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