Spartan RX point-of-care CYP2C19 test to guide treatment in acute coronary syndrome

The technology described in this briefing is the Spartan RX point-of-care DNA test. It is used to detect mutations in the CYP2C19 gene. This can help guide treatment of people with acute coronary syndrome who have a percutaneous coronary intervention (PCI).

The innovative aspects are that the technology is a point-of-care test that provides results at the time of PCI without the need for follow-up hospital appointments.

The intended place in therapy would be in addition to standard care or in place of lab-based CYP2C19 genotyping for people with acute coronary syndrome who have PCI.

The main points from the evidence summarised in this briefing are from 6 studies (2 randomised controlled trials, 3 prospective cohort studies, and a report on a subset of 1 of the randomised controlled trials) including a total of 3,930 patients having or intending to have PCI. They show that genotype-guided antiplatelet therapy is non-inferior to standard treatment for thrombotic events and has a statistically significantly lower incidence of minor bleeding. They show that using Spartan RX is clinically feasible, with results usually available 1 hour to 2 hours after collection.

Key uncertainties around the evidence or technology are that guided antiplatelet therapy using CYP2C19 genotyping is not currently recommended as standard practice in the NHS, and that it has not been shown to be better than standard care for thrombotic outcomes (myocardial infarction, stent thrombosis, stroke or major bleeding). It is also not clear what impact repeat testing with Spartan RX, which may be needed if results are not conclusive, may have on the timing of treatment decisions and resource use.

The cost of the Spartan RX test is £10,000 for the platform plus £175 per test for consumables (excluding VAT).