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Diagnostics Policy & Legislation

News on government policy and legislation impacting life science and diagnostics.

The US DOJ had alleged Boston Heart Diagnostics conspired to pay doctors kickbacks that were disguised as investment returns.

Athena and its supporters have asked the Supreme Court to clarify patent eligibility, but Mayo recently countered that this is a job for legislators.

The study, sponsored by the US Centers for Disease Control and Prevention, focused on men who have sex with men and members of their social networks.

Since the FDA issued its safety communication in 2017, some lab test developers have mitigated the biotin interference of their assays, but others have not.

The nonpartisan federal agency's report suggests ways for Congress, the FDA, FTC, and CMS to expand oversight of the genetic testing market.