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Spartan Bioscience Unveils 'World's Smallest' PCR-Based Diagnostic Device


NEW YORK (GenomeWeb) – Spartan Bioscience today announced a sample-to-result device that purports to be the world's smallest PCR-based molecular diagnostics platform.

The Spartan Cube is four inches on each side and enables 30-minute diagnostic tests, CEO Paul Lem told GenomeWeb in an interview. The company also noted that it is smaller than other commercially available point-of-care, sample-to-result systems from Alere and Roche, as well as a proposed device from Cepheid.

Lem did not say when the platform would be available for purchase, nor did he specify its price, but said Spartan plans to make it "the most affordable" compared to all the competitors in the space.

The Ottawa, Ontario-based firm plans to showcase the platform in early August at the American Association of Clinical Chemistry conference in Philadelphia. It will divulge menu plans at that time, but Lem said Spartan intends to release infectious disease and pharmacogenetic tests on the Cube. The system uses swab-based samples specifically, and connects wirelessly to a tablet or laptop that displays test instructions and results with a touch interface.

Spartan's CYP2C19 test, which aids clinicians in determining strategies for therapeutics metabolized by the cytochrome P450 2C19 gene product, was cleared by the US Food and Drug Administration in 2013 and by Health Canada the following year.

That test uses the firm's Spartan RX system, which has an hour-long workflow. Spartan attempted to get the CYP2C19 test on the RX system CLIA-waived in the US, and it was approved in Canada for near-patient use. The test was also approved by the Korean FDA and other regulatory bodies around the world, Lem said.

"Now that we have that experience getting those approvals, we plan to do the same with the Spartan Cube," he said.

The firm will be seeking CE-marking and CLIA-waived status for the Cube so that it can be used in places like physician offices, clinics, and pharmacies. To reach customers in these markets, Spartan will rely on existing distribution relationships globally, but it is also looking for additional partnerships, Lem said.

Spartan also received a strategic investment last year from Canon's Biomedical subsidiary to develop "breakthrough technologies in the area of genetic testing," although financial details of the investment were not disclosed.

Lem said the Cube integrates DNA extraction, PCR, fluorescence detection, and automated results calling in one box. It uses a PCR-based chemistry and a solid state thermal cycler system that is sped up via patented chemistries and hardware.

The Alere system, the Alere i, and Roche's cobas Liat are roughly shoebox-sized. The Cepheid Omni has a small footprint, but is taller. Thus, a coffee mug-sized device such as the Spartan Cube is smaller, which may improve portability or make it so the device fits easily into any space.

The Alere system is expected to become a part of the Abbott family of products if the acquisition announced in February proceeds. There was speculation the deal was hung up on Alere failing to file annual earnings and being subpoenaed by the Securities Exchange Commission for matters related to the Foreign Corrupt Practices Act. Abbott attempted to terminate the merger, but that was since negated when the firm noted it anticipates the completion of the transaction.

The Cepheid system, meanwhile, is still in development, but its launch has been delayed because the firm is engineering the platform so it can be compatible with more test functionalities in the future.

Other companies are currently developing point-of-care molecular diagnostic products. These include the FlashDirect platform from Thermal Gradient, with a slightly larger footprint than the Spartan Cube, and Mesa Biotech, with a palm-sized platform about to enter clinical trials.

To compete in a growing point-of-care molecular testing market, Lem said Spartan will exploit its advantages. "I think ELISA-based immunoassays have had the largest reach so far because they are fast, affordable, and easy to use — everyone has been waiting for the day when a molecular diagnostic device could approach the level of immunoassays, and that is what we think we have with the Spartan Cube," Lem said.

Spartan is currently arranging clinical trials to validate the Cube as part of the CLIA-waiver application.