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Regulatory submission and expected year-end India launch create near-term catalysts with potential revenue upside; aligns with multi-market regulatory momentum (FDA and CDSCO). Historically, CDSCO approvals or timelines can trigger upside before launch milestones, though execution risk remains.
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Co-Diagnostics reports CoSara's TB test study in India showing high sensitivity (97.3%) and specificity (96%), supporting CDSCO submission. With India accounting for roughly 25% of global TB cases, regulatory clearance could unlock commercial sales before year-end 2026, aided by the firm’s integrated mobile and cloud infrastructure already deployed in-country.
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