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
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)
Personalized or Precision Medicine needs reliable and accurate diagnostic tests to guide clinical intervention and treatment decisions. Traditional testing of germline variants is site-specific and therefore only provides information on one or at most, several variants at a time. Advances in DNA sequencing technology, notably Next Generation Sequencing (NGS), permit the analysis of millions of variants … Continue reading this entry Tags: Genetic Test,Personalized Medicine,Precision Medicine Initiative,U.S. Food and Drug Administration (FDA)
On May 4, 2016, the USPTO released a “May 2016 Subject Matter Eligibility Update” (“Update”) providing guidance to patent examiners on formulating a subject matter eligibility rejection and evaluating an applicant’s response to that rejection. The USPTO concurrently released new life science examples to assist examiners and applicants evaluate whether claimed discoveries satisfy 35 U.S.C. … Continue reading this entry Tags: Genetic Test,Genetic Testing,Personalized Medicine,Subject Matter Patent Eligibility
Earlier this year, the American Academy of Pediatrics (AAP) and the American College of Medical Genetics and Genomics (ACMG) issued recommendations and proposed best practices for genetic testing and screening of infants and children. In Ethical and Policy Issues in Genetic Testing and Screening of Children, the AAP and ACMG reviewed the scenarios in which genetic … Continue reading this entry Tags: Genetic Test,Genetic Testing,Personalized Medicine
As reported in my January 24th, 2013 post, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) issued an omnibus final rule (the Rule) implementing changes in current regulations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), pursuant to the Health Information Technology for Economic and … Continue reading this entry Tags: Genetic Test,Genetic Testing,Health Care IT
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 Tags: Genetic Test,Genetic Testing,Personalized Medicine
Those seeking to conduct research involving human genetic material within the People’s Republic of China or to import into China such material should review China’s recently issued draft regulations (“Draft”) for the management of its human genetic resources. The regulations apply to the collection, preservation, research, development, immigration and other activities involving human genetic material. The Draft … Continue reading this entry Tags: Genetic Test,Genetic Tests,Personalized Medicine
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 Tags: Bioethics,Gene Patent,Genetic Test,Genetic Testing,Personalized Medicine,Privacy
The U.S. Supreme Court has sent the ACLU “gene patenting” case back to the Federal Circuit for reconsideration in light of its unanimous decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (S. Ct. 2012). For a review of the issues, please see Foley & Lardner’s client alert “Supreme Court Tells Federal Circuit to … Continue reading this entry Tags: Gene Patent,Gene Patenting,Genetic Test
On the same day that the personalized medicine testing market was reported to have exceeded $28 billion in 2011, the New England Journal of Medicine (NEJM) also reported a perceived stumble to the use of genomic tests that serve personalized medicine.… Continue reading this entry Tags: Diagnostic Test,Genetic Test,Patents,Personalized Medicine
On June 23, 2011, the United States House of Representatives passed the “Leahy-Smith America Invents Act” (H.R. 1249) to amend title 35 of the United States Code, to provide for patent reform. Within the numerous provisions related to the examination, administration and enforcement of U.S. patents is a proposed amendment that may affect the value … Continue reading this entry Tags: Gene Patent,Genetic Test,Patent Eligibility,Patent Reform
Posted in Genetic Testing; Personalized Medicine
