Fifteen members of Congress have asked the Department of Health and Human Services (HHS) and the Medicare Payment Advisory Commission (Medicare) to examine how the federal government can help improve patient access to genetic testing. In a March 7, 2017 letter to Secretary Price of HHS and Dr. Crosson, Chairman of Medicare, the congressmen seek a … Continue reading this entry Tags: Genetic Test,Genetic Testing,Personalized Medicine
In Life Technologies Corp. v. Promega Corp., Slip Op. 14-1538 (Feb. 22, 2017), the U.S. Supreme Court held that the supply of a single component of a multicomponent invention for manufacture abroad does not give rise to liability under 35 U.S.C. § 271(f)(1). The Court’s decision is important for manufacturers of kit components and those that … Continue reading this entry Tags: Diagnostic Method Claims,Genetic Testing,Personalized Medicine
On January 13, 2017, the U.S. Food and Drug Administration (FDA) issued a Discussion Paper on Laboratory Developed Tests (LDTs) (LDTs) (Discussion Paper). The Discussion Paper follows FDA’s late 2016 announcement that, contrary to the Agency’s earlier reports, it would not issue a final guidance on its proposed oversight of LDTs to allow “for further … Continue reading this entry Tags: 35 U.S.C. 101,Genetic Test,U.S. Food and Drug Administration (FDA)
The Personalized Medicine Coalition (PMC) recently reported that for the third year in a row, personalized medicines accounted for more than 25% of all new molecular entities (NMEs) approved by the US Food & Drug Administration (FDA). Personalized Medicine at FDA, 2016 Progress Report (Report). Personalized medicines are new drugs, agents or therapeutic biologics where … Continue reading this entry Tags: Companion Diagnostics,FDA,Genetic Testing,U.S. Food and Drug Administration (FDA)
GUEST POST BY Vicki Albrecht, Ph.D., Senior Vice President and General Manager of ION Solutions Fueled by technological advances, scientific breakthroughs and significant financial investments, precision medicine (PM) has emerged as a promising approach to disease prevention and treatment. A multi-faceted solution to patient care, PM can improve patient outcomes and increase the effectiveness of … Continue reading this entry Tags: Diagnostic Test,Genetic Testing,Personalized Medicine,Precision Medicine Initiative
Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on their unique genetic or clinical profiles. According to an article published by the FDA in the spring of 2015 (FDA Continues to Lead … Continue reading this entry Tags: Gene Patents,Genetic Testing,Personalized Medicine,Personalized Medicine Coalition
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 Tags: Diagnostic Method Claims,Genetic Testing,Personalized Medicine
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 … Continue reading this entry Tags: Companion Diagnostics,FDA,Genetic Tests,Personalized Medicine,U.S. Food and Drug Administration (FDA)
Low cost sequencing of a patient’s genome and advances in the interpretation of a patient’s genetic information is promised to transform the delivery of health care. To date, much of personalized medicine has focused on the use of genetics and data analytics to match a patient to the best treatment, especially in the area of … Continue reading this entry Tags: Personalized Medicine
The United States Patent and Trademark Office (USPTO) published its examiner training materials (Training Materials) for applying “2014 Procedures For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products” (Guidance), that advised U.S. patent examiners and the public of the factors for determining whether a patent claim satisfies the … Continue reading this entry Tags: Myriad,USPTO
On March 4th, 2014, the U.S. Patent and Trademark Office (USPTO) issued “2014 Procedures For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products” Guidance, advising examiners and the public of the factors for determining whether an invention satisfies the U.S. Supreme Court’s interpretation of 35 U.S.C. §101, as … Continue reading this entry Tags: 35 U.S.C. 101,Gene Patenting,Genetic Testing,Personalized Medicine,Prometheus,Subject Matter Patent Eligibility
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 Tags: Personalized Medicine
The U.S. Preventive Services Task Force (“USPSTF”) recently issued a report regarding the effectiveness of BRCA1/BRCA2 genetic tests for women and within the report, issued recommendations for preventive screening for women with and without confirmed familial history of breast, ovarian, tubal, or peritoneal cancer (“BRCA-related cancers”). Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related … Continue reading this entry Tags: Diagnostic Test,Genetic Testing,Personalized Medicine
Posted in Genetic Testing; Personalized Medicine
