The U.S. FDA released another series of regulations for de novo devices, but the attendant regulation is not always available for these de novo devices.
The 23andme Holding Co.’s saga came full circle with founder Anne Wojcicki regaining control of the bankrupt genetic testing company in a bidding battle against Regeneron Pharmaceuticals Inc.
The bankruptcy of genetic testing service 23andme Holding Corp. prompted a reaction from many quarters, but a June 11 Senate hearing highlighted an interest in federal privacy legislation that would be directed toward genetic privacy as well as comprehensive and preemptive federal privacy legislation.
The bankruptcy of genetic testing service 23andme Holding Corp. prompted a reaction from many quarters, but a June 11 Senate hearing highlighted an interest in federal privacy legislation that would be directed toward genetic privacy as well as comprehensive and preemptive federal privacy legislation.
UL16 binding protein 6 (ULBP6) is a molecule belonging to the stress-induced NKG2D ligand family and its expression is up-regulated on the surface of cancerous cells, binding to the immune-activating NKG2D receptor on natural killer (NK) and T cells, thus promoting immune evasion.
After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome approach to validating these systems. However, drug and device manufacturers registered concerns about a lack of clarity in the draft, including 23andMe Holding Co., which said the draft’s references to methods that merely “help to fulfill” validation requirements leave too much gray area to be helpful.
The U.S. Federal Trade Commission (FTC) has been active for some time in enforcement of its regulations for direct-to-consumer (DTC) gene testing firms, but Linda Malek, a partner at the New York office of Moses & Singer LLP, told BioWorld MedTech that while FTC compliance is becoming a bigger lift for DTC gene testing firms, the controversy in 2018 over a gene testing firm's sharing of data with a drug maker suggests that DTC gene testing companies might want to "hold yourself to an even higher standard in order to maintain trust in your product."
Sleep is universal on both the species and the individual level. Though there have been reports of individuals, both in humans and other species, who need almost no sleep, a truly sleepless individual has never been identified.
Sleep is universal on both the species and the individual level. Though there have been reports of individuals, both in humans and other species, who need almost no sleep, a truly sleepless individual has never been identified.
23andme, of Mountain View, Calif., may appeal to the U.S. Court of Appeals for the Federal Circuit to hear a patent dispute the company has with Ancestry.com of Lehi, Utah, without having to wait for the conclusion of a parallel dispute over trademarking. At risk is a gene profiling method for determining ancestry dubbed "identical-by-descent," but recent developments in case law suggest the patent has a tough road ahead of it.
