QuantaMatrix Enters Global Sepsis Diagnostics Race with World’s Fastest Integrated Antimicrobial Susceptibility Testing System

Founded in 2010 as an incubation project from the Biophotonics and Nanoengineering Laboratory at Seoul National University in South Korea, this in vitro diagnostics company offers products for the detection of sepsis, cardiovascular diseases, Alzheimer’s disease, and tuberculosis. Its products are commercially available in South Korea, Europe, and the Middle East. In 2020, QuantaMatrix was listed on the Korea Exchange (KRX).

The aforementioned “integrated antimicrobial testing” refers to ultra-rapid antimicrobial susceptibility testing. According to research published by the R&D team in Nature, this test bypasses the patient blood culture step and, compared with conventional antimicrobial susceptibility testing methods, can reduce the detection time by 40–60 hours, thereby significantly improving diagnostic efficiency for conditions such as sepsis.

Every 3 seconds, someone dies from sepsis.

This statement perfectly illustrates the brutality of sepsis—its substantial morbidity and mortality. In the United States alone, epidemiological studies have shown that over the past two decades, the prevalence of sepsis has been rising rapidly at an annual rate of 8.7%, causing more than 250,000 deaths each year.

The high mortality rate is closely linked to factors such as the difficulty in early detection of sepsis and prolonged testing times. It is reported that sepsis, particularly in its early stages, lacks specific clinical manifestations, making it often difficult to identify. Furthermore, the concurrent presence of respiratory or gastrointestinal symptoms can easily lead to misdiagnosis, thereby delaying optimal treatment.

However, even when physicians suspect sepsis and order tests, the current gold standard for diagnosing sepsis—blood culture of specimens—typically requires 72 hours to yield results, resulting in a prolonged turnaround time and significant diagnostic delay.

Prior to this, the physician’s treatment plan may involve the use of potent broad-spectrum antimicrobial agents. However, resistance rates to broad-spectrum antimicrobials have approached 30%, and this figure continues to rise with the emergence of drug-resistant bacteria. If the pathogenic bacteria infecting the patient develop resistance to the relevant antimicrobial drugs, the consequences can include rapid clinical deterioration and even death.

Therefore, in addition to accuracy, the market now has an additional requirement for sepsis testing: speed!

QuantaMatrix’s newly developed ultra-rapid antimicrobial susceptibility testing eliminates the need for blood culture by leveraging immune protein-synthesized nanoparticles. These synthetic nanoparticles specifically bind to pathogenic bacteria, enabling the isolation of pure pathogens directly from patient blood.

Based on this, the team integrated and developed a new technology capable of rapidly performing pathogen identification and antimicrobial susceptibility testing. In a clinical trial involving 190 patients with suspected sepsis, all tests were completed within an impressive 13 hours. Compared to other mainstream testing technologies currently available on the market, this new technology reduces testing time by 40–60 hours.

Furthermore, the test achieved an accuracy rate of 94.9%, comparable to that of other detection methods. Meanwhile, QuantaMatrix emphasized that this testing method is also proficient in detecting low levels of bacteria at early stages.

Furthermore, it is worth noting that by integrating all diagnostic techniques required for sepsis diagnosis, this study has achieved full automation of detection, thereby enabling true 24/7 operation.

Sunghoon Kwon, CEO of QuantaMatrix, stated, “By significantly reducing testing time, we aim to lead the global market in antimicrobial susceptibility and blood culture testing, which together represent a market value of approximately $20 billion.”

Focusing on the sepsis testing market, according to Bizwit Research & Consulting LLP, the global sepsis diagnostics market size reached RMB 3.788 billion in 2022, with China’s sepsis diagnostics market accounting for RMB 963 million. Looking ahead, Bizwit Research & Consulting LLP predicts that the global sepsis market will grow at a compound annual growth rate of 7.25%, reaching RMB 5.797 billion by 2028.

Meanwhile, market competition is also intensifying.

Specifically, according to research by VBInsight, the current sepsis diagnostics market involves dozens of companies, including but not limited to Beckman Coulter, Inc., Cepheid Inc., T2 Biosystems, Inc., Becton, Dickinson and Company, Thermo Fisher Scientific, Inc., and Bruker Corporation.

Notably, the 31% year-over-year decline in T2 Biosystems’ sepsis-related revenue in Q3 2023 was seen as a signal of intensifying industry competition. In this competitive landscape, nearly all companies are converging on a common direction: “faster.”

In November 2023, Ad Astra Diagnostics’ QScout RLD (Rapid Leukocyte Differential) device received FDA 510(k) clearance. The device can be used to screen for infections, allergies, and blood-related cancers, including leukemia. Additionally, it measures immunoglobulins, enabling the detection of sepsis 24 hours earlier than methods based on lactate and procalcitonin measurements.

In the same month, Cytovale announced the completion of its Series C financing round, planning to use the $84 million raised to support the expanded commercialization of its 10-minute sepsis diagnostic product, IntelliSep.

Furthermore, T2 Biosystems, as previously mentioned, has launched the T2Dx Instrument along with the T2 Biothreat Panel, T2Bacteria Panel, and T2Candida Panel series, which can also identify pathogens directly from whole blood samples within 3–5 hours.

As for the Chinese market, in 2021, China’s Saili Group invested in Inflammatix by subscribing to newly issued shares in its Series D financing round, and secured collaboration rights for the research and development, manufacturing, and sales of Inflammatix’s core product—the TriVerity™ acute infection and sepsis diagnostic system—in the Chinese market.

In October 2023, Sansure Biotech also announced that the Hunan Xiangjiang Sansure Biotech Industry Fund, which it initiated and established, had signed a cooperation agreement with Canada’s Sepset Biosciences to set up a company in Changsha, thereby entering the field of rapid sepsis diagnostics.

In the same month, Fapon Biotech also signed a strategic cooperation agreement with LASCCO SA and Abionic SA, obtaining an exclusive license to use the pancreatitis-associated protein (PAP) biomarker for sepsis diagnostic applications.

Chinese enterprises have also begun to take the “stage” in rapid sepsis diagnosis, competing alongside international companies.