This year’s list of winners celebrates both large leaps and small (but important) steps in life science technology.

The blood-testing company must respond to the US Centers for Medicare and Medicaid Services’ allegations of substandard conditions at one of its labs.

The Association for Molecular Pathology finds fault in the agency’s report on safety issues associated with certain lab tests.

The US Food and Drug Administration cites cases in which laboratory-developed tests “may have caused or have caused actual harm to patients.”

So-called laboratory-developed tests will eventually face regulations similar to those that currently govern diagnostic tests or kits that are sold to hospitals.