3STEP: A swab-seal-read assay for tuberculosis and RIF resistance enabled by autonomous extraction technology

ABSTRACT In 2021 there were 10.6 million new cases of Mycobacterium tuberculosis (TB) and 1.6 million TB-related deaths, making TB the second leading infectious cause of death worldwide behind only COVID-19. Standard TB diagnostic methods are insufficient in that they either 1) utilize challenging sample types and are often invasive

(e.g., sputum, gastric aspiration, lymph node biopsy), 2) lack sufficient sensitivity and/or specificity (e.g., culture, reliance on clinical observation alone), or 3) cannot be widely implemented in community point-of-care (POC) settings. As a result, there remains a significant unmet need for affordable POC technologies that can be used

at local or temporary clinics, urgent care facilities, pharmacies, and school health clinics with easier to acquire samples (e.g., urine or oral swabs). In addition, TB is notoriously difficult to lyse adding another challenge to the creation of a POC solution. Salus Discovery has developed 3STEP, a new LAMP-based POC NAT for TB that directly overcomes the above

mentioned challenges. 3STEP provides lab-quality, PCR sensitivity (