Genomeweb9 Aug 2024 09:36
The article is behind the paywall so I had to copy paste here for everyone to read .
Stanford Adds CYP2C19 Rapid Test to Genomics Menu, Plans Future PGx Expansion
Jul 29, 2024 | Molika Ashford
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NEW YORK – Stanford Medical Center has added rapid PCR-based testing for CYP2C19 to its larger menu of genomic and molecular tests, in line with growing data on its value in treating patients with transient ischemic attacks (TIA) or small strokes.
Using a platform called the Genomadix Cube, which was cleared by the US Food and Drug Administration last year alongside a paired CYP2C19 assay, Stanford's genomics lab can now provide results for ordering neurologists within 24 hours, with the test itself taking approximately 45 minutes to run.
While CYP2C19 testing has faced some resistance from clinicians in other settings based on skepticism regarding clinical utility, Stanford stroke biologist and neurology professor Neil Schwartz said that the benefit to patients in this setting, especially with new rapid and point-of-care testing options, seems clearer.
"What's emerged over the last decade or two is that the addition of Plavix (clopidogrel) to aspirin in patients presenting with TIA is really beneficial," Schwartz said.
He added that it has become standard for the center to put patients on a dual antiplatelet treatment, "but it turns out that a not-insignificant number of people may be Plavix non-responders because they have a 2C19 polymorphism such that Plavix is not converted into the active drug."
The CHANCE-2 study, which was performed in China and published in 2021 in the New England Journal of Medicine, confirmed this, finding that the risk of stroke at 90 days was lower, albeit modestly, with the alternative blood thinner ticagrelor than with clopidogrel in 2C19 variant carriers.
Importantly, the risk of severe or moderate bleeding did not differ between the study's two treatment groups, as bleeding risk has been somewhat of a barrier to test adoption in the cardiology community.
Strokes are a leading cause of adult disability in the US, Schwartz said, so the ability to prevent them in patients presenting with TIA is crucial.
Stuart Scott, director of Stanford's Clinical Genomics Laboratory, said that Schwartz first proposed instituting CYP2C19 testing almost two years ago.
"It took us some time to think through the trends and the platform, but that ultimately led us to Genomadix last summer when the FDA approved their instrument," Scott said.
Although Stanford's neurologists have had access to genetic testing prior to this, ordering a 2C19 test from an outside lab could take weeks.
"That's not particularly helpful because this high-risk period is a few days to a few weeks, so we really would like to get that result within hours to help make this decision," said Schwartz.
He added that it was "a lot of work by many folks" to get the Genomadix test rolled out. The lab began clinical testing early this
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