October Clinical News and Product Briefs

News Briefs

Sequence Bioinformatics and the Government of Newfoundland and Labrador selected Genospace’s Population Analytics platform to support a precision medicine initiative. Sequence Bio, in partnership with the Government of Newfoundland and Labrador, seeks to engage 100,000 consenting participants in a large-scale initiative to capture a wealth of genomic and phenotypic data. The initiative will make the resulting information and analysis available to a variety of organizations in order to improve patient care. Genospace Population Analytics will enable collaboration between academic, government and industry partners, and provide translational medicine capabilities for patient care. Press release

The National Heart, Lung and Blood Institute (NHLBI) awarded approximately $40 million to the Broad Institute of MIT and Harvard to provide whole genome sequencing of 20,000 individuals, as well as data to support smaller pilots in transcriptome sequencing and metabolite profiling. This project is part of NHLBI's Trans-Omics for Precision Medicine (TOPMed) program, which will use whole genome sequencing in the study of heart, lung, blood and sleep disorders (HLBS). In addition, the program aims to gather additional data on DNA methylation, RNA expression patterns and metabolic profiling, along with phenotypic and clinical outcome data. Press release

Good Start Genetics established a national relationship with UnitedHealthcare to serve as an in-network laboratory partner for a variety of genetic screening tests. These tests include carrier screening tests for guideline-recommended diseases, such as cystic fibrosis, sickle cell disease and Tay-Sachs disease. UnitedHealthcare is the largest insurer in the country, providing health benefits to over 43 million individuals. Press release (PDF)

SERMO, a social network for physicians, and Global Genes, a rare disease patient advocacy organization, are partnering to provide patients with access to hundreds of thousands of physicians from around the world who may be able to accelerate their diagnoses and treatments through medical crowdsourcing. As part of the partnership, SERMO is launching a new program called SERMOheroes, which will allow patients and their families who are working with Global Genes to have their cases submitted to SERMO for advice on diagnostics and treatments for free. SERMO is creating a Rare Disease Hub on the network to house SERMOheroes patient cases. Press release

GenomeDx Biosciences and Cedars-Sinai partnered on the Decipher Genomics Resource Information Database (Decipher GRID), a clinical genomics data sharing program. Through the program, Cedars-Sinai will use GenomeDx’s Decipher Prostate Cancer Classifier to aid with treatment decisions following prostate cancer surgery. GenomeDx is conducting whole genome profiling for patients included in the program and matching those data to prospectively collected clinical outcomes for patients treated at major cancer centers. The program around Decipher GRID is initially for men with prostate cancer and is expected to expand into other urologic cancers. Press release

IO Informatics became a member of the tranSMART Foundation, which provides an open-source knowledge management platform for scientists to share pre-competitive translational research data. IO Informatics also announced that CEO Robert Stanley will join the Foundation’s Board of Directors. (For more on tranSMART, see “Michael J. Fox Foundation Brings Parkinson’s Data to tranSMART.”) Press release

Tactio Health Group will provide its TactioRPM Remote Patient Monitoring Platform to the University of Michigan Department of Family Medicine in a pilot study that will implement a mobile pharmacist-led home blood pressure (BP) monitoring program. The intervention will test the effectiveness of pharmacist-directed home BP monitoring and medication reminders in patients with uncontrolled hypertension. Twenty-five subjects will be equipped with Bluetooth-enabled BP monitors and Tactio mobile apps, and required to send over their patient-generated data through TactioRPM to clinical pharmacists, who will intervene as necessary when remotely observing uncontrolled hypertension. Press release

Genomics plc entered into a collaboration agreement with Oxford University and the Oxford University Hospitals NHS Foundation Trust in a research project focused on the translation of whole genome sequencing into clinical practice. The project, which is supported by the Wellcome Trust and Department of Health through the Health Innovation Challenge (HIC) Fund, aims to establish genome sequencing as a clinical tool across disorders including rare diseases and cancers. As part of the agreement, Genomics’ bioinformatics tools will be applied to analyze and interpret up to 500 genome sequences. Press release

CRF Health launched its new website, www.crfhealth.com, which includes an online electronic Clinical Outcome Assessment (eCOA) resource hub. The platform provides webinars, eBooks, articles and videos covering the implementation, management and scaling of eCOA technology for global clinical trials. Press release

New Products

HelpAround announced Alert for Apple Watch with support for watchOS 2. Alert for Apple Watch allows seniors in physical or emotional distress to simultaneously text their location and conference-in all of their caregivers at once with a simple tap on their wrist. The data is also incorporated into the Health app on iPhone, allowing care providers to access health information with user permission. (For more on Alert and HelpAround, see “HelpAround Explores the Social Aspects of Mobile Health.”) Press release

Cepheid received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert TV, a qualitative in vitro diagnostic test for identification of Trichomoniasis in symptomatic and asymptomatic female patients, using urine, endocervical swab or vaginal swabs collected by the patient in a clinical setting.  Xpert TV becomes the 18th test available to run on Cepheid's GeneXpert System in the US. Press release

Luminex Corporation received CE-IVD marking for its NxTAG Respiratory Pathogen Panel. The Panel detects 21 viral and bacterial respiratory pathogens, including the atypical bacteria Chlamydophila pneumoniae, Mycoplasma pneumoniae, and Legionella pneumophila. The panel requires no upstream reagent preparation, and extracted samples can be added directly to pre-plated, lyophilized reagents. The tubes are then sealed and ready for closed tube amplification and subsequent detection using the Luminex MAGPIX instrument, which can process as many as 96 samples per run. Press release

CluePoints announced a partnership with Bracket Global, to offer CluePoints’ risk-based monitoring software in combination with Bracket’s Blinded Data Analytics and Rater Training and Quality Assurance oversight program for psychiatry and neurology trials. Press release