Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 126: Josh Arant, COO, Mako Medical
Abstract - Event data recorders (EDRs) were harvested and imaged after Insurance Institute for Highway Safety (IIHS) 56 km/hr frontal and 64.4 km/hr frontal offset crashes of 15 different brands of 2016-2022 vehicles. The...more
A new study shows that approximately 371,000 people die and 424,000 sustain permanent disabilities due to diagnostic error, including brain damage, blindness, loss of limbs or organs or metastasized cancer....more
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
The cloud of uncertainty over patent eligibility of patents for medical diagnostic methods remains. On Monday, the Supreme Court declined the opportunity to revisit patent eligibility under its two-step Mayo test when it...more
On August 9, 2019, the Federal Circuit issued a public opinion in Genetic Veterinary Sciences, Inc. v. LABOKLIN GmbH & Co. KG, finding claims directed to methods for detecting a genetic marker for a canine hereditary disease...more
In a decision underscoring that the U.S. stands (nearly) alone in holding most diagnostic methods to be not eligible for patenting, the Federal Court of Australia upheld Sequenom’s Australian patent directed to prenatal...more
In 2012, the U.S. Supreme Court decided the landmark case of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), which was hailed by some as banning patents on methods of medical diagnosis. It...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
The Federal Circuit Friday held in Ariosa Diagnostics, Inc. v. Sequenom, Inc. that Sequenom’s patent directed toward its MaterniT21 test—involving methods of detecting and using cell-free fetal DNA— was invalid for lack of...more
Last week, the U.S. Patent and Trademark Office issued U.S. Patent No. 8,628,920, which is entitled "Method for early diagnosis of liver cancer and prediction of metastasis." The '920 patent, which is assigned to National...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