Development of Diagnostics for Mycoplasma genitalium Infection

Fast-Track proposals will be accepted. Direct-to-Phase II proposals will not be accepted. Number of anticipated awards: 1-2 Budget (total costs): Phase I: Up to $300,000 for up to 1 year Phase II: Up to $1,500,000 for up to 3 years Background Mycoplasma genitalium (Mg) is a significant cause of urethritis in men and cervicitis in women. Prevalence of Mg infection in the US is about 1.7%, however prevalence rises to 5-17% for special populations such as those seeking care at STI or other public health clinics. Repeated or prolonged infection is associated with significant issues in women's health such as pelvic inflammatory disease, ectopic pregnancy, and infertility. Significant antimicrobial resistance, particularly to macrolides where resistance is over 50%, has led to the global use of resistance-guided therapy to treat the infection. Detection of Mg by PCR for diagnosis is commercially available, however resistance-guided therapy requires the determination of macrolide and quinolone resistance by PCR which are laboratory developed tests that are not commercially available and can take days to weeks to perform. Thus there is a potential commercial need for an Mg diagnostic that combines nucleic acid-based detection and antimicrobial susceptibilities.