Improved System Streamlines Laboratory Workflow and Increases Sample Transport Flexibility
Baltimore, MD (October 18, 2005) - BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE:BDX), announced today that it was granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a next generation urine specimen processing system that improves laboratory workflow and sample transport flexibility when testing urine specimens on its BD ProbeTec™ System.
The BD ProbeTec™ Urine Preservative Transport Kit (UPT) with NAP Guard™ technology provides a safer, labor-saving enhancement for the already efficient BD ProbeTec system and helps streamline diagnostic testing for a variety of infectious diseases. The BD ProbeTec UPT also extends the time and temperature of urine specimen transport to the laboratory when testing is not immediately possible; for example, when samples are held over the weekend or transported by mail. In addition, the BD ProbeTec UPT reduces laboratory processing steps associated with repetitive motion injuries in lab technicians, while speeding up the handling of samples.
Improved Lab Process
"Like the BD ProbeTec™ ET System
, the BD ProbeTec UPT is a significant development in clinical molecular diagnostics," said Dennis Ferrero, Director (Emeritus), Disease Control and Prevention Division, San Joaquin County Public Health Services. "The improved system's design, workflow and ease-of-use overcome many of the practical concerns associated with molecular testing, particularly in labs with higher workloads and concerns about specimen transport conditions."
Better Detection, Better Diagnosis
Products such as the BD ProbeTec UPT further enable use of easy-to-collect urine specimens for amplified DNA methods that may increase the use of these sensitive technologies within the public health setting. "Broad use of simple amplified methods such as the BD ProbeTec ET System helps to make public health screening programs more acceptable and effective, allowing for improved detection of asymptomatic, yet transmittable, infections," explained Dr. Ferrero.
For example, Chlamydia affects one in 10 sexually active adolescent girls and is the most common sexually transmitted disease in the US. Most young women who become infected never experience symptoms that would prompt them to see a doctor. Left untreated, up to 40% of infected women develop pelvic inflammatory disease, and of these cases, 20% become infertile, 18% develop chronic pain, and 9% have a life-threatening tubal pregnancy.
"The BD ProbeTec UPT is an example of our continued investment in molecular diagnostics and our commitment to products that meet the needs of the medical industry," said Michael Little, Ph.D., Director of Molecular Diagnostics, BD Diagnostics. Customers seeking additional product information may call BD Diagnostics at 800-638-8663, selection 2.
About BD ProbeTec ET
Assays for the BD ProbeTec™ ET System
feature homogeneous amplification and real-time detection technology, combining the power of BD proprietary strand displacement amplification (SDA) with an energy transfer (ET) detection method. SDA is a patented isothermal amplification technology capable of generating billions of copies of target molecules from a single DNA or RNA template in just minutes.
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. The short time to results, minimal labor, high-throughput and ease-of-use have combined to make the BD ProbeTec ET System the choice for laboratories throughout the world.
BD is a medical technology company serving healthcare institutions, life science researchers, clinical laboratories, industry, and the public. BD manufactures and sells a broad range of medical supplies, devices, laboratory equipment and diagnostic products. For the fiscal year ended September 30, 2004, BD reported total revenues of $4.935 billion.
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