RND Group provided software engineering services working with Gen-Probe to develop the system software application that controls the operation of the TIGRIS System. The TIGRIS System is the first fully automated, high throughput instrument for the molecular diagnostics marketplace. The TIGRIS System has also been approved to run Gen-Probe’s APTIMA COMBO 2® assay, an FDA-approved amplified nucleic acid test (NAT) for simultaneously detecting Chlamydia trachomatis and Neisseria gonorrhea. Gen-Probe announced that the company received marketing clearance for the TIGRIS System.

RND has been associated with the TIGRIS System development effort since early in the design process. The company’s responsibilities have included requirements development and management, software architecture, software design and development, software verification testing, and documentation of the system software in accordance with FDA guidelines for software in medical devices. Throughout the effort, RND has managed distributed development and testing efforts carried out by teams of software engineers in San Diego and Indianapolis. “We are proud of this achievement and of the opportunity to be part of such cutting-edge technology and product development,” said Tim DeFrench, President of RND. “This has been a monumental effort requiring hard work and close cooperation between scientists, hardware and software engineering teams, and other teams carrying out hardware and software verification and validation testing,” DeFrench continued. “The RND Group has devoted a team of highly experienced, skilled software engineers to this project and, we believe we have played a key role in the success of this effort.” Greater than 90 percent of RND’s software engineering business is for companies that produce medical devices performing real-time PCR, molecular analysis, immunoassays, and clinical assays. RND is a member of the Indiana Health Industry Forum (IHIF) and has grown from a startup team of 2 people in 1997 to as many as 23 full-time and contract engineers. For more information on the RND Group, contact RND at 1-317-841-8070 or via email at info@RNDGroup.com.

About the RND Group
The RND Group provides full life cycle software engineering services specializing in medical device product development for FDA regulated products. We work with companies by partnering with their product development organizations in providing project management, requirements management, software engineering, and product testing services as needed to complement our clients’ existing engineering departments.

RND is proud to be celebrating ten years of providing quality software engineering services to our customers.

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