NEW YORK (GenomeWeb) – Thermo Fisher Scientific announced this week that it has formed the Immuno-Oncology Consortium to drive adoption of highly sensitive, next-generation sequencing clinical research panels designed to help identify predictive and prognostic biomarkers associated with cancer immunotherapy. The consortium brings together a group of clinical researchers from institutions in Europe. It will initially spearhead efforts to validate Thermo Fisher's previously launched Oncomine Immune Response Research Assay, with the expectation to extend studies with the new immune repertoire assay and an application to interrogate tumor mutational burden currently under development by Thermo Fisher.
Laboratory Corporation of America this week completed its previously announced $1.2 billion cash acquisition of contract research organization Chiltern, which will become part of the company's Covance drug development business. The acquisition creates a CRO unit with more than 20,000 employees worldwide, and builds Covance's business in the high-growth, emerging and mid-market biopharma segments, according to LabCorp. The combined company will have approximately 11,000 employees in the Americas; 7,100 employees in Europe, the Middle East and Africa; and 2,400 employees in the Asia-Pacific region. The executive team of the new Covance unit will comprise leaders from both companies, and will be integrated immediately. Chiltern CEO Jim Esinhart will not be joining the new company.
Premaitha Health said this week that its Iona test has been approved for Brazilian Good Manufacturing Practice by Brazil's regulatory authority, the Agência Nacional de Vigilância Sanitária (ANVISA). The B-GMP approval enables Premaitha to proceed with an official application to register Iona with ANVISA, Brazil's National Health Surveillance Agency, to be sold as an in vitro diagnostic product. Premaitha is working closely with Thermo Fisher Scientific's local team, which will be the Brazilian registration holder, and Premaitha anticipates that registration will take approximately six months. The Iona test estimates the risk of a fetus being affected with Down syndrome and other genetic conditions. The test is performed on a maternal blood sample, containing traces of fetal DNA, which is then analyzed using next-generation DNA sequencing.
Seegene said this week that it recently signed collaborative deals with 30 general hospitals and reference labs in 15 countries for the codevelopment of products. The deals are part of the company’s Project 100, which seeks to lay the groundwork to create a single instrument to run most of the available molecular diagnostic tests. As part of the effort, the South Korean molecular diagnostics firm aims to develop 100 MDx assays by 2018 in disease areas including infectious diseases, cancer, and drug resistance. Through the project, the firm plans to apply its Random Access System, an MDx solution, to all new products that will be launched in the future. Seegene’s new partners will offer clinical samples for assay development, as well as their know-how. The parties will proceed through on-site clinical trials and data analysis. The collaborations include partners in Italy, Belgium, Austria, Portugal, the Netherlands, Finland, Romania, Poland, Israel, Malaysia, India, Canada, and Mexico.
Commonwealth Diagnostics International this week relaunched its gastroenterology-focused diagnostic testing business in the US, including its hydrogen and methane breath testing portfolio for small intestinal bacterial overgrowth and carbohydrate malabsorption. The firm received ISO 13485 and CE marking for its hydrogen and methane breath testing kits, and it has entered into joint ventures and commercial partnerships to make its diagnostic products and services available in the US, Latin America, the UK, and Switzerland.
In the UK, Commonwealth Dx and the Functional Gut Clinic have created a joint venture called Functional Gut Diagnostics to offer Commonweath Dx’s entire suite of products in the UK region and expand its R&D activities and clinical trial capabilities. In Switzerland, the firm has partnered with UniLabs to distribute Commonweath Dx’s blood test for IBS-D/M called IBSchek. Commonweath Dx also said that it plans to expand into Australia in 2018.
AccuGenomics announced this week that it provided an AccuKit to the HIV Cure Center at the University of North Carolina at Chapel Hill and to Qura Therapeutics for evaluation in HIV research. AccuKit-HIV is designed to characterize and quantify HIV reservoir and viral expression in human CD4+ T cells before and after pharmacological intervention. The HIV Cure Center is a joint initiative between the University of North Carolina at Chapel Hill, NC and GlaxoSmithKline. Qura Therapeutics is jointly owned by UNC-CH and GSK. The AccuGenomics AccuKit is a standardized molecular testing kit, used to provide critical controls in test reactions. It will be further qualified in vitro using clinical samples from fully-suppressed subjects by the HIV Cure Center/Qura Therapeutics, for accuracy, reproducibility and superiority compared to standard methods of measurement of the HIV reservoir in CD4+ T cells.
Streck and Biomedical Diagnostics this week signed an exclusive distribution agreement for Streck’s cell stabilization and molecular products in Belgium, the Netherlands, and Luxembourg.
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