June Clinical News and Product Briefs

News Briefs 

The National Cancer Institute will enroll up to 1,000 patients in a new national oncology clinical trial called NCI-MATCH (Molecular Analysis for Therapy Choice), using genetic sequence information obtained from Thermo Fisher Scientific’s targeted next-generation sequencing (NGS) technology. As many as 3,000 tumor samples will be sequenced for this program across multiple academic centers. The targeted sequencing assay will include 143 genes selected using the Oncomine Knowledgebase, the world’s largest collection of oncology data. The panel design also enables simultaneous sequencing of a wide range of genetic alterations, including single nucleotide variants (SNV), small insertions and deletions (indels), copy number changes, and chromosomal translocations. Press release 

Parallel 6 and Sentrian announced as technology partners that Clinical Reach’s Reachlink Connector will now send patient data securely to Sentrian’s remote patient monitoring platform, Sentrian RPI. Parallel 6 will power Sentrian mobile applications to help care teams engage with chronic disease patients, turning patient self-report data into another data input for the Sentrian analytics engine. Clinical Reach is a HIPAA compliant, end-to-end patient lifecycle management and engagement platform. Press release 

OmniSeq has begun its spin out from Roswell Park Cancer Institute (RPCI) and will immediately begin commercializing its suite of products to support a physician-driven, collaborative approach to genomic diagnostics, matching cancer patients to therapies tailored specifically to them. The OmniSeq Precision Medicine Technology platform provides physicians with information about a patient’s cancer through a proprietary genomic sequencing algorithm and a system that continuously ingests and analyzes peer-generated clinical experiences and therapeutic outcomes for patients. Press release 

Merck & Co. is making The Merck Manuals, a series of medical reference books, available digitally for the launch of Global Medical Knowledge 2020. Users can access the new multimedia website, MerckManuals.com, at no charge. The content will soon be translated into multiple languages and made available as a mobile app. The move to an electronic platform will allow for regular updates to the material and real-time news-feeds about the latest developments in medicine. The website also features expert commentary, infographics, animations, video clips, health calculators and trackers, quizzes, as well as a drug interaction checker, pill identifier, and guide to pronunciation of medical terms. Press release 

Qubole announced that Station X is using Presto on Qubole's cloud-based big data platform to power GenePool, a software-as-a-service solution for real-time analytics of genomic and medical information. GenePool allows researchers to manage, visualize and analyze processed genomic data from one to thousands of patients and securely share this data with colleagues. Qubole's self-service platform for big data analytics runs on Amazon AWS, Google Compute Engine and Microsoft Azure. Press release 

New Products 

Quanterix Corporation announced commercial availability of its multiplex panels, providing users with the ability to develop their own multiplex assays using the company’s Simoa technology. This allows users to achieve similar sensitivity with each marker in a multiplex panel as they would if they were to test individual assays. Quanterix has also developed a multiplex homebrew kit, allowing customers to use their own antibody pairs to develop custom multiplex Simoa panels. The first commercially available multiplex kits are 3-plex panels of cytokines, for measuring inflammatory response. (For more on the Simoa, see “Quanterix Aims for Early Clinical Adoption with High-Throughput Protein Assays.”) Press release 

CRF Health introduced TrialMax ConMed, an eDiary-based solution for real-time collection of concomitant medication data from patients in clinical trials. TrialMax ConMed allows patients to report medications that they are taking alongside a study drug in real-time. With access to TrialManager, CRF Health’s online patient management portal, investigators are alerted to new medication entries to allow them to assess the completeness and accuracy of the data and correct as appropriate. Press release 

Oracle Health Sciences released Oracle Health Sciences InForm Cloud Service 6.1. The platform supports complex trial protocols and environments with data capture/query management and real-time visibility into data. The latest release adds new capabilities, including expanded risk-based monitoring capacity with source verification at the individual and subject level; a single location for defining and managing study administrative data in Oracle Health Sciences Central Designer; and a modeling environment for validation of protocol amendments. Press release 

At DIA 2015, CluePoints introduced software to analyze operational data using a risk-based monitoring approach. The new software includes Key Risk Indicators (KRIs) that complement the statistical analysis of clinical data. This KRI+ approach allows sponsors and CROs to set their own subjective threshold levels, while also statistically examining data to show how a single site's KRIs can be judged against results across all other sites. The solution runs on CluePoints' SMART Engine. Additionally, the new software will soon support an online, customizable version of the Transcelerate-recommended Risk-Assessment Categorization Tool (RACT), allowing the CluePoints monitoring platform to provide upfront study/site risk assessment. Press release 

PAREXEL International Corporation expanded its Perceptive MyTrials Data-Driven Monitoring (DDM) solution with new risk-based monitoring capabilities. Data-Driven Monitoring now allows clients to perform cross-study analysis of quality, risk, and monitoring work effort by combining analytics, reporting and monitoring activity into a single solution.It is a component of the Perceptive MyTrials platform, an integrated suite of applications for managing clinical trials. Press release 

Comprehend Systems launched Continuous Quality for ClinOps, a solution for clinical operations (ClinOps) to deliver clinical trial submissions. The cloud-based solution unifies and analyzes ClinOps data and automates alerts and collaboration across executives, teams and contract research organizations (CROs). The solution was unveiled at the DIA 51st Annual Meeting. Press release