Personalized Medicine Bulletin

Latest from Personalized Medicine Bulletin

Artificial Intelligence (AI) has changed our lives. Improvements in data mining, personal and automotive navigation, cybersecurity, personal entertainment and healthcare are several examples of the impact of AI.[1] Recognizing that technological process can be measured by a review of the patent literature, the USPTO recently examined the patent literature from 1976 through 2018 to gauge the potential impact of AI on technology and innovation.[2] It found a significant increase in patents using or covering AI.…
Does payer coverage of genomic testing drive utilization? That is the question The Personalized Medicine Coalition (“PMC”) asked and answered in its recent report “Understanding Genomic Testing Utilization and Coverage in the US” (“Study”). PMC’s Study, conducted in collaboration with BlueCross/BlueShield Association, Concert Genetics, and Illumina, sought to uncover patterns between the clinical use of genomic testing and payer coverage. Three clinical areas were studied: noninvasive prenatal testing (NIPT) in prenatal screening, whole…
On December 12, 2019, an outbreak of a severe pneumonia broke out of Wuhan, China.  The causative agent of the outbreak was determined to be a coronavirus, an enveloped positive- and single-stranded RNA virus that infects vertebrates.  The newly discovered coronavirus belongs to the severe acute respiratory syndrome related coronavirus (SARS-CoV)1 species.  The new infectious respiratory syndrome is now known as the Coronavirus Disease 2019 (COVID-19).2 Since the declaration of a public health emergency on…
The National Institutes of Health recently opened its data platform for user feedback of its “All of Us Researcher Workbench.”  Researchers are now able to use the initial datasets obtained from nearly 350,000 participants in the All of Us research program and the tools in the All of Us studies. Initially branded as the “Precision Medicine Initiative®” Cohort Program, “All of Us” will be the largest volunteer health and medical research program on precision medicine…
On April 27, 2020, Representatives Fred Upton (R-Michigan) and Diana DeGette (D-Colorado) released a “concept paper” to build on the success of the 21st Century Cures Act (Pub. L. 114-255) and improve the country’s surveillance and testing capabilities urgently needed to respond COVID-19 and future pandemics.  Representatives DeGette and Upton originally introduced the first 21st Century Cures Act in the House on May 19, 2015. The House passed the bill with strong bipartisan support…
In 2014, the U.S. Supreme Court’s Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014) (“Alice”) held that technologies that merely implemented an abstract idea with a generic computer were not eligible for patent protection. As a result, the patent-eligibility of personalized medicine diagnostics and therapies that may rely on computers or mental analysis to diagnose disease or analyze medical information faced a new standard for patent-eligibility. (See, e.g., Federal Circuit Frames Test for
“As the emergence of COVID-19 grips the global psych, policymakers and citizens will increasingly turn to thought leaders in health and medicine for answers about how to equip our health systems to respond to medical challenges in a new era. Proponents for personalized medicine are ready.” Christopher J. Wells, PMC Vice President, Public Affairs, Personalized Medicine In Brief, Vol. 14, Page 8, Spring 2020 (“Newsletter”) The Personalized Medicine Coalition (“PMC”) recently published its 2020 Spring
In Illumina, Inc. v. Ariosa Diagnositcs, Inc., (Fed. Cir. Slip Op. 2019-1419, March 17, 2020) the Federal Circuit held that process claims that exploit the discovered size differences between fetal and maternal DNA in serum or plasma are patent eligible. The Federal Circuit reversed the decision of the U.S. District Court for the Northern District of California (356 F. Supp. 3d 925 (N.D. Cal. 2018)) that the contested claims of U.S. Patent 9,580,751 (the…
Personalized medicine selects the best therapy or course of treatment for each patient based on diagnostic testing. In one aspect, personalized medicine uses pharmacogenetic testing to provide information regarding: 1) how an individual’s genes affect that person’s response to medications; 2) the best dose of a medication; and/or 3) whether the individual could suffer serious side effects from a medication.i  Pharmacogenetic testing is currently being used to select therapies to treat a wide range of…
Personalized medicine selects the best therapy or course of treatment for each patient based on diagnostic testing. In one aspect, personalized medicine uses pharmacogenetic testing to provide information regarding: 1) how an individual’s genes affect that person’s response to medications; 2) the best dose of a medication; and/or 3) whether the individual could suffer serious side effects from a medication.i  Pharmacogenetic testing is currently being used to select therapies to treat a wide range of…