Quanterix’s Simoa analyzer gains medical device registration in S.Korea

Published 23/06/2025, 12:38
Quanterix’s Simoa analyzer gains medical device registration in S.Korea

BILLERICA, Mass. - Quanterix Corporation (NASDAQ:QTRX), a medical technology company with a market capitalization of $237.64 million, announced Monday that its HD-X Simoa Immunoassay Analyzer has received Class 1 Medical Device registration from South Korea’s Ministry of Food and Drug Safety through regional partner HS Biosystems. According to InvestingPro analysis, the company maintains a strong financial position with more cash than debt on its balance sheet.

The company’s Simoa technology platform enables ultrasensitive biomarker detection in blood, serum or plasma, capable of measuring proteins at levels below the quantification threshold of traditional platforms. This innovative approach has contributed to Quanterix’s solid revenue growth of 7.71% over the last twelve months, with a healthy gross profit margin of 59.67%.

"Quanterix is the only platform in the neurodegenerative space that can be used in research to discover a biomarker, power an endpoint in a clinical trial and progress to a diagnostic test," said Masoud Toloue, Chief Executive Officer at Quanterix.

The company has established new global collaborations with laboratories and testing centers focused on Alzheimer’s disease detection, including ARUP Laboratories, Neurogen Biomarking, NSW Health Pathology, and Rede D’Or, Richet Laboratory. With a strong current ratio of 8.29, Quanterix appears well-positioned to support its global expansion. For detailed financial analysis and additional insights, investors can access the comprehensive Pro Research Report available on InvestingPro, which covers over 1,400 US stocks.

According to research cited in the press release, early signs of Alzheimer’s disease may begin 20 years or more before symptoms appear. The Simoa platform aims to accelerate early detection during this period, potentially allowing patients access to treatments before disease progression reaches advanced stages.

Luis Eduardo da Silva Santos, Scientist at Rede D’Or Institute for Research and Education, noted that their institution was the first Brazilian organization to acquire a Simoa HD-X analyzer, with work published in Nature Communications serving as the basis for implementing P-tau217 and NfL testing in Brazil.

The information in this article is based on a press release statement from Quanterix Corporation. Based on InvestingPro’s Fair Value analysis, the stock currently appears to be trading below its estimated Fair Value, suggesting potential upside for investors interested in the medical technology sector.

In other recent news, Quanterix Corporation reported its Q1 2025 earnings, revealing a revenue of $30.3 million, which represents a 5% decline year-over-year. The company missed earnings per share (EPS) expectations, reporting -$0.53 compared to the forecasted -$0.43. Quanterix has revised its full-year 2025 revenue guidance to a range of $120-130 million. Additionally, the company is targeting positive cash flow by 2026, with a focus on expanding its Alzheimer’s diagnostic capabilities and reducing core operating costs by $30 million. In a strategic move, Quanterix has appointed KPMG LLP as its new independent auditor following the dismissal of Ernst & Young LLP due to reported material weaknesses in internal controls. The company is also in the process of merging with Akoya, a transaction expected to close in the third quarter of 2025. Canaccord Genuity has maintained its Buy rating for Quanterix, despite reducing its second-quarter and full-year 2025 estimates due to funding challenges. The firm believes new product launches and the benefits from the Akoya acquisition could drive future performance improvements for Quanterix.

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