BD Diagnostics, a segment of BD (Becton, Dickinson and Company) has announced that it received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) for the BD FocalPoint(TM) GS Imaging System.
This innovative new system is designed to enhance cervical cancer screening for cytology laboratories using the BD SurePath(TM) Pap test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.
"The launch of the BD FocalPoint(TM) GS System represents a key milestone in our effort to expand BD's presence in cancer diagnostics," said Vincent A. Forlenza, BD Executive Vice President. "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."
Despite significant improvements in cervical cancer screening over the past 40 years, nearly 4,000 women die from the disease each year in the United States, and costs to treat the disease exceed $2 billion annually. 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.
The new BD FocalPoint(TM) GS Imaging System seeks to address this problem by offering laboratories key advantages over current cervical cancer imaging systems. Its state-of-the-art guided screening (GS) technology helps rapidly relocate the fields of view that the system has identified as the most likely to contain cells of interest.
"Our clinical trial results give us confidence that the BD FocalPoint(TM) GS Imaging System will provide cytology labs with the advanced tool they need to improve cervical cancer detection and enhance their productivity," said Wayne Brinster, Vice President and General Manager, BD Diagnostics - TriPath. "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."