July Clinical News and Product Briefs
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