persona biomed customized medical research services€¦ · • many factors and disorders increase...

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PERSONA BioMED CUSTOMIZED MEDICAL RESEARCH SERVICES PREDICTIVE MOLECULAR PROFILES FOR HEALTH LABORATORY DIAGNOSTIC TESTS Inflammation-Associated Atrial Fibrillation and Recurrent Arrhythmia Atrial fibrillation (AF) is the most common arrhythmia in clinical practice, affecting up to 10% of the population over 60 years old. Its occurrence rises with age and leads to heart failure, peripheral embolism and stroke, and its mortality remains high despite effective anticoagulation. In addition, about 20% of all cases of AF remain undiagnosed and its recurrence ranges from 40 to 50%, despite the attempts of electrical cardioversion, ablation and the administration of antiarrhythmic drugs. Therefore, every effort should be made to prevent arrhythmias in the clinical setting. Many factors and disorders increase the risk of AF, including obesity, diabetes, male sex, chronic low-grade inflammatory rheumatic diseases, symptomatic skeletal pathologies, chronic osteomyelitis, hypertension, coronary artery disease, chronic kidney disease, sepsis, obstructive sleep apnea, high-level physical training in active or former competitive athletes, subclinical hyperthyroidism, cancer, cigarette smoking, NSAIDs and alcohol consumption.

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Page 1: PERSONA BioMED CUSTOMIZED MEDICAL RESEARCH SERVICES€¦ · • Many factors and disorders increase the risk of AF, including obesity, diabetes, male sex, chronic low-grade inflammatory

PERSONABioMED CUSTOMIZEDMEDICALRESEARCHSERVICESPREDICTIVE MOLECULAR PROFILES FOR HEALTH LABORATORY DIAGNOSTIC TESTS

Inflammation-Associated Atrial Fibri l lation and

Recurrent Arrhythmia

• Atrialfibrillation(AF)isthemostcommonarrhythmiainclinicalpractice,affectingupto10%ofthepopulationover60yearsold.Itsoccurrenceriseswithageandleadstoheartfailure,peripheral embolism and stroke, and its mortality remains high despite effectiveanticoagulation. In addition, about 20% of all cases of AF remain undiagnosed and itsrecurrencerangesfrom40to50%,despitetheattemptsofelectricalcardioversion,ablationand the administrationof antiarrhythmic drugs. Therefore, every effort shouldbemade topreventarrhythmiasintheclinicalsetting.

• Many factors and disorders increase the risk of AF, including obesity, diabetes, male sex,chronic low-grade inflammatory rheumatic diseases, symptomatic skeletal pathologies,chronicosteomyelitis,hypertension,coronaryarterydisease,chronickidneydisease, sepsis,obstructivesleepapnea,high-levelphysicaltraininginactiveorformercompetitiveathletes,subclinicalhyperthyroidism,cancer,cigarettesmoking,NSAIDsandalcoholconsumption.

Page 2: PERSONA BioMED CUSTOMIZED MEDICAL RESEARCH SERVICES€¦ · • Many factors and disorders increase the risk of AF, including obesity, diabetes, male sex, chronic low-grade inflammatory

• AmongpotentialpathogenicfactorsofAF,inflammatoryimbalancemayplayacriticalrole.Notsurprisingly, thepresenceof inflammation in theheart and systemic circulation canpredictthe onset of AF and AF-associated thromboembolism in the general population; and AFrecurrenceinpatientsaftercardiacsurgery,cardioversion,andcatheterablation.Moreover,inflammatory cells and mediators modulate calcium homeostasis and connexins therebyalteringcardiactissuestructureandconduction,whichinturnleadstostructuralremodelingoftheatriaandincreasedvulnerabilitytoAF.

• WecustomizeaneffectiveassessmentofAF riskand recurrence, supportedbyaLaboratoryDiagnosticTest(LDT)usingaproteinexpressionprofilingmethodbasedonamultiplexfullyautomated,proteinarraychipsystem.TheLDTdeterminesbloodlevelsof:o Cardiomyocyteinjuryandstressbiomarkers(troponin-T,N-t-B-typenatriureticpeptide).o Inflammatorymarkers(IL-6,C-reactiveprotein,IL-2/IL-4,IFNgamma/IL-4,SolubleRAGE).o Fibrosis markers (matrix metalloproteinases (MMPs), plasminogen activator (PA)

inhibitor1,tissuePA,MMP-9/TIMP-1).o Atrialremodelingmarkers(procollagenIIIC-terminalpropeptide,TGF-β1,adiponectin).

• OfferedLDTmayhelp:

o ToidentifypatientswithoutAFwhosedisease(s)andtreatment(s)mayleadtoaninflammatoryimbalanceathighriskofAF.

• ThetestwouldhelptopredicttheriskofAFandwouldrecommendtreatingtheinflammatoryimbalanceforpreventingorrevertingonsetofAF.

o TostratifypatientswithAFaccordingtotheirinflammatoryimbalancelevel.

! AFPatientswithinflammatoryimbalance.• ThetestwouldidentifypatientswithInflammation-dependentAFathigh-risk

of reconnection after RF ablation; and it would recommend anti-inflammatorytreatmenttopreventreconnectionafterRFablation.

• The test would alert on the occurrence of occult cancer (Colon, Lung,Kidney)inpatientswithoutchronicdiseasesaccountingfortheinflammatoryimbalance.

! AFPatientwithoutinflammatoryimbalance.• The testwould identifypatientswith inflammation-independentAFat low-

riskofreconnectionafterRFablation.

• ThistestwasdevelopedanditsclinicalperformancefeaturesdeterminedbyPBM.IthasnotbeenclearedorapprovedbytheFDA.Itshouldnotberegardedasinvestigationalorforresearch.

• Finaldiagnosisandoptimalpatientmanagementaretheresponsibilityofthereferringphysicianorhealthcareprovider.

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PERSONA BIOMED Inc. is a clinical-stage biotech company devoted to the development of clinically-validated gene and molecular expression profiling methods for contributing to the success of Precision Medicine.

Contact Information: Persona Biomed, Inc. 625 N. Washington St., Suite 425 Alexandria, VA 22314 [email protected]; www.personabiomed.com