August Clinical News and Product Briefs
News Briefs
Invitae Corporation published new data describing the clinical actionability of multi-gene testing for hereditary breast and ovarian cancer risk in JAMA Oncology. The study was a collaboration among Massachusetts General Hospital, Harvard Medical School, Stanford University, Beth Israel Deaconess Medical Center and Invitae. More than 1,000 patients were tested with multi-gene panels, and the clinical actions that would be considered were reviewed for all 63 patients testing positive for cancer genes other than BRCA1 or BRCA2. For more than half of these patients, the genetic test suggested a change in care, based on the most recent recommendations from the National Comprehensive Cancer Network. Invitae recently made tests like these available for direct patient orders, as reported in Bio-IT World. Press release
Inova Translational Medicine Institute (ITMI) has implemented SGI’s UV 2000 advanced symmetric multiprocessing system in its 512-core data center. The system will power analyses in ITMI’s genomic database, which is one of the largest in the world and is connected directly to a community health system. ITMI has conducted three core studies using this system, including a study of 1,000 families to predict and prevent pre-term births; a longitudinal genomic study that will enroll over 5,000 families to track infants’ health outcomes over the course of 18 years; and a translational study that focuses on babies in the neonatal intensive-care unit who are sick and not yet diagnosed. Press release
Animas Corporation announced a collaboration with technology nonprofit Tidepool, allowing Animas users to use Tidepool’s open-source software for diabetes management. With this technology collaboration, data gathered from Animas insulin pumps will be combined with data from patients’ other diabetes devices in the cloud-based Tidepool Platform. The Tidepool Platform and associated applications will combine this device data with contextual information such as meals, exercise, and life events. Press release
CareDx, a company focused on diagnostic surveillance solutions for organ transplant recipients, has selected DNAnexus’ cloud genomics platform to support its ongoing R&D activities as well as clinical trials and registries. The platform will also host the release of CareDx’s analytically validated cell-free DNA assay later this year. Press release
iCardiac Technologies acquired the clinical trials division of nSpire Health, adding respiratory and ePRO services to its suite of offerings. As part of the transaction, iCardiac has also opened a new office in Longmont, Colorado. nSpire Health has conducted over 225 clinical trials during the past decade, providing centralized spirometry, pulmonary diagnostics, challenge testing, eDiary and data management services for Phase I-IV studies. Press release
Nuclea Biotechnologies is partnering with the Institut de Recherches Cliniques de Montréal (IRCM) to validate quantitative mass spectrometry-based assays for insulin, proinsulin, and c-peptide with the goal of developing new assays to determine risk and progression of type 2 diabetes. The partnership will include running studies on clinical samples in both locations, testing the assays for precision, sensitivity, and reproducibility. Nuclea plans to incorporate these new assays into its CLIA lab in Cambridge. Press release (PDF)
Duke University selected Greenphire’s ClinCard system to support financial data management and tracking in more than 3,000 clinical studies that the organization conducts each year. Duke will implement Greenphire's solution to automate the management of payments to research participants and associated data. The ClinCard System combines global electronic payment technology with real-time messaging to automate payments, tracking and reporting all payments in a web-based portal. Press release
New Products
PierianDx released a new version of its bioinformatics software platform to address exome sequencing workflow. The PierianDx Clinical Genomicist Workstation (CGW) version 3.0 provides clinical insights for somatic cancer as well as constitutional assays, based on the American College of Medical Genetics and Genomics’ most up-to-date guidance on variant classification. Press release
CRF Health introduced a new TrialMax electronic Clinical Outcome Assessment (eCOA) solution specifically for oncology clinical trials. The solution features an eCOA capture system with site and patient management tools. CRF Health has incorporated its new TrialMax ConMed solution into the platform, allowing patients to report concomitant medication taken during a trial in real-time and deliver this data to investigators. Press release
Liaison Technologies and ClearDATA have partnered to launch a secure, HIPAA-compliant solution for data integration and management. Healthcare and life sciences organizations can now use Liaison’s ALLOY Health platform inside ClearDATA’s cloud environment. The solution will have the data storage and application hosting capacity to accommodate intermittent surges in demand from researchers and healthcare providers for data analytics. Press release
Insight Genetics announced the launch of its Insight RET Screen, a CLIA-validated assay to detect oncogenic RET expression in non-small cell lung cancer patients. The Insight RET Screen is a qPCR assay that detects RET expression driven by chromosomal fusions regardless of the fusion partner. The new assay provides results within 48 hours and with minimal tissue requirement. In a head-to-head comparison to a RET FISH assay, the Insight RET Screen identified 67% more patients who were RET fusion-positive. Press release