By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies
A virtually unlimited number of genes tied to hereditary cancer risk can be simultaneously assessed in commercially available tests given both advances in technology and the Supreme Court's two-year old ruling overturning gene patents. By screening multiple genes in parallel, research has shown that diagnostic yields are on the rise and time to results are down, with the added benefit of not adding much incremental cost for delivery of additional information. Clinical adoption of multigene panels faces some hurdles, however, including questions about… Read more...
Quadax delivers transformative revenue cycle management services through secure cloud-based systems to molecular diagnostic and genetic testing organizations across the United States. Our deep industry expertise enables us to implement successful strategies for overcoming the reimbursement challenges unique to this critical segment of our healthcare system. Quadax delivers customized solutions incorporating SaaS, outsourcing and hybrid offerings to meet the needs of providers in all laboratory disciplines. We build long-term partnerships with our clients, helping them optimize their financial performance and strengthen their market presence via our customer centric approach to support. For more information visit www.quadax.com
By Kelly A. Briganti, Editorial Director, G2 Intelligence
Building on discussions started in February this year, the FDA has announced two workshops it will be holding this fall regarding next-generation sequencing standards and use of databases to establish clinical relevance of genetic variants. The first workshop, to be held Nov. 12, will focus on potential analytical standards for next generation sequencing (NGS)-based in vitro diagnostic tests, including laboratory developed tests. The FDA seeks "sufficiently flexible assay performance standards that can accommodate innovation, including test modifications, while assuring NGS test safety and… Read more...
By Ron Shinkman, Editor, Laboratory Industry Report
San Diego-based genomic laboratory Trovagene is developing an unconventional approach to liquid biopsies for lung cancer patients, relying on specimens of urine rather than blood.
According to Trovagene's research, it is able to track the DNA of circulating tumors through urine samples in patients with lung cancer. The findings are being presented at the ongoing World Conference on Lung Cancer in… Read more...
Visiun, Inc. is the leading provider of performance analytics to the laboratory industry, with over 120 laboratories installed throughout the United States. Performance Insight™, Visiun's core product, provides laboratory directors and managers with business intelligence and analytics to help their management teams monitor key service commitments and improve workflow, quality, test utilization, and financial performance. With a depth of analytics that is unsurpassed in the industry and a team of experienced laboratorians, Performance Insight provides immediate insight into key areas that are critical to success in today's laboratory, transforming the way mangers and their teams work together to meet the challenges of today's environment. For additional information, please visit www.visiun.com.
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies
The Air Force Medical Service (AFMS) in partnership with the Coriell Institute for Medical Research (Camden, N.J.) have launched phase II of the longitudinal Clinical Utility Study (CUS). CUS evaluates the effects of returning personalized genomic risk information to Air Force personnel by examining changes in participants' lifestyle and health-related behavior, changes in medical management, and… Read more...
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