April Clinical News and Product Briefs
News Briefs
The BRCA Challenge, a project of the Global Alliance for Genomics and Health, released the newest version of the BRCA Exchange web portal. BRCA Challenge is an international effort to advance understanding of breast, ovarian, and other cancers by pooling genomic and clinical data on the genes BRCA1 and BRCA2. The BRCA Exchange, the first product of the BRCA Challenge, is a publicly accessible web portal that lets patients, clinicians, and researchers access curated expert interpretations and some supporting evidence for genetic variants identified in BRCA1 and BRCA2. The new release represents the first time that all publicly available BRCA1 and BRCA2 variant data contained in databases such as ClinVar, LOVD, ExAC, and the 1000 Genomes Project have been pooled in a single, federated resource. Press release (PDF)
Dassault Systèmes and the French National Institute of Health and Medical Research (Inserm) signed a joint agreement to accelerate clinical research programs by deploying a virtual collaborative platform. Inserm will use Dassault Systèmes’ 3DEXPERIENCE platform to conduct its biomedical research programs in the areas of aging, cancer, genomics and microbiota. In turn, Dassault Systèmes will leverage data from Inserm’s research programs to calibrate and validate scientific models that can be applied to future technologies for the clinical research domain. Press release
Genestack partnered with the Cancer Molecular Diagnostic Laboratory (CMDL), an organisation involving Cancer Research UK, the University of Cambridge, the Cambridge University Hospitals NHS Trust and the Medical Research Council, to bring genomic technologies into clinical practice. The collaboration will focus on using next-generation sequencing to develop a ‘sequence to report’ solution for the prognosis and post-treatment monitoring of bone marrow transplant patients. This collaboration is the first use of the Genestack platform in a clinical setting. Press release
Macrogen Corp. has selected N-of-One to provide clinical interpretation for its newly launched clinical next-generation sequencing (NGS) panels used for cancer patients. Macrogen offers genomic testing services to North American hospitals and patients. N-of-One’s patient-specific analysis identifies therapeutic options based on each patient’s specific molecular profile identified by the sequencing data. These therapeutic options include therapies in guidelines, off label therapies, and relevant clinical trials. Press release
Leti, an Institute of CEA Tech, and ARaymondlife announced a joint initiative to develop medical devices in the field of microfluidic cartridge analysis. The initiative will focus on cartridges that enclose portable bio-med systems that enable sample analysis at the point of care. Leti has also joined the network of selected partners initiated by ARaymondlife to guide its product-development projects, and ARaymondlife is a preferred partner for the development platform of medical devices that Leti has recently established. Press release (PDF)
Bristol-Myers Squibb selected the Medidata’s Clinical Cloud to help manage, monitor, and analyze its clinical trials. Medidata’s technology platform will support Bristol-Myers Squibb’s research in immuno-oncology, oncology, immunoscience, virology, cardiovascular, fibrotic diseases, genetically modified diseases and metabolics. Bristol-Myers Squibb will utilize a full suite of Medidata solutions, including Medidata Rave for electronic data capture, management and reporting, and Medidata TSDV and Medidata CSA for prioritization of resources around patient safety and data integrity. Press release
Good Start Genetics appointed Jeffrey Luber to the post of president and CEO. Luber has also been appointed to the Good Start Genetics Board of Directors. Prior to his appointment as CEO, Luber served as Good Start Genetics’ general counsel and head of corporate development. Previously, Luber co-founded SynapDx, developer of blood-based technologies for the early detection of autism, and held several executive positions at EXACT Sciences Corporation including president and CEO. Press release
New Products
goBalto released goBalto Select, for optimizing site selection. With this release, goBalto now offers an end-to-end platform for starting clinical trials, from site feasibility assessment and selection through activation, with metrics to track adherence to timelines and budget. Select applies selection and performance variables to aid in the identification of sites and target populations ideally suited to studies. Its integrated workflows allow globally dispersed clinical research teams to collaborate in real-time. The release is designed to combine with goBalto Activate and goBalto Analyze. Press release
LifeMap Solutions announced a new service to develop custom smartphone apps and research studies for partners worldwide. LifeMap is the only commercial developer to participate in the launch of Apple’s ResearchKit, and has worked with organizations including the Icahn School of Medicine at Mount Sinai, Stanford University School of Medicine, and 23andMe on studies with a mobile component. Press release
Bracket announced platform updates to Bracket eCOA and Bracket RTSM to include native support for SMS messaging with patients and other stakeholders in clinical research programs. This update expands the medication compliance and adherence functionality across Bracket’s eClinical portfolio, and supports patients participating in clinical trials. In addition to direct-to-patient communication, the mobile text messaging platform can issue alerts to clinical trial sites, study sponsors, and CROs who are working with Bracket’s RTSM and eCOA tools. Press release
Kailos Genetics formed a partnership with TapGenes, to give people tools to exchange health information acquired through genetic testing. This includes gauging the risk of breast cancer or understanding the effectiveness of certain medications among family members. The TapGenes Family Health Tree gives users a centralized platform to store and share health information—such as their genetic data results from the Kailos test—allowing them to see hereditary health trends. Users can then control who has access to their personal data. For Kailos, genetic test results will only be shared with the individual and their approved physician. Press release
PAREXEL and EMC entered into an alliance to offer an end-to-end Regulatory Information Management (RIM) and Regulatory Content Management solution. The solution, combining the PAREXEL LIQUENT InSight Regulatory Information Management platform and the EMC Documentum for Life Sciences software solution suite, is available through PAREXEL’s Regulatory Cloud. Press release