While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.
The group notes the importance of lab CLIA certification, clear test reports, and clinical validity support for test claims in the literature, guidelines, and FDA labels.
The test is the cornerstone of a study involving roughly a thousand patients from two British neonatal centers that is set to commence this fall.
Industry players, faced with vague communications from the agency, scramble to decipher regulatory expectations and criticize the agency for trying to control PGx knowledge.
The firm reported total revenues of $215.4 million, up from $193.9 million in fiscal Q4 2018, but below the consensus Wall Street estimate of $221.0 million.
While the FDA has expressed concerns about PGx testing, CEO Erik Hennings said the company has taken measures to limit the risk of consumer harm.
The firm said that UHC will cover the test for patients with major depressive disorder or anxiety who have failed to respond to one or more treatments.
Five hundred pharmacies will provide information about pharmacogenetic testing to members who have failed one or more antidepressant treatments.
CPIC wants to issue guidelines for non-actionable genes, standardize PGx terms, and work with groups like ClinGen and ClinVar to expand use of its guidelines.
With 10,000 of Mayo's patients now sequenced for 77 genes, a subset of this information is being used to inform care while the bulk of the data is spurring research projects.