Unlocking the Promise of Personalized Medicine: Reimbursement, Coverage, and Clinical Utility

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AmerisourceBergen, in connection with the Business of Personalized Medicine Summit, released “Unlocking the Promise of Personalized Medicine: Perspectives on Reimbursement, Coverage, and Clinical Utility” (“Report“). The Report explores the role of personalized medicine in today’s health care system with an overview of payer perspectives and provides recommendations to innovators to navigate the path to commercialization of these products. Continue reading this entry

Federal Circuit Frames Test for Patent-Eligibility

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Personalized medicine relies on diagnostics to analyze a patient for individualized therapy and for monitoring a patient’s health status. Some diagnostic tests use natural products, for example gene sequences, either as the target of the diagnostic test or as a tool to identify a genetic trait or anomaly. Personalized medicine also may rely on the analysis and management of large data sets using computer processes and analytics to identify correlations between a therapy and an individual’s genetic or clinical markers. Continue reading this entry

Considering Sex-Specific Variation for Personalized Medicine

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Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a particular cancer therapy. In some instances, the prediction of clinical outcome is related not only to the genetic variance but also to the sex of the patient.

The Food and Drug Administration (FDA) recently issued a new guidance for industry and FDA staff that may be relevant in the design and development of medical devices that serve personalized medicine, especially those that categorize patients into responders and non-responders. “Evaluation of Sex-Specific Data in Medical Device Clinical Studies” (Guidance) should be carefully reviewed by clinical device manufacturers, especially manufacturers of devices that separate individuals into two or more groups, such as those that respond to a particular treatment and those that do not respond. The Guidance is intended for devices that require clinical information in support of a marketing submission, whether a premarket notification (510(k)), premarket approval (PMA), a de novo request, or a humanitarian device exemption application. The recommendations reported in the Guidance also apply to post-approval study submissions and postmarket surveillance. Continue reading this entry

Will the USPTO Respond to Public Feedback of Its Eligibility Guidance?

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Periodically, the USPTO holds open meetings with the public to discuss its thinking on current topics relating to the patent procurement process. Late last week, the Biotechnology, Chemical and Pharmaceutical Customer Partnership of the USPTO announced the first bi-coastal meeting to be held via webcast in Washington, D.C. and San Jose, California on September 17th, 2014. Included on the September 17th agenda is a panel discussion of the U.S. Supreme Court patent-eligibility decision, Assn. for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) (“Myriad”). Continue reading this entry

Yamanaka iPSC Patent Challenged

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Dr. Shinya Yamanaka of Kyoto University shared the 2012 Nobel Prize in Physiology or Medicine with Dr. John B. Gurdon for their respective discoveries that mature, specialized cells can be reprogrammed to become immature cells capable of developing into all tissues of the body. In the 2012 Nobel announcement, the Nobel Assembly at Karolinka Institutet stated that the findings of Drs. Yamanaka and Gurdon “have revolutionized our understanding of how cells and organisms develop.”

Dr. Gurdon was recognized for his 1962 discovery that the specialization of cells is reversible when he replaced the immature cell nucleus in an egg cell of a frog with the nucleus from a mature intestinal cell. The modified egg developed into a normal tadpole. Dr. Yamanaka was recognized for his later discovery that intact mature cells in mice could be reprogrammed to become immature stem cells, now known as induced pluripotent stem cells (iPSCs). Continue reading this entry