News & Analysis as of

Genetic Testing

Nationwide Class Claims Under A Single State’s Consumer Protection Laws?

by Carlton Fields on

A flurry of recent consumer protection cases in California federal courts led to mixed results for defendants attempting to dismiss nationwide class claims based on the state’s choice of law rules. The U.S. District Court for...more

Canada expands protection of individual rights with new legislation on genetic testing and privacy

by DLA Piper on

Significant legislative changes are on the horizon in the field of genetic testing with Parliament’s recent passage of Bill S-201: An Act to Prohibit and Prevent Genetic Discrimination (“Act”). The Act will implement broad...more

FDA Relents, Grants Premarket Authorization to 23andMe Genetic Diagnostics Test

On April 6th, the U.S. Food and Drug Administration (FDA) continued to loosen the reins on the genetic diagnostic and DNA analysis company 23andMe with regarding to direct-to-consumer (DTC) genetic testing related to...more

FDA Cleared First DTC Genetic Tests for Health Risks

by Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more

FDA authorizes first direct-to-consumer genetic test panel for predisposition to Alzheimer's disease and other serious disorders

by DLA Piper on

The FDA has announced its decision to grant a de novo application submitted by 23andMe for the company's direct-to-consumer (DTC) Personal Genome Service Genetic Health Risk ("GHR") tests. The GHR test panel currently...more

HHS and Medicare Asked to Expand Coverage for Genetic Tests

by Foley & Lardner LLP on

Fifteen members of Congress have asked the Department of Health and Human Services (HHS) and the Medicare Payment Advisory Commission (Medicare) to examine how the federal government can help improve patient access to genetic...more

House Bill Would Allow Employers to Require and Access Genetic Testing Results

House bill HR 1313, introduced by Representative Virginia Foxx (R.N.C.), proposes to allow companies to require employees to undergo genetic testing, then allow employers to see the results, and impose financial penalties on...more

Cures Act Developments: FDA Proposes Class II Device Exemptions

Since the 21st Century Cures Act became law on December 13, 2016, we have been blogging on regulatory and clinical areas affected by its provisions. On March 14, 2017, FDA made further progress on its Cures Act obligations by...more

New House Bill Would Open Door for Genetic Testing in Wellness Programs

by Bass, Berry & Sims PLC on

Under a new proposed H.R. bill, employers may be able to strongly encourage employees to participate in genetic testing. H.R. 1313, entitled the Preserving Employee Wellness Programs Act, was recently approved by a House of...more

Quantity - Not Quality - Matters in Assessing Liability for Patent Infringement under Section 271(f)(1)

by Bryan Cave on

In Life Technologies Corp. v. Promega Corp., the Supreme Court ruled that, as a matter of law, “the supply of a single component of a multicomponent invention” from the United States does not trigger liability under Section...more

Supreme Court Limits Potential Liability for Overseas Patent Infringement

by Lathrop Gage on

Sale from the U.S. to overseas destination of a single component cannot violate § 271(f) - On February 22, the Supreme Court announced its latest unanimous decision in a patent case....more

The Supreme Court Chooses Quantity over Quality – Supplying a Single Component of a Multicomponent Invention Does Not Constitute...

On February 22, 2017, the U.S. Supreme Court addressed the issue of whether the supply of a single component of a multicomponent invention qualifies as an infringing act under 35 USC §271(f)(1) of the U.S. Patent Act. In its...more

Supreme Court Limits § 271(f)(1) Overseas Infringement Reach: More than One Exported Component Required for Offshore Manufacturing...

The US Supreme Court held in Life Techs. Corp. v. Promega Corp., Slip No. 14-1538 (Feb. 22, 2017) that supplying a single component of a multi-component invention manufactured abroad does not give rise to patent infringement...more

U.S. Supreme Court Limits Patent Law's Reach over Extraterritorial Infringement Liability

Today, in Life Technologies Corp. v. Promega Corp.,1 the U.S. Supreme Court unanimously held that supply of a single component of a multicomponent invention for manufacture abroad does not give rise to liability under 35...more

Genetics a Likely Factor in Variability of Outcome Following Concussion

by Downs Rachlin Martin PLLC on

Most experts in traumatic brain injury (TBI) agree that there is a high degree of variability in outcomes after TBI, including concussions (usually characterized as “mild” TBIs – mTBI.) In other words, this injury is...more

Genomics and FDA Regulation: A Work in Progress

by Robins Kaplan LLP on

It took over a decade to sequence the human genome the first time, at a cost between half a billion and a billion dollars. Now, however? An entire human genome can be sequenced for one or two thousand dollars, in a matter of...more

Privacy Tip #38 – Genetic Privacy and the Use of Genomic Information

Genetic information is basically one’s DNA sequence, which includes health information and genetic information about the individual and their family. It is at the core of one’s individual privacy, as well as providing...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

The Government Whittles Away at Life Sciences Patents

The current U.S. Supreme Court has been noted for its hostility to patent holders in general, but the Supreme Court has been especially hostile to any sort of life sciences or software invention. The Court has attempted to...more

Supreme Court Corner: Q1 2016

by DLA Piper on

CASES TO WATCH IN 2016 Life Technologies Corp. v. Promega Corp PATENT – Cert. PENDING Issue: Whether the Federal Circuit erred in holding that a single entity can “actively induce” itself to infringe a patent...more

Sequenom Petitions for Certiorari

Sequenom filed its anticipated petition for certiorari today for Supreme Court review of the Federal Circuit's decision in Ariosa v. Sequenom. The petition advises the Court that it "should take this opportunity to provide...more

FDA Public Workshop on Patient, Medical Professional Perspectives on Receiving Genetic Test Results (March 2)

by Reed Smith on

On March 2, 2016, the FDA is hosting a public workshop on “Patient and Medical Professional Perspectives on the Return of Genetic Test Results.” FDA is convening the workshop to discuss the specific information...more

Genetic Testing, Genome Sequencing, and the FDA

In recent years, the Food and Drug Administration has been struggling with how to adapt the regulatory paradigm for in vitro diagnostic devices (IVDs) – any test that detects a disease, condition, or infection – to the...more

Three Pressing Challenges for Personalized Medicine

by Foley & Lardner LLP on

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

Millennium Health to Pay $256 million in False Claims Act Settlement

by Polsinelli on

Millennium Health, one of the nation’s largest urine drug testing laboratories, has agreed to pay the government $256 million to resolve claims that it violated the Federal False Claims Act (“FCA”). The Settlement...more

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