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 STD testing on the TIGRIS® DTS™ SYSTEM, the first fully automated, amplified molecular diagnostic testing instrument.

INDIANAPOLIS, IN – The RND Group, Inc.’s, client, Gen-Probe Incorporated, has received marketing clearance for sexually transmitted disease testing on its TIGRIS® DTS™ System. RND, one of Gen-Probe’s development partners, helped Gen-Probe develop the master 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 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 gonorrhoea. 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 the design of the software architecture, software design and development, software verification testing, and documentation of the software system development and testing in accordance with FDA guidelines. Throughout the effort, RND has managed distributed development and testing efforts carried out by teams of software engineers in San Diego, Denver, and Indianapolis. “We are proud of this achievement and of the opportunity that Gen-Probe has given us 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.” Approximately 90 percent of RND’s software engineering business is in support of companies that produce electronic medical devices. 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 at the peak of the TIGRIS effort. RND currently has a combined force of 17 full-time and contract people involved in ongoing projects. “RND Group’s work is an excellent example of how life sciences work can extend beyond the recognized big players like Lilly, Cook, and Roche locally and Gen-Probe on the west coast,” commented Wade Lange, IHIF President and CEO. “Companies like RND that are part of the life sciences supply chain play a significant role in contributing to the growing number of jobs in the overall life sciences industry.”

The TIGRIS System, which is intended initially for clinical diagnostics and later for blood screening laboratories, is the first diagnostic instrument to fully automate NAT testing from start to finish. For example, no manual sample preparation is required to initiate a run and generate test results. The TIGRIS System is expected to significantly reduce labor costs, minimize testing errors, improve operator ergonomics, and increase laboratory productivity.

The TIGRIS System has the ability to process approximately 500 samples in an eight-hour shift and up to 1,000 samples in approximately 13 hours. Because one trained operator can run two or three TIGRIS machines simultaneously, the productivity of a single technician using the TIGRIS System could be as much as 10 times greater than a technician using semi-automated systems.

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 and consumer electronic product development. 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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