Daye's Founder Highlights Funding, Regulatory and Market Hurdles for Diagnostic Tampons
Valentina Milanova explains how Daye's FDA-cleared diagnostic tampon faces a funding gap, regulatory ambiguity and a market that treats it as a contraceptive.
Daye’s diagnostic tampon, which can identify high-risk HPV strains responsible for most cervical cancers, has been peer-reviewed and named one outlet Best Invention of 2024, yet Google mistakenly classifies it as a contraceptive. Founder Valentina Milanova launched the firm in London in 2017 after traditional tampon makers refused higher standards, leading her to build a Bulgarian facility that complies with ISO 13485, GMP and EU MDR, and to obtain FDA 510(k) clearance.
The company has attracted roughly $28 million in venture capital and $4 million in grants, but investors are hesitant due to CPT code reimbursement timelines and questions about the focus on broader cancer detection. Daye’s self-sampling device matches clinician-collected swabs in accuracy and is now an NHS-approved supplier, with a pilot at Chelsea and Westminster Hospital and trials in Tanzania and Nigeria. Milanova urges the creation of a regulatory sandbox to resolve the absence of a clear FDA route for sterile tampons, emphasizing that the technology is ready but systemic barriers impede widespread adoption.
Why it matters
The story shows how innovative women's-health diagnostics struggle for funding and clear regulation despite proven medical value.
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