CYP2C19 Genotyping
1-hour CYP2C19 Genotyping can help guide P2Y12 inhibitor therapy to reduce the risk of ischemic events while minimizing bleed risk in minor stroke/high risk TIA, ACS and PCI patients.
510(k) Cleared & CE Marked
Minor Stroke and TIA patients are at the highest risk of a recurrent stroke within the first week and especially in the first 48 hours after initial symptoms.1 PCI patients are at the highest risk of an ischemic or bleed event within the first 3 days after a PCI, with an average daily event rate over 1% per day for both ischemic and bleed events.2,3
Most genotyping methods return results outside the window of recurrent stroke prevention for minor stroke/TIA and recurrent adverse event prevention for PCI and ACS patients4,5
Receive a CYP2C19 genotype report an hour after starting the test
Receive a CYP2C19 genotype report an hour after starting the test
PCR- based CYP2C19 genotyping offers the confidence and accuracy with proven results. Results of 433 patient clinical trial showed that analyzing a buccal sample using the Genomadix Cube CYP2C19 System will provide an accurate genotype call 99.1% of the time.
The buccal swabs can be run up to 20 hours after collection from the patient.
The Genomadix Cube CYP2C19 System requires a simple cheek swab and cartridge to operate. Swab the patient’s cheek and insert the sample into the cartridge.
- No pipetting.
- No DNA extraction.
- No complicated procedures.
- No calibration or maintenance required.
Reimbursement is available from most insurers in the US (including Medicare), using CPT Code 81225- Gene analysis (cytochrome P450, family 2, subfamily C, polypeptide 19; CYP2C19) common variants
The Genomadix CYP2C19 Test: Rapid Genetic Insights for Targeted Antiplatelet Therapy
Effective antiplatelet therapy for minor stroke/TIA, ACS and PCI patients is critical. Prescribing effective dual anti-platelet therapy (DAPT) within 12 hours of symptom onset for stroke patients and de-escalating ACS and PCI patients in a timely manner is essential for improving patient outcomes.5 Specific patient care begins with understanding genetic variations that can affect antiplatelet therapy response. The Genomadix CYP2C19 test delivers rapid genotyping, allowing the switch to a more appropriate antiplatelet therapy in patients where standard treatments may not work.5,6 Obtain the answers you need within about 1 hour to improve patient-specific care.
Genomadix has developed the Cube, the world’s first real-time PCR point of need platform for precision medicine testing and other applications.
- Genomadix produces molecular tests for precision medicine genotyping and environmental/water safety testing.
- Genomadix commercializes the Cube CYP2C19 Genotyping Test, the world’s fastest and easiest FDA-cleared CYP2C19 genotyping test, which can be used to support dual antiplatelet therapy decisions for stroke and cardiology patients.
- The Genomadix Cube is a point of care open platform, and is available for partnering with assay developers, clinical labs, laboratory service providers, and others.
- Genomadix’s technology for the cube includes over 3 million hours of research and development, 11 patents and 23 peer-reviewed scientific publications
Non-invasive Test, No Preparation.
Our test requires a simple cheek swab to operate. Swab the patient’s cheek and insert the sample into the tube. No pipetting. No DNA extraction. No complicated procedures.
510(k) Cleared
The Genomadix CYP2C19 test is backed by gold standard PCR technology and has FDA 510 (k) clearance. Trust in our commitment to quality and innovation in genetic testing.
Medicare Reimbursed. CPT Code 81225.
Reimbursement is available from Medicare and most insurers, using CPT Code 81225. CYP2C19 gene analysis of common variants for drug metabolism.
- Johnston et al. Circulation. 2019;140:658–664. DOI: 10.1161/CIRCULATIONAHA.119.040713
- Giustino, G et al., JACC. 2017;70(15):1846-1857
- Yusuf S., et al. Circulation. 2003;107:966-972.
- Pan Y, et al. JAMA Neurol. 2022;79(8):739–745.
- Pereira et al. Circulation. 2024;150:e129-e150. DOI: 10.1161/CIR.0000000000001257.
- Lee et al., Clin Pharmacol Ther. 2022 November ; 112(5): 959–967. doi:10.1002/cpt.2526 |
