Cancer
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,...
Aeterna Zentaris, Ventana Medical Systems to Develop Companion Diagnostic
Aeterna Zentaris Inc. entered into a collaboration agreement with Ventana Medical Systems Inc., a member of the Roche Group, to develop a companion diagnostic for the immunohistochemical determination of luteinizing hormone-releasing hormone (LHRH) receptor expression, for the Company’s doxorubicin LHRH targeted conjugate compound, AEZS-108. In humans, LHRH receptors are expressed in a significant proportion of endometrial, ovarian, breast, bladder, prostate and pancreatic tumors. AEZS-...
Vermillion Sharpens Focus, Streamlines Operations
Vermillion Inc. announced a plan to streamline its organization and extend its cash runway. Vermillion's management and Board of Directors have reviewed the company's first complete year of commercialization progress and put in place a plan aimed to leverage the milestones achieved in 2011. With approximately $22.5 million in cash as of December 31, 2011, the company has commenced a restructuring program to reduce headcount and other expenses. The company intends to reduce cash-based operating...
HistoRx Licenses Assay from Yale
HistoRx licensed from Yale University a new clinical diagnostic assay based on AQUA technology. This assay enables doctors treating patients with melanoma to identify a subset of those patients who, despite having no detectable cancer in their lymph nodes, have a 40% risk of recurrence of their disease. AQUA technology is an automated, quantitative IHC testing method that enables measurement of protein biomarkers in tissue as an aid to a pathologist's diagnosis. Such precise determination of...
FDA Approves Hologic System for Cervical Cancer Screening
Hologic Inc. announced that FDA has approved its Cervista HTA (high throughput automation) system for use with the Company's previously approved Cervista human papillomavirus (HPV) HR test. The Company's HPV HR test utilizes Hologic's proprietary Invader technology to detect 14 high risk types of HPV that are associated with cervical cancer and precancerous lesions. The Company's Cervista HTA system automates the DNA extraction and detection steps of the Hologic Cervista HPV HR test allowing...
Clarient, Acorn Research Collaborate on Cancer Testing
Clarient Inc. and Acorn Research LLC announced their strategic collaboration around molecular testing of tumor samples. The agreement will establish a standardized testing protocol across the Acorn network of oncology community practices and hospitals with treatment guidelines and clinical trial opportunities. These processes have the potential to improve oncology treatment and research that aim to deliver targeted treatments based on the specific genetic markers for each patient. The...
MDxHealth, Univ. Hospital of Bonn Enter Agreement for Use of Epigenetic MGMT Test
MDxHealth SA has entered into a companion diagnostic agreement with Prof. Dr. Ulrich Herrlinger of the Division of Clinical Neuro-oncology of the University Hospital of Bonn (Germany) to provide MGMT epigenetic testing. MDxHealth’s epigenetic MGMT test (PredictMDx for Glioblastoma) will be used to select patients to enroll in a randomized, multicenter phase III clinical study examining the addition of lomustine (also known as CCNU) to the current therapy of temozolomide/radiotherapy in...
Abbott, GSK Pump Up Companion Diagnostic Agreement
Abbott will expand its existing agreement with GlaxoSmithKline Biologicals SA (GSK) to include the development of an additional companion diagnostic test in support of GSK’s cancer immunotherapy research program. Companion diagnostic tests are designed to identify specific DNA sequences to help guide physicians in determining which patients are more or less likely to benefit from a particular therapy. The existing agreements between the two companies, announced in July 2009 and March 2010...
MDxHealth Reports Positive Results for Prostate Cancer Diagnostic Test
MDxHealth SA announced data showing that a prototype of its Prostate ConfirmMDx test can help urologists distinguish patients who have a true negative biopsy from those who may have occult cancer undetected by prostate biopsy and histopathological review. If this early data is validated in a larger study, the results suggest that 30% of men suspicious for cancer after an initial negative biopsy could be spared a repeat biopsy. Prostate ConfirmMDx detects epigenetic changes in specific prostate...