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MobiDiag Developing Next-Generation Multiplexing Platform; Plans Migration of Prove-It Array Tests

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NEW YORK (GenomeWeb) – MobiDiag, a Finnish molecular diagnostics company, is developing a new system to complement its existing catalog of quantitative PCR and microarray-based tests.

CEO Tuomas Tenkanen told BioArray News this week that the firm is at work on a new, high-throughput multiplexing platform and related diagnostic kits. While he declined to provide a launch date for the system, he described it as a "closed, cartridge-based instrument capable of detecting many targets in one assay."

MobiDiag will target small- to medium-sized clinical microbiology laboratories with the new system, envisioning it as a complementary offering to its quantitative PCR-based AmpliDiag kits for infectious disease testing, which are geared toward higher-throughput labs with established qPCR infrastructure, Tenkanen said.

Moreover, Tenkanen believes that MobiDiag will eventually migrate its menu of microarray-based Prove-It tests over to the new multiplexing platform in the future. The company currently offers three array-based tests: Prove-it Herpes, Prove-It Sepsis, and Prove-It Bone&Joint. All three are CE-IVD marked. The assays are run using MobiDiag's TubeArrays, 2 milliliter tubes containing an array at the bottom.

The assays are sold for use with the company's 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.

Tenkanen stressed that "there are many happy Prove-It customers" and that the products exist and will continue to exist, but reiterated that the firm plans to move those assays over to the new multiplexing system once completed.

Much of the R&D for the new multiplexing system is taking place at MobiDiag's subsidiary in Paris, gained through last year's merger between MobiDiag, AmpliDiag, a Helsinki-based developer of qPCR kits for infectious diseases, and Genewave, a French microarray instrumentation maker.

At the time of the merger, Genewave had developed GeneSpress, an automated platform for highly multiplexed molecular diagnostic tests. According to the firm's website, the compact system integrates DNA purification, PCR amplification, microarray hybridization, and detection into an automated workflow on a single, closed lab-on-chip cartridge about the size of a credit card. The system also relies on Genewave's TouchArray optical detection technology for array imaging.

Genewave touted as some of the more notable attributes of the system its 20-plex, on-chip PCR, which "obviates the need for splitting of the sample into several, few-plex PCR reactions, thereby increasing sensitivity and decreasing cost," and a reader with an "order of magnitude higher sensitivity than the top microarray readers currently used in the industry."

Tenkanen said that most of the technology and knowhow behind the new multiplexing system in development comes directly from Genewave. "That was one of the main reasons for the merger last year," he said. He noted that Genewave has been developing the platform for 10 years.

Genewave also had IP related to its platform, including US Patent Nos. 6,867,900, "Support for chromophoric elements"; 8,153,066, "Device for supporting chromophore elements"; and 8,440,985, "Method and a device for detecting the fluorescence of a biochip."

The method described in the '985 patent relies on illuminating chromophores associated with probes of a substrate placed on a sensor having photodetectors, a stop filter that rejects the excitation light of the chromophores being provided between the probes and the sensor, where the substrate is separable from the sensor and can be reused.

While MobiDiag proceeds with the development of its new multiplexing system, the company is also investing in the menu of qPCR tests it gained from AmpliDiag.

The company announced separately this week that it had achieved a CE-IVD mark for its AmpliDiag Bacterial GE test, which enables the detection of eight, gastroenteritis-causing bacteria, and will enable the firm to offer the test clinically in Europe.

Tenkanen said that MobiDiag sells directly both in Northern Europe and in France via its Paris subsidiary. For all other markets within Europe, the company relies on distributors.

Tenkanen noted that MobiDiag is planning to launch multiple follow-on in vitro diagnostics for gastrointestinal infections in coming months based on the GE panel. He declined to discuss the firm's pipeline of tests, but said they would become available for clinical use.

All of the AmpliDiag tests are targeted toward larger labs that "prefer qPCR, have the automated robotos and the capacity to run such tests." The company is trying to appeal to those labs by offering "similar assays but with different features and different targets."

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