By Ben Butkus
This article was originally posted on Dec. 20.
Canada's Spartan Bioscience said this week that its CYP2C19 molecular test, which runs on the company's Spartan Rx PCR-based point-of-care testing platform, has received a CE Mark for in vitro diagnostic use in Europe.
In addition, Spartan has already sold four systems to undisclosed customers in Europe and is "very close" to signing its first distribution agreement on the continent for the Spartan Rx CYP2C19 test, Spartan CEO Larry D'Andrea told PCR Insider this week.
"We have a plan to basically march through Europe," D'Andrea said. "We're starting with the larger countries and working our way through. It's a country-by-country decision because, despite the CE Mark, there is translation and a bunch of other things we will need to look at."
Spartan, based in Ottawa, Ontario, will also now be able to market its test in other non-European countries recognizing the CE Mark, including in the Middle East, Africa, Latin America, and Asia-Pacific.
The CE IVD Mark is Spartan's first non-investigational regulatory approval for a molecular test on the Spartan Rx platform, a fully automated, sample-to-answer molecular testing system. The company unveiled Spartan Rx in August for research use only, and said it was conducting various clinical trials to generate data to support diagnostic regulatory filings around the world (PCR Insider, 8/12/10).
At the time, D'Andrea noted that the company believed it would be able to obtain a CE Mark in as little as six months, but that regulatory approval in Canada and the US would likely not happen until late 2011. D'Andrea this week firmed that timeline up, saying that the company is targeting the third quarter of 2011 for such regulatory approvals.
Spartan Rx CYP2C19 will test patients 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.
A number of CYP2C19 mutation molecular tests are available through centralized laboratories, but the threat of major cardiac events in heart attack patients within the first 24 to 48 hours of receiving Plavix has upped the need for a point-of-care test with a fast turnaround time.
To wit, in July researchers at Hôpital Pitié-Salpêtrière in Paris published a meta-analysis in the Journal of the American College of Cardiology showing that patients who carry the CYP2C19 loss-of-function gene variant appeared to have an excess risk of cardiovascular events and mortality. As such, the researchers concluded that a "rapid and inexpensive" test for CYP2C19 "is of the utmost importance" to identify patients at excess risk of developing cardiovascular events and death while taking Plavix.
"There are other companies that can do [CYP2C19] molecular tests," D'Andrea said. "The difference we have is that our test can be used by a nurse in the lab. There is no sample preparation, no reagent mixing, and no pipetting of any kind. You take the buccal swab, put it in the cartridge, put it in the device, press go, and the results print out in an hour. I don't believe there is anyone else that has that capability, where it can be used by a non-lab-trained person."
In October, AutoGenomics received 510(k) clearance from the US Food and Drug Administration for its Infiniti CYP2C19 molecular test, a microarray-based test that runs on the company's fully automated Infiniti Analyzer platform.
Nevertheless, the market need for POC testing for CYP2C19 mutations is still high, according to Spartan, and the CE Mark for the Spartan Rx test is important for the company from a financial standpoint. To this point it has recognized little if any income from Spartan Rx CYP2C19, as it has been providing the test to early users for investigational use only.
Now, "we've already sold our first four systems, and have quotes out for more," D'Andrea said. "We expect revenue will ramp up as we are able to put distribution into place."
The company has not published a price for the Spartan RX platform. However, D'Andrea noted in August that Spartan RX CYP2C19 pricing "will be very favorable compared to the $250 to $500 it costs today to run the same type of tests."
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