Company Overview#
BeyondDx is a precision diagnostics company developing AI-enabled blood-based in vitro diagnostic solutions for cancer and other major disease areas. By integrating multiple circulating biomarkers with artificial intelligence, BeyondDx aims to improve clinical decision-making through earlier, more accurate, and less invasive disease assessment from a single blood sample. Its flagship product, ForeCheck LC, focuses on supporting the management of LDCT-positive pulmonary nodules through biological malignancy risk assessment.
Technology & Product#
BeyondDx’s lead product, ForeCheck LC, is a blood-based adjunctive in vitro diagnostic (IVD) designed to assist in assessing the malignancy risk of LDCT-positive pulmonary nodules. Rather than replacing LDCT or providing a definitive diagnosis, the test offers complementary biological risk information to support clinical decisions regarding follow-up imaging, biopsy, or referral.
ForeCheck LC measures three serum protein biomarkers and applies a locked machine-learning algorithm to generate a simple High-Risk or Low-Risk result. The assay is completed in approximately 150 minutes and is integrated into BeyondDx’s iDXGate AI diagnostic platform. Clinical studies have demonstrated encouraging performance in differentiating malignant from benign pulmonary nodules, while earlier studies also showed strong potential for early-stage lung cancer detection.
Market & Use Cases#
ForeCheck LC is intended for patients with pulmonary nodules detected by LDCT, where distinguishing benign from malignant nodules remains a major clinical challenge. By providing additional biological risk information, the test aims to support physicians in patient management and potentially reduce unnecessary diagnostic procedures while improving confidence in clinical decision-making.
BeyondDx is currently pursuing Korean regulatory approval while preparing for future CE-IVDR certification by expanding European clinical validation, performance evaluation, and technical documentation. In the longer term, the company’s AI-enabled biomarker platform is expected to expand into companion diagnostics, treatment decision support, recurrence monitoring, and additional disease areas, including mental health disorders.
Traction & References#
BeyondDx raised seed funding from Bluepoint Partners and was selected for the DeepTech TIPS program in 2024(The Bio News). The company is also a member of the IBK Changgong(Kpanews), supporting its continued technology and business development.
BeyondDx has established an ISO 13485-certified quality management system and Korean GMP manufacturing capability for in vitro diagnostics(The Yakup). The company has accumulated clinical datasets from more than 3,400 human specimens and has conducted clinical studies and validation work in collaboration with Seoul National University Bundang Hospital. Clinical findings have been presented at ASCO 2025 and ASCO 2026(The Yakup), demonstrating the clinical potential of ForeCheck LC.
In 2025, BeyondDx signed an MOU with Shanghai Kehua Bio-Engineering to pursue joint development and commercialization opportunities for ForeCheck LC, leveraging the partner’s international network across Asia, Europe, and Latin America(The Bio News). The company also received the Grand Prize at the 2025 Women’s Startup Competition organized by Korea’s Ministry of SMEs and Startups(Womennews).
Collaboration Relevance#
BeyondDx is seeking long-term collaboration with European hospitals, research institutes, diagnostic laboratories, and industry partners to generate robust clinical evidence in European populations and support future CE-IVDR certification and European market entry. Areas of collaboration include European clinical validation studies, performance evaluation, biobank-based research, joint scientific publications, companion diagnostic development, treatment decision support, and commercialization partnerships.
BeyondDx views Germany as a strategic gateway for building long-term scientific and clinical collaborations. The company believes that high-quality clinical evidence generated together with leading European institutions will be essential for bringing AI-enabled precision diagnostics to patients worldwide.