SEOUL, South Korea — September 22, 2025 — Lunit and Agilent Technologies have launched a non-exclusive collaboration to co-develop AI-powered companion diagnostic (CDx) solutions that combine Lunit’s artificial intelligence technology with Agilent’s expertise in tissue-based diagnostics in order to enhance precision medicine and biomarker testing for drug development.
Science Significance
The collaboration aims to integrate AI algorithms with state-of-the-art tissue-based assays to improve detection, quantification, and interpretation of biomarkers critical for patient stratification in oncology, reducing reliance on manual evaluation and enabling more reproducible, accurate diagnostic outputs.
Regulatory Significance
By targeting companion diagnostic tools, the partnership engages regulated medical device/diagnostic pathways; CDx approvals often require rigorous validation against clinical endpoints. Leveraging both AI and established diagnostic assay platforms may help satisfy regulatory requirements for analytical validity, clinical validity, and performance consistency under oversight bodies like the U.S. FDA and equivalent agencies in Europe and Asia.
Business Significance
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For companies developing biomarker-driven therapies, access to reliable CDx tools enhances marketability and reduces development risk. This collaboration is positioned to benefit pharma partners by accelerating time-to-market, improving trial design, and offering differentiated diagnostic services. The non-exclusive nature allows wider adoption while preserving growth potential for both diagnostic and pharmaceutical markets.
Patients’ Significance
For patients, improved companion diagnostics mean more tailored treatments, fewer treatment failures due to misdiagnosis or patient misclassification, and potentially better treatment outcomes with reduced side effects. Faster and more accurate biomarker detection could translate into earlier treatment and fewer delays in receiving effective therapies.
Policy Significance
This partnership underscores growing policy emphasis on precision oncology, AI in healthcare, and regulatory innovation to keep pace with digital diagnostic tools. Policies facilitating oversight for AI-based diagnostics, data governance, and validated biomarker use will be essential for safe adoption. Reimbursement frameworks will need to adapt to support diagnostic precision as a core of therapy decision-making.
The Lunit-Agilent collaboration represents a meaningful step toward integrating artificial intelligence with companion diagnostics in precision medicine. By combining AI expertise with established diagnostic assay strengths, the partnership promises to enhance biomarker accuracy, improve trial performance, and ultimately support better patient care. As this collaboration progresses into research and clinical trial phases, its impact may reshape diagnostic standards and accelerate the development of more effective, personalized treatment strategies.
Source: Lunit Press Release
