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TB-MBLA
TB-MBLA
Discovery
Planning & Feasibility
Development
Validation & Verification
Market Launch
Disease Area
Infection
Modality
qPCR/ddPCR
Advantages
Faster than current methods; more sensitive and specific than current standard of care
Background info
Culture-free method to accurately estimate viable (active) bacteria targeting a high copy number biomarker
Indication
Tuberculosis – pulmonary TB detection and treatment monitoring assay
Intellectual property
No patents relating to the assay; however, know-how and technical design files to ISO13485
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