CurieDx Plans Clinical Trials for FDA Diagnostic Approval in Q4 2025
Dr. Therese Canaris · This App Detects Strep from a Selfie…What?! · May 14, 2025 · at 6:34
Dr. Therese Canaris discusses CurieDx's clinical and regulatory roadmap on The Pitch.
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“The intention is to go through clinical trials, which we're planning for in Q four of 25, go through FDA and get approved as a diagnostic.”
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More from Dr. Therese Canaris
CurieDx's strep diagnostic is 88% accurate, beating physician visual evaluations
“The rapid swab that you traditionally do at the doctor's office, the one that comes back in 15 minutes, that's about 95% accurate, so it's good, but it's not perfect, and, ah, the, you know, physicians are 64%, so we are around 88% right now accuracy”
Canaris: CurieDx Proof-of-Concept UTI Model Achieves 88% Accuracy
“And we have, just on the proof of concept model, we have 88% accuracy on that.”
CurieDX is raising $4M to reach 10,000 patients and secure FDA clearance
“We're now raising four million, which helps us reach our first 10,000 patients and get the strep product through FDA from a screening tool to a diagnostic.”
Advisors say enterprise health organizations evaluate strategic partnerships at 10,000 users
“We have advisors at Amazon One Medical and also Care First Blue Cross Blue Shield and feedback that they've given us is when we get into the 10,000 user range, that's when they start paying attention and looking at strategic partnerships.”
CurieDx will pivot from direct-to-consumer back to B2B in Q3 2025
“The intention is direct to consumer for the relatively short period, around six months from now, so like Q three of 25, we start pouring efforts back into the B to B component and slowly build up that urgent care and small to medium practice customer base.”