News & Analysis as of

Diagnostic Tests

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18, 2016, the Food and Drug Administration (FDA) notified industry groups that it no longer plans to finalize its draft guidance on laboratory developed tests (LDTs).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

Wearable Medical Devices Market Trending Upwards

by Knobbe Martens on

New reports, such as the Global Diagnostic Wearable Medical Devices Market 2016-2020 Report, bring good news to the rapidly growing wearable medical device market. According to the Report, the diagnostic wearable medical...more

Next-Generation Sequencing: FDA Issues New Guidance for Genetic Tests

by Epstein Becker & Green on

On July 6, 2016, the U.S. Food and Drug Administration (“FDA” or “Agency”) released the following two draft guidance documents on the oversight of next-generation sequencing (“NGS”) tests...more

FDA Comes Through on Promise to Release NGS Device Draft Guidelines Expeditiously

by Mintz Levin on

Building on last year’s public workshops related to Next-Generation Sequencing (NGS) and expanding its efforts to advance the Obama Administration’s Precision Medicine Initiative, the FDA late last week released two draft...more

CMS Releases Final Rule Implementing Reforms to Medicare CLFS Payment Rates Under PAMA

by Epstein Becker & Green on

On June 23, 2016, the Centers for Medicare & Medicaid Services (“CMS”) released a final rule implementing Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”), which established a new payment methodology for...more

Summary: PAMA Final Rule

by Foley Hoag LLP on

Market Based Payment for Clinical Diagnostic Laboratory Tests - Summary - On June 17, 2016 the Centers of Medicare & Medicaid Services (CMS) issued the long awaited Medicare Clinical Diagnostic Laboratory Tests...more

Supreme Court Denies Sequenom’s Cert Petition, Leaving the Federal Circuit’s Interpretation of the Mayo/Alice Patent Eligibility...

The Supreme Court today denied Sequenom Inc.’s petition for writ of certiorari, in which Sequenom asked the Court to review a decision of the Federal Circuit invalidating its patent on a breakthrough prenatal diagnostic...more

CMS Finalizes Changes to Medicare Clinical Lab Test Payment Policy, Pushes Back Effective Date to 2018

by Reed Smith on

On June 23, 2016, the Centers for Medicare & Medicaid Services (CMS) is publishing a major final rule to base Medicare clinical laboratory fee schedule (CLFS) reimbursement on private insurance payment amounts, as required by...more

First-Ever FDA Approval of Liquid Biopsy for Detecting Lung Cancer

by Knobbe Martens on

The New York Times reports that Roche, a Swiss biotech company, recently received the first-ever FDA approval for a “liquid biopsy” test for diagnosing non-small cell lung cancer (NSCLC).  The Times reports that while the...more

EU Reaches Deal on New Medical Device Regulations

by Knobbe Martens on

The European Parliament and European Council recently jointly announced an agreement regarding new rules on medical devices and in vitro diagnostic medical devices. The process that lead to the agreement began in 2012. ...more

Despite Barriers, Community Speciality Clinics are Eager to Adopt Precision Medicine Tools

by Foley & Lardner LLP on

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

CMS Announces July 18 Public Meeting on 2017 Medicare Clinical Lab Fee Schedule

by Reed Smith on

CMS has scheduled a July 18, 2016 public meeting on payment for new and substantially revised clinical diagnostic laboratory test codes for payment under the 2017 Medicare clinical laboratory fee schedule (CLFS). The meeting...more

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