Antoinette F. Konski

Antoinette F. Konski

Foley & Lardner LLP

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Unlocking the Promise of Personalized Medicine: Reimbursement, Coverage, and Clinical Utility

AmerisourceBergen, in connection with the Business of Personalized Medicine Summit, released “Unlocking the Promise of Personalized Medicine: Perspectives on Reimbursement, Coverage, and Clinical Utility” (“Report“). The...more

9/16/2014 - Healthcare Personalized Medicine

Considering Sex-Specific Variation for Personalized Medicine

Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a...more

9/3/2014 - 510(k) RTA FDA Healthcare Medical Devices Personalized Medicine Premarket Approval Applications

Managing IP Risk in the Age of Personalized Medicine

As discussed on Foley’s Health Care Law Today blog, personalized medicine treatment trends and innovations are leading diagnostic and therapeutic companies to form complex arrangements and partnerships with the ultimate goal...more

8/8/2014 - Confidential Information Healthcare Patents Personalized Medicine Trade Secrets

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8/4/2014 - CLIA Clinical Laboratories CMS Diagnostic Tests Draft Guidance Enforcement FDA Healthcare Laboratory Developed Tests NIH Physicians

Personalized Medicine Today: PMC Issues Fourth State of the Industry Report

Personalized medicine is changing the paradigm of the research, development and delivery of health care. The Personalized Medicine Coalition (PMC), a consortium of interested stakeholders that seeks to promote the...more

7/8/2014 - CMS FDA Healthcare Personalized Medicine

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

Recommendations for NextGen Health IT Infrastructure

Health care information technology (health IT) facilitates the delivery of personalized medicine by providing and supporting the infrastructure for patients, consumers and health care providers to communicate and distribute...more

4/21/2014 - FCC Healthcare Medical Devices ONC Technology

Genentech’s Distribution of Prescribing Information to Physicians is Alleged to Infringe Method Patent

On January 31, 2014, Phigenix, Inc. (“Phigenix”) filed a lawsuit in federal district court in Georgia alleging that the sale and use of the drug Kadcyla by Genentech, Inc. (“Genentech”) infringed U.S. Patent No. 8,080,534B2,...more

2/25/2014 - Genentech Healthcare Patent Infringement Patent Litigation Patents

Six Hot Opportunities in Genomic Medicine

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

1/28/2014 - Birth Defects Cancer DNA Genetic Markers Genetic Services Genetic Testing Healthcare Personalized Medicine

FDA Reaffirms Commitment to Personalized Medicine

In a report released on October 29, 2013, the U.S. Food and Drug Administration (FDA) announced its continued commitment to advancing personalized medicine. “Paving the Way for Personalized Medicine: FDA’s Role in a New Era...more

10/30/2013 - FDA Healthcare Personalized Medicine

Study Advances Personalized Medicine for Newborns

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

9/13/2013 - American Academy of Pediatrics Genetic Testing Healthcare Medical Research Personalized Medicine

From Personal Computers to Personalized Medicine

Personalized medicine offers something for everyone. Dell Corporation, most notably known for producing computers has recently become deeply involved in the health industry....more

8/22/2013 - Biotechnology Healthcare Personalized Medicine Technology

Clinical Progress in Regenerative Medicine

Two separate clinical initiatives were recently announced that support the therapeutic use of regenerative medicine. The first utilzing induced pluripotent stem cells and the second, a state-wide network in support of...more

8/7/2013 - Healthcare Medical Research Personalized Medicine Stem cells

Expanding Access to, and Development of, Personalized Medicine

In a July 8th, 2013 letter to the Centers for Medicare & Medicaid Services (CMS), the Personalized Medicine Coalition (PMC) advised that proposed reimbursement schedules for diagnostic medicine will threaten the development...more

7/24/2013 - CMS Diagnostic Method Healthcare Medical Reimbursement Patients Personalized Medicine

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

Genetic Testing and Screening of Children: Ethics and Best Practices

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

3/5/2013 - Genetic Testing Healthcare Pediatrics

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