Updating the HHS Secretary's Advisory Committee on Genetics, Health, and Society regarding New York’s regulatory stance on consumer genomics firms, a health department official said companies that obtain raw data from an analytical testing facility and send a report to an ordering practitioner are considered laboratories.
Navigenics decided to acquire Affy’s 10,000-square-foot Clinical Services Lab in Sacramento, Calif., after seeing an increase in the volume of orders for its genetic screening service. In addition to the advantages of having an internal CLIA lab, however, the consumer genomics firm will now have to navigate a complex regulatory environment.
Affy transferred ownership of the 10,000-square-foot Clinical Services Lab to Navigenics earlier this year though an increasing number of drug makers outsource their molecular diagnostic research needs to CLIA labs.
454 says some of its customers outside the US are close to using the GS FLX for clinical HLA typing. It is also working with the FDA to find ways to provide the tool to US testing labs, some of which doubt it is robust and cheap enough for such use.
The bill, the "Ethical Treatment of Human Embryos Act," would prevent cloning, animal-human hybrids, and new embryonic stem cell lines in Georgia, but would not restrict research with existing stem-cell lines or lines created outside the state.
The goal of the project is to build a dynamic model of liver function in rats and humans that will account for effects of genetic variations and other variables, such as patient gender, age, behavioral traits, and environmental factors.
CompuCyte, Children's Hospital Boston, US Senate, National Institutes of Health, Albert Einstein College of Medicine, Empire State Stem Cell Board, MDS, Caliper Life Sciences, CHDI, GlobalStem, ADMEcell, Advancell