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CEO Paul Lem poses says the Spartan RX, said is the first device anywhere that allows almost immediate genetic testing. (Dave Chan For The Globe and Mail)
CEO Paul Lem poses says the Spartan RX, said is the first device anywhere that allows almost immediate genetic testing. (Dave Chan For The Globe and Mail)

DNA device gains FDA approval Add to ...

A Canadian biotech company has received a green light from U.S. regulators to sell an almost-instantaneous DNA testing device that could change the way genetic checks are performed around the world.

Spartan Bioscience Inc. of Ottawa was granted clearance from the U.S. Food and Drug Administration for its bedside unit, which lets hospital staff get DNA test results within an hour. The results ensure that the patient gets the right heart medication for their genetic makeup.

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Paul Lem, Spartan’s chief executive, said this is the first device anywhere that allows almost immediate genetic testing. “It is a milestone in biotech,” he said. Until now, genetic testing had to be done in large laboratories, and was much more time consuming, he said. Often, it can take a week to get test results back.

While the Spartan RX device has already been used in clinical trials in North America – including a large trial involving almost 6,000 patients that is being funded by the Mayo Clinic – the company could not do any commercial marketing or sales until it got FDA approval. “We are now able to go in and massively sell and market,” Mr. Lem said.

The first use of the device will be to help doctors decide which heart patients in a hospital should be given Plavix, a widely used blood thinner that helps prevent blood clots.

Some people have a genetic variant that means they do not respond well to Plavix or its generic equivalent, and the complications can be catastrophic. This device allows a quick test – using a cheek swab that is then placed in the device, about the size of a toaster. The results show whether the patient should be treated with more expensive alternative drugs.

Because cardiologists can now pinpoint the best and most cost-effective treatment, its use could save lives and millions of dollars, Mr. Lem said.

The hardware itself is essentially a platform that can be modified for other genetic tests in the future, he said. “I use the metaphor of Microsoft’s Xbox [computer game console]. Our device is the box, and our first game for it is this genetic test for drugs like Plavix.”

The next application will likely be a test that determines which individuals have a mutation that affects the dose they should take of Warfarin, an anticoagulant used to treat irregular heartbeats. That test should be available within two years, Mr. Lem said.

Currently, the Spartan RX box costs about $10,000, and each test costs about $250. Over the long run, the company hopes that the price of these devices will fall enough that they will be available outside of a hospital setting, in doctor’s offices or even drugstores, for instance.

That would allow a much more personalized approach to medicine, as many drug treatments could be designed specifically for individuals, instead of the one-size-fits-all approach that is prevalent today, Mr. Lem said.

“We know from 10 years of research on the Human Genome Project, that everyone is different,” he said. “Your genetics mean that you should get different doses or different drugs, because 25 to 50 per cent of drugs don’t work for any given individual.”

Spartan will take its FDA filing and submit it to Health Canada, which will be asked to follow with approval in this country. In the United States alone, there is a market of more than $300-million a year for the device, Mr. Lem said. More than one million U.S. patients a year have surgery to insert cardiac stents, and are then put on Plavix.

The DNA testing device will be manufactured at Spartan’s plant in Ottawa. That city is a good location for its development and manufacturing work, Mr. Lem said, because many high-tech suppliers are looking for work after the implosion of companies like Nortel Networks.

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