November Clinical News and Product Briefs

News Briefs

The San Antonio 1000 Cancer Genomes Project (SA1kCGP), WuXi NextCODE, and South Texas Accelerated Research Therapeutics (START) announced a city-wide cancer genomics project. The SA1kCGP brings together hundreds of doctors, oncologists and surgeons, and a thousand patients to create the basis for this resource: tumor samples from breast, lung, prostate, skin, colorectal, uterine, pancreatic, ovarian, stomach, brain cancers, collected at the time of diagnosis. WuXi NextCODE will sequence and interpret the samples. START is connecting this “delta file” to anonymized patient electronic clinical records using the Medidata Rave system, and will make it available to qualified researchers and clinicians via the cloud. (For a similar population genomics effort featuring WuXi NextCODE, see “Sidra Medical Center Deploys NextCODE for Qatar Genome Project.”) Press release

Illumina is teaming up with the Hartwell Autism Research and Technology Initiative (iHART) to further the genomic analysis of Autism Spectrum Disorder (ASD). This collaboration is part of iHART’s mission to establish the largest shared, open-access repository of bioinformatic data on autism. iHART will place 5,000 genomes of individuals with autism and their families from the National Institute of Mental Health (NIMH) genetics repository in BaseSpace, Illumina’s cloud-based genomic analysis platform. Press release

Sophia Genetics revealed that its platform, Sophia DDM, now hosts the world’s largest clinical genomics community for molecular diagnosis. After growing by 400% this year, it now supports over 100 institutions across 18 countries, making it the largest network globally for interpreting anonymized genomic data and sharing knowledge on clinical interpretation. The company performed over 20,000 patient analyses in 2015, and expects to quadruple this number in 2016. Press release

CluePoints announced a strategic collaboration with clinical trials business solutions consultancy, Widler & Schiemann Ltd. The collaboration will bring together CluePoints’ risk-based management software with Widler & Schiemann's risk-assessment consulting expertise, to deliver a solution that covers all elements of risk and quality management. Widler & Schiemann works with clients to identify how workflows, processes and systems need to be adapted to support more targeted approaches to monitoring in clinical trials. The company's services complement CluePoints' Central Statistical Monitoring (CSM) software, which provides an agnostic approach to risk-based monitoring by using statistical methodology to identify unexpected patterns in trial databases and focus monitoring efforts. Press release

Station X, Inc., a developer of cloud-based genome management systems, announced that Circulogene Theranostics will use its GenePool platform to analyze and interpret data generated from their cell-free DNA (cfDNA) sequencing-based liquid biopsy services. Circulogene’s technology searches for nearly 3,000 cancer mutations on 50 well-established cancer-associated genes and can provide information on current FDA-approved and NCCN/ASCO-endorsed treatment options for the tumor DNA mutations identified. Press release

New Products

LifeMap Solutions announced that its HealthKit-compliant iOS app, COPD Navigator, is available for free download from the App Store. The app is designed for patients with Chronic Obstructive Pulmonary Disease (COPD) to monitor and manage their condition. An enhanced version branded as SuperCare iBreathe will be clinically deployed by SuperCare Health, a chronic care management company specializing in respiratory diseases. The iBreathe app is customized with unique data collection points and allows SuperCare Health’s clinical care team to track them in real time and respond immediately to COPD patients enrolled in their Healthcare at Home program. (For more on LifeMap Solutions’ COPD programs, see “LifeMap Solutions Teams Up with Mount Sinai on Digital Health.”) Press release

Dassault Systèmes launched three industry solution experiences for life sciences, focused on biopharma. “ONE Lab” integrates people, resources, processes, data, analysis and documentation so that laboratories can collaborate on researching, developing and testing products. “Made to Cure for BioPharma” uses process and quality data across multiple organizations to reduce process development times and technology transfer costs. “Designed to Cure” uses predictive analytics and virtual design and simulation to model therapeutic candidates. Press release

PAREXEL introduced IMPACT Express Clinical Trial Management System, a clinical trial management and monitoring solution. IMPACT Express’s out-of-the-box deployment eliminates the need for technical infrastructure or resources. Processes addressed within IMPACT Express include trial oversight, trial tracking and management, site monitoring, investigator management and selection, and payment management. Press release

Veeva Systems announced an integrated clinical trials study start-up solution, Veeva Vault Study Start-Up, which will allow users to manage content and activities associated with activating sites for clinical trials. Vault Study Start-Up will be interoperable with Veeva Vault eTMF. A top 20 pharmaceutical company and a top 10 global CRO have already signed on as early Vault Study Start-Up customers. Veeva also announced Veeva Vault RIM, a regulatory information management suite. Press release

NanoString Technologies expanded its 3D Biology portfolio with the launch of nCounter PanCancer Profiles, seven new gene expression panels each designed to interrogate a focused area of cancer biology including immuno-oncology. These panels may be combined with nCounter protein expression modules for simultaneous analysis of gene and protein expression. The new panels can be customized with up to 24 additional gene expression targets defined by the user. Press release