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
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Does Payer Coverage Drive Genomic Test Utilization in the United States?
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…
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Coronavirus Innovation Guideposts on the Eve of the COVID-19 Pandemic
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…
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All of Us Research Workbench Open for User Feedback
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…
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Improving 21st Century Cures Act: Personalized Medicine and COVID-19
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…
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Adjusting to Alice: USPTO’s View of Its Examination Guidelines
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…
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Personalized Medicine Coalition Releases Spring 2020 Newsletter Amid COVID-19
“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.…
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Utilization of Natural Phenomenon Found Patent Eligible
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…
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Collaborative Review of Scientific Evidence Announced By FDA
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;…
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Collaborative Review of Scientific Evidence Announced By FDA
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;…
Continue Reading Collaborative Review of Scientific Evidence Announced By FDA