Quanterix Receives Class 1 Medical Device Registration in South Korea, Expanding Global Reach and Advancing Alzheimer's Disease Detection.

Quanterix's HD-X Simoa Immunoassay Analyzer has received Class 1 Medical Device registration in South Korea, marking a milestone in global expansion of its biomarker detection technology. The company has established several new collaborations with laboratories and testing centers for Alzheimer's disease testing, including ARUP Laboratories, Neurogen Biomarking, and NSW Health Pathology. Quanterix's ultrasensitive Simoa technology enables early disease detection and is used in research, clinical trials, and diagnostics.

Quanterix Corporation (NASDAQ: QTRX), a leader in ultrasensitive biomarker detection, has announced that its HD-X Simoa Immunoassay Analyzer has received Class 1 Medical Device registration by the Ministry of Food and Drug Safety (MFDS) in South Korea. This registration marks a significant milestone in the global expansion of Quanterix's biomarker detection technology.

The HD-X Simoa Immunoassay Analyzer, part of Quanterix's Simoa® technology platform, is renowned for its unparalleled sensitivity and multi-marker testing capability. It enables the detection of proteins in blood, serum, or plasma at levels far below the Level of Quantification (LoQ) of traditional measurement platforms. This advanced technology has been instrumental in accelerating early detection of various diseases, including Alzheimer's disease (AD).

Quanterix has established several new collaborations to enhance its infrastructure for Alzheimer's testing. These include ARUP Laboratories, Neurogen Biomarking, and NSW Health Pathology. ARUP Laboratories, a leading national reference laboratory, has launched a blood test for phosphorylated tau 217 (P-tau217) using Quanterix's SP-X® platform and Simoa® assay kit. Neurogen Biomarking has announced an at-home blood biomarker collection test that can measure P-tau217, a specific marker for AD pathology and mild cognitive impairment (MCI). NSW Health Pathology, the largest public pathology service in Australia, has validated NfL for patient testing.

Rede D’Or, Richet Laboratory (IDOR) in Brazil, has also made significant strides. As the first Brazilian institution to acquire a Simoa HD-X, IDOR has implemented P-tau217 and NfL for testing. Their recent publication in Nature Communications highlights the potential of these tests to reduce the underdiagnosis of AD in Brazil.

According to research, early signs of AD may begin 20 years or more before symptoms appear. Quanterix's Simoa platform equips researchers and clinicians with advanced insights to accelerate research, diagnosis, and early detection during this crucial timeframe.

For more information on the Simoa platform, visit [Quanterix](https://www.quanterix.com/).

References:
[1] https://www.stocktitan.net/news/QTRX/quanterix-expands-reach-with-ivd-and-large-reference-lotpjkyodpv9.html
[2] https://pmc.ncbi.nlm.nih.gov/articles/PMC12168238/