Issue Stories

Digene Granted FDA Approval for Rapid Capture System

 Digene Corp was granted FDA approval for the Rapid Capture® System application that allows high-throughput testing with its Hybrid Capture® 2 (hc2) High-Risk HPV DNA Test™. Using the Rapid Capture System, 352 patient specimens can be processed by one technologist in 6.5 hours with 3.5 hours of hands-free operation. As testing volumes increase, one technologist can easily operate two Rapid Capture Systems simultaneously, further increasing productivity. The new menu for the Rapid Capture System now includes CT, GC, and High-Risk HPV from Digene specimens or Cytyc ThinPrep® PreservCyt® specimens.
     The hc2 High-Risk HPV DNA Test is FDA approved to detect high-risk HPV as part of routine cervical cancer screening, in conjunction with a Pap test in women age 30 and older. It is marketed as the DNA with Pap™ test. The Rapid Capture System offers laboratories increased productivity as well as better performance and simplicity when using the hc2 High-Risk HPV DNA Test.
     The Rapid Capture System fits on a standard benchtop, eliminating the need for separate work areas. It provides bar-code capabilities and LIS interface connectivity, further increasing productivity. When the system is combined with the newly released Digene Multi-Specimen Tube (MST) Conversion protocol, multiple racks of specimens from the ThinPrep® PreservCyt® medium can be prepared and processed at one time, reducing the labor required for these tests by 35%. Despite the complexity of what the Rapid Capture System can accomplish, its intuitive software is designed to make it easy to set up and run.

Digene Corp
(800) 344-3631; www.digene.com

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