MD Anderson, Exact Sciences to Develop Screening and Diagnostic Tests for Lung Cancer

The University of Texas MD Anderson Cancer Center and Exact Sciences have entered a partnership to develop and commercialize blood-based screening and diagnostic tests to detect early-stage lung cancer. This collaboration seeks to build upon MD Anderson’s extensive research into predictive biomarkers for lung cancer and Exact Sciences’ development and commercialization of Cologuard, the only Food and Drug Administration–approved, non-invasive colon cancer screening test.

The two groups plan to develop a new blood test that targets biomarkers associated with lung cancer and determines the need for low-dose computed tomography (CT). MD Anderson’s research into lung cancer markers spans a variety of biomarker types, including DNA, proteins, metabolites, and autoantibodies. The partnership’s goal is to choose the best-performing biomarkers for a panel across multiple technologies, as opposed to the more common practice of relying on a single type of biomarker. Such a test could make it possible to screen for lung cancer in both smokers and non-smokers.

The partnership also aims to develop a diagnostic test to determine the malignant status of nodules found through low-dose CT screening. While low-dose CT scanning is about 94% sensitive, it has a 73% specificity for the initial screen. As a result of this lower specificity, about 96% of all nodules discovered via scans are benign, leading to unnecessary and often harmful invasive procedures, radiation exposure, and high costs. MD Anderson and Exact Sciences intend their planned test to be used to guide follow up procedures for and treatment of the nearly 4 million Americans diagnosed with lung nodules each year.

Paradigm Partners With Cure Forward to Power Novel Social Data Platform

Paradigm and Cure Forward have joined forces to create a new communication platform that will give cancer patients access to their next-generation sequencing (NGS) test data. Under the terms of the collaboration, Paradigm will serve as a core diagnostic laboratory partner and will conduct molecular profiling of oncology patients with PCDx, the company’s NGS-based test that interrogates the most relevant genomic targets at over 5,000 times average depth of coverage with 66 therapeutic associations. Results from Paradigm’s test will then be reported to physicians, and patients will be able to use Cure Forward’s web platform to access their genetic data. Through this platform, patients will also be able to find relevant information, be invited to clinical trials, and participate in communities with other similar patients in order to advance their care and accelerate cures for disease subtypes.

European Commission, Chinese Ministry of Commerce Approve Merck Acquisition of Sigma-Aldrich

On September 2014, Merck signed a definitive agreement to acquire Sigma-Aldrich for $17 billion. The European Commission (EC) has now conditionally cleared the deal, and the transaction also has received full antitrust clearance from the Chinese Ministry of Commerce. To satisfy the conditions required by the EC for clearance of the transaction, both Sigma-Aldrich and Merck have agreed to sell parts of Sigma-Aldrich’s solvents and inorganics chemicals business in the European Economic Area as an integrated, stand-alone business; this includes the rights to all solvents and inorganics sold globally under the Fluka brand.

These latest jurisdictions to grant antitrust clearance of the acquisition follow approval by the Japanese authorities in May, as well as earlier clearance in the United States, Russia, Serbia, Ukraine, South Africa, and Taiwan. The closing of the transaction remains subject to other conditions, including clearance by antitrust authorities in Brazil, Israel, and South Korea. As of June, both companies continue to work toward finalizing the deal in mid-2015.

Seattle Children’s, NextGxDx to Tackle Genetic Test Utilization Management

Seattle Children’s Hospital plans to collaborate with NextGxDx to develop a joint genetic test utilization management solution for children’s hospitals and pediatric practices. The collaboration will combine the hospital’s Pediatric Laboratory Utilization Guidance Services (PLUGS) program and its team of genetic testing experts with NextGxDx’s GeneConnect platform. PLUGS aims to help clinical laboratories and practitioners decrease costs and errors associated with unnecessary laboratory testing by providing practical resources, expert advice, and a peer network for members to develop sustainable utilization management programs. GeneConnect is a solution designed to help curb rising genetic testing send-out costs by offering hospitals the ability to establish preferred reference lab relationships, track electronic orders and results, monitor physician/department test utilization, and easily compare testing options.

“The growth in the cost and complexity of genetic testing is overwhelming children’s hospitals and their ability to manage genetic test ordering,” said Michael Astion, MD, PhD, medical director in the Department of Laboratories at Seattle Children’s. “NextGxDx’s GeneConnect solution and its real-time market analytics and optimized clinical workflow will strongly benefit the PLUGS network of institutions as they develop and improve their genetic test utilization management programs.” Astion also chairs CLN’s Patient Safety Focus editorial board.