October Clinical News and Product Briefs

News Briefs 

The Global Alliance for Genomics and Health convened its second major meeting of 2014, bringing together more than 250 international leaders to collaborate on innovative solutions to accelerate sharing of genomic and clinical data. At their plenary meeting, held in San Diego, California, Alliance members shared progress to date and discussed next steps for the effort. Current Alliance projects include a global BRCA Challenge, which aims to learn from genotype and phenotype data from many BRCA-related cancer risk studies without compromising patient privacy; and the Matchmaker Exchange project, designed to help patients and doctors grappling with rare genotypes and phenotypes to overcome siloed data, find one another through a federated architecture, and work together. The Global Alliance now claims over 140 member organizations dedicated to improving human health by maximizing the potential of genomic medicine. Press release 

DNAnexus announced its support of the industry’s first cloud-based genome center to integrate next-generation sequencing with de-identified clinical records, a collaboration between the Regeneron Genetics Center (RGC) and leading healthcare providers. DNAnexus provides the data sharing and an analytics environment for various RGC research partnerships. In one major collaboration, the RGC plans to sequence over 100,000 de-identified DNA samples obtained from Geisinger Health System and provide the data to Geisinger. (See Bio-IT World’s coverage for details.) Via the cloud-based genome center, the RGC will integrate the resulting genomic data with corresponding de-identified clinical information, also provided by Geisinger, to guide drug discovery. Press release 

The Jackson Laboratory received a $10 million gift from technology investor David Roux and his wife Barbara, to support research on genetically-based diseases. A new Roux Family Center for Genomics and Computational Biology, based in Maine and Connecticut, will be endowed with three new faculty chair positions and a permanent fund for recruiting staff and driving research and discovery at the Laboratory. Press release 

Foundation Medicine and WuXi PharmaTech are partnering to offer Foundation Medicine’s genomic profiling products to biopharmaceutical companies conducting clinical trials in China. Under the terms of the collaboration, Foundation Medicine will license and enable WuXi to perform the laboratory component of Foundation Medicine’s FoundationOne assay at the WuXi Genome Center in Shanghai, the first and only CLIA-certified laboratory in China.  Press release 

IBM, working with Cleveland Clinic, formed a new initiative to use IBM Watson technology in the area of genomic research to help oncologists deliver personalized medicine by uncovering new cancer treatment options for patients. The Lerner Research Institute’s Genomic Medicine Institute at Cleveland Clinic will evaluate Watson’s ability to help oncologists develop more personalized care to patients for a variety of cancers. Press release 

QIAGEN formed a collaboration agreement with Astellas Pharma, an R&D-driven global pharmaceutical company headquartered in Japan, to develop and commercialize companion diagnostics paired with Astellas drugs for use in cancer and other diseases. The agreement gives Astellas access to QIAGEN’s development capabilities for assays based on PCR, NGS and multi-modal testing technologies using liquid and tissue biopsies. Initial projects in the collaboration focus on oncology and will pair QIAGEN diagnostics with two Astellas compounds in early-stage clinical trials: a fibroblast growth factor receptor (FGFR) inhibitor, and an EGFR inhibitor. Press release 

InSilixa, a new Sunnyvale, California-based molecular diagnostic (MDx) platform developer, completed a $13 million financing round led by PointGuard Ventures and Morningside. InSilixa is developing MDx platforms that use integrated circuit manufacturing technologies, with the aim of creating cost-efficient, mass-deployable, and disposable devices. Among these products will be point-of-care systems to identify pathogens in clinical samples, and simultaneously verify the absence or presence of genetic mutations that result in antibiotic resistance. Press release 

GenomOncology and med fusion have partnered to optimize cancer treatment strategies based on patients’ disease states and tumor profiles. The companies will combine GenomOnoclogy’s GO Clinical Workbench and support services, with med fusion’s solid tumor disease-specific panels to deliver a comprehensive laboratory report detailing relevant drug and clinical trial options. med fusion anticipates launching a solid tumor menu expansion later this year with disease specific panels including for non small cell lung cancer and colorectal cancer. Press release 

CRF Health, a global provider of eCOA solutions for the life sciences industry, joined the PAREXEL Perceptive Partner Program. As a member, CRF Health will provide standard integrations between its eCOA solutions and the Perceptive MyTrials eClinical platform. The Perceptive Partner Program connects members specializing in system integration, technology, training, reseller and CRO capabilities to simplify the eClinical technology space through convergence of environments. Press release 

Visterra completed a $30 million Series B financing round to advance multiple product candidates from the company’s pipeline of novel monoclonal antibodies that target infectious diseases, including seasonal and pandemic influenza and dengue fever, into the clinic. The financing round was led by new Visterra investors, Merck Research Labs Venture Fund, Vertex Venture Holdings Ltd. and Temasek. Press release 

New Products 

Metamark released ProMark, a protein-based biopsy test to improve the accuracy of prognosis for men diagnosed with prostate cancer. ProMark was validated in multiple clinical studies totaling more than 1,250 cases, all of which demonstrated the ability to differentiate between aggressive and non-aggressive forms of prostate cancer at early stages of disease, helping to identify patients who may be appropriate candidates for active surveillance or in need of aggressive therapy. ProMark works by measuring the amount of specific protein biomarkers obtained by needle biopsy from regions of prostate tissue where the biomarkers are altered during tumor formation. Press release 

BioDiscovery launched the NxClinical software for clinical case review. Based on the company’s experience in the market with its Nexus Copy Number software, NxClinical was created specifically for the needs of the clinical users, handling everything from raw data to reports in a single enterprise-wide database system. The system incorporates multi-user collaborative communication, audit-trail features, and automation of standard processes. Press release 

Vela Diagnostics made available to early access customers the Sentosa SQ Non-Small Cell Lung Cancer (NSCLC) Panel and the Sentosa Colorectal Cancer (CRC) Panel for next-generation sequencing (NGS) based detection of sequence variants, for research use only. Both the NSCLC Panel and the CRC Panel target 11 relevant genes with 28 amplicons. The NSCLC Panel allows laboratories to check for 113 mutations, while the CRC Panel screens for 112 mutations. The automated Sentosa NGS workflow, with a turnaround time of two days, supports DNA extraction, library preparation, sequencing and comprehensive result reporting. Press release