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Home Biodetection

U.S. Army Seeks Leishmaniasis Rapid Diagnostic Device

by Stephanie Lizotte
January 1, 2012
Leishmaniasis

a patient who’d been ill with leishmaniasis, having been infected with Leishmania sp. protozoa, which had manifested itself as a cutaneous form of the disease. Credit: CDC - Dr. Martins Castro, San Paulo, Brazil; Dr. Lucille K. Georg

The U.S. Army Medical Material Development Activity (USAMMDA) is conducting market research to survey available or emerging technologies for a diagnostic device to rapidly diagnose cutaneous leishmaniasis. Ideally the device would be used in point-of-care settings.

Manufacturing of the device would need to comply with cGMP requirements as FDA clearance would be ultimately required.

Candidate devices should be at the Technology Readiness Level 5 (TRL 5). If the device development is at the proof of concept stage (TRL 3) and current manufacturing is not cGMP, companies should include a gap analysis and estimated time by which cGMP manufacturing could be achieved.

Additional requirements on sensitivity, specificity and shelf-life are outlined in the formal announcement here. The response deadline is 12 January, 2012.

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Tags: LeishmaniasisPOC DiagnosticsRFI

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