A small Ottawa biotechnology company has received Health Canada approval to sell an innovative DNA testing device that will allow quick genetic checks in doctors' offices or pharmacies.
Spartan Bioscience Inc. has the regulator's approval to sell the device, which can help ensure heart patients get the right medication for their genetic makeup. Up to now it has only been able to use the machine in Canada in clinical trials.
The portable device, called Spartan RX, could dramatically change the way genetic tests are performed because it is almost instantaneous. Generally these tests are done in large laboratories, and are time consuming – it can take up to a week to get results. Using the new technology, patients find out within an hour if they are suitable candidates to receive certain medications.
Spartan has already received regulatory approval to sell the device in the United States, although in that country it can only be used in a hospital. The Health Canada approval allows for its use by front-line health care professionals such as doctors, nurses and pharmacists. That means it could be set up in a doctor's office, for example, or pharmacists could use it to make sure that patients are getting an appropriate medicine.
The first application of the device helps doctors decide if patents 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 serious. The Spartan technology allows a quick check, using a cheek swab that is placed into the device, which is about the size of a toaster. The results show whether the patient should be treated with an alternative drug.
In essence, the device can help select the most effective and most cost-effective treatment, said Spartan chief executive officer Paul Lem. That could save lives and a lot of money for the health-care system, he said. The Spartan device will be adapted to check patients' genetic suitability for many other widely used medications, including cholesterol-lowering agents, beta blockers and anti-depressants.
The fact that Health Canada is allowing the device to be used in "near-patient" locations and not just in labs is crucial, Mr. Lem said. Currently there are "no genetic tests that are allowed to be done in pharmacies or doctors' offices, anywhere in the world. This would be the first time," he said.
Allowing pharmacists to do genetic testing can help the shift to truly personalized medicine, Mr. Lem said. "Where you pick up your drugs is the pharmacy, and the pharmacist knows the most about the drugs. This gives pharmacists the power to run that test right there, get the results and then tailor your treatment."
Currently the Spartan device is pricey. The unit costs about $10,000, and each test costs about $250. But Mr. Lem said his company will experiment with different price points and contract structures to make sure "the cost of the equipment is not a barrier for anyone to adopt it." He would not say how many of the devices have been sold so far in the United States and other markets where it has already received regulatory approval.
But he expects sales to jump sharply after the company gets the results of a large North American clinical trial involving more than 5,000 patients that is being funded by the Mayo Clinic.