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DNA DTC: The Return of Direct to Consumer Whole Genome Sequencing
This morning, Gene By Gene, Ltd. – better known as the parent company of the popular genetic genealogy provider Family Tree DNA – formally announced a corporate reorganization that includes the debut...
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Supreme Court to Rule on Patentability of Human Genes
Robert Cook-Deegan contributed to this commentary. Dr. Cook-Deegan is a research professor in the Institute for Genome Sciences and Policy and the Sanford School of Public Policy at Duke University....
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Implications of Amgen/deCODE Deal for Genetic Testing Consumers
The big biotech news of the day is the $415 million sale of deCODE Genetics to Amgen. Coverage of the deal is everywhere, including a typically excellent overview from Matthew Herper of Forbes. We’ve...
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As deCODE Departs, 23andMe Reloads
A day after Amgen purchased deCODE Genetics for a whopping $415M, in part for access to its unique data (as described in yesterday’s post), 23andMe announced today it had raised $50M in new financing...
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All Eyes on Maryland v. King: Recapping the Supreme Court Oral Argument
Seating was in short supply to hear oral arguments before the Supreme Court in what J. Alito referred to as “the most important criminal procedural case that this court has heard in decades,” Maryland...
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The FDA, Social Media & Consumer Genomics: A Lot Not to “Like”
Last week, the FDA published on its website a warning letter to AMARC Enterprises, Inc., a marketer of a dietary supplement known as Poly-MVA. (Here is the company’s description of the supplement.)...
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House Holds mHealth Hearings, FDA Promises Final Guidance Forthcoming
Three days of hearings by a House of Representatives committee concluded yesterday with a pledge from an FDA official to finalize long-awaited guidance on the regulation of mobile medical applications...
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Some Thoughts on Myriad After the Supreme Court Argument
On April 15, the Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics. This was another significant step—probably the penultimate one—in the long-running Myriad...
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DNA Fingerprinting as Routine Arrest Booking Procedure Upheld as Anticipated
Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare...
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Myriad, Finally: Supreme Court Surprises by not Surprising
After what seemed like an eternity, the epic saga known as AMP v. Myriad Genetics has finally come to a close. On June 13, 2013, the Supreme Court ruled (1) that isolated genomic DNA (gDNA) is not...
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Undeterred by the Supreme Court, Myriad Starts Suing
As soon as the Supreme Court issued its decision in AMP v. Myriad Genetics, Myriad issued public statements saying that it had many surviving patents that would perpetuate its BRCA testing monopoly. We...
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Approved North Carolina State Budget Includes Funds to Compensate...
Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare...
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Readers Respond to ACMG Recommendations Post
The GLR received some interesting comments on my recent post about the American College of Medical Genetics Gene Screening Recommendations. Here are two of the comments. As we are still in the early...
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Ninth Circuit Orders Rehearing of Haskell v. Harris
When the Supreme Court issued the Maryland v. King opinion on June 3, 2013 upholding Maryland’s DNA Collection Act, numerous cases were pending in which similar DNA fingerprinting upon arrest statutes...
View ArticleGenomic Research Ethics: Special Rules for HeLa Cells
In her 2010 book The Immortal Life of Henrietta Lacks, Rebecca Skloot told the story of Henrietta Lacks and the cell lines derived from her cervical tumor biospecimen (cell lines known to scientists...
View ArticleMaryland v. King: Three concerns about policing and genetic information*
With its decision in Maryland v. King [pdf], the Supreme Court finally stepped into the debate about the use of DNA databases in the criminal justice system. The United States now has the largest DNA...
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Revisions to the Ethical Standards for Research
The World Medical Association published revisions to the Declaration of Helsinki (DoH) in JAMA on October 19, 2013. As noted previously on the Genomics Law Report, the DoH was adopted in 1964 and is...
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Designing Children
With this post the GLR introduces a new Contributing Writer, Jonathan Webber. Jonathan is a web editor at Robinson, Bradshaw & Hinson, the law firm that sponsors the GLR. His duties include...
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The Sky is Falling for Personal Genomics! Oh, nevermind. It’s just a cease &...
Genomics Law Report has paid close attention to the FDA’s potential regulation of laboratory developed tests (or LDTs) over the years. We have decided to address the most recent development – a cease...
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If 23andMe Falls in the Forest, and There’s No One There . . .
Genomics Law Report has paid close attention to the FDA’s potential regulation of laboratory developed tests (or LDTs) over the years. We have decided to address the most recent development – a cease...
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