May Clinical News and Product Briefs

 

News Briefs 

The Broad Institute of MIT and Harvard received a $10 million gift from the Gerstner Family Foundation to expand cancer research in collaborations with Dana-Farber/Harvard Cancer Center and Memorial Sloan Kettering Cancer Center. The research will focus on the changes tumors undergo as they become resistant to drugs. The Gerstner Family Foundation gift will support a two-pronged approach to the problem of cancer drug resistance. First, researchers at the Broad Institute plan to identify mechanisms of drug resistance, using CRISPR genome-editing technology to rapidly test which genes are responsible for cancer drug resistance in a lab setting. Second, the Broad Institute will help orchestrate the largest study to date of pre-treatment and drug-resistant tumors. At the same time, a Broad Institute team will build on efforts to develop liquid biopsies. Press release 

Rare Genomics Institute (RG) announced the Amplify Hope Initiative, a new study aimed at determining how crowdfunding can promote scientific research to help rare disease patients. RG is an international non-profit providing rare disease patients with access to genomics sequencing technology, connections to scientists and researchers, and help paying for these services through grants, insurance, or crowdfunding. Through a grant from the Templeton Foundation, Amplify Hope will measure the effectiveness of different crowdfunding strategies, the resulting scientific impact and community engagement. Scientific partners include Ambry Genetics and Baylor Miraca Genetics Laboratories. Study page 

Fluoresentric announced plans to spin out XCR Dx, a new wholly owned subsidiary focused on developing the XCR chemistry hardware platform. All company instrument development and manufacture will now flow through XCR Dx. XCR assay development, XCR strategic partner relationships, sales and other XCR chemistry activities remain inside Fluoresentric. This spinout is part of the company’s plan to first demonstrate the chemistry’s flexibility and speed, then couple it with inexpensive instrumentation as a “Portable Diagnostic System” for deployment in near patient settings. Press page 

N-of-One, Inc., signed a partner agreement with Affymetrix, a provider of DNA microarrays. N-of-One will provide copy number variation (CNV) interpretation for Affymetrix OncoScan assay customers. The OncoScan assay provides a genome-wide copy number profile from a solid tumor sample. The analysis of copy number aberrations has been shown to inform therapeutic strategies in oncology. N-of-One is working closely with Affymetrix to ensure that data from OncoScan assay combined with N-of-One interpretation optimize for clinicians the value of tumor profiling based on CNV analysis. Press release 

CRO Analytics, a provider of validated clinical trial performance data, announced a partnership with the Association of Clinical Research Professionals (ACRP) focused on measuring investigator site personnel views of clinical trial quality. CRO Analytics will develop a statistically validated data collection instrument to be used with the Performer platform, and work with ACRP to collect assessments from investigator site personnel. That data will be analyzed to generate benchmarking, key driver analytics, and predictive analytics. Press release 

Insight Genetics presented data on classifying distinct molecular subtypes of serous ovarian cancer at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation focused on the company’s Insight TNBCtype algorithm, based on subtyping technology for triple-negative breast cancer (TNBC) exclusively licensed from Vanderbilt University Medical Center. Based on prior observations of genetic abnormalities shared between TNBC and serous ovarian cancer, Insight Genetics applied Insight TNBCtype to existing serous ovarian cancer gene expression datasets and noted a similar distribution of molecular subtypes as previously found in TNBC. Based on treatment data studied to date, certain subtypes appear to have promise in predicting patient outcomes to various therapies in ovarian cancer. Press release 

CRF Health, a provider of electronic Clinical Outcome Assessment solutions, introduced video-on-demand access to its 2015 eCOA Forum Scientific Sessions. Attendees of the Forum participated in two days of sessions, workshops and panel discussions covering topics relating to electronic clinical outcome assessments in clinical trials. All the sessions filmed live at the event are now available on-demand at www.crfhealth.com/ecoaforum2015. Topics include “PRO Strategy ― Why Early is Better,” “Equivalence to Paper: Does it Matter Anymore?” and “eCOA in the Age of Rare Disease Research Proliferation.” Press release 

New Products 

Virtru announced Virtru Pro, a HIPAA-compliant email service for the healthcare industry. Virtru Pro is intended to protect data while avoiding the cost and complexity of health portals or Electronic Medical Record (EMR) and Electronic Health Record (EHR) systems. With Virtru Pro, organizations can send and receive secure, HIPAA-compliant encrypted emails, revoke sent messages, restrict forwarding, and set expiry for emails and files to auto delete. Confidential information remains private, audit ready, and protected, and the risk of inadvertently forwarding patient data is eliminated, while added controls determine how information is viewed and shared. Press release 

Brooks Automation, Inc., a provider of automated cold-chain sample management for drug discovery and biostorage applications, announced the introduction of the BioStore III Cryo, an automated cryogenic sample management system. BioStore III Cryo incorporates sample monitoring, tracking, and inventory control with the industry's standard cryo storage vessel. The system can access virtually any type of sample within a cryobox format and retrieve a box of samples in less than 60 seconds. The new system was developed in collaboration with Chart Industries. Press release 

Veeva Systems announced it will launch Veeva Vault Registrations to manage product registration data worldwide, including registration status, variations, and health authority interactions. Veeva is previewing Vault Registrations at this week’s Drug Information Association eRegulatory and Information Conference. Vault Registrations will be available as a stand-alone product, or as part of the Veeva Vault RIM suite. Press release 

Quest Diagnostics launched QNatal Advanced, a noninvasive prenatal screening service for detecting chromosomal abnormalities in high-risk pregnancies. QNatal Advanced analyzes cell-free fetal DNA in circulating maternal blood to screen for common and rare chromosomal abnormalities, including those associated with trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome) and monosomy X (Turner syndrome), as well as fetal sex aneuploidies and select copy number variants. The company is only promoting QNatal Advanced as a screening service for women defined as high-risk under medical guidelines. Press release 

EMC announced updates across its Documentum portfolio of enterprise content management (ECM) applications. The latest Documentum 7.2 platform includes Top Secret-level encryption (AES-256) for content in transit and at rest, and new storage certifications enabling storage management optimization within the software-defined data center, while Captiva 7.5 offers distributed capture and enhances image recognition and mobile development kits. Press release