Antoinette F. Konski

Antoinette F. Konski

Foley & Lardner LLP

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Latest Posts › Diagnostic Tests


Navigating the Diagnostic Commercialization Process

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 CLIA Clinical Laboratories Clinical Trials CMS Coding Data Collection Diagnostic Tests FDA Health Care Providers Health Insurance Healthcare Manufacturers Personalized Medicine Physicians Reimbursements

FDA Oversight of Diagnostic Medicine – A Trap for the Unwary

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 FDA Approval Medical Devices Patent Infringement Patent Invalidity Patent Litigation Patents Personalized Medicine Premarket Approval Applications Proposed Regulation Regulatory Oversight USPTO

AmerisourceBergen Guest Post: Solutions to Overcome Reimbursement Challenges in Personalized Medicine

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 FDA Health Care Providers Health Insurance Healthcare Medical Devices Patients Personalized Medicine Pharmaceutical Industry Prescription Drugs Reimbursements

FDA Considering New Regulatory Approaches for NGS – Part II

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

1/5/2015 - Diagnostic Tests FDA Regulatory Agenda Rulemaking Process

FDA Considering New Regulatory Approaches for NGS – Part I

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

12/29/2014 - Diagnostic Tests FDA Healthcare Regulatory Agenda

Another Patent Challenge for Personalized Medicine

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

12/9/2014 - Diagnostic Tests Genetic Materials Healthcare Patent Litigation Patent-Eligible Subject Matter Patents Personalized Medicine

FDA Set to Regulate LDTs - Citing Safety Concerns and Advanced Technologies

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 - CLIA Clinical Laboratories CMS Diagnostic Tests Draft Guidance Enforcement FDA Healthcare Laboratory Developed Tests NIH Physicians

Regulating Point of Care Diagnostics

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

6/2/2014 - CLIA CMS Diagnostic Tests FDA Healthcare Medical Devices

Is Next Generation Sequencing Ready for Personalized Medicine?

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

5/20/2014 - Clinical Laboratories Diagnostic Tests FDA Genetic Materials Healthcare Laboratories Personalized Medicine

California Court Holds Diagnostic Claims Not Patent-Eligible

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

11/4/2013 - Biotechnology Diagnostic Tests DNA Genetic Materials Genetic Testing Patent-Eligible Subject Matter Patents Pharmaceutical Industry

Risk-Sharing and Reimbursement of Diagnostic Tests

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

9/30/2013 - Diagnostic Method Diagnostic Tests Fee-for-Service Innovation Reimbursements Risk Management

Supreme Court Asked for Further Clarity on Patent-Eligibility of Diagnostic Claims

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

6/12/2013 - Birth Defects Diagnostic Method Diagnostic Tests Healthcare Mayo v. Prometheus Patent-Eligible Subject Matter Patents Pregnancy SCOTUS

FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

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

2/25/2013 - CMS Diagnostic Tests FDA Labeling Laboratory Developed Tests Marketing Personalized Medicine Pharmaceutical Industry

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