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.
President Donald Trump might not approve the stricter standards the US Food and Drug Administration is developing for authorizing a SARS-CoV-2 vaccine, according to Politico.
