Originally published Oct. 31.
NEW YORK (GenomeWeb) – Spartan Bioscience is gearing up to commercialize its CYP2C19 test in Canada in the point-of-care setting, a previously untapped market for the company.
Health Canada's regulatory approval of the Spartan RX CYP2C19 System in the "near-patient" setting opens up "completely new markets" for the company, CEO Paul Lem said this week. Spartan can now sell its test at "doctors' offices and pharmacies in addition to the usual hospitals and cardiac catheterization labs that we have been targeting in the rest of the world," he said.
The Spartan RX CYP2C19 System has an approximate hour-long workflow, during which a healthcare provider swabs a patient's cheek, places the sample in a tube, scans the test's barcode, deposits the sample tube in the Spartan RX CYP2C19 System, and pushes the start button on a laptop linked to the machine.
In the US, the Food and Drug Administration has updated the label of the antiplatelet treatment Plavix with a boxed warning informing healthcare providers that patients carrying certain CYP2C19 SNPs have impaired ability to metabolize the drug and may need dosing adjustments or alternative therapies. The agency has cleared several CYP2C19 tests that can be used to guide treatment strategies with Plavix and other drugs metabolized by CYP2C19 enzymes, and last year cleared Spartan's test, but without a point-of-care designation.
In the US, Spartan didn't satisfy the evidence requirements to garner a point-of-care indication from the FDA, according to Lem, and the agency has asked for additional studies that would satisfy such a designation. Lem told PGx Reporter this week that Spartan is still working with the FDA to provide the additional studies that it needs to garner such a claim, but didn't provide a timeline for when those studies would be completed or submitted. Getting the point-of-care indication in the US for the Spartan RX CYP2C19 System "is definitely something that we still want to do," Lem said.
With Health Canada, Spartan submitted the same data that it submitted to the FDA and was able to garner a "near patient" claim. According to the US label for Spartan's test, the company submitted data to the FDA from multiple studies to establish the analytical validity of the test and compare it with others out on the market.
Spartan conducted a trial at three sites to establish the reproducibility of the test, which gauges CYP2C19 mutations *2, *3, and *17. Out of 960 tests, 10 yielded inconclusive results and had to be repeated. After retesting those samples with inconclusive results, Spartan's diagnostic yielded a correct call rate of 99 percent, with one incorrect call. Spartan referenced published literature to establish the clinical validity of the CYP2C19 test. The company also conducted an analysis to see if test calls would be impacted by substances in patients' mouths before their cheeks were swabbed, such as mouthwash, cigarette smoke, and chewing gum.
Of the FDA-approved tests, Spartan's test boasts the fastest turnaround time, returning results within an hour. Nanosphere's test yields results in 2.5 hours, while the turnaround time for AutoGenomics' test is longer.
With access to the point-of-care market in Canada, Spartan is in the process of pinning down its marketing strategy for the CYP2C19 test. At the moment, Lem said the firm is in discussions with pharmacies and pharmacy chains to place its test in stores.
Currently, customers can go to pharmacies and get their blood pressure checked at a kiosk. Spartan's idea for its test is somewhat similar in that Spartan RX CYP2C19 Systems will placed at the pharmacies and the testing will be done in house, but pharmacists will need training to identify which individuals should receive testing, learn the procedure for swabbing the customer's cheek, and to correctly place the sample in the instrument for analysis. Similarly, nurses at doctors' offices will also need to be trained.
As such, Spartan is planning to conduct pilot programs to assess healthcare providers' needs and establish the best practices for their training before broadly launching the test. "The pharmacies we're now in discussions with have some budget and they are going to put our system in and start testing patients on a pilot basis," Lem said. Still, the test needs to be performed, even in the near-patient setting, under the supervision of a lab director. "So, at the pharmacies we're talking to, we will have lab partners involved that will provide that oversight," he added.
The company hasn't figured out whether it will use a specialized sales force to spread word about the test in Canada. "That's something we will think about doing once we start to get the first accounts in Canada," Lem said.
In the US, Spartan estimates that as many as 1.2 million cardiac patients on stents who may get Plavix may be appropriate for CYP2C19 testing. In Canada, the market for Spartan's test in this setting is approximately 100,000 patients.
"We think [the Canadian approval] could greatly increase the market for the test because obviously hospitals represent just a small section of the medical care side," Lem said. "There are way more pharmacies and way more doctors' offices than hospitals. So there is potential for higher volume."
Having a rapid test such as this at hospitals enables doctors to test patients in acute care settings. The ability to test patients at pharmacies and doctors' offices, meanwhile, allows healthcare providers to garner patients' CYP2C19 status in a preemptive manner and store it in the medical record for future use.
In the US, several academic centers have employed programs to gauge whether preemptive pharmacogenomic testing of this kind improves patient outcomes and lowers healthcare costs.
The Spartan RX CYP2C19 System is list priced at a few hundred dollars in the US, but the company hasn't yet set a price for the Canadian market. "As we do these pilots, we're going to get feedback from the market and see what is the right pricing for Canada," Lem said. He added, however, that as test commercialization rolls out in Canada, patients will initially have to pay an out of pocket fee.
Healthcare interventions performed at Canadian hospitals are paid for out of the hospitals' operating budget. Under Canada's universal healthcare system, if certain medical products aren't paid for, patients can purchase private insurance for supplemental coverage or pay out of pocket. "Over the long term we're thinking about approaching the private insurers, and seeing whether they'd be willing to cover [CYP2C19 testing]," Lem noted.
There are a number of drugs metabolized by CYP2C19 enzymes, among them proton pump inhibitors. Spartan is hoping to expand the use of its test to guide therapeutic strategies with these agents as well. "Proton pump inhibitors are taken by hundreds of thousands of people in Canada," Lem said. "This could be another application for the test."