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Mobidiag Jumps Into High-Throughput Dx Market with Amplidiag Easy Platform

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NEW YORK (GenomeWeb) – Finland's Mobidiag last week unveiled two new diagnostic platforms, one that targets large laboratories with high-throughput requirements, and another currently in validation testing that is being positioned to replace the company's existing Prove-It assays.

The product introductions come roughly two years after Mobidiag's three-way merger with AmpliDiag, a Helsinki-based developer of qPCR kits for infectious diseases, and French microarray instrumentation maker Genewave, and represent the fruits of that transaction, CEO Tuomas Tenkanen told GenomeWeb this week.

Currently, Mobidiag is limiting the initial roll out of the platforms to Europe, he noted, but the company anticipates hitting the US market as early as 2017.

The first platform, dubbed Amplidiag Easy, is an automated system designed to perform batch nucleic acid extraction and PCR plate setup from stool samples and runs with the company's suite of test kits of bacterial pathogens.

According to Tenkanen, the platform is targeted "mainly to the large hospital laboratories that have skilled personnel in place, but need high-throughput systems" and could benefit from the system's automation.

Currently, there are two Amplidiag tests with CE-IVD marking and available for sale. The first, Bacterial GE, detects Campylobacter, Salmonella, Shigella, Yersinia, and five different Escherichia coli pathotypes. The test offers 99 percent specificity and 99 percent sensitivity, according to the firm.

Also available is the Amplidiag C. difficile+27 test, which identifies toxin-producing Clostridium difficile with 97.8 percent sensitivity and 100 percent specificity, and can differentiate between the hypervirulent 027 ribotype and non-027 ribotypes with 94.1 percent sensitivity and 100 percent specificity.

Tenkanen said that a test for Helicobacter pylori infection and clarithromycin resistance is set to launch "very soon," and that additional tests — including ones for detecting carbapenem-producing organisms and vancomycin-resistant enterococci; for identifying parasites such as Cryptosporidium spp. and Giardia lamblia; and for identifying five clinically important enteric viruses — will be available by the end of the summer.

Mobidiag's second new platform, which is still being validated, is called Novodiag and represents the successor to the company's Prove-It line of microarray tests. Aimed at small- to medium-sized clinical microbiology laboratories with lower-throughput requirements, Novodiag is a closed, cartridge-based system designed to detect multiple targets in a single assay.

Prove-It assays, meanwhile, comprise 2 milliliter tubes containing an array at the bottom. They are run on the TubeArray system, which includes a small reader device coupled with a laptop, and the StripArray System, an automated microarray detection and analysis robot with a built-in computer.

The company touts Novodiag as an automated "sample-in, results out" system that can provide readouts in about an hour. Each system has four independent slots, but up to four instruments can be stacked on one another to boost capacity.

Tenkanen also said that Mobidiag sees affordability of the cartridges as giving the system an edge over competitors among small labs with cost constraints. However, he declined to provide pricing details.

Novodiag will not be available in Europe until mid-2016, he said, making it "a bit early" to comment on the cost of the panels. However, he said the first Novodiag tests are likely to be ones for detecting diarrhea-causing bacteria, viruses, and parasites, as well as antibiotic resistance. The company is also developing cartridges for infections of the respiratory tract, central nervous system, and skin and soft tissue.

He also confirmed that Mobidiag is planning to move its line of Prove-It tests for herpes, sepsis, and osteoarticular infection-causing bacteria over to the Novodiag platform, although that transition will be done over time.

Tenkanen did not say whether the Prove-It line will be retired, but said that "after we have moved the assays to the new platform … we will then concentrate … on Novodiag."

In keeping with its Finnish and French roots, Mobidiag intends to focus commercialization of Amplidiag Easy and Novodiag to Europe, but it remains interested in the US, he said.

"It is clear that the US market is huge and we have to be present there," Tenkanen said. "But we also realize it is going to take more time" given the stringent regulatory requirements around in vitro diagnostics in the US and the company's lack of sales and marketing infrastructure in the country.

The company hopes to be able to begin launching tests in the US in 2017, he said. And while Mobidiag may try to go it alone, it is more likely that it will strike distribution partnerships similar to those it has in place for territories outside Northern Europe and France.

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