EBV EA-IgA IFA

Restalyst Pte Ltd

Singapore, Singapore

Restalyst , established in 2007, is a fully integrated in-vitro diagnostics (IVD) company providing reliable, clinically validated diagnostic solutions for oncology and infectious diseases. Our operations cover the full product lifecycle, ranging from research and development to manufacturing and commercialisation, ensuring compliance with the highest regulatory standards. Our research development, and manufacturing facilities have been ISO 13485 certified since 2009 and comply with the Health Products Act and Health Products (Medical Devices) Regulations 2010 in Singapore. We are IVDD-compliant and are actively transitioning to meet IVDR requirements. Robust quality management practices, including the implementation of an electronic quality management system (eQMS), enable us to maintain strict regulatory adherence and operational consistency. Restalyst has developed a range of diagnostic assays using proprietary and patented biomarkers. Our key oncology products include NPC-REAAD™ EBV EA-IgA ELISA for nasopharyngeal carcinoma, GC-REAAD™ ITIH3 ELISA for gastric cancer, and HCC-REAAD™ ERBB3 ELISA for hepatocellular carcinoma. With extensive experience in product improvement, assay design, and scale-up manufacturing, we ensure that our products meet rigorous quality and efficacy standards. We actively engage international partners to distribute our products globally, expanding beyond the Asia Pacific into Europe, the Middle East, Africa, and the Americas. In addition to product commercialisation, we offer contract development and manufacturing services (CDMO) to organizations seeking testing, assay design, and manufacturing under stringent regulatory standards. Restalyst is committed to quality, regulatory compliance, and scientific excellence, enabling seamless market entry for new diagnostic solutions while supporting healthcare providers and research organizations worldwide.