MedicalResearch.com Interview with:
Szilard Voros, MD, FACC, FSCCT, FAHA
CEO of Global Genomics Group
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Atherosclerotic coronary artery disease (ASCAD) is the leading cause of death and morbidity in the United States and worldwide, despite relatively successful medical therapies such as statins, like Zocor or Lipitor. A significant majority of patients with ASCAD present with sudden cardiac arrest, and the clinical evaluation of those patients who present with chest pain to their physicians is very inefficient. Based on current clinical guidelines, patients who present to their physician with complaints of new onset chest pain or its equivalent, such as exertional dyspnea should be assessed for the probability of the presence of significant ASCAD based on simple clinical predictors. Approximately 60% of such patients have an intermediate probability, and they are typically referred for initial non-invasive evaluation, such as a stress test with cardiac imaging, or for some other type of non-invasive test. Strikingly, no more that 5% of such stress tests performed in the United States are actually positive, and even when patients with positive stress test are taken for invasive coronary angiography, no more than 40% have significant ASCAD.
A blood test that could serve as first step, as a “gatekeeper”, to non-invasive evaluation, would be highly desirable. Global Genomics Group, or G3, has performed one of the largest, unbiased, mass-spectrometry-based discovery studies in over 1,000 patients who underwent detailed cardiac CT to assess the presence or absence of ASCAD, by measuring over 1,000 metabolites from the blood. Using sophisticated bioinformatics tools, the researchers identified 8 important metabolites that were significantly abnormal in patients with ASCAD, and generated a biomarker signature for the detection of ASCAD based on those analytes, called “knowPLAQUETM”. The biomarker signature was generated in approximately 800 subjects, and was validated in an independent set of approximately 400 subjects, showing an area under the curve (“AUC”) of 0.82 for the diagnosis of Atherosclerotic coronary artery disease. This biomarker signature can be adapted relatively easily on commercial mass spectrometry platforms, and the researchers anticipate that this signature may be available for physicians to use by 2018. In addition to its diagnostic power, this biomarker signature also has uncovered important biological insights for the development of ASCAD, which can be leveraged for therapeutic purposes.
MedicalResearch.com: What should readers take away from your report?
Response: The most important take-away is that this research generated a simple blood test that can determine whether Atherosclerotic coronary artery disease, a potentially life-threatening disease, may be the cause of a patient’s chest pain. If this novel diagnostic blood test, “knowPLAQUETM”, is negative, it indicates that the patient has “no plaque”, or ASCAD.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: In addition to the clinical use described above, this simple blood test can be used in future clinical trials to enrich them in patients with the presence of ASCAD.
By way of disclosure, Global Genomics Group, or G3, was the sponsor of the study.
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