The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.
The tests from Asuragen and MolecularMD are designed for use in chronic myeloid leukemia patients, including those receiving tyrosine kinase inhibitor therapy.
The genetic testing community is having a tough time deciphering FDA's intentions based on its authorization of 23andMe’s PGx test and a recent safety alert.
The agency informed the public that most PGx tests haven’t been reviewed by the agency, and they should refer to information in FDA approved product labels when using such tests.
The market authorization came with a number of caveats and special requirements that 23andMe must follow when selling its PGx tests to consumers.
Abbott said that the next-generation molecular POC assays have also been CLIA waived for use on the Abbott ID NOW instrument, formerly called Alere i.
The United Nations is to consider a ban on field testing gene drives at a meeting being held next week, Technology Review reports.
The Associated Press reports that gene-edited food may soon be for sale.
The US Department of Health and Human Services is beginning a series of meetings on human fetal tissue research, Stat News reports.
In Cell this week: epigenetic change linked to glioblastomas, rare and low-frequency variants contributing to multiple sclerosis risk, and more.