The Personalized Medicine Coalition (PMC) recently released its annual report on the progress of precision medicine as measured by precision medicine FDA approvals in 2022 (“Report”). As summarized in the Report, 2022...more
...The Personalized Medicine Coalition (“PMC”) recently published its 2020 Spring Newsletter that examines the landscape and outlook for personalized medicine as COVID-19 prompts new discussions about the effect of COVID-19...more
4/8/2020
/ American Medical Association ,
Clinical Laboratories ,
Coding ,
Coronavirus/COVID-19 ,
Diagnostic Imaging Services ,
Diagnostic Tests ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Facilities ,
Personalized Medicine ,
Physicians
On February 21, 2020, the Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: The Scope and Significance of Progress in 2019” (Report) that monitors FDA approvals of precision medicine...more
According to the American Cancer Society (“ACS”), lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women (not counting skin cancer). About 14% of all new cancers are lung...more
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,...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
Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen
The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more
10/13/2015
/ American Medical Association ,
Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Clinical Trials ,
Coding ,
Data Collection ,
Diagnostic Tests ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Manufacturers ,
Personalized Medicine ,
Physicians ,
Reimbursements
Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more
9/24/2015
/ 510(k) RTA ,
Diagnostic Tests ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Personalized Medicine ,
Premarket Approval Applications ,
Proposed Regulation ,
Regulatory Oversight ,
USPTO
The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more
8/28/2015
/ Diagnostic Tests ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medical Devices ,
Patients ,
Personalized Medicine ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reimbursements
In Akamai Techs. Inc. v. Limelight Networks, Inc., (August 13, 2015 Fed. Cir.) an en banc Federal Circuit unanimously held that direct infringement under Section 271(a) can occur...more
8/25/2015
/ Akamai Technologies ,
CLS Bank v Alice Corp ,
Diagnostic Tests ,
Direct Infringement ,
En Banc Review ,
Induced Infringement ,
Limelight v Akamai ,
Mayo v. Prometheus ,
Myriad ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Personalized Medicine ,
SCOTUS ,
USPTO
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...more
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...more
The U.S. Supreme Court’s recent trilogy of patent-eligibility decisions (Prometheus, Myriad and Alice) have called into question the validity of many U.S. patents on diagnostic medical methods. Nevertheless, legal battles...more
Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that...more
8/4/2014
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Diagnostic Tests ,
Draft Guidance ,
Enforcement ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
National Institute of Health (NIH) ,
Physicians
Personalized medicine relies on diagnostic medicine to identify the best therapy for the patient at the right time. Tests that match a therapy to the patient fall into one of two categories. In vitro diagnostic devices or...more
Next generation sequencing (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application...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
Five industry executives argue for an overhaul of the current approval and reimbursement framework for diagnostic tests. In A Pay-For-Value, Data-Driven Approach for the Coverage of Innovative Genetic Tests a case is made for...more
Did the Federal Circuit incorrectly interpret and apply the holding of the U.S. Supreme Court’s decision regarding patent-eligibility of medical methods as set forth in Mayo Collaborative Services v. Prometheus Laboratories,...more
The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more