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Q-linea, Setting Sights on Clinical Dx Market, Aims to Launch Antibiotic Susceptibility Test by 2015

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UPPSALA, Sweden — Swedish technology firm Q-linea hopes to deliver to market within the next three years a clinical assay that can identify bacteria responsible for sepsis and determine its susceptibility to antibiotics.

CEO Jonas Jarvius said that the privately held company is "putting all of its focus" on the diagnostics market, looking to parlay its nucleic acid- and protein-detection capabilities into a steady revenue stream from hospitals that would use the test to select the most effective antibiotics regimens for patients.

"We have put all of our focus to blood testing and antibiotics susceptibility testing," Jarvius told BioArray News during a visit to the firm's offices here last week. He said that Q-linea's interest in antibiotics susceptibility testing is "obvious" as bacterial resistance to medicines is increasing and "sepsis care is a very big cost in Europe." He estimated that hospital laboratories in the EU spend about SEK 10 billion ($1.5 billion) on sepsis-related testing, much of which is still done using blood cultures and can take several days.

"Mortality is about 7 percent per hour so time is very important," said Jarvius. "And because obtaining an answer takes days, it means that you will be started on broad-spectrum antibiotics immediately, because you can't wait, and this broad spectrum drives the resistance to nearly everything," he added. Q-linea's goal is to shorten the time between the onset of sepsis, pathogen identification, and treatment decisions "from days to hours," said Jarvius.

Ultimately, Q-linea hopes to place its first systems in collaborators' labs in 2014 and then to have a test on the market by the following year.

Q-linea's interest in diagnostics reflects a shift of focus within the company. The firm initially positioned its technology for use in biodefense applications, and has worked with Swedish, French, and American companies and agencies to develop a system, called Aquila, for detecting airborne biowarfare agents (BAN 7/22/2008). However, Jarvius portrayed the biodefense market as "difficult to predict" as agencies have "long purchasing cycles," meaning that while a successful deal could provide secure income for years, an unsuccessful one could leave the firm waiting years for another opportunity with the same potential customer.

"This is one of the reasons we are moving into diagnostics," said Jarvius. "Having a market presence [in biodefense] is good if you are a big company but harder if you are a small company." Indeed, he portrayed sepsis diagnostics as a lucrative market.

"Looking at these assays, just the academic hospital here [in Uppsala] reports around 20,000 assays yearly, and the price of each assay is about 800 SEK," said Jarvius. "These assays are run in all hospitals with intensive care units," he said. "For us, as a small company, the ideal is to have a few customers that require a large number of reagents."

In line with its new business objectives, Q-linea has taken part in a number of projects. Last year, it announced its participation in the RAPP-ID project. Funded by the Innovative Medicines Initiative, a joint undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations, RAPP-ID aims to develop a point-of-care test for countering antibiotic resistance. And at the end of 2010, VINNOVA, the Swedish Governmental Agency for Innovation, awarded Q-linea funding to develop its platform for the analysis of antibiotic resistance patterns in bacteria.

One attribute that Jarvius said makes Q-linea's platform "unique" is its ability to analyze nucleic acids and proteins simultaneously in the same assay. The company's approach relies on arrays of padlock capture probes and proximity ligation probes directed towards specific nucleic acid sequence motifs or surface epitopes for detection, identification, and quantification of pathogens. Reacted probes are detected using Q-linea's amplified single-molecule detection approach, which involves converting individual target-recognition events into fluorescent micrometer-sized DNA molecules that are amenable to optical detection and enumeration in Q-linea's instrument.

A number of companies have delivered multiplexed sepsis tests to market. Helsinki, Finland-based Mobidiag, for instance, sells Prove-it Sepsis, an array-based CE-IVD marked assay that the company claims can identify sepsis-causing bacteria and fungi from positive blood culture in less than four hours. Roche Diagnostics, meantime, offers SeptiFast, a PCR-based test that it claims can identify 25 of the leading sepsis-causing bacteria in about six hours.

Jarvius said that one thing that could differentiate Q-linea's technology from major competitors is that, upon availability, the firm's system would be fully automated, and that it could provide both the identity of the pathogen and its susceptibility to different treatments in the same assay for all investigated pathogens. "Our susceptibility [assay] is not limited to look at resistance genes as our competitors are," he added.

Unlike some other microarray and biochip platforms, Q-linea's assays are run in microfluidic channels molded into plastic compact discs. Jarvius said that Q-linea selected the CD-based approach to cut down on assay costs. "One of the problems with traditional microarrays is that you are dealing with glass slides that are very expensive," said Jarvius. "We want to do it in a cost-effective way and we have hundreds of spots, not thousands, so it is not as complex as many other systems," he said. Jarvius added that Q-linea designs the discs, which are replicated by an undisclosed external partner, but that Q-linea manufactures its detection instruments.

Jarvius did not discuss pricing details for the firm's future tests, but said that its system could cost around €150,000 ($191,970), which is similar to the cost of a mass spectrometry instrument. "What has happened at least in Sweden in the past few years is that mass spectrometry has come into the microbiology lab," said Jarvius. "Those systems are not very cheap," he said. "Our system would be on that order of magnitude, with one in each hospital."

Q-linea is working toward placing its first systems in hospitals in 2014. Jarvius said that the system would not replace culturing, but would rather be used as an adjunct test "for many years," he said. Johan Stenberg, a senior applications scientist at the firm, said that it is not possible to provide information in a short enough timeframe for patients to receive targeted antibiotics first, but that Q-linea hopes to have an assay available in time for the second round of treatment.

"When a patient comes in, he is given broad-spectrum antibiotics, and that is done so quickly that no method would replace that because they just do it," said Stenberg. "That lasts for a few hours and then it is time for the second treatment," he told BioArray News. "Our aim is by that second treatment the physician should know what treatment is going to work."

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