Direct-to-Consumer Genetic Test Authorized by FDA


23andMe is not a traditional diagnostics company. Rather than seeking to directly sell its services to health care professionals, 23andMe went straight to the consumer, offering genetic screening and analysis in a mail-order fashion. For ninety-nine dollars, customers only needed to send in a saliva sample and the company would analyze the customer’s genetic information, interpret and report the results directly to the consumer, bypassing the physician or genetic counselor. Continue reading this entry

Patenting Stem Cells in View of the USPTO’s New Interim Guidance


Late last year, the USPTO issued its modified and revised 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Guidance) to assist patent examiners and the public in determining if a claim presented for examination is patent-eligible in view of recent U.S. Supreme Court decisions, namely Alice Corp., Myriad, and Mayo. In addition to streamlining the analysis of patent claims directed to any one of the judicial exceptions to patent-eligibility (abstract ideas, laws of nature and physical phenomena), the USPTO provided illustrative examples to be used in combination with the Interim Guidance. One such example discussed the patent-eligibility of claims directed to stem cells or regenerative medicine. Fortunately for these industries, application of the Interim Guidance as discussed in the example finds that many stem cell technologies are patent-eligible. Continue reading this entry

Details Emerge for President’s Precision Medicine Initiative


Personalized medicine has a friend in high places. President Obama recently announced an initiative to support “precision” or personalized medicine. In very general terms, the President stated during his 2015 State of the Union address that he wanted the United States to lead a new era of medicine – an era that delivers the right treatment at the right time. Continue reading this entry

President Obama Revisits Interest in Personalized Medicine


President Obama announced during his 2015 State of the Union Address that he is launching a new “precision” or personalized medicine initiative to advance personalized, effective therapies for the American public. As reported by the Personalized Medicine Coalition, President Obama stated:

“21st century businesses will rely on American science, technology, research and development. I want the country that eliminated polio and mapped the human genome to lead a new era of medicine – one that delivers the right treatment at the right time. In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable. Tonight, I’m launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes – and to give all of us access to the personalized information we need to keep ourselves and our families healthier.” Continue reading this entry

FDA Considering New Regulatory Approaches for NGS – Part II


The Food and Drug Administration (“FDA”) announced a workshop to be held February 20th, 2015, entitled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests” to obtain public input regarding its regulation of next generation sequencing (“NGS”). Specifically, the agency seeks public comment and feedback on the issues and questions raised in its discussion paper “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests – Preliminary Discussion Paper” (“FDA Discussion Paper”) (attached here). My post of December 28th, 2014 highlighted FDA’s issues and concerns regarding the analytical performance of NGS. This post will address FDA’s issues and concerns relating to the clinical performance of NGS. Continue reading this entry