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Quanterix's Ultra-Sensitive Blood Test Platform Wins Medical Device Approval in South Korea

Author: Benzinga Newsdesk | June 23, 2025 07:34am

Quanterix Corporation (NASDAQ:QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, today announced that the HD-X Simoa Immunoassay Analyzer has received Class 1 Medical Device registration by the Ministry of Food and Drug Safety (MFDS) in South Korea through its regional distribution partner, HS Biosystems.

The continued expansion of the industry-leading Simoa® technology platform into global markets demonstrates a key milestone in broadening validation of biomarker-based testing and providing clinicians with minimally invasive tools that can help enhance diagnostic accuracy and improve accessibility. Through its unparalleled sensitivity and multi-marker testing capability, the Simoa platform delivers ultrasensitive biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification (LoQ) of traditional measurement platforms.

Posted In: QTRX

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