Key Takeaways
· OneCell has received its CLIA certification in the US and is pursuing CAP and FDA 510(k) pathways, aiming to scale its lab-developed tests without delaying commercial traction.
· With partnerships across 20+ hospitals and hundreds of oncologists in India, OneCell is now targeting Southeast Asia and Africa, and building automated systems for broader reach.
· Backed by a globally trained team and strategic investors, the company is balancing deep scientific R&D with scalable operations and strategic biopharma collaborations.
In the second half of the Medtech Insight’s interview, Mohan Uttarwar, co-founder and CEO of OneCell Diagnostics, dive deeper into the commercial challenges and strategic roadmap for scaling precision oncology...
Uttarwar expands on how OneCell is navigating regulatory pathways, its plans for real-world validation of its AI-powered cancer recurrence tools and why building trust with oncologists and patients is central...
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