Cancer
Pacific Edge Diagnostics to Open U.S. Office
Hershey Center for Applied Research (HCAR) prepares to welcome another international company to its thriving research facility. Based in Dunedin, New Zealand, Pacific Edge Diagnostics Ltd., a developer of cancer diagnostic and prognostic technology, plans to open its first U.S. franchise to market the company's bladder cancer detection test, Cxbladder, to urologists in the United States by the end of the year. Looking to build a better understanding of the U.S. marketplace, Pacific Edge chose...
Opko Health Acquires Next Generation Prostate Cancer Tests
Opko Health Inc. announced the acquisition of an exclusive license from Arctic Partners Ab Oy (Turku, Finland) for two biomarkers in the kallikrein family which, used together with prostate specific antigen (PSA), can reduce the need for prostate biopsies by over 50%. These novel biomarkers were developed by investigators at the University of Malmo, Sweden, University of Turku, Finland, and Memorial Sloan Kettering Cancer Center, New York. The research results indicate that these markers can...
New Test Offers Greater Accuracy in Early Detection of Colorectal Cancer
Results of two studies suggest that a new, investigational colorectal cancer screening test developed in a collaboration between Mayo Clinic and Exact Sciences Inc. (Madison, WI) is highly accurate and significantly more sensitive than other noninvasive tests at detecting precancerous tumors (adenomas) and early-stage cancer. The first study, to be published in the February issue of Gastroenterology, shows that a new multi-marker stool DNA test is highly accurate at detecting precancerous...
LabCorp to Offer Test to Assess Whether Ovarian Mass is Malignant
Laboratory Corporation of America Holdings (LabCorp) announced the nationwide availability of a new FDA-cleared risk stratification tool (ROMA, Risk of Ovarian Malignancy Algorithm) that combines the results for Fujirebio HE4, Abbott’s ARCHITECT CA 125 II, and menopausal status into a numerical score that, along with clinical and radiological evaluation, can aid in evaluating whether a woman over the age of 18 who presents with an ovarian mass and for whom surgery is planned is at high or...
Ventana, Bayer to Collaborate on Companion Diagnostic for Cancer Therapy
Ventana Medical Systems Inc., a member of the Roche Group, has entered into a strategic collaboration agreement with Bayer Bayer Pharma AG (Bayer) to develop a molecular companion diagnostic test intended to identify patients most likely to benefit from a Bayer antibody-drug conjugate (ADC). Ventana’s diagnostic immunohistochemistry platform aims to analyze the expression level of certain tumor targets serving as biomarkers in clinical studies for patient selection. This will support the...
Nuclea Biotechnologies Submits PMAs for Fatty Acid Synthase Assays
Nuclea Biotechnologies Inc. has filed premarket regulatory filings for FDA review on its Fatty Acid Synthase (FAS) and USP2a diagnostic assays in both breast and prostate cancer. The premarket filings were submitted for review by FDA beginning in mid 2011 outlining the use of FAS as a monitoring tool in prostate cancer and in breast cancer. “This is a major achievement for Nuclea and the way prostate cancer and breast cancer will be managed in the future,” said Patrick J. Muraca,...
GE Healthcare Discusses Companion Diagnostics in Personalized Medicine
Pascale Witz, President and CEO, GE Healthcare, Medical Diagnostics discussed diagnostics as the future of personalized medicine at the 30th JP Morgan Healthcare Conference in San Francisco, CA. During her presentation, Witz noted that diagnostics and pathology screening are core enablers of personalized medicine, and outlined how GE Healthcare partners with the pharmaceutical industry to support market entry of new therapies via providing complex technologies that can aid in the conduct of...
Ventana to Collaborate with Pfizer, CST on Lung Cancer Companion Diagnostic
Ventana Medical Systems Inc., a member of the Roche Group, has entered into a collaboration agreement with Pfizer Inc. and a license agreement with Cell Signaling Technology (CST) to develop the first fully automated and standardized immunohistochemistry (IHC) companion diagnostic test for ALK gene rearrangements. Ventana will develop the test which is intended to identify non-small cell lung cancer (NSCLC) patients with anaplastic lymphoma receptor tyrosinekinase (ALK) gene rearrangements who...
Qiagen Gains Approval in Japan for EGFR Companion Diagnostic, Rights to Cancer Biomarkers
Qiagen announced the regulatory approval of its therascreen EGFR Mutation Detection Kit RGQ in Japan. EGFR, the epidermal growth factor receptor, has been shown to play an important role in certain cancers and is the target of many new anticancer drugs. The approval is a milestone in Qiagen's Personalized Healthcare strategy, as Japan is one of the world's largest markets for companion diagnostic tests. In April 2011, Qiagen's therascreen KRAS Mutation Detection Kit was approved in Japan,...
Syndax Pharmaceuticals, Ventana Medical Systems to Develop Companion Diagnostic Test for Lung Cancer
Syndax Pharmaceuticals Inc. and Ventana Medical Systems Inc. have entered into an agreement to develop a companion diagnostic assay to select patients with non-small cell lung cancer (NSCLC) for treatment with erlotinib and Syndax’s proprietary lead molecule entinostat. “Syndax is pleased to partner with Ventana, a world leader and innovator of tissue-based diagnostic solutions for patients worldwide, as we advance the development of entinostat in NSCLC,” said Joanna Horobin,...