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Canada's Spartan Bioscience Launches POC DNA Testing System for PGx Applications

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By Ben Butkus

Canadian molecular diagnostics firm Spartan Bioscience this week unveiled the Spartan RX, a fully automated, point-of-care, PCR-based testing platform for personalized medicine.

According to the company, the platform, which is currently available for research use only, is easy to use and will allow medical staff to obtain pharmacogenomic data to help tailor patients' treatments in a fraction of the time and at a "very favorable" cost compared to centralized laboratory testing.

In addition, Spartan said that the first available test on the system, for the CYP2C19*2 mutation that guides how patients metabolize the anti-coagulant Plavix, is currently being studied in a clinical trial in Canada. The company expects that data from the study will help support regulatory filings around the world for the combined test and instrument platform.

Privately held Spartan, based in Ottawa, was founded in 2005 to develop and market DNA testing systems for "decentralized applications where rapid and convenient DNA testing is particularly important, such as pharmacogenetics, infectious diseases, and food and water safety testing," according to the company's website.

The company launched its first DNA testing device, the Spartan DX, in 2007. Then, last year, it launched a next-generation device, the Spartan DX-12 DNA analyzer, as an easy-to-use, lightweight benchtop instrument for non-batched PCR applications.

According to the company, the DX-12 features 12-well sample capacity, dual-channel optical detection, two- or three-temperature PCR programs, and melt curve analysis; is compatible with leading reagents and test kits; and typically produces results in 30 to 60 minutes.

Spartan CEO Larry D'Andrea told PCR Insider this week that the DX-12 "was really more designed for researchers who want to … do different programming and develop and run their own tests. The company has also developed an extensive menu of tests for the device for investigational use only.

D'Andrea said that sales of the device "are ramping up," though "not as quickly as we would like." Nevertheless, he said the company has sold devices worldwide and is focusing heavily on its ability to diagnose infectious diseases. The company is especially marketing this latter capability to resource-poor areas of the world. D'Andrea also said that the US Centers for Disease Control is using the DX-12 in water testing research.

Meantime, the new Spartan RX platform is a pared-down version of the DX-12 that is designed to deliver the same ease of use and small footprint as its predecessor, but with an even more acute application focus.

"I could teach you how to run a test in about 10 minutes," D'Andrea said. "You take a buccal swab, you basically put that in our tube, put it in the machine, and press go, and an hour later it prints out the results. All the sample prep, purification, everything is integrated."

The major difference between the RX and the DX-12 is that "we've basically taken away a lot of functionality," D'Andrea added. "You can't enter your own program in, so if scientists want to … develop their own tests, they won't be able to do that with the RX. It only runs one test with our set of reagents. We've boiled it down so it does one thing and only one thing."

That "one thing," at least initially, is to test for the CYP2C19*2 mutation, which is found in up to 30 percent of the world's population and is associated with impaired metabolism and possible adverse cardiac events following administration of Bristol-Myers Squibb's anti-blood-clotting medication Plavix, also known as clopidogrel.

In March, the US Food and Drug Administration issued a black box warning on the label for Plavix, which informs healthcare providers that patients with diminished CYP2C19 function are at greater risk of cardiovascular adverse events after an acute coronary syndrome or percutaneous coronary intervention than normal metabolizers of Plavix.

However, CYP2C19 tests that are currently on the market have long turnaround times, which could limit their application in the acute setting. In light of this, point-of-care CYP2C19 tests such as the Spartan assay stand to capture this untapped market.

A number of labs offer tests for the CYP2C19 mutation through centralized laboratories. The problem with this, however, is that such tests "take one to seven days to get a test result back," Derek So, a staff cardiologist at the University of Ottawa Heart Institute, said in a statement.

"As a one-hour point-of-care test, the Spartan RX CYP2C19 has the potential to significantly reduce major cardiac events in heart attack patients," So added.

D'Andrea said that Spartan's development of the CYP2C19 test "was really driven by need. Interventional cardiologists approached us and said 'You have this device, could you run a test for us?' And we said we could, and that it would take an hour. They were excited … because they know that gene has a big say in how people respond."

Spartan is currently selling the platform to interested parties for investigational use, but in the meantime, it has begun a clinical trial called Rapid Gene at UOHI to test the platform for clinical use. Specifically, the randomized trial will determine if alternative anti-coagulant therapy with Eli Lilly's Effient, or prasugrel, reduces major adverse cardiac events for carriers of CYP2C19*2.

"This will be the first time that the genotyping will be done as patients are coming in for the surgery, rather than looking at it after the fact," D'Andrea said.

If all goes well, Spartan is hoping that data from the trial will help support regulatory filings for the combined test and platform "around the world," D'Andrea added.

"It's just a question of where we're going to do it first," he said. "The suspicion is that FDA approval will take the longest time, and likely a CE Mark will take the least amount of time."

Spartan's original timeline for a first regulatory approval was about five quarters, so sometime near the end of 2011, D'Andrea said. However, because initial testing has revealed that the test "is in extremely high concordance with confirmatory testing," the company now believes it may be possible to gain at least a CE Mark in as little as six months, he added.

Spartan is not publishing pricing for the Spartan RX platform. "We haven't set it yet," D'Andrea said. "We're just looking at it now." However, when the company released the DX-12 last year, it said that it would sell for less than $12,500.

D'Andrea also noted that the cost of the Spartan RX CYP2C19 platform "will be very favorable compared to the $250 to $500 it costs today to run the same type of tests."

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