Leprosy Diagnostic Landscape

Biomeme Franklin Field qPCR (Lyophilised RLEP)

A battery-powered, three-channel thermal cycler running lyophilised, ambient-stable RLEP reagents with a non-instrumented extraction step. It is under use-case evaluation for confirmatory testing outside reference laboratories.

Technology
Molecular (NAAT) · Portable real-time PCR
What it measures
RLEP (M. leprae DNA)
Developer
Biomeme Inc. (Philadelphia, PA, USA)
Specimen
Slit-skin smear
Development status
Commercial RUO with analytical validation
Regulatory status
None / RUO
Intended use
Confirmatory molecular testing outside reference laboratories
Main limitation
No independent peer-reviewed clinical validation.
Availability
The Franklin instrument is sold by Biomeme. Leprosy reagents are not among the products on its website (checked 18 September 2026).
Linked publications
Manufacturers and partners
Hope Rises International, formerly American Leprosy Missions
TPP-1, confirming leprosy
59.0 of 100, partial alignment
TPP-2, infection in contacts
51.0 of 100, partial alignment
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