Results from a randomized clinical trial known as GIFT suggest that genotype-guided warfarin dosing is linked to fewer adverse events than clinical dosing.
Nanosphere said that it believes the deficiencies cited in the letter from the FDA are resolvable, and it believes that the test will ultimately gain clearance from the agency.
Findings in a NEJM study this week challenged previously reported data that alleles in the CYP2C19 gene can limit how certain carriers of the polymorphisms respond to Plavix.
Lawmakers have asked four direct-to-consumer genetic testing companies to explain their privacy policies and security measures, according to Stat News.
