Evidence

Spartan's molecular diagnostic test is based on more than 15 years of R&D and decades of scientific research. The following studies support Spartan's technology.

American Heart Association: Prospective CYP2C19 genotyping to guide antiplatelet therapy following percutaneous coronary intervention

Medical
  • 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

New England Journal of Medicine: A Genotype-Guided Strategy for Oral P2Y12 Inhibitors in Primary PCI

Medical
  • This randomized, prospective trial of 2,488 patients undergoing primary PCI with stent implantation assessed the use of a genotype-guided approach to oral P2Y12 inhibitor selection
  • This study showed that a genotype-guided approach to therapy was noninferior to standard treatment with ticagrelor or prasugrel with respect to thrombotic events, and resulted in a lower incidence of bleeding
  • Considering that ticagrelor/prasugrel cost 10-20X more than generic clopidogrel, CYP2C19 genotyping can significantly lower healthcare costs

American Society for Clinical Pharmacology and Therapeutics: Precision Medicine at the University of Alabama at Birmingham: Laying the foundational processes through implementation of Genotype-Guided Antiplatelet Therapy

Medical
  • 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.

The Pharmacogenomics: Cost-effectiveness of CYP2C19-guided antiplatelet therapy in patients with acute coronary syndrome and percutaneous coronary intervention informed by real-world data

Medical
  • A cost-effectiveness analysis (CEA) was performed using real-world data from acute coronary syndrome (ACS) patients receiving percutaneous coronary intervention (PCI)
  • The CEA compared three antiplatelet treatment strategies: (1) universal clopidogrel, (2) universal ticagrelor, or (3) genotype-guided therapy
  • Only genotype-guided therapy resulted in an improvement in quality-adjusted life years (QALYs) and was cost-effective

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

Medical
  • 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.

IWA Publishing: Validation and in-field testing of a new on-site qPCR system for quantification of Legionella pneumophila according to ISO/TS 12869:2012 in HVAC cooling towers

Environmental
  • 53 cooling towers were tested for 12 weeks by Spartan's on-site qPCR test and lab culture.
  • On-site qPCR detected Legionella above the acceptable limit of 10 bacteria/mL in 21 towers (40%).
  • In contrast, lab culture only detected Legionella above the limit in 8 towers (15%), and completely missed a tower with contamination >100× the limit.
  • A major reason for culture's poor performance was that bacteria degraded in 72% of water samples shipped to the lab.
  • Lab qPCR showed no correlation with lab culture and suffered the same bacterial degradation effect during shipping.
  • 11 cooling towers (21%) experienced rapid Legionella growth of 3X to 21X over 7 days.
  • Spartan's on-site Legionella qPCR test was validated according to ISO 12869 and detects live not dead bacteria.