Mirvie

Executive Summary

Mirvie is a pioneering biotechnology company based in South San Francisco, developing a novel RNA-based diagnostic platform aimed at transforming pregnancy care. Founded in 2018, the company’s lead product, the Encompass Test, analyzes tens of thousands of RNA messages from a simple maternal blood draw to predict serious pregnancy complications such as preeclampsia and preterm birth, often months before symptoms appear. By shifting from reactive crisis management to proactive, personalized intervention, Mirvie addresses a critical unmet need in maternal-fetal medicine. The platform has the potential to improve outcomes for millions of pregnancies annually, reduce healthcare costs, and empower clinicians with early actionable insights. Mirvie operates in the high-growth diagnostics sector with a unique approach leveraging liquid biopsy and RNA analytics. While the company has not disclosed total funding or valuation, its technology has generated significant interest given the large addressable market and rising maternal morbidity rates. Key near-term milestones include advancing clinical validation, pursuing FDA clearance, and establishing commercial partnerships. The company’s success hinges on demonstrating clinical utility and securing regulatory approval, but its novel platform positions it as a potential game-changer in prenatal diagnostics.

Upcoming Catalysts (preview)

• Q2 2027FDA clearance or breakthrough device designation for Encompass Test40% success
• Q4 2026Publication of pivotal clinical trial results demonstrating predictive accuracy60% success
• Q2 2026Series B or later funding round to support commercialization70% success