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
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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
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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
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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.
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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
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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
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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?
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