BioImagene Develops Companion AlgorithmsTM to Further Enable Personalized Medicine

BioImagene Develops Companion AlgorithmsTM to Further Enable Personalized Medicine

SUNNYVALE, Calif. -- BioImagene, the leading provider of innovative digital pathology solutions, announced today that the company is advancing its goal of bridging personalized medicine and the clinical practice of pathology by providing Companion AlgorithmsTM. These specialized algorithms, which BioImagene develops for use with its VirtuosoTM suite of web-based software, aid pathologists in the quantitative assessment of specialized diagnostic tests used to determine patient suitability for specific cancer therapies. As pharmaceutical companies work to develop companion diagnostics to individualize therapy for cancer patients, Companion Algorithms further enable pathologists to correctly identify and accurately measure specific biomarkers used to determine appropriate treatment options for patients.

"Companion diagnostics will play an increasing role in cancer care as physicians strive to provide the therapies that are most likely to be advantageous to individual patients," said Keith J. Kaplan, M.D., Mayo Clinic. "Companion Algorithms bring personalized medicine one step closer to reality and can help the pathologist provide the most actionable information to the oncologist."

Ajit Singh, Ph.D., chief executive officer of BioImagene, commented: "The Human Genome Project opened the doors to research in the field of biomarkers and cancer diagnostics; however, challenges still exist in using biomarkers to identify subpopulations of patients that are likely to respond favorably to targeted treatments. Providing pathologists with Companion Algorithms will ultimately move our industry closer to the goal of personalized medicine."

BioImagene's Companion Algorithms can be used by pathologists to aid in the interpretation of digitized images of cancer diagnostic tests including immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH). Digitized images can be generated by one of BioImagene's iScan slide scanning systems, such as Coreo, Concerto, or Solo. In February 2009, BioImagene received clearance from the U.S. Food and Drug Administration (FDA) for use of one of its Companion Algorithms in the company's PATHIAMTM IVD Imaging Software for HER2/neu immunohistochemistry tests. The iScan Coreo and associated software are used to detect and provide a quantitative measurement of HER2/neu, a protein measured in breast cancer patients to determine their candidacy for treatment with the Genentech drug HerceptinTM.

"The Herceptest, the first FDA-approved companion diagnostic, is used to identify the subset of breast cancer patients who over-express the HER2/neu protein and will therefore have a high probability of responding to Herceptin," said Robert Monroe, M.D., Ph.D., chief medical officer of BioImagene. "BioImagene's FDA-cleared HER2/neu Companion Algorithm improves the accuracy and reproducibility of Herceptest interpretation. BioImagene offers additional Companion Algorithms for breast cancer and is committed to developing new Companion Algorithms for other companion diagnostic tests used in prostate, colon, lung and other cancers."

About BioImagene

BioImagene ( is the leader in providing innovative digital pathology solutions for clinical diagnostics and drug discovery. BioImagene products are FDA-cleared for specific clinical applications and are intended for research use for other applications.