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Human Genes Genetic Testing Life Sciences

Robinson+Cole Data Privacy + Security Insider

Privacy Tip #385 – 23andMe Sends Letter to Data Breach Victims that Suing Over Breach is Futile

We previously alerted readers to the fact that the most recent data compromise of 23andMe exposed data related to Ashkenazi Jews and individuals of Chinese descent. It is reported by Ars Technica, citing TechCrunch, that...more

Epstein Becker & Green

Beyond HIPAA: FTC’s Data Protection Authority Results in Settlement with Genetic Testing Company

Epstein Becker & Green on

A recent enforcement action by the Federal Trade Commission (“FTC”) against 1Health.io—which sells “DNA Health Test Kits” to consumers for health and ancestry insights—serves as a reminder that the FTC is increasingly...more

Hogan Lovells

Gene therapy development in Europe brings layers of liability risks

Hogan Lovells on

The investments in Advanced Medicinal Products (ATMPs) that use gene therapy, somatic cell therapy, and engineered tissues for preventing, treating, or curing human diseases probably represent the biggest innovation in the...more

Robinson+Cole Data Privacy + Security Insider

Privacy Tip #314 – Got a Genetic Testing Kit for Christmas? Read this Before you Send In That Swab

I have written about genetic testing kits before, but this subject matter is worth repeating. I find that people don’t always understand the consequences when sending a swab to a genetic testing company.  Consumer Reports...more

Wyrick Robbins Yates & Ponton LLP

California’s New Genetic Testing Law Applies to 23andMe – AND Me (or my Company)?

Last month, California Governor Gavin Newsom signed Senate Bill 41, the Genetic Information Privacy Act (“GIPA”), a law that regulates “direct-to-consumer genetic testing companies” that handle the “genetic data” of...more

Manatt, Phelps & Phillips, LLP

Delivering Breakthrough Treatments Affordably

Editor’s Note: In a recent webinar, Manatt Health’s Anthony Fiori, Senior Managing Director, and Alex Dworkowitz, Partner, hosted a panel of innovative thought leaders—including Dr. Sanjiv Shah, Chief Medical Officer of...more

Quarles & Brady LLP

California Governor Signs the Genetic Information Privacy Act

Quarles & Brady LLP on

On October 6, 2021, California Governor Gavin Newsom signed into law the Genetic Information Privacy Act (GIPA). This follows Governor Newsom’s veto of an earlier version of the bill almost exactly one year ago. ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Epigenetic Changes Implicated in Age-related Diminution in Vision and Its Possible Reversal

The Fountain of Youth -- an enduring aspiration, particularly as the ravages of age reduce human faculties prior to leading inexorably to death.  Reduction in sight is the human faculty that can have the greatest effect on...more

McDonnell Boehnen Hulbert & Berghoff LLP

Neanderthal-specific Variants in Sodium Ion Channel Gene Associated with Sensitivity to Pain in Modern Humans

Over the past decade, genetic archeology has revealed two branches of the human family tree, one known since the 19th Century (the Neanderthals) and the other more recently discovered (the Denisovans, an Asian relative of the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Inherited Neanderthal Gene Encodes Genetic Risk for COVID-19

Svante Pääbo created the science of detecting Neanderthal DNA in archeological samples (and living humans) almost single-handedly (see Neanderthal Man: In Search of Lost Genomes).  So it will come as little surprise to many...more

McDonnell Boehnen Hulbert & Berghoff LLP

Sequence Variants in Human Olfaction Genes Associated with Perceptual Differences

Perception by the five human senses (sight, hearing, taste, smell, and touch) varies significantly between individuals and populations.  Some use these differences to their advantage, such as sommeliers capable of detecting...more

Knobbe Martens

California Genetic Information Privacy Act Vetoed

Knobbe Martens on

On September 25, 2020, Governor Gavin Newsom vetoed the California Genetic Information Privacy Act (“GIPA”), about which we reported. Governor Newsom expressed his support for protecting the privacy of individuals’ genetic...more

Hogan Lovells

California Governor vetoes bill to establish the Genetic Information Privacy Act

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California’s “Genetic Information Privacy Act” (SB 980), vetoed on September 25, 2020 by Governor Gavin Newsom, would have established obligations for direct-to-consumer (“DTC”) genetic testing companies and others that...more

McDonnell Boehnen Hulbert & Berghoff LLP

Genetic Research Continues to Reveal Ancestry Relationships in Early Human Migrations

The human tendency to identify with tribes of "like" humans (related by family, place of origin, or religion, among other bases) was perverted during the Twentieth Century (and in some places remains so today) into the idea...more

Robinson+Cole Data Privacy + Security Insider

Consumer-Facing DNA Testing Company Suffers Data Breach

Last week, Veritas Genetics, a consumer-facing DNA testing company, suffered a security breach affecting customer information in its database. Veritas offers whole-genome sequencing to consumers for $599. The security...more

Sheppard Mullin Richter & Hampton LLP

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 genetic tests for predicting medication...more

Bass, Berry & Sims PLC

FDA Warns Against Direct-to-Consumer Lab Developed Tests

Bass, Berry & Sims PLC on

Despite it being a continual topic of discussion, the Food and Drug Administration (FDA) enforcement in the realm of laboratory developed tests (LDTs) has been relatively quiet in recent years. That is, until earlier this...more

Carlton Fields

How State and Federal Laws Are Addressing the Use of Direct-to-Consumer Genetic Testing by Insurance

Carlton Fields on

While life insurers traditionally have set premiums based on a multitude of complex actuarial tables, the recent boom in direct-to-consumer DNA testing produces, such as 23andMe and AncestryDNA, is expanding the universe of...more

McDonnell Boehnen Hulbert & Berghoff LLP

Using Genetics to Uncover Human History

Human history is often something modern man only sees as through a glass, darkly. This is particularly the case when that history did not occur in the Mediterranean, the Nile Valley, India, or China, or when there is no...more

McDonnell Boehnen Hulbert & Berghoff LLP

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

Hogan Lovells

FDA Cleared First DTC Genetic Tests for Health Risks

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

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