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...more
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...more
The Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: A Progress & Outlook Report” (Report) that monitors current successes and challenges in bringing personalized therapies to market....more
8/27/2019
/ Annual Reports ,
Biosimilars ,
Cancer ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Genetic Markers ,
Genetic Testing ,
Health Care Providers ,
Personalized Medicine ,
Pharmaceutical Industry ,
Prescription Drugs
The Personalized Medicine Coalition, or the “PMC” is an organization of over 250 members that seeks to promote the understanding and adoption of personalized or precision medicine concepts, services, and products by health...more
On February 15, 2018, representatives Eric Swalwell (CA-15), John Shimkus (IL-15), Scott Peters (CA-52), Erik Paulson (MN-03), and Juan Vargas (CA-51), introduced the Advancing Access to Precision Medicine Act (H.R....more
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...more
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...more
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...more
11/4/2015
/ AMP v Myriad ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
Complete Genomics ,
Diagnostic Method ,
Diagnostic Tests ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Genetic Testing ,
Health Insurance ,
Healthcare ,
Healthcare Costs ,
Healthcare Reform ,
Innovation ,
Insurance Industry ,
Intellectual Property Protection ,
Life Sciences ,
Medicaid ,
Medicare ,
Personalized Medicine ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Reimbursements ,
Research and Development ,
SCOTUS
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...more
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...more
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...more
In one of the first district court decisions applying the U.S. Supreme Court’s new Myriad patent-eligibility standard, the Northern District of California held that diagnostic claims containing only conventional and existing...more
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...more
In a July 12, 2013 letter to Dr. Francis S. Collins of the National Institutes of Health (“NIH”), Senator Patrick J. Leahy urged the NIH to exercise its march-in rights under the Bayh-Dole Act to directly license the genetic...more
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...more