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.
According to the DOJ, the company also accepted a 25-year ban on participating in any federal healthcare program.
The companies have expanded an existing partnership to allow physicians to order mental health PGx tests from the EHR and receive CME credit for learning about PGx.
The organizations noted in a letter to HHS and FDA that they "believe the agency's actions may in fact inflict greater harm on patients and impede innovation."
The industry organization issued a letter urging the agency to reconsider recent decisions to demand several laboratories stop offering pharmacogenetic testing.
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.
Coriell will offer its Enterprise PGx platform to clinicians, backed by Thermo Fisher content, for analysis by KPMG clinical intelligence technology.
The company will provide counseling in multiple languages and connect people to local healthcare resources so they can use the genetic information they've learned in their own care.
Industry players, faced with vague communications from the agency, scramble to decipher regulatory expectations and criticize the agency for trying to control PGx knowledge.
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.
By studying koalas and a retrovirus that infects them, researchers may have uncovered a new sort of 'immune response' that occurs at the genomic level, Agence France Presse reports.
23andMe has a holiday popup shop at a mall and could open additional stores, Bloomberg reports.
NPR reports that the first person in the US given a gene editing-based therapy for a genetic disorder is heading home.
In Science this week: ancient genomes reveal social inequality within individual households, new method for quantifying genetic variation in gene dosage, and more.