Aug 29, 2014, 08:50
by
Michael Croft
August 29, 2014 | Clinical news and product releases from the past month:
The MD Anderson Cancer
Center and Foundation
Medicine are opening a randomized-controlled trial, to determine
whether targeted therapies based on tumor molecular profiling result in longer
progression-free survival in patients with advanced disease. This study,
IMPACT2, aims to support the broader use of targeted therapies across all types
of cancers, not just in select ones for which existing diagnostic and treatment
options were insufficient. It builds on promising results from the first IMPACT
trial, presented at the American Society of Clinical Oncology’s Annual Meeting
in 2011. Foundation Medicine will provide support with their FoundationOne profiling
assay, which detects genomic alterations in solid tumors across 315
cancer-related genes and 28 other genes often rearranged in cancer. Press
release
MolecularHealth added a new
component to its TreatmentMAP offering in the United States, called RxAssistance,
providing an extra level of reimbursement support. RxAssistance evaluates
insurance options for both the TreatmentMAP molecular diagnostic service, and the
therapies recommended by its tests. Each patient’s TreatmentMAP results report
and insurance information is reviewed by MolecularHealth’s reimbursement
specialist, a Certified Professional Coder, prior to results being sent to the
physician. Off-label or investigational products recommended for treatment are
flagged and information is gathered, including the likelihood a payer will
reimburse for the suggested treatments and any additional information that will
be needed to receive reimbursement, such as a letter of medical necessity. Press
release
Comprehend secured $21 million in
Series B financing. The round was led by Lightspeed Venture Partners with
support from existing investor Sequoia Capital. Lightspeed partner Peter Nieh
joined the company’s board of directors. Comprehend’s cloud-based business
intelligence platform provides universal access to clinical trial data and
analytics, allowing all stakeholders in clinical development to access
up-to-date information. In the past year, Boston Scientific, Karyopharm, MERGE,
Atlantic Research Group and Versartis have become clients. The company will use
the new round of capital to expand its product development and customer
solutions teams. Press release
ElMindA announced that the FDA has approved the company’s Brain
Network Activity Analysis System (BNA) for the assessment of brain function.
BNA combines non-invasive, multi-channel EEG technology with signal
processing and analysis algorithms to measure patterns of brain networks
activated during specific brain processes. The BNA output allows healthcare
providers to assess a patient’s functional brain network activity and compare
it with functional network activity of healthy brains. BNA is now cleared for
14- to 24 year-olds, and the company is conducting additional research
activities to further expand the indicated age group. Press
release
iMedicor,
Inc. launched
its second cloud-based software product, iCoreDental, a cloud-based electronic heath
record (EHR) system for dentists. iCoreDental is a platform EHR that is
customizable-on-demand, for specific functionality within a practice's EHR
software. It includes a practice management system, e-prescription
functionality, integrated laboratory information system, electronic claims
processing, medical billing, and patient scheduling with notifications. All
sensitive patient information is transmitted securely in a HIPAA-compliant
manner via the iCoreExchange, allowing providers to apply for Meaningful Use
Federal Incentive funds available to qualified dentists. Press
release
Cancer Genetics, Inc. closed the acquisition of BioServe
Biotechnologies India, a genomics services provider serving both the research
and clinical markets in India. BioServe India, which operates a genomics
facility in Hyderabad, provides next-generation sequencing, genotyping and DNA
synthesis services. CGI acquired BioServe India for approximately $1.9 million,
largely in CGIX stock and other deferred consideration. BioServe India will be
a wholly owned subsidiary of CGI that will be renamed Cancer Genetics India.
CGI plans to retain BioServe India’s 33 employees, and hire additional members.
Press
release