Robinson Bradshaw

Topic: diagnostic tests

Update: Continued Speculation on Myriad’s Motives Down Under

Last week, we wondered what Myriad Genetics had in mind by offering to surrender one of its Australian breast cancer patents as a “gift…to the people of Australia.” This week, in an interview with Turna Ray of the Pharmacogenomics Reporter, Luigi Palombi, director of the Genetic Sequence Right Project at The Australian National University, attempted […]

Surrendering a Gene Patent: An International Twist in Myriad Debate

Several months ago we reported that a group of Australian plaintiffs had initiated litigation challenging the validity of Myriad’s Australian BRCA patents. Much like its U.S. counterpart, the Australian lawsuit represents a frontal attack on the patentability of genes. Here in the U.S., the gene patent litigation shows no signs of reaching a swift resolution. Over […]

The Past, Present and Future of DTC Genetic Testing Regulation

[Editor’s Note: Newsweek science editor Mary Carmichael has a DNA Dilemma. As Carmichael debates whether to take a direct-to-consumer (DTC) genetic test, she is soliciting feedback from the DTC community, from the public and from other commentators, including myself. At the end of the week, she will make her decision. On Tuesday, Carmichael and five […]

Myriad Gene Patent Litigation Goes Down Under

On Tuesday, June 9, 2010, several plaintiffs, including a breast cancer patient and a cancer advocacy group, sued in a Sydney, Australia federal court to invalidate Myriad Genetics’ patents on the breast cancer susceptibility genes BRCA-1 and 2. According to published reports and comments by Australian patent law experts, the suit substantially tracks the much-publicized […]

Breaking: FDA Moves to Broadly Regulate LDTs

Earlier today, the U.S. Food and Drug Administration (FDA) announced that it will hold a public meeting July 19-20 to “discuss how the agency will oversee laboratory-developed tests (LDTs).” The FDA has made several high-profile announcements over the past month – particularly in the area of direct-to-consumer (DTC) genetic testing – but today’s development, despite its not […]

Five Questions for Personal Genomics in 2010

Death, taxes and January prediction columns: these things are inevitable. So what? A new year offers a convenient—if arbitrary—time to review the year that was and contemplate what lies ahead. Without further ado, here are five of the questions the Genomics Law Report is asking as we kick off 2010. 1. Will the $1,000 genome […]