SG Bioscience gets nod for COVID-19, flu, RSV combo test kit

SG Bioscience has secured approval from South Korea's Ministry of Food and Drug Safety for a groundbreaking simultaneous diagnostic kit. This innovative test can detect COVID-19, influenza A and B, and the respiratory syncytial virus (RSV) all at once.

The kit, branded 'InstaQ COV/Flu/RSV Ag Multi,' employs quantum dots (QD) for detection, a technology that uses nano-materials emitting different wavelengths of light based on particle size. This allows for the differentiation of multiple targets within a single test. Notably, SG Bioscience has achieved a world-first by applying cadmium-free, indium phosphide-based quantum dots, ensuring an eco-friendly and non-toxic product.

Clinical trials conducted at a domestic university hospital demonstrated high accuracy, with sensitivity rates of 93.5% for COVID-19 and 97.1% for RSV, alongside specificity rates of 100% for COVID-19 and 99.8% for RSV. Influenza A and B also showed strong performance with sensitivity above 92% and specificity at 100% for both.

SG Bioscience plans to release the InstaQ kit and its accompanying reader, 'InstaRead M,' in October. The company aims to expand its product line beyond respiratory viruses to include diagnostics for other infectious diseases, hormones, and cancer markers, while also pursuing international approvals. "This approval marks the beginning of the commercialization of our QD-based multiplex diagnostic platform, going beyond a single product," stated Oh Se-moon, CEO of SG Bioscience. "Starting with respiratory diagnostics, we will expand our products into various diagnostic areas such as infectious diseases, hormones, and cancer markers."

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This approval marks the beginning of the commercialization of our QD-based multiplex diagnostic platform, going beyond a single product. Starting with respiratory diagnostics, we will expand our products into various diagnostic areas such as infectious diseases, hormones, and cancer markers.