LeadCare II
Commercial- Indications
- Lead poisoning
Company intelligence / Profile preview
Magellan Diagnostics
Billerica, Massachusetts, USAmagellandx.com ↗
- Ownership
- Private
- Development stage
- Commercial
01
Overview
Magellan Diagnostics pioneered point-of-care and laboratory-based blood lead testing devices using ASV technology. Their products—LeadCare II, LeadCare Ultra, and LeadCare Plus—are widely used for detecting lead exposure in children and adults. The company faced regulatory scrutiny due to device malfunctions affecting venous sample results between 2013–2017 but has since remediated these issues. Their systems remain the leading CLIA-waived solutions for blood lead level testing in the U.S.[1][2][5][6]
A third-generation platform with additional pediatric tests was planned as of acquisition but not yet commercialized[5].
- Therapeutic areas
- Other
- Modalities
- Device
- Industry
- Metabolite Diagnostics
02
Drug pipeline
3 assets2 more assets in the full pipeline.
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Partnerships
Not specified; distribution through Meridian’s global network post-acquisition
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