April News and Product Briefs

April 3, 2015 | News Briefs 

Medidata, a provider of cloud-based solutions for clinical research in life sciences, and Cancer Research UK, the world’s largest charitable funder of cancer research, announced that the Medidata Clinical Cloud has been selected to support the charity’s drug discovery research. Cancer Research UK’s Centre for Drug Development (CDD) will use Medidata’s cloud-based technology for electronic data capture and management in clinical trials at institutes, universities and hospitals. Medidata’s cloud-based data management and capture system will make clinical data from CDD’s future trials accessible to researchers in real time. Press release 

CluePoints, which provides Centralized Statistical Monitoring (CSM) solutions for clinical trials, announced a partnership with the Alliance for Clinical Research Excellence and Safety (ACRES), a non-profit organization dedicated to building an integrated global system for clinical research. The agreement will bring CluePoints into the ‘ACRES Alliance,’ as CluePoints’ CSM solutions will be integrated into the ACRES shared global platform. CluePoints and ACRES will also explore the potential of identifying operational and performance problems in a trial before they actually happen, using historical databases of data quality and performance indicators from selected investigative sites. Press release 

Version 3.0 of the Trial Master File (TMF) Reference Model to be released at the Drug Information Association Annual Meeting in Washington, DC on June 16, 2015. The next major release of the TMF Reference Model will incorporate feedback from its extensive industry use to enhance content clarity and add a XML-based mechanism for simplifying the interchange of electronic TMF content between organizations. The V3.0 development team is currently composed of nearly 100 experts, and more volunteer participation is always welcome. To get involved, please visit http://tmfrefmodel.com/join-the-tmf-reference-model-project-team/join-here/


Texas Medical Center
(TMC) and Village Capital announced the winners of the TMC-VilCap US: Health IT 2014 program. Twelve early-stage digital health companies competed for two prizes. The winners —1DocWay, which builds telepsychiatry networks for hospitals, and AsthmaMD, which has created a mobile application for asthma care — each received a $50,000 investment from TMC and Village Capital. Press release

QIAGEN expanded its portfolio of liquid biopsies through the acquisition of AdnaGen. AdnaGen’s proprietary technology enriches disease-specific tumor cells using magnetic particles in an antibody mixture, then isolates and purifies mRNA for analysis. QIAGEN also announced a partnership with Tokai Pharmaceuticals to combine this new circulating tumor cell technology with a molecular assay to co-develop a companion diagnostic for Tokai’s drug compound galeterone, which is in late-stage clinical trials for treatment of castration-resistant prostate cancer. Press release 

 

Nebraska Medicine, a leader in oncology, cardiology and neurology services as well as organ and transplant services, is replacing its legacy network with a private enterprise network powered by Ciena’s packet networking and converged packet optical solutions. The new network will connect five geographically dispersed facilities and enable Nebraska Medicine to utilize bandwidth-intensive applications. The healthcare provider will be able to take advantage of technology advances like digital breast tomosynthesis (DBT) machines that help detect early stages of breast cancer, and also provide improved services in cardiology, radiology and other areas of medicine where enhanced digital imaging is essential. Press release 


New Products
 

Quest Diagnostics launched Neurome, a whole exome sequencing service designed to aid the diagnosis of rare neurological disorders in pediatric populations. Personalis, Inc., developed and performs the lab-developed test exclusively for Quest Diagnostics. Based on Personalis’ proprietary ACE Exome technology, Neurome specifically interrogates areas of the genome that affect the nervous system, including clinically interpretable genes as well as certain medically significant non-protein coding regions. The resulting test report provides sequencing findings and their clinical interpretation specific to the patient’s suspected disorder. Press release 

Berry Genomics Co. announced that its subsidiary Hangzhou Berry Genomics has received premarket clearance from the Chinese Food and Drug Administration (CFDA) for the NextSeq CN500, a high-throughput sequencing instrument developed with Illumina to meet Chinese clinical needs. Hangzhou Berry Genomics also received premarket clearance for its non-invasive prenatal testing (NIPT) detection kit for trisomies 13, 18 and 21. The NextSeq CN500 uses Illumina’s sequencing by synthesis technology and was designed for operations in a clinical setting. Press release 

CRF Health, a provider of eCOA solutions for the life sciences industry, release a complete TrialMax eCOA solution for diabetes clinical trials. Developed with clinicians and, the solution allows investigators to collect patient reported outcome assessments, and is already being used in four diabetes trials covering 700 investigative sites and 3,250 patients. The TrialMax Touch eDiary leads patients through data collection and integrates with the Entra Health MyGlucoHealth wireless glucometer, allowing automatic transfer of measurements to a patient's eDiary. Sites are also made aware of hypoglycemic events via CRF Health's TrialManager, email or SMS in near real time. Press release 

goBalto, Inc., a provider of cloud-based clinical study startup solutions, announced the latest version of goBalto Activate. Activate’s new features include expired document management, alerts that highlight opportunities to improve cycle times and track activities and milestones, and an API enhancement to support integration with investigator portals. Press release 


Cypher Genomics
released a software update to automate the interpretation of sequencing data from cancer genomes. With this update, Cypher’s Mantis technology will provide faster insight into how different genetic variants may impact cancer progression and therapeutic effectiveness. The Mantis update will also provide a summary of somatic and germline variants, and resolve difficult to classify variants of unknown significance. The resulting information will also provide pharmacogenetic impact for anti-neoplastic agents. Press release 

 

Veeva Systems announced Veeva OpenKey, a new approach to customer reference data for the life sciences industry. To eliminate the burden of managing multiple data feeds and duplication of health records across European markets, Veeva OpenKey customer data will be sourced locally and consolidated into a single global reference database. Veeva also announced the Veeva OpenKey Partner Program, which establishes a partner ecosystem designed to make it easy for life sciences companies to access the customer data they purchase without restrictive vendor contracts. Press release