Magellan Diagnostics, Inc.
Lead poisoning threatens millions of people, yet is entirely preventable. Our mission is to help identify and protect those at risk.
Magellan Diagnostics is a medical device company that provides point-of-care systems, clinical laboratory instruments, and analytical laboratory services focused on lead testing. Headquartered outside Boston in Billerica, Massachusetts, Magellan is dedicated to offering high-quality, reliable products that help identify children and adults at risk of harm due to lead exposure.
We are committed to educating clinicians, policy makers, payers, families and communities about the permanent health damage caused by lead, and how to detect and address lead risk and exposure.
Magellan Diagnostics has been a pioneer in the analysis of blood lead since the late 1960s, when the company (then called ESA, Inc.) was founded by four PhD graduates from the Massachusetts Institute of Technology (MIT). Applying a novel technique called Anodic Stripping Voltammetry (ASV), they designed and built a bench top analyzer for the measurement of lead in blood. The company then adapted this technology to create smaller, portable instruments that can be used outside of the traditional reference laboratory. This major achievement broadened the accessibility of lead testing by bringing it to the point of care.
In March 2016, Magellan Diagnostics was acquired by Meridian Bioscience, Inc., an established diagnostics and life science industry leader. Magellan continues operations in Billerica, MA, as an independent business unit of Meridian.
Annual Certification of Compliance with the Corporate Comprehensive Compliance Program for California:
As part of our continuing efforts in the area of compliance, Magellan Diagnostics, Inc. (“Magellan”) has established and is operating under a Comprehensive Compliance Program (“CCP”), tailored to its business as an in vitro medical device manufacturer. Where applicable, our CCP is in accordance with The AdvaMed Code of Ethics on Interactions with Healthcare Professionals (“AdvaMed”).
While the California law makes reference to compliance with the PhRMA Code on Interactions with Healthcare Professionals, Magellan manufactures in vitro diagnostic devices, rather than pharmaceutical products, and has therefore adopted the AdvaMed Code. While AdvaMed is substantially similar to the PhRMA Code, it recognizes significant differences applicable to the medical device industry. We believe that adherence to the AdvaMed Code also constitutes compliance with the PhRMA Code for purposes of satisfying the requirement of the California law.
To the best of our knowledge and belief, and based on our good faith understanding of the statutory requirements, we have established a CCP that in all material respects is compliant with the requirements of California Health and Safety Code §§119400-119402, to the extent they apply to Magellan.