Topic
Diagnostic Testing
41 published works
Health Care and Life Sciences
Update: Key FDA Actions for COVID-19 Devices and Therapies
FDA is taking action every day to increase the availability of Personal Protective Equipment (PPE) and COVID-19 diagnostic tests, to support the development of therapeutics, and to facilitate remote patient…
Wills, Trusts & Estates Prof Blog
Alzheimer’s Tests Soon May Be Common. Should You Get One?
Though doctors could determine that a person had Alzheimer's disease by particular symptoms, a formal diagnosis could not be performed until examining the brain during an autopsy. This may be…
Food Safety News
CDC says better testing can help identify and therefore reverse upward spiral of foodborne infections
By Coral Beach
Disease researchers say infections from foodborne pathogens increased in 2018 when compared with 2015-17, with the increasing use of culture-independent diagnostic tests. The overall safety of food eaten in the…
Healthcare Law Blog
FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests
In an April 4, 2019 Press Release, the U.S. Food and Drug Administration (FDA) announced its issuance of a Warning Letter to Inova Genomics Laboratory (Inova) in Virginia for marketing…
Take Stock: Federal Policy Watch
Washington Healthcare Update: December 10, 2018
This Week: Congress averts government shutdown by passing two-week extension for Continuing Resolution, pushing the funding issues to Dec. 21. House Bipartisan, Bicameral Legislators Unveil FDA-Inspired Bill Regulating Diagnostic Tests On…
Work Comp & Employment Law Insight
Compensability of Diagnostic Testing?
Let’s take a moment to consider this hypothetical scenario: John Smith is at work for the Widget Company working on the assembly line. Mr. Smith has been working for about…
Health Law Diagnosis
CMS Approves Laboratory Alerts to Physicians in Rare Stark Law Advisory Opinion
By Conor Duffy
The Centers for Medicare & Medicaid Services (CMS) issued a rare advisory opinion (CMS-AO-2017-1) under the Stark Law (Section 1877 of the Social Security Act, codified at 42 U.S.C. §…
Prosecution First Blog
Myriad, Mayo, Chakrabarty, Oh My: Strategies for Life Sciences Diagnostics – Part II
As former Chief Judge Giles Rich proclaimed, “The name of the game is the claim.” In Part II of “Myriad, Mayo, Chakrabarty, Oh My: Strategies for Life Sciences Diagnostics” (link…
Prosecution First Blog
Another Diagnostic Patent Falls Apart under Ariosa/Mayo
By Carla Mouta-Bellum Jessica L. Roberts
CAFC Decision: Genetic Technologies Ltd. v. Merial LLC, No. 2015-1202 (Fed. Cir. Apr. 8, 2016)Read more
IP Intelligence
Sequenom Asks the Supreme Court to Clarify the Limits on Section 101
By Ron Kern
On March 21, 2016, Sequenom filed a writ of certiorari with the U.S. Supreme Court, asking the Court to provide clarification regarding the limits of 35 U.S.C §101 as it…