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Spain's Stat-Diagnostica Aims to Market Near-patient IVD System in Europe, US in 2015

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Having closed a €17 million ($22.1 million) financing round earlier this month, Spanish molecular diagnostics developer Stat-Diagnostica is aiming to market its portable, cartridge-based, sample-to-answer analyzer for both molecular and immunoassays in Europe in early 2015 and in the US later that year, the company said recently.

Stat-Diagnostica believes that its platform — which can perform fully automated semi-quantitative molecular assays for up to 50 targets or four immunoassays in parallel, depending on the test cartridge — is a "true contender" to Cepheid's GeneXpert system, one of the most successful benchtop in vitro diagnostics systems on the market.

Stat-Diagnostica was founded in 2010 in Barcelona primarily by former employees of international healthcare company Werfen Group in order to develop and commercialize a near-patient clinical diagnostics testing system that would simplify current procedures and reduce time to result, primarily in the areas of infectious disease and antibiotic resistance testing, and biomarker assessment in critically ill patients.

In 2011, the company closed a €2 million Series A financing round, which enabled the company to validate and demonstrate the feasibility of its technology, co-founder and CEO Jordi Carrera told PCR Insider.

The Series B financing announced this month — which included new investors Kurma Life Science Partners, Idinvest, Boehringer Ingelheim Venture Funds, and Caixa Capital, as well as existing investors Ysios Capital and Axis — will help Stat-Diagnostica complete development of the system and clinically validate its first products.

According to Carerra, the yet-to-be-named platform meshes several well-vetted and commonly used technologies for sample prep, PCR amplification, and immunoassays into different fluidics-enabled cartridges that run on a single analyzer.

Even though Stat-Diagnostica plans to sell closed test cartridges, its platform uses "standard technologies and concepts," Carerra said. For molecular assays, "it has to be regarded as a conventional thermal cycler," he added. "Any assay that can be run on a [Life Technologies] Applied Biosystems, Roche, or Bio-Rad [thermal cycler], we could introduce those reagents into our test cartridge. This is very important so that once we have a platform we can increase and have a large menu of products in a short time."

The company's molecular assay cartridges will be capable of automated swab extraction, mechanical cell disruption, nucleic acid purification, PCR amplification, and detection. "From sample introduction, it really does the sample homogenization from a thick sample like sputum to liquefy it, and then cell disruption," Carrera said. "We use mechanical means … to free the DNA, to really have times to results compatible with a near-patient testing environment. Then we purify the nucleic acids, which can be DNA or RNA. And then we perform amplification."

Amplification will be based on real-time PCR chemistry, although Carrera declined to provide specific details at this point in time, noting that the cartridges will in theory be able to accept a wide variety of chemistries.

What may set the system apart from other molecular diagnostic systems in development is that it will be able to provide semi-quantitative information on up to 50 targets by running multiplexed reactions in one of several reaction chambers located on the cartridge.

"We are multiplexing by wavelength and by reservoirs," Carrera said. "The system could go higher but we think that's a good number at this stage. Arranging the reagents in a different configuration, we can do absolute quantification, which very few systems can do in a near-patient test cartridge. So we could have [for instance] four calibration curves to really quantify amounts of analyte. That would be of interest for HIV and hepatitis."

In general, this multiplexing capability would open the platform up to running highly multiplexed panels. Even though Carrera declined to provide details on the initial test menu, a recent company presentation lists as examples pneumonia, respiratory virus, meningitis, gastrointestinal, and sepsis panels; as well as assays for Clostridium difficile and methicillin-resistant Staphylococcus aureus. The company said its molecular tests will be able to provide results in less than an hour in most cases.

Meantime, the immunoassay cartridges will be able to perform automated plasma separation, internal dosing and mixing, and up to four washes to ready a whole blood or plasma sample for analysis. The assay will use time-resolved fluorescence and provide sensitivities in the pg/mL range; run four parallel reactions; and provide a result in less than 12 minutes.

"The idea is to [have] a consolidated platform for both molecular and immunoassay … because you can [think] about analytes in two different ways," Carrera said.

For instance, he added, in the case of sepsis, a physician could run an immunoassay test such as a procalcitonin assay to determine whether the patient has a serious bacterial infection. "That would take about 15 minutes or so, maybe less," Carrera said. If the immunoassay is positive, depending on how critical the patient is, doctors could then administer a molecular sepsis test on the same platform to identify the microorganisms causing the infection to obtain information on antibiotic resistance and formulate an appropriate therapy.

"It is a complementary tool for critical care situations," Carrera said. "This is considering the same patient, the same sample, with results in two different ways."

According to the company, both the molecular cartridges and immunoassay cartridges will cost in the neighborhood of €1.5 each without reagents. Meantime, the estimated cost of an analyzer will be €2,500 to €3,000 per unit. The analyzer is expected to weigh less than a kilogram and take up less bench space than current competing IVD systems.

In its presentation, Stat-Diagnostica noted that Cepheid's GeneXpert system is currently the most complete product on the market for near-patient IVD testing, although dozens of other companies have recently commercialized or are developing competing systems.

But Stat-Diagnostica believes that the attributes of its system make it a "true contender" to Cepheid, and may even offer some advantages.

"The difference with Cepheid is there are significant manual steps in filling up the test cartridge for the liquid reagents, whereas with our system, the cartridge is pre-loaded with liquids and the dry reagents," Carrera said. "Our system should be much easier to use than the Cepheid system."

In fact, Stat-Diagnostica is developing its platform with the goal of one minute of operator hands-on time and a CLIA waiver, which would allow relatively unskilled workers to operate it.

Carrera said that the company is first targeting the European and US markets, but its platform may eventually be a boon for diagnostics in resource-poor countries — just as Cepheid's Xpert TB assay has been successfully deployed in those areas of the world.

"It's obvious that emerging markets are an interesting area and a lot of big companies are moving there," Carrera said. "We have been contacted by several organizations to see if we would be interested down the road. At this stage we are open, but it's not our priority, because we're being funded by venture capital and need to commit to their objectives. But certainly we are open and are in … very preliminary conversations."

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