NEW YORK – QuantaMatrix, a South Korean in vitro diagnostics company, recently expanded its European business through a deal with MVZ Labor Ravensburg, one of the major labs within the Limbach Group’s network of 30 laboratories.
The Seoul-based company established its European office in Paris in 2018 and has worked to develop the market for its flagship dRAST platform for rapid antibiotic susceptibility testing in the region ever since, and the agreement with the Limbach Group's network of laboratories is a milestone, according to a QuantaMatrix official.
"Limbach's adoption of dRAST has two big implications," noted Stéphane Rougale, chief marketing officer at QuantaMatrix. First, Limbach is the largest private laboratory chain in Germany with a strong reputation, meaning QuantaMatrix will grow its user base.
"Entering lab procurement is one of the most difficult hurdles to overcome," said Rougale. "However, now that we are in, we hope to see installations throughout the network of Limbach labs."
He added that other European laboratories look at decisions made by organizations like Limbach, which could lead to uptake by other networks looking to invest in rapid antimicrobial susceptibility testing to guide treatment of patients with sepsis. "We believe this step forward will help other labs recognize the value proposition that dRAST has to offer," underscored Rougale.
QuantaMatrix is a 2010 spinout of Seoul National University. Its underlying technology was developed in SNU's Biophotonics and Nanoengineering Lab under the leadership of Sunghoon Kwon, a professor of electrical and computer engineering, who is the firm's president and CEO.
QuantaMatrix's dRAST platform combines microfluidic, optic, and artificial intelligence technologies to provide minimum inhibitory concentration-based phenotypic antimicrobial susceptibility testing from positive blood cultures in four to six hours. This shaves days' worth of time off conventional methods and enables clinicians to select the best therapy for patients with bloodstream infections and sepsis, rather than prescribing broad-spectrum antibiotics, which can fuel antibiotic resistance.
"When a patient arrives at the hospital with suspicion of sepsis, a doctor would administer empirical antibiotic treatment with cocktails of antibiotics until he finds an effective antibiotic," commented Miles Yoo, head of investor relations and business development at QuantaMatrix. "But what are the consequences after having administered all of those antibiotics?" he said. "This is a process that develops antimicrobial resistance and leads to development of superbugs that could be potentially fatal."
QuantaMatrix's dRAST platform is a sizable piece of equipment, with a height of 1,090 mm, a width of 580 mm, and a length of 680 mm. It has a capacity of 15 samples and a capacity of 12 samples with random access, and it supports both Gram-negative and Gram-positive bacterial panels. Its Gram-positive panel includes 17 antimicrobial agents and its Gram-negative panel has 19 antimicrobial agents.
During the testing process, a positive blood culture is combined with agarose, a polysaccharide, for immobilizing bacteria cells for imaging. Testing is carried out on an array of 96 wells with dried antibiotics that are rehydrated via a culture medium. Automated imaging and accompanying informatics help to track bacterial growth, according to the company.
No sample preparation or McFarland standards are required to run an assay on the dRAST instrument, and the automated system requires less than a minute of hands-on time, according to the company. The offering is supported by software that guides users on interpreting results.
QuantaMatrix and its customers have published multiple papers describing the system. A study, undertaken by researchers at Georges-Pompidou European Hospital, which assessed the performance of the dRAST system, appeared in the journal Infectious Diseases Now in August.
QuantaMatrix has secured approval from the Korean Ministry of Food and Drug Safety, as well as a CE-IVD mark for dRAST in June 2019. The firm opened its European office in a suburb of Paris, in 2018, and following its CE-IVD marking, quickly began installing systems around the region. In August 2020, it announced a dozen installations in labs at hospitals in France, Denmark, Switzerland, Germany, Ireland, the UK, Italy, Norway, and Sweden.
The recent deal with Limbach Group continues that trajectory, and into one of Europe's most important markets, Germany, which is not only at the heart of the EU, but, with 84 million people, has its largest population. Founded in 1979, Limbach has grown to include more than 30 labs throughout the nation.
While the adoption by Limbach Group is encouraging for QuantaMatrix, Yoo underscored that the market for rapid antibiotic susceptibility tests is a new one, and that much of the market still relies on conventional workflows that take multiple days. There has also been a cloudburst of activity around developing rapid, molecular tests to meet an unmet clinical need, with offerings from companies like Accelerate Diagnostics, T2 Biosystems, Molzym, and others either in development or already on the market.
Yoo declined to provide information around pricing at this time. However, he said that QuantaMatrix, given its user-friendly focus and deep bench of expert engineers, is a "strong candidate in this new market to become a dominant player in the space."
The company is also eyeing expansion to the US, the largest market for sepsis testing in the world, and in November 2019 it announced that it had held a presubmission meeting with the US Food and Drug Administration.
"With sepsis, the whole world is our market," said Yoo. "This is going to be a fight that will span decades."