BD Receives FDA Approval for the BD FocalPoint™ GS Imaging System





BD Diagnostics, a segment of BD announced that it received U.S. FDA Premarket Approval (PMA) for the BD FocalPoint™ GS Imaging System. This innovative new system is designed to enhance cervical cancer screening for cytology laboratories using the BD SurePath™ Pap test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.

BD Diagnostics, a segment of BD announced that it received U.S. FDA Premarket Approval (PMA) for the BD FocalPoint™ GS Imaging System. This innovative new system is designed to enhance cervical cancer screening for cytology laboratories using the BD SurePath™ Pap test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.

Vincent A. Forlenza, BD Executive Vice President, The launch of the BD FocalPoint™ GS System represents a key milestone in our effort to expand BD’s presence in cancer diagnostics . It is the first in a series of innovative products aimed at improving the detection and clinical management of cancer, resulting from our TriPath acquisition.

The key to detecting cervical cancer early is regular Pap testing. However, limitations exist with current technologies. Approximately one-third of Pap smear false negatives can be attributed to screening and interpretive errors in which abnormal cells are incorrectly classified.

Wayne Brinster, Vice President and General Manager, BD Diagnostics – TriPath said, Our clinical trial results give us confidence that the BD FocalPoint™ GS Imaging System will provide cytology labs with the advanced tool they need to improve cervical cancer detection and enhance their productivity. It demonstrates BD’s commitment to providing innovative, world-class products and services for the oncology market that help improve patient outcomes by offering clinicians better tools to detect and manage disease