Other than of course raising funds, what's your next operational steps - (a) what are you working on that doesn't require you to raise beyond $1M and (b) what's key item you'll work on upon raising $1M?

James, thank you for asking. I want to make sure I answer this with precision because milestone-based thinking is exactly how we run this company.Our current Wefunder raise targets $300K, serving as a bridge to a $ 5M-priced seed round we are actively building toward. So let me answer in those terms, because that is the honest picture:We are in the final stages of analytical validation for our Strep A assay, while advancing our manufacturing partnership and building our FDA pre-submission. Th...

Hello, I have some questions. I apologize if these were already answered in the pitch. What specific FDA pathway do you expect for the at-home Strep A test, and what milestones remain before submission and clearance? The pitch deck says q2 2026 for this “de novo vs 510k” How m...

Thank you, Ali, for these questions. This is exactly the kind of diligence we welcome, and I will answer each one directly.On the FDA pathway, we are targeting 510(k) clearance for our at-home Strep A test. The Q2 2026 date in the deck has been updated, and our current near-term milestone is a Q-sub meeting with the FDA, which is the formal pre-submission step that aligns us with the agency on our pathway and data requirements before we proceed to submission.For clinical samples, we are progr...

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At-home diagnostics for time-sensitive infections: starting with strep

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