Category Archives: Genomics

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EMA’s New Draft Guideline On Good Pharmacogenomic Practice - Implications For Personalized Medicine

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Embracing personalized medicine, the European Medicines Agency (EMA) released a draft guidance document titled Draft Guideline on Good Pharmacogenomic Practice (“Guidance”) on good pharmacogenomic practice with the stated goal of developing and laying out appropriate genomic methodologies for use during the development and life-cycle of a drug. Past issues and problems that have been encountered … Continue reading this entry

Breaking Through to Business Solutions for Personalized Medicine: A Thought-Provoking, Can’t-Miss Industry Event

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Just as with patient treatments, one size does not fit all when it comes to companies involved in personalized medicine. Each is unique in its mission, culture, and capabilities, so it should come as no surprise that each demands a distinct business strategy that can evolve alongside the industry. The annual Business of Personalized Medicine … Continue reading this entry

Federal Circuit Invalidates Another Diagnostic Patent

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In Ariosa Diagnostics, Inc. v. Sequenom, Inc., Slip Op. 2014-1139, 2014-114 (Fed. Cir. June 12, 2015), the U.S. Court of Appeals for the Federal Circuit held that Sequenom’s U.S. Patent No. 6,258,540 (the ‘540 Patent) was invalid under 35 U.S.C. § 101, for failing to claim patent-eligible subject matter. The Court’s decision is yet another application … Continue reading this entry

Six Hot Opportunities in Genomic Medicine

Advances in DNA sequencing technology and the interpretation of the acquired data have fueled advances in genomics and its application in the delivery of personalized healthcare. Illumina recently announced a new milestone that will move the industry in ways that are yet to be realized, or even envisioned – a DNA sequencing super computer (HiSeqX) … Continue reading this entry

Clinical Adoption of Personalized Medicine

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 … Continue reading this entry

Genetic Testing and Screening of Children: Ethics and Best Practices

The application of medical technology in the pediatric setting must serve the best interest of the child. Genetic testing of children and infants presents unique challenges. In contrast to the testing of adult patients, most children cannot understand the risks and benefits or provide informed consent. The American Academy of Pediatrics (AAP) and the American College of Medical Genetics and … Continue reading this entry

Myriad Urges Dismissal of "Gene Patenting" Case

Yesterday Myriad urged the Federal Circuit to dismiss the “gene patenting” case on the ground that subject matter jurisdiction no longer exists. Myriad argued that in the alternative, the case should be remanded to the district court to address whether declaratory-judgment jurisdiction exists under the current facts of the dispute. … Continue reading this entry

Presidential Commission to Study Management of, and Access to, Human Genome Sequencing Data

On November 24, 2009, President Obama established the Presidential Commission for the Study of Bioethical Issues (Commission) to advise him on bioethical issues generated by novel and emerging research in biomedical and related areas of science and technology. As part of this initiative, the Commission issued a Notice on March 27, 2012 (Federal Register) seeking comments … Continue reading this entry

CIRM Pledges $40 Million to Support Stem Cell Genomics Centers

The California Institute for Regenerative Medicine (CIRM) announced on January 17, 2012 that its governing board approved a $40 million initiative to fund one or two Stem Cell Genomics Centers of Excellence in California. CIRM was created by California’s Proposition 71, which authorized the state to issue $3 billion in grants over ten years to … Continue reading this entry