Apr 3, 2015, 12:00
by
Michael Croft
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