A recent study published in the American Journal of Medical Genetics, “Barriers for Integrating Personalized Medicine into Clinical Practice: A Qualitative Analysis” investigated physicians’ perceptions about the future of personalized medicine and identified factors that would influence their decisions in using genetic testing in their practice. The study is an interesting read for any innovator in genomic testing and analysis and provides insight into what factors will facilitate adoption of genetic testing into clinical care. Continue reading this entry
Five industry executives argue for an overhaul of the current approval and reimbursement framework for diagnostic tests. In “A Pay-For-Value, Data-Driven Approach for the Coverage of Innovative Genetic Tests“, a case is made for a move from a Fee-For-Service (FFS) system to a Pay-For-Value (PFV) model based on risk sharing among innovators, payors, physicians and patients.
The Current System Stifles Innovatin
To explain the deficiencies in the current FFS system, the authors first note that approximately 25% of all Americans receive health care benefits through the Centers for Medicare & Medicaid Services (CMS). In 2006, a new program, the Coverage with Evidence Development (CED) system was formalized by CMS to allow it to provide cutting-edge health care coverage. The authors argue that the CED process, created for the development of drugs, is not well suited for molecular diagnostics. Continue reading this entry
As reported in my July 8, 2013 post, Consumer Watchdog (formerly known as The Foundation for Taxpayer and Consumer Rights) and the Public Patent Foundation (collectively “CW”) asked the Federal Circuit to determine if in vitro cultured human embryonic stem cells (hESCs) are patent-eligible. Consumer Watchdog v. Wisconsin Alumni Research Foundation, No. 13-1377 (Fed. Cir. 2013). The issue is presented in an appeal from the inter partes reexamination (No. 95/000,154) of U.S. Patent No. 7,029,913 (the ‘913 Patent) wherein the USPTO Board of Patent Appeals confirmed the patentability of the claims of the ‘913 Patent, entitled “Primate Embryonic Stem Cells”. The ‘913 Patent issued on April 18, 2006 naming Dr. James A. Thomson of the University of Wisconsin as the sole inventor and is assigned to Appellee Wisconsin Alumni Research Foundation (“WARF”). WARF has now responded to CW’s challenge, urging the Federal Circuit to dismiss the patent-eligibility challenge on procedural and substantive grounds. Continue reading this entry
Earlier this year, the American Academy of Pediatrics (AAP) and the American College of Medical Genetics and Genomics (ACMG) issued recommendations and proposed best practices for genetic testing and screening of infants and children. In Ethical and Policy Issues in Genetic Testing and Screening of Children, the AAP and ACMG reviewed the scenarios in which genetic testing or screening of minors may occur and recommended best practices for such testing (See post of March 4, 2013 for a review of the report). The University of California, South Francisco (UCSF) and UC Berkeley recently announced a pilot project that will study and address several issues raised but by the AAP and ACMG, and in particular, whether large-scale gene sequencing to detect disorders and conditions should be performed routinely for newborns. The study is one of four projects supported by the National Institutes of Health (NIH) to evaluate the accuracy and feasibility of conducting genetic sequencing along side current newborn screening that relies on biochemical analysis. The study will also evaluate what additional information would be useful to have at birth and the ethics and public interest in conducting newborn genetic tests.
Personalized medicine offers something for everyone. Dell Corporation, most notably known for producing computers has recently become deeply involved in the health industry. But the company isn’t just creating computers for the industry; they are currently working on significant, life-saving advancements, such as products and services to apply genomics to treatments.
Dell announced that its interest in health comes from the top and it’s not just about profits. Dell reported that Michael and Susan Dell have their own non-profit foundation that has funded children’s health-related causes worldwide and they have supported initiatives such as Dell Children’s Medical Center of Central Texas. But when Dell realized that big data could be applied to emerging areas such as genomics which in turn makes a real impact on patient outcomes, Dell applied its computing power to improve the delivery of health care. For example, for children afflicted with cancer, Dell has partnered with the industry to apply big data, high performance computing, and the cloud to help doctors derive treatment cocktails in days rather than weeks or months. The data needed to devise the optimal cocktail for one patient is 30 terabytes—a massive amount of data that must be processed to understand how to treat each patient.
The attached infographic provides a statistical overview of Dell’s involvement in the health industry.