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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


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