November and December Clinical News Briefs

News Briefs 

Researchers at Brigham and Women's Hospital (BWH) and Boston Children’s Hospital published a study in Genetics in Medicine exploring new parents’ attitudes toward newborn genomic testing. The majority of the 514 parents surveyed were interested in newborn genomic testing after receiving a brief orientation to the genome and its impacts on human health, with 82.7 percent of parents saying they were somewhat, very, or extremely interested. Parents who had experienced concerns about the health of their newborn, however, were less likely to be interested in genomic testing. The study was also the first to survey parents separately, finding that most couples were in agreement about their level of interest in newborn genomic testing. Press release 

Claritas Genomics selected NextCODE Health’s integrated clinical and research platform, Clinical Sequence Analyzer, to speed the delivery of genetic test results for its pediatric testing business. Using NextCODE’s unique database architecture, Claritas plans to build a centralized, cloud-based variant database to help solve the toughest cases and discover new disease genes. Claritas and its researchers have developed over a hundred tests for single genes associated with pediatric disorders as well as dynamic whole exome-based tests, all of which have been integrated directly into NextCODE’s clinical interface. Press release 

INC Research Holdings, a global Phase I to IV contract research organization, became the first Circle of Sustainability Sponsor for the Society for Clinical Research Sites (SCRS). Through this enhanced relationship, INC Research will be the first organization to support SCRS’ new member Scholarship Program. INC Research will support the society’s efforts in retaining and sustaining sites currently participating in clinical research, with a goal of expanding site membership in SCRS to approximately 5,000 sites in 2015. INC Research will also be the first CRO to establish a Site Advocacy Group (SAG), engaging with investigative sites globally to exchange perspectives on methods, tools and technologies to enhance clinical research efficiency. Press release 

Members of the CollabRx scientific team, in collaboration with clinical researchers and physicians at a variety of cancer centers and universities, published a clinical decision support model for oncology in the open-access journal Oncoscience. The publication provides a framework for cancer treatment decisions based on the results of genetic testing. While treatment guidelines already exist for genetic mutations in a small number of genes and cancer types, physicians have no such guidelines for the vast majority of mutations that can be detected using broad next generation sequencing panels. The new framework seeks to help physicians prioritize among mutations, and offer a clinical rationale for treating a patient with relevant FDA-approved or investigational drugs when potentially actionable mutations are found. Press release 

QIAGEN entered into a master collaboration agreement with Novartis AG to develop and commercialize companion diagnostics paired with Novartis therapeutics. The agreement can cover all QIAGEN platforms, indications or biomarkers. The collaboration with Novartis is the ninth master framework agreement reached by QIAGEN for the development of companion diagnostics, allowing the company to pursue more than 20 collaborative projects with pharma and biotech companies to develop, validate and market companion diagnostics designed to guide the treatment of cancers and other diseases. Press release 

N-of-One, a provider of clinical interpretation for precision medicine in oncology, announced an agreement with BloodCenter of Wisconsin to support the center’s HemeOnc panel for the diagnosis, prognosis, and risk stratification of hematologic malignancies using next generation sequencing. BloodCenter offers molecular testing for diagnostic and prognostic markers within acute myeloid leukemia, myeloproliferative neoplasms, and chronic myelogenous leukemia. Press release 

TriCore Reference Laboratories has partnered with Wave, the Salesforce Analytics Cloud, to develop an integrated medical platform that can display chronological patient health data in order to optimize clinical processes. With Wave, TriCore aims to provide better decision support to physicians ordering tests. As a provider of clinical testing for nearly 70 percent of New Mexico, TriCore has an opportunity to pursue large population health programs. Press release 

New Products 

Definiens announced the newest version of its image analysis software for quantitative digital pathology, Tissue Studio 4.0. The new release adds the ability to use any chromogen for single and dual stain immunohistochemistry (IHC) quantification. By providing morphological fingerprints and biomarker expression profiles on a cell-by-cell basis, Tissue Studio produces consistent data across samples for any tissue-based assay, while accounting for biological variation and staining heterogeneity. For more on Definiens’ use of image analysis in developing diagnostics and prognostics, see “Definiens Brings Big Data to the Tissue.” Press release 

Certara, a drug development and drug safety consultancy, launched version 1.4 of its Phoenix product family. Phoenix is a PK/PD software platform used by more than 5,000 biopharmaceutical companies, veterinary and academic researchers, and regulatory agencies to analyze, manage, report and validate pre-clinical and clinical PK, PD and toxicokinetic (TK) data. Key upgrades in Phoenix 1.4 include a new user interface to automate sequential PK/PD analysis in Phoenix NLME; use of dynamic memory allocation in Phoenix NLME that will vastly reduce memory demands; and a Watson LIMS plug-in within Phoenix Connect to connect to the widely-used Watson LIMS database. Press release 

AB SCIEX introduced DiscoveryQuant 3.0 Software, a new version of its ADME software designed to significantly reduce LC/MS method development and optimization time for high-throughput drug discovery laboratories in both small molecules and biotherapeutics. DiscoveryQuant 3.0 Software offers a fully automated workflow to optimize hundreds of compounds, a searchable database of compound history for optimization and chromatography development, and support for AB SCIEX’s TOF mass spectrometry system to continue acquisition of quantitative data and mine for other information simultaneously. Press release 

The Center for Connected Health released a first-of-its-kind research tool to help companies, device manufacturers, startups and investors better understand what consumers want from personal health technologies, and how these technologies are actually used. The cHealth Compass mobile platform creates customized surveys targeting a large research panel of U.S. adult health care consumers, patients, caregivers and health care professionals, to support the design, testing and implementation of connected health technologies and products. The cHealth Compass tool can also be used to quickly identify and recruit participants for research studies. For more on the Center for Connected Health’s activities in mobile and digital health, see “Thinking Outside the Office Visit at the Center for Connected Health.” Press release