[IP Hot Topics Podcast] Innovation Conversations: Walter Isaacson, Part 1
Clinton: SCOTUS Myriad Genetics Decision 'Terrific'
Can You Patent Human Genes? ACLU Says No
Yours, Mine and Ours (not yet!): An Update on the Patentability of Human Genes
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
The Food and Drug Administration’s approval of Guardant Health’s Guardant360 CDx assay marks a new era for genetic mutation testing in cancer treatment. On August 7, 2020, the FDA approved the first diagnostic test that...more
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
The two draft guidance documents are intended to streamline the review of next generation sequencing-based tests. On July 8, the US Food and Drug Administration (FDA or Agency) issued two draft guidance documents...more
In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement...more