Cancer
Researcher Presents Positive Data on Combining Vermillion Test with Imaging
Fred Ueland, MD, Associate Professor of Gynecologic Oncology at the University of Kentucky's Markey Cancer Center, and principal investigator of the multi-center OVA1 clinical trial, presented data demonstrating the improvement in sensitivity when using imaging in conjunction with OVA1. These data were highlighted at the 17th Annual European Society of Gynecologic Oncology (ESGO) meeting being held in Milan. The key finding from Ueland's presentation is that OVA1, when combined with imaging,...
GE Healthcare to Invest $1B in Oncology Solutions
GE Healthcare announced its plans to dedicate $1 billion of its total R&D budget over the next five years to expand its advanced cancer diagnostic and molecular imaging capabilities, as well as its world-class technologies for the manufacture of biopharmaceuticals and for cancer research. Announced alongside a $100 million open innovation challenge in New York City, the $1 billion investment crosses all lines of GE Healthcare’s global business and is an example of the company’s...
LabCorp to Offer Companion Diagnostic for Melanoma
Laboratory Corporation of America Holdings (LabCorp) announced the nationwide availability of a new FDA-approved diagnostic for melanoma patients. The drug Zelboraf and the cobas 4800 BRAF V600 Mutation Test companion diagnostic, both from Roche, were approved by FDA on August 17 for use in patients with inoperable or metastatic melanoma with the BRAFV600E gene mutation. The companion diagnostic is now available through LabCorp under the name BRAF Gene Mutation Assay, Melanoma. This test...
Qiagen to Develop Companion Diagnostic for Compound in Clinical Trials for Blood Cancers
Qiagen has entered into a partnership with Eli Lilly and Co. for the development, manufacturing and commercialization of a molecular companion diagnostic for an early stage investigational compound currently being developed by Lilly. Financial terms of the agreement were not disclosed. Lilly's proprietary compound, called a JAK2 inhibitor, targets the Janus kinase 2 (JAK2) gene, which has been shown to play a role in myeloproliferative neoplasms. Under the terms of the agreement, Qiagen will...
Arizona State to Develop Early Diagnostics Against Colorectal Cancer
Arizona State University (ASU)and China’s Sun Yat-Sen University (SYSU) have formalized a research collaboration aimed at developing early and predictive diagnostics to improve patient outcomes for colorectal cancer. ASU’s Leland Hartwell, Nobel laureate and chief scientist at the Biodesign Institute’s Center for Sustainable Health, spearheaded the agreement with Jianping Wang, director of the SYSU Gastrointestinal Institute of the Sixth Affiliated Hospital in Guangzhou,...
Abbott Introduces Genetic Test for Lung Cancer
Abbott announced the availability of a new molecular test in the European Union and New Zealand designed to identify the presence of gene rearrangements associated with a specific form of non-small-cell lung cancer (NSCLC). These rearrangements in a gene known as ALK (anaplastic lymphoma kinase) have been implicated in the formation of cancerous tumors in patients with NSCLC. The Vysis ALK Break Apart FISH probe kit, commonly known as the Abbott ALK test, uses Abbott’s fluorescence...
FDA Clears Abbott Genetic FISH Panel for Leukemia Patient Prognosis
Abbott has received 510k clearance from FDA for a new IVD test to aid in determining the prognosis of patients with chronic lymphocytic leukemia (CLL). Abbott’s Vysis CLL FISH Probe Kit is the first FDA-cleared CLL test to aid in prognosis. The test detects genetic abnormalities in lymphocytes. "The recent clearance of the CLL test is another example of Abbott Molecular’s commitment to providing clinically validated products that support and improve patient care," said...
Test Based on DiagnoCure Biomarker Obtains Canadian Regulatory Approval
DiagnoCure Inc. announced that Health Canada has granted Gen-Probe, the Company's commercial partner for the PCA3 biomarker, a medical device license for the Progensa PCA3 assay, a new molecular urine test that helps determine the need for repeat biopsies in men suspected of having prostate cancer. "DiagnoCure is very proud of this Canadian approval. Thanks to a successful partnership with Gen-Probe, Canadian patients will now have access to a much more accurate test to help determine the...
FDA Approves Roche Companion Diagnostic for BRAF Mutation-Positive Melanoma
Roche announced that FDA approved Zelboraf (vemurafenib) for the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma, as determined by an FDA-approved test. The FDA also approved the cobas 4800 BRAF V600 Mutation Test, a diagnostic test developed by Roche to identify patients eligible for treatment. Zelboraf is the first and only FDA-approved personalized medicine shown to improve survival in people with BRAF V600E mutation-positive metastatic melanoma, demonstrating...
Firefly BioWorks Announces Award of $2M NIH Grant
Firefly BioWorks Inc. was awarded a $2M Phase II Small Business Innovation Research (SBIR) grant from the National Cancer Institute for microRNA profiling. MicroRNAs are an emerging class of biomarkers that are proving to be important indicators for early diagnosis of cancer and other diseases. The company will use the award to expand production capacity and validate its microRNA assay against the current state of the art. The goal of the Phase II studies is to develop a product providing a...