BioImagene, Inc. Receives FDA Clearance for HER2/neu Application on Pathiam™ Imaging Software

CUPERTINO, Calif.--(BUSINESS WIRE)--BioImagene, the leading provider of digital pathology solutions, today announced that it has received clearance from the US Food and Drug Administration (FDA) for the use of its Pathiam™ Imaging Software for HER2/neu for in vitro diagnostic use.

BioImagene’s Pathiam™ is intended for use as an accessory to the Dako HercepTest® to aid a pathologist in semi-quantitative measurement of HER2/neu in breast cancer tissue. When used with the Dako HercepTest® it is an aid in the assessment of breast cancer patients for whom Herceptin® treatment is being considered. The imaging software detects and classifies cells of interest by analyzing digitized images of microscope slides based on recognition of cellular objects of a color, size and shape.

Pathiam™ provides an easy to use viewing, analyzing, and reporting software solution for the pathology laboratory. Its powerful analysis algorithm and its user friendly interface enables pathologists to provide accurate and objective quantitation of tissue samples stained with HER2/neu.

Mohan Uttarwar, CEO, said, “This FDA clearance is a significant regulatory milestone for our company. Complying with FDA regulations helps ensure safety and effectiveness for patients and this product is a welcome advancement in the automation of cancer diagnostics. We are very pleased with the FDA’s decision to clear BioImagene’s HER2/neu application. Interest from pathologists for Pathiam™ has been very strong and it shows the growing market adoption for our digital pathology solutions. This success has accelerated our efforts to seek clearance for our other analysis algorithms in order to provide a total digital pathology solution to clinical customers.”

About BioImagene

BioImagene, Inc., based in Cupertino, California, is a leading provider of image informatics solutions for life sciences research, drug discovery & development and digital pathology. BioImagene has developed a product line from the web enabled management platform 3i. BioImagene’s products deliver a comprehensive and searchable image database while maintaining powerful processing and advanced analysis algorithms. With the exception of Pathiam™ Imaging Software for HER2/neu, BioImagene products are for research use only. Contacts

BioImagene, Inc. Suchitra Parthasarathy, 408-207-4285

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