News & Analysis as of

Diagnostic Tests

Federal Government To Revamp The Continuous Diagnostics And Mitigation Program

by King & Spalding on

The Federal Government is reportedly upgrading its Continuous Diagnostics and Mitigation (“CDM”) program, administered by the Department of Homeland Security (“DHS”) and the General Services Administration. The redesigned...more

The Challenges of Concussion Diagnosis, Prognosis and Treatment: The Most Complicated Disease of the Most Complex Organ of the...

by Downs Rachlin Martin PLLC on

A review published in the September 2017 issue of Frontiers in Neurology proposes use of “systems science” to better understand concussion diagnosis and prognosis. This is a discipline that analyzes complex problems as whole...more

USPTO and EPO Examiners Discuss Key Considerations for Filing Effective Precision Medicine and Bioinformatics Applications in the...

At a symposium and webinar presented by Fenwick & West and Mewburn Ellis, we asked U.S. Patent and Trademark Office and European Patent Office examiners to provide perspective on the preparation and prosecution of patent...more

As medical costs climb, it’s not just drip, drip waste, look at hospital bloat, too

Whether it happens in the drip, drip, drip of costly eye drops or it occurs in the flash of a pricey imaging scan, patients get gouged by modern medicine’s wasteful practices. The inefficiencies can be traced to many and...more

FDA Approves Companion Dx for PD-1 Inhibitor

by Foley & Lardner LLP on

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

Does Mayo Preclude the Patenting of Medical Diagnostics?

by Burns & Levinson LLP on

On August 4, 2017, the U.S. District Court in the District of Massachusetts found U.S. patent 7267820 (the ‘820 patent), owned by Athena Diagnostics, Inc., to be directed to non-patentable subject matter, and therefore...more

Medical Diagnostic Patents Found to Claim Patent Ineligible Subject Matter—Motions to Dismiss Granted

by Locke Lord LLP on

On August 4, 2017, a pair of decisions reaffirmed that claimed methods which apply routine and conventional techniques to a law of nature are invalid and do not satisfy the “inventive concept” step of the patent eligibility...more

Embrace™ Neonatal MRI Device Gains FDA Clearance

by Knobbe Martens on

On July 20, 2017, the Food and Drug Administration announced the clearance of “the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU)” to...more

CMS May Decide to Permit Labs to Bill for Certain Tests Provided to Outpatients

In the recently published proposed rule related to the CY 2018 Hospital Outpatient Prospective Payment System (OPPS), the Centers for Medicare & Medicaid Services (CMS) announced that it is considering changes to the...more

EMA envisage to link development of companion diagnostics and personalised medicines

by Hogan Lovells on

The European Medicines Agency (EMA) has released a concept paper on the development of personalised medicines and companion diagnostics. EMA proposes to develop a guideline that will provide guidance relating to the interface...more

Federal Circuit Finds That Fetal Diagnosis Claims Survive Written Description Attacks

by Knobbe Martens on

Stanford University v. The Chinese University of Hong Kong. Federal Circuit Appeal No. 2015-2011. Decided June 27, 2017. In an appeal from the Patent Trial and Appeal Board (PTAB), the Federal Circuit held that claims...more

New CRISPR Technology May Be a Breakthrough for Low-Cost Disease Diagnostics

by Knobbe Martens on

An MIT group consisting of the CRISPR pioneer Feng Zhang and 18 of his colleagues recently published a paper in Science demonstrating a new platform for using CRISPR technology as a diagnostic tool for detecting nucleic...more

CMS Give Clinical Labs Reporting Deadline Extension

by Dorsey & Whitney LLP on

Clinical laboratories have until May 30, 2017 to make required reports to the Centers for Medicare & Medicaid Services (“CMS”) regarding payment rates paid by private payors for certain diagnostic tests and the volume of such...more

FDA Hits “Pause” on Regulation of LDTs

by Foley & Lardner LLP on

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

FDA Advances LDT Dialogue with New Discussion Paper Containing Updated CMS/FDA Oversight Proposal

by Reed Smith on

On January 13, 2017, the Food and Drug Administration (FDA) released a discussion paper concerning an updated proposed framework for oversight of laboratory developed tests (LDTs). According to FDA, the updated proposal is...more

U.S. Access Board Issues Standards for Medical Diagnostic Equipment

by Seyfarth Shaw LLP on

Seyfarth Synopsis: Many years in the making, today the Access Board issued design criteria and other standards for medical diagnostic equipment. Today, the U.S. Access Board issued new accessibility standards for medical...more

Rx IP Update - December 2016

by Smart & Biggar on

Janssen seeks leave to appeal to SCC regarding FCA decision upholding Minister of Health’s decisions relating to administrative drug submissions - As reported previously, on October 12, 2016, the Federal Court of Appeal...more

FDA Indefinitely Delays Action on Regulating Laboratory Developed Tests

by Ropes & Gray LLP on

On November 18, 2016, the Food and Drug Administration (FDA) notified industry groups that it no longer plans to finalize its draft guidance on laboratory developed tests (LDTs). FDA stated that it intends to work with the...more

Myriad Genetics Announces an Assay that Identifies Patients for Olaparib Treatment

by Knobbe Martens on

Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a...more

CMS to Host November 2 Call on Clinical Diagnostic Lab Test Payment System Data Reporting

by Reed Smith on

CMS is hosting an educational call on November 2, 2016 to discuss reporting obligations under the June 23, 2016 Clinical Diagnostic Test Payment System final rule. As previously reported, under the Protecting Access to...more

FDA Uses Summer to Issue Numerous Device Guidance Documents

by Morgan Lewis on

The Agency shows no signs of slowing regulatory activity. Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more

Health Alert (Australia) August 1, 2016

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: - Victoria 27 July 2016 - Hamm v South Gippsland SC [2016] VCAT 1253 - South Gippsland Shire Council issued a...more

FDA’s new Next Generation Sequencing Draft Guidance leaves fundamental questions unanswered: key points

by DLA Piper on

The Food and Drug Administration has released a 25-page Draft Guidance document addressing FDA oversight of certain applications of Next Generation Sequencing (NGS)-based technology. The Draft Guidance - "Use of Standards in...more

CMS Issues Final Rule on Overhaul of Clinical Diagnostic Laboratory Test Payment System

by Ropes & Gray LLP on

On June 17, 2016, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule (the “Final Rule”) that makes significant changes to Medicare reimbursement for clinical diagnostic laboratory tests (“CDLTs”)....more

Media gulled by prostate cancer study hyped by Windy City windbags

A well-known research university and some excitable journalists have sown confusion about prostate cancer and the value of the PSA screening test. The mess can be traced to a study by physicians from Northwestern University...more

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