July 29, 2015 | New products and announcements from around the clinical research and healthcare industries:
The
Patient-Centered Outcomes Research
Institute (PCORI) Board of Governors approved nearly $142.5 million to
support the ongoing development and expansion of a new resource for health
research known as PCORnet, the National Patient-Centered Clinical Research
Network. The funds include support to add seven health data networks to this initiative, which is designed to
link researchers, patient communities, clinicians, and health systems in
research partnerships around large volumes of health data maintained by the
partner networks. The new partner networks bring
additional resources focused on Alzheimer’s disease and dementia, autism
spectrum disorders, heart disease, obesity, Parkinson's disease, behavioral
health disparities among low-income populations, and health disparities among
sexual and gender minorities. Through the active participation of
patients and other healthcare stakeholders, PCORnet aims to ensure that
research focuses on the questions and outcomes that matter most to patients and
those who care for them. Press release
PrenaTest, the first non-invasive prenatal test in Europe for the detection
of chromosomal disorders from maternal blood, is now being reimbursed by Switzerland’s
statutory health insurance (OKP). This is the first time worldwide that
non-invasive prenatal tests (NIPT) are covered by a state-based health system
as part of general health care. The OKP will cover the costs for the PrenaTest
for pregnant women from the twelfth week of pregnancy, when a first trimester
test has determined an increased risk for chromosomal disorders. The Swiss
Federal Office of Public Health expects that the number of performed invasive
examinations will be significantly reduced. Press release
Six
months after President Obama announced the Precision Medicine Initiative (PMI), the White House hosted
a Champions of Change event honoring individuals from across the country who have
played central roles in contributing to personalized medicine. The Champions of
Change event also introduced commitments by federal agencies and private-sector
groups to advance the PMI, through efforts to make health data more portable; ensure
patients can easily access and share their own health information, including
contributing it for research; protect patient privacy, security and choice; and
support new research platforms connecting researchers and participants. (For more on the infrastructure needs of the PMI, see “ClinGen and Lessons for the Precision Medicine
Initiative.”) Announcement
SHYFT Analytics, a provider of cloud-based data and guided analytics
solutions for life sciences, announced formal availability of its Real
World Evidence (RWE) Analytics Solution for real-world and outcomes-based
insights. SHYFT’s RWE insights analyze treatment preferences, physician and
patient dynamics, behavioral influence, and utilization patterns. The solution includes
an RWE Data Hub that can integrate EMR, claims, sales, marketing,
reimbursement, and health economics outcomes research (HEOR) data. Analytics
and alerts are intended to maximize patient adherence, including predictive
targeting and call priority. Press release
goBalto,
Inc., a provider
of cloud-based clinical study startup solutions, released its latest version of
goBalto Activate.
The second major release of 2015 offers new features, including milestone re-planning indicators to improve cycle times; automatic
distribution of study documents; and enhanced single sign-on (SSO) for
streamlined integration with adjoining customer systems. Press release
CEA-Leti and Diabeloop formed a joint lab to develop
an artificial pancreas to improve treatment for Type 1 diabetes patients. The
artificial pancreas will automatically deliver the appropriate dose of insulin
to patients. It includes a sensor that measures patients’ glucose levels, a
pump that delivers insulin, and a smartphone with an embedded algorithm and
patient interface that links the sensor and the pump. It also includes
telemedicine capabilities for monitoring patients and linking them with
health-care providers and dedicated nurses. The lab
builds on a previous three-year research partnership that included clinical
trials in hospitals, and will exploit both real and
simulated data to improve insulin physiology models. Press release
TriCore Reference Laboratories announced a partnership with Sunquest Information Systems to jointly
develop diagnostic laboratory software to support population health, precision
medicine and integration pathology. Development efforts will include new
technologies for improved data analytics in connected, multi-organization
environments. Press release
Rancho BioSciences announced that they will work
with BT to provide cloud-based data
curation services to their joint customers. Rancho BioSciences curates life
science data such as clinical data, case report forms, protocols, molecular
data, phenotypic data, target and pathway knowledge, assays, medical records
and claim forms. BT provides a cloud infrastructure in its BT Connected Science
platform. Users will be able to combine private datasets with public data and
data from third-party applications such as tranSMART. Press release
Nuclea Biotechnologies announced that it will begin
offering more than fifty research use only (RUO) mass spectrometry-based
biomarker tests as part of their laboratory services. The RUO tests are
designed for the detection and quantification of key protein biomarkers in
human serum or plasma, and are available to pharmaceutical companies for
clinical trials, researchers, and as companion diagnostics. Nuclea will also
launch a second CLIA lab in their Cambridge, MA facility in late 2015, which
will offer IHC and ELISA tests and mass spectrometry-based multiplexed assays. Press release (PDF)
Vitalyze Me partnered with BaseHealth,
integrating BaseHealth’s health assessment engine data into the Vitalyze Me
mHealth platform. Using the BaseHealth API, Vitalyze Me will track risk factors
for more than 40 common complex diseases as well as information on 17 drug
responses and 9 food responses, to help physicians create personalized action
plans for preventative health. (For more on the BaseHealth API, see “BaseHealth Opens Its Genomic Health Engine to Outside Developers.”) Press release
A
multi-site study using products from PreAnalytiX
GmbH and NuGEN Technologies has
clinically validated an end-to-end workflow for the collection, storage,
transport and preparation of human whole blood samples for RNA-Sequencing
(RNA-Seq). The study was performed in collaboration with RUCDR Infinite
Biologics at Rutgers University, undertaking transcriptome profiling with
clinical samples. The study used the PreanalytiX PAXgene Blood RNA System for
whole blood collection, storage, and RNA extraction, and NuGEN’s Insert
Dependent Adaptor Cleavage (InDA-C) technology from the NuGEN Ovation Human
Blood RNA-Seq System to prepare strand-specific RNA-Seq libraries. Press release