Public Statement From Magellan/ LeadCare2

I know the people at Magellan Diagnostics personally. They are a revolutionary company that has pioneered amazing technology for performing fast and efficient screening tests for lead (for humans and endangered wildlife!) in real-time (results in three minutes) in the field. Their technology is nothing short of miraculous.

I wholly support their work and their products. I have personally worked in the field with teams using the LeadCare2 in Flint, in New Hampshire, and in New Orleans, making free blood lead testing available to hundreds (both adults and children.)

In my opinion the news reports (and initial FDA press release and subsequent re-quoting of the information in that press release) and especially the headlines in today’s news have been misleading and unecessarily dramatic.

I will write more on this subject a.s.a.p., however in the meantime I wanted to share with you the public statement from Magellan’s CEO (and my friend), Amy Winslow.

Thank you for reading.

Tamara Rubin

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Magellan’s Public Statement in Response to Today’s Headlines:

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Magellan will continue to work closely with the FDA to address the concerns identified with venous samples as quickly as possible.

The vast majority of tests performed on LeadCare Systems use capillary samples and are performed at the point of care, in physician offices and clinics. The LeadCare II System was designed to help ensure broad-based blood lead screening is available by providing a quick, easy and accurate way to identify children, pregnant women and adults at risk for lead exposure.  We remain committed to the importance of providing results at the point of care, as this creates the best opportunity to facilitate patient education and intervention.

In addition to the point-of-care system, LeadCare II, Magellan Diagnostics has three moderately complex systems in use – LeadCare Ultra and LeadCare Plus, which were FDA cleared in 2013 and 2015, respectively, as well as the original LeadCare, launched in 1997 and which the company has been phasing out.  In contrast to the LeadCare II, these systems are used in laboratory settings, and therefore are used with both venous and capillary samples.

Amy Winslow
President & CEO
Magellan Diagnostics