Spartan CYP2C19 Test

Rapid genotyping for antiplatelet therapy.

1 in 3 people carry mutations.

CYP2C19 is a liver enzyme that metabolizes 15% of all prescribed drugs, including antiplatelet drugs, antidepressants, and PPIs. Carrying a CYP2C19 mutation can impair drug metabolism.

This mutation impacts the effectiveness of widely-used drugs such as Plavix®, Inderal®, Celexa®, and Losec®. Over 120 million people have been prescribed Clopidogrel (Brand name Plavix®) since its launch in 1998. However, 30% of Caucasians and 50% of Asians and Indians carry CYP2C19 mutations that impair drug metabolism. For heart attack patients, most complications from poor Plavix® response occur in the first 24 to 48 hours after cardiac stenting. There are currently over 20 million prescriptions of Plavix® worldwide. Knowing whether or not a patient will respond positively to a medication prescribed, has the potential to improve healthcare for many. Rapid CYP2C19 genotyping helps doctors treat patients with the most effective drugs.

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.

Accurate results
in one hour.

A third-party study of 325 individuals found that the Spartan RX CYP2C19 test was 100% sensitive and 100% specific compared to bi-directional DNA sequencing. Results of the test are available, after just one hour. No other analysis is required.

Medicare Reimbursed.
CPT Code 81225.

Reimbursement available from Medicare and most insurers, using CPT Code 81225. CYP2C19 gene analysis of common variants for drug metabolism.

Evidence

Spartans technology has been included in over 16 clinical studies including the POPular Genetics 8-year, 2,500 European patient trial published in the New England Journal of Medicine and RAPID GENE published in Lancet. Spartan's platform is also being used in the much anticipated TAILOR-PCI US clinical trial sponsored by the Mayo Clinic and NIH with results to be available at ACC in March 2020.

Precision Medicine at the University of Alabama at Birmingham: Laying the foundational processes through implementation of Genotype-Guided Antiplatelet Therapy

  • This independent report describes concordance of the Spartan RX with gold standard genotyping.

The use described in this publication is not approved or cleared by the US FDA. This study was supported in part by University of Alabama at Birmingham's Health Service Foundations' General Endowment Fund; The Hugh Kaul Precision Medicine Institute; by grants from the National Institutes of Health (grant numbers RO1HL092173, K24HL133373 to N.L.); and the National Human Genome Research Institute of the National Institutes of Health (grant number T32HG008961 to B.D.). Spartan knows of no other financial interests. Spartan knows of no significant risks or safety concerns associated with the use described in this publication.

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Point-of-care genetic testing for personalisation of antiplatelet treatment (RAPID GENE): a prospective, randomised, proof-of-concept trial

  • Rapid genetic testing after PCI can be effectively done at the bedside to identify CYP2C19*2 LOF allele carriers
  • This prospective, randomized 200-patient study reported that tailored, genotype-guided treatment of CYP2C19*2 carriers can reduce high on-treatment platelet reactivity, which is commonly associated with increased risk for major adverse cardiovascular events
  • This study is the first reported use of an FDA-cleared, rapid CYP2C19 genetic test, and offers a novel solution to overcome limitations in pharmacogenomics

*The Spartan CYP2C19 test is not cleared for point-of-care use in the US.

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Prospective CYP2C19 genotyping to guide antiplatelet therapy following percutaneous coronary intervention

  • Spartan's rapid CYP2C19 genotyping test was implemented at the University of Pennsylvania Health System for patients receiving percutaneous coronary intervention (PCI)
  • 28% of patients carried loss-of-function CYP2C19 mutations
  • Prasugrel or ticagrelor were used in 30% of the genotyped group vs. 21% of the usual care group who were not genotyped
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Spartan CYP2C19 testing