Magellan Diagnostics

The story begins with a breakthrough innovation. What was then called ESA, Inc. was founded by four PhD graduates from the Massachusetts Institute of in Technology (MIT). They developed a novel way to measure lead in blood, eventually creating portable devices that could give results in just three minutes at the point of care. This was a game-changer for pediatricians, as their LeadCare II system made screening for lead poisoning faster and more accessible. For years, the company, later named Magellan Diagnostics, grew, with its LeadCare II system accounting for more than half of all blood lead tests in the U.S. from 2013 to 2017. The company’s trajectory changed in March 2016 when it was acquired by Meridian Bioscience for $66 million. At the time, Magellan's CEO was Amy Winslow. The acquisition was presented as a way to expand Magellan's mission to protect children from the effects of lead poisoning. However, a critical flaw was hidden from view. Magellan had known since 2013, before the acquisition, that its devices could produce inaccurately low lead test results when used with venous blood samples. This information was allegedly concealed during the sale to Meridian Bioscience. The malfunction meant that potentially tens of thousands of children received false, dangerously low readings. In 2024, Magellan agreed to plead guilty to criminal charges and pay $42 million in fines, forfeiture, and victim compensation. Former executives, including CEO Amy Winslow, also pleaded guilty to charges related to concealing the defect.