August Clinical News and Product Briefs

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