4/27/2015 1 The Future of Laboratory Testing
4/27/2015 OBJECTIVES • Describecurrenttrendsinclinical laboratorytesting. • Discussup‐and‐cominglaboratorytesting methods. • Discussthepotentialimpactoffuturistic The Future of Laboratory Testing testingmethodologiesontheclinical laboratory. Lee Ellen Brunson-Sicilia, MHS, MLS(ASCP)CM DISCLOSURES WHEREWECAMEFROM… • IhaveNOaffiliationwithanyoftheproductsor • 420BC:Hippocrates– originofrational companiesdiscussedtoday. medicine • 1250AD:Firstmagnifyingglassconstructed • 1800s:diagnosisandtreatmentreliedheavily onpatienthistoryandphysicalexam • 1870:PasteurandKoch– germtheoryof disease WHEREWEARENOW… WHEREWECAMEFROM… • Early1900s:discoveryofbloodgroupsystems; developmentofchemicalanalysisofbodyfluids • 1950s:numberofinsuredincreased,asdid demandforlabtesting • 1985:AutomatedDNAsequencing,PCR • 1998:Stemcelltherapy • 2000:Humangenomesequenced 1 4/27/2015 WHEREWEAREHEADED… SMARTPHONES • Towardafutureinwhichpatients,not • Averagesmartphone hasmoreprocessingpower physicians,haveprimarycontrolover healthcaredata • Alreadyusedtotrackhealth‐relatedinformation: – 2/3/14FederalamendmenttoCLIA:labsmay provideresultsdirectlytopatients thanNASAhadwhenitputamanonthemoon – Measureheartrates – Tracknumberofstepstaken – Mapsleepcycles • Widespreadsmartphone usehasbroad implications,includinginareaswherelaboratories arenotfound. • ManytestingplatformsawaitingFDAapproval SMARTPHONETESTING:HIVAND SYPHILIS SMARTPHONETESTING:HIVAND SYPHILIS,CONT. • $34dollarsmartphone attachmentdetectsHIV • Resultsin15minutes,loadedintophone’s • Usesdisposablecartridgesthatcostjust • Smallamountofcurrentfromaudiojack • Goldnanoparticles bindtoantibodies;silver • ~40testsperphonecharge andsyphilisantibodiesinjustdropsofblood pennies nanoparticles forma“film”aroundthegold, blockinglight storage,uploadedtoaserver providespower • SmallstudyinRwandacorrelatedwellwith ELISAresults • PotentialtosavemillionsoflivesinruralAfrica SMARTPHONETESTING:HIVAND SYPHILIS SMARTPHONETESTING:URINE • Scanaflo • Colorimetricmethodologylikecurrentdipstick • Measuresupto12analytes,including microalbumin andcreatinine • Smartphonedetectscolorchanges,takespicturein anylight • Recordsinformationwhichmaythenbesentto physician • Tracksresultsovertime • AwaitingFDAapproval HIV smartphone.mp4 2 4/27/2015 SMARTPHONETESTING:URINE SMARTPHONETESTING:COAG TESTS • Single‐use,microfluidic plastic“sticker”applied toscreensurface • Bloodpassesthroughtinychannelswhich containparticlesthatinitiateclotting • Smartphonescreendetectschangesin electricityasbloodclots • Appinterpretstheelectricalsignalandgives coagulationresults,whicharesenttophysician • Medicationmaybeadjustedquicklyifneeded Scanaflo Home Urine Testing.mp4 SMARTPHONETESTING:COAG TESTS SMARTPHONETESTING: ProsandCons • Decreasedmedical costsandTAT • Convenience • Increased accessibility • Accuracyoftesting • Performanceof testing • Potentialfor contamination • Interpretation 23andMe HOWDOESITWORK? • Saliva‐based,direct‐to‐consumerpersonalDNA • ~0.5%ofsalivaismadeupofDNA‐containing • Introducedin2007,originally$999 • Salivacollectedupto“fillto”line • TIME magazine’sInventionoftheYearin2008 • Tubelidcontainspreservative testing • Firstmarketedasafun waytolearnaboutgenetics cells bufferthatenterstubeupon closing • Tubeismailedtolab • Resultsonlinewithin6– 8weeks 3 4/27/2015 23andMe:HEALTHREPORT 23andMe:HEALTHREPORT • Inheritedconditions – CysticFibrosis – SickleCellAnemia – Tay‐SachsDisease • Responsetotreatments – Plavix – Warfarin – 5‐FU • Geneticriskfactors – Alzheimer’sDisease – Parkinson’sDisease – BreastCancer • Genetictraits – Lactoseintolerance – Odordetection – Caffeinemetabolism – Cilantroaversion – Photic sneezereflex – Sweettastepreference 23andMe:ANCESTRYREPORT • Ancestrycomposition– somepopulationsat greaterriskforcertaindiseases • DNArelatives • Maternalandpaternallineages • Familytreetool • Relative‐finder 23andMe:RESEARCH • Voluntaryparticipation • Oneconsentingusercontributesto~230genetic researchstudies – Onlinesurveys – WorldwideanalysisofDNAdatafromdatabase • Peoplewithcertaindiseasesmaybeencouraged toparticipatewithfreegenotype. • Researchsubjectsarenotifiedofresearchresults. 4 4/27/2015 23andMe:PRIVACY 23andMe • Hasgeneticinformationfor>900,000people • Personalizedsecurewebaccount,with multiplelevelsofencryptionandsecurity worldwide,combinedwithsurveyinformation voluntarilysubmittedbycustomers • HealthreportshaltedbyFDAin2013 • Optiontodeleteallinformationfrom • InU.S.,only“rawgeneticdata”andgenealogy • Customersownsalldata. • FirstFDA‐approvedtestin2015,forBloom servers. informationprovidedtocustomers Syndrome:autosomal recessive,shortstature, sun‐sensitivechanges,↑↑cancerrisk • Usefulforprospectiveparents 23andMe:ProsandCons • Preventative • Securityof • Decreasedmedical • Privacy healthcare costs • Familyhistory THERANOS:ELIZABETH HOLMES information • Dealingwith results THERANOS:ELIZABETH HOLMES THENANOTAINER • ChemicalengineeringmajoratStanford;dropped outat19in2003 • Usedremainingtuitionmoneyasstart‐upfunds • Youngestself‐madefemalebillionaireintheworld • Owns50%ofcompany;worth$4.5billion • NamedtoTIME’s100MostInfluentialPeopleinthe Worldin2015 • AFRAIDOFNEEDLES 5 4/27/2015 THERANOS • Startedin2003 • “Consumerhealthcompany” • Currentlyworth$9billion • High‐complexity,CLIA‐certified • AwaitingFDAapprovalfortestmenu,eventhough notrequired • Currently41locationsinCAandAZ– Walgreen’sWellnessCenters – Planstoexpandto~8000Walgreen’sstoresandrivals THEUNKNOWN THERANOS • Companyfoundedtotestbloodextensivelyfrom fingersticks,BEFOREsymptomsappear • Microfluidic technology • Canrunover30testsusingafewdropsofblood • DecreasedTATs • Decreasedtestpricing,regardlessofinsurance – Priceslistedonwebsite:https://www.theranos.com/test‐ menu?ref=footer – PledgetochargelessthanhalfofwhatMedicare,Medicaid reimburse • Pushtowardpatientsorderinglabtests THERANOS:ProsandCons • Testmethodologiesused? • Validationdata? – Onepeer‐reviewedstudyinonlinejournal • Capillarybloodvs.venousblood? • Anticoagulantinnanotainers? • Certifiedpersonnelrequiredtodotesting? • Willinsurancepayforpatient‐orderedtests? • Willresultsbesenttophysiciansautomatically? • Preventative healthcare • Decreasedmedical costs • Lessblood required • Potentialfor unnecessaryor excessivetesting • Testinterpretation • Dealingwith results 6 4/27/2015 RECENTDEVELOPMENTS • 3/9/15– Theranos partnerswithClevelandClinic • 3/13/15– Theranos seeksFDAapprovalforearly‐ detectionEbolatest • 4/6/15– Arizonabillsignedsopatientscanget labtests,resultswithoutdoctors’orders – 9statesallowlimitedtestingw/oauthorization – 27statesandDCallowconsumerstoorderdirectly – 13statesprohibittestingunlessauthorized • 4/19/15– LabCorp toletpatientsorderownlabs, getresults FDAOVERSIGHTOFLDTs • Laboratorydevelopedtest(LDT) • Originallyrelativelysimpletestswithlimited availability • Advancesintechnologyhavecausedevolutionof LDTs – Morecomplex – Nationwidereach – Presenthigherrisks:breastcancer,Alzheimer’s • 7/31/14– FDAannouncesintenttochange oversightofLDTsaccordingtorisk;phasedinover manyyears PARTINGTHOUGHTS… • Canpatientsknowtoomuch? • Whowillensurethattestsareruncorrectly? • Willtestsbeinterpretedcorrectly? • Willphysiciansseeallresults? • Implicationsforregionswithfewresources? • Willpatientsbeencouragedtoself‐monitorand changelifestyles? • Howmightchangesincostsaffectlaboratories? 7
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