Robinson Bradshaw

Author: Jennifer K. Wagner

EEOC Tries to Harmonize ACA’s Promotion of Employer Wellness Programs with GINA’s Ban Against Employer Access to Genetic Information of Employees and Employees’ Family Members

The Equal Employment Opportunity Commission (EEOC) is responsible for enforcing Title II of the Genetic Information Nondiscrimination Act (GINA), which prohibits employers from requesting genetic information (defined broadly) from their prospective, current, or former employees. GINA contains only six limited exceptions to this prohibition, one of which is an exception for wellness programs in which […]

Australia revokes Myriad’s three patent claims on isolated BRCA1 DNA

In a decision issued on October 7, 2015, the High Court of Australia (High Court) ruled unanimously in D’Arcy v. Myriad Genetics Inc., [2015] HCA 35, that three BRCA1 patent claims held by Myriad Genetics, Inc. under Australian Patent 686,004 were invalid. While Myriad’s patent had actually expired on August 11, 2015, the court decision […]

Groundhog Day: FDA and Proposed Oversight of LDTs

Once again, attention in Washington, DC has turned to the Food and Drug Administration (FDA) and its proposed oversight of all laboratory developed tests (LDTs). The occasion for this attention was the FDA’s separate releases on October 3, 2014 of its proposed LDT framework and proposed notification and medical device reporting guidance. The former describes […]

Long-Awaited Announcement from the FDA on LDTs

On July 31, 2014, the FDA gave Congress notice that in the next 60 days it would be announcing draft guidelines on the regulation of laboratory developed tests (LDTs). This topic has been discussed on the Genomics Law Report frequently for years. [You can access the previous coverage here]. The “Anticipated Details of the Draft […]

FTC Takes Action to Protect Consumers from False Genetic Advertising Claims

For the past few years, discussions regarding the regulatory oversight of direct-to-consumer (DTC) genetic tests have focused heavily on one agency: the FDA. Attention has grown since 2010 when the FDA began hinting the agency would broadly regulate laboratory developed tests (LDTs) and has only intensified since the issuance of the infamous cease-and-desist letter issued […]

Property Rights and the Human Body

A Canadian court made headlines this month when it decided, as a preliminary matter, that human tissue removed from the body for diagnostic medical tests is “personal property” that belongs to the hospital where the procedure was performed. The case was a medical negligence action brought against two doctors by the estate of Snezana Piljak, […]

Judicial and Legislative Reactions in California to Maryland v. King, 133 S. Ct. 1958 (2013)

This year’s first news in the area of genetics and criminal law comes to us from California, where both the judicial and legislative branches are reacting to the U.S. Supreme Court decision in Maryland v. King. In Maryland v. King, the Supreme Court upheld DNA fingerprinting as a routine booking procedure for serious crimes as […]

What does the FDA Approval of the MiSeqDx Platform Mean for DTC?

On November 19, 2013—three days before the highly-publicized warning letter to 23andMe (See here and here)—the U.S. Food and Drug Administration announced that it had given approval for the marketing of four Illumina MiSeqDX medical devices. They include two cystic fibrosis genetic assays as well as the Illumina MiSeqDX instrument platform and Illumina Universal Kit […]

Update: 23andMe appeases FDA

In an effort to quiet the storm, 23andMe has announced that it does intend to continue seeking FDA approval and that, while that process is ongoing, it will no longer provide health-related information to new customers. Customers whose Personal Genome Service® kits were ordered prior to November 22, 2013 will still have access to that […]

Troubles keep coming for 23andMe

As if the FDA warning letter wasn’t enough, 23andMe, Inc. now has a lawsuit on its hands. The suit, known as Casey v. 23andMe, was initiated on November 27, 2013, in federal court for the Southern District of California (Case 3:13-cv-02847-H-JMA). The suit is being brought as a class action and on the general basis […]