10 Most Trusted Medical and Clinical Laboratories in 2022

August Issue 05 2022

1 Most Trusted Medical and Clinical Laboratories in 2022

Health Economics The Potential Impact of Diagnostic Capabilities

Robust Upgradation Integration of IT into Laboratory Systems

NAMSA

Translating Innovative Ideas into Transformational MedTech Products

Dr. Christophe Berthoux

The best and most efcient pharmacy is within your own system.

Editor’s Note

A New Dimension in Healthcare: Robotics

Artificialintelligenceandroboticsaretwo

technologiesthathavedemonstratedthepotential toaddressandsolvemanycontemporaryissues. Roboticshaslongbeenusedinthemanufacturingindustry However,overthelastthreedecades,robotshavebeenused inavarietyofotherindustries,includinglaboratory research,earthandspaceexploration,transportation,and manyothers.Theuseofrobotshasreducedproduction costsandincreasedproductivity,resultinginthecreationof manynewjobsinthetechsector,aswellaseconomic growth.Robotsaretypicallyusedforrepetitiveand monotonoustasks;however,withartificialintelligence (AI),thescopeisexpanding.Theyaretakingtheplaceof humanworkersandprovidingefficientresults.

Astheapplicationandcapabilitiesofrobotsimprove, sectorssuchashealthcareanditsalliedfieldsareadopting

themforvarioustasks.Robotsarenowusedforcomplex surgeries,clinicaltraining,medicinedispensing,personal care,andavarietyofothertasks.

Robotsarechanginghowsurgeriesareperformedinthe medicalfield,streamliningsupplydeliveryanddisinfection, andfreeinguptimeforproviderstointeractwithpatients. Inadditiontotheoperatingroom,theyarenowusedin clinicalsettingstoassisthealthworkersandimprovepatient care.Focusingoninnovationsintechnologyinthemedical field,Roboticshasthepotentialtorevolutionizethesector duetoitsvariousapplicationsandbenefitsbeing advantageoustobothhealthcareprovidersandpatients.

InthelatesteditionofInsightsCare's10MostTrusted MedicalandClinicalLaboratoriesin2022,wewalkyou throughthecompanieswhosegoalsarealignedwiththe

currentmarkettechnology,trendsandinnovations,bringing inawiderrangeofopportunitiesintreatmentcateringto patients'needs.

Hope you have an interesting read!

-PoojaShah

10 Most Trusted Medical and Clinical Laboratories in 2022

Company Featuring Person

CATHOLIC HEALTH SYSTEM

Description

Catholic health care providers are committed to providing the highest quality health care to all people in their communities and using their resources to promote the health of the communities they serve.

Danaher is a global science and technology innovator committed to helping its customers solve complex challenges and improve quality of life around the world.

DaVita Inc's mission is to be the Provider, Partner and Employer of Choice, and it is building the greatest health care community the world has ever seen, guided by its core values of: Service Excellence, Integrity, Team, Continuous Improvement, Accountability, Fulfillment, and Fun.

Kronos Bio is a clinical-stage biopharmaceutical company developing therapeutics that target the dysregulated transcription that causes cancer and other serious diseases.

London Medical Laboratory is the UK's largest phlebotomy network providing blood tests and health checks for employers, clinicians and individuals. Next day results with a doctor’s comments at a very competitive price.

Helping medical device Sponsors improve healthcare since 1967, NAMSA is the world’s leading MedTech Contract Research Organization (CRO) offering global end-to-end development services.

New Orleans BioInnovation Center is empowering Louisiana innovators to create successful biotech businesses by providing them with access to customized commercialization services, premier facilities, and a comprehensive support network

A full service reference laboratory and CRO specializing in molecular genetic testing and DNA analysis located in Savannah, GA, Hilton Head, SC and Guaynabo, PR. Now testing infectious diseases like STI's, Bacterial Vaginosis and COVID-19 with an EUA from the FDA issued on May 21, 2020

Proteomics International proteomics.com.au

Proteomics International is a medical technology company focused on proteomics – the industrial-scale study of the structure and function of proteins.

UTAK is proud to call itself “control freaks”, but not in the way you might think. That’s because its obsession lies not in taking control but in giving control—to the testing labs that need the finest quality control materials for its clinical and forensic toxicology test methods.

chsbuffaloorg

Barbara McManus VP Marketing

Danaher Corporation danahercom

Blair Rainer CEO

DaVita Inc davita.com

Javier Rodriguez CEO

Kronos Bio kronosbiocom

Marni Kottle VP of Corp Comms

Flavia Araujo-Rankin Co-founder and Joint CEO

Dr. Christophe Berthoux CEO

Cameron Poole BDA

Richard Lipscombe MD

UTAK Laboratories Inc. utakcom

Larry Plutchak Founder

P23 Labs p23labs.com

Tiffany Montgomery CEO & MD

London Medical Laboratory londonmedicallaboratorycouk

NAMSA namsa.com

New Orleans BioInnovation Center neworleansbio.com

NAMSA

Translating Innovative Ideas into Transformational MedTech Products

NAMSA's services have grown to include regulatory, reimbursement, quality consulting, product development strategy and clinical research solutions.

Dr. Christophe Berthoux NAMSA

Medicaldevicecompanies'demandforclinical evidencehasupsurgedlikeneverbefore. Professionalswanttoseemoreclinicaldata beforeandafterapprovingmarketeddevices.Thistask oftenliesontheshouldersofContractResearch Organizations(CROs),suchasNAMSA,aglobalcompany providingMedTechSponsorswithtrustedend-to-end developmentservices.

Drivenbyitsglobalregulatoryexpertiseandin-depth therapeuticknowledge,NAMSAisdedicatedto acceleratingmedicaldeviceproductdevelopment,offering onlythemostprovensolutionstomoveClients'products throughthedevelopmentlifecycleefficientlyandcosteffectivelyaspossible.

NAMSAistheindustry'spremier,trustedpartnerfor successfuldevelopmentandcommercializationoutcomes: frommedicaldevicetestingandpreclinicalresearchto regulatory,reimbursement,qualityconsultingandclinical researchservices.NAMSAemploysover1,700Associates across20locationsthroughouttheAmericas,APACandthe EU.

AnInspirationalJourney

In1967,aglassmanufacturerinToledo,Ohioapproacheda clinicallaboratorytotestpolymericmaterialsfor pharmaceuticalcontainertesting.Dr TheodoreGorski,a scientist-entrepreneur,recognizedtheopportunityand acceptedtheproject.

ByfollowingmethodsoutlinedintheUnitedStates Pharmacopeia,hesuccessfullyperformedtherequested testing.Thereafter,Dr.GorskiestablishedScience Associates,aContractResearchOrganization(CRO) focusedonmedicaldeviceandmaterialstesting.Nearlya decadelater,theUnitedStatesCongressauthorizedtheU.S. FDAtoregulatemedicaldevices.

Bythattime,NAMSAhadalreadydevelopedatesting matrixtoassurethebiologicalsafetyofmedicaldevices andmaterials,whichwaslaterincorporatedintothe TripartiteGuidance,TC194andispartoftoday'sISO 10993requirements.

Overthelastseveralyears,whileregulationshave continuedtoevolveandbecomemorecomplex,NAMSA hasproudlyplayedanintegralroleindevelopingdomestic andinternationalstandardsfortestingmedicaldevices, materials,andInVitroDiagnostic(IVD)products.In

additiontomedicaldevicelaboratorytesting,NAMSA's serviceshavegrowntoincluderegulatory,reimbursement, qualityconsulting,productdevelopmentstrategyand clinicalresearchsolutions.

Theseserviceadditionshavehelpedpavethewayfor NAMSAtobecometheindustry'spremierchoiceforglobal manufacturersseekingCROservices—offeringestablished, strategicsolutionsthroughoutthefulldevelopment continuum—toallowSponsorstofast-track commercializationeffortswhileachievingtimeandcost efficienciesineverymajormarketoftheworld.

GuidedbyStrategicLeadership

Dr.ChristopheBerthouxbeganhiscareerinthehealthcare industryin1990withCharlesRiverLaboratories,an internationalcompanydedicatedtoearly-stage developmentandsafemanufactureofnoveldrugsand therapeutics.ThroughoutDr.Berthoux's19-yearcareerat CharlesRiver,heheldseveralleadershippositions, ultimatelyservingasExecutiveCorporateVice PresidentofGlobalSalesandMarketingandChief CommercialOfficer.

Followingthis,heactedastheChiefExecutive Officer(CEO)ofSynexus,afirmassisting globalmedicaldeviceSponsorswithpatient recruitmentforclinicaltrialsandresearch sitechallenges.

InMarch2021,NAMSAnamedDr. BerthouxCEO,wherehebroughthis manytalentsandexpertiseintheareas ofstrategicvision,M&A, diversification,operationsand leadershipofglobal,multicultural teams.

At NAMSA, the organization utilizes over 55 years of experience in assisting Clients with virtually every development hurdle/obstacle to help them achieve success.

10 Most Trusted Medical and Clinical Laboratories in 2022

Today,hisdedicatedfocusisonsupportingNAMSAasthe world'sleadingfull-continuumMedTechContractResearch Organization(CRO),includinggrowththroughsignificant outsourcingdealsandhelpingClientsunderstandthe incrediblebenefitsofworkingwithapartnerthatprovides full-servicedevelopmentsolutionsunderoneroof.

"NAMSAprovidesunparalleledmedicaldevicetesting capabilities,strategicguidanceandtacticalsupporttofasttrackmarketintroductionofinnovativeMedTechproducts aroundtheworld.I'mexcitedtoworkwithateam committedtohelpingClientsovercomedevelopment hurdles,mitigateconcerns,streamlinecommercialization effortsanddeliverexceptionaloutcomesthroughoutevery stageofthedevelopmentjourney,"Dr.Berthouxstated.

"I'minspiredbytheworkourglobalteamof1,700+ Associatesconductseachandeverydayandthedirect impactithasonacceleratingthedeliveryoflife-saving medicaltechnologyandimprovinghealthcareoutcomes aroundtheworld,"heconcluded.

Dr.BerthouxisaDoctorofVeterinaryMedicineandalso holdsanExecutiveMBAfromPurdueUniversityanda MicrosurgeryDegreefromLyonMedicalSchool-Alexis Carrel.

AWell-PlannedProductDevelopmentProcess

Whileelaboratingondevelopmentandtestinginthe healthcareindustry,Dr.Berthouxobserves,"Intheproduct developmentprocess,akey,essentialfactoriscreatinga robustProductDevelopmentPlanandaclearexecution strategy."

Hefurtherexplainsthatitshouldintegratethekeypillarsof medicaldevicecommercialization,includingmanufacturing andprototypedevelopment,regulatoryandquality requirements,preclinicalandclinicalresearch, reimbursement,andscientificcommunicationstoreceive regulatoryapprovalbasedonexpectedtargetmarkets.

Oneofthemostcriticalfactorsinthetestingprocessis compliancewithglobalregulatoryrequirements.Thiscan behighlychallengingforMedTechSponsorsdueto constantlyshiftingglobalregulatoryenvironments.The risksofnon-complianceareseveral:significanttimedelays, increasedcostandpotentialmarketerosionfrom competitiveproductentry.

Inaddition,experienceisakeyfactorofsuccessforany testinglaboratory.AtNAMSA,theorganizationutilizes55 years'experienceinassistingClientswithvirtuallyevery developmenthurdletohelpthemachievesuccess.Basedon thisexperienceandreal-worldknowledge,NAMSAoffers onlythemostprovendevelopmentsolutionstoallow Clientstoachievecost-efficient,timely,successful developmentoutcomes.

Flexibilityiscriticaltoproductdevelopmentandtesting. Whilethissoundscontradictoryinahighlyregulated environment,itisbecauseoftheintensescrutinythat flexibilityisnecessary Startingwithawell-thought-out planisthefirststep,butthenoncedataisproduced, understandingtheimplicationsandactingquicklyisthe keytosuccess.

Thedevicedevelopmentprocesstakesaconsiderable amountoftimeinthebest-casescenarios.Still, whenunexpectedchallengesarise,NAMSAmoves swiftlytoaddresseachsituationandprovidea pathforwardthatwillsetthestageforsafe, acceleratedandeffectivemarketintroduction.

Dr.Berthouxconcludedbystating,"While patientsafetyiseveryone'sgoal,the regulatorsmustbesatisfiedfirst. Sometimes,theonlysolutionis conducting moretestingorhaving extensivewrittenjustifications.A companymustknowwhenandhowto applythesetools."

NAMSA has proudly played an integral role in developing domestic and international standards for testing medical devices, materials and In Vitro Diagnostic (IVD) products.

CateringtotheGlobalMedicalIndustry

Themedicaldevicetestingindustrycontinuestogrow.In 2022,theglobalmedicaldevicemarketsizeisestimateto reach$516Bwithcontinuedgrowthof3%CAGRthrough 2024{GlobalData}.IthasapositiveoutlookasMedTech companiesfocusonproductdevelopmentofnewand innovativedevicestodrivegrowth,revenueand profitability.

Akeydriverofsuccessintheproductdevelopmentprocess isspeed-to-market.Today,manycompaniesare experiencinglaunchdelaysasthemarketisstillrecovering fromCOVID-19-relateddemand,placingextreme constraintsonSponsors'internalresourcesandthoseof theiroutsourceddevelopmentpartners(includingtheglobal testingindustry).

NAMSAisacutelyawareofthecurrentglobalconstraints onthelaboratorytestingmarketandcontinuestobe committedtodoingtheirparttofindaresolution.Thishas beendonebymakingsignificantinvestmentsinboth NAMSA'sfutureandthefutureofthemedicaldevice industrythroughthecontinuedadoptionoftechnology, serviceadvancementsandexpansionofgloballaboratory capacity.

IntegrationofTechnologicalKnow-How

Whenspeakingabouttheinculcationoftechnology,Dr Berthouxasserts,"Advancesintechnologyarechanging howtestingisaccomplished."Hefurtherstatesthatearlyin silicomodelscanruleoutcertainmaterialsveryearlyinthe process,sotimeandeffortarenotspentonbiological testing.Invitrotestingmodelsarecontinuingtoevolve, replacingInVivotesting(medicaltestsandexperimentson livingorganismsandanimals).Andlast,improvementsin chemicalcharacterizationapproachesareleadingtobetter quantitativesafetyassessmentsandtheavoidanceofinvivo testingincertaincases.Theseshiftsprovidemore actionabledatathatallowforearlyandbetterproduct developmentdecisions.

For the Product Development Process:

Theadvancementandincreaseduseoftechnologyinthe MedTechmarketplacecertainlyimpacttheproduct developmentprocess.SoftwareasaMedicalDevice (SaMD),useofArtificialIntelligence(AI),HumanFactors Engineeringandcybersecurity—tonameafew—are

creatingsignificantimprovementsinsavingandimproving humanlives.

However,theseadvancementsalsocreatechallengesfor Sponsorsandtheglobalregulatoryinstitutionsthatare continuallyevolvingrequirementstokeeppacewiththe rapidchangeintechnology Asaresult,MedTech companiesneedtocloselymonitorandunderstandthese regulatorychangesandquicklyadaptproductdevelopment planstoensuresuccessinsuchanenvironment.

Dr.Berthouxbelieves,"AtNAMSA,wemaintaina dedicatedteamofregulatoryandtestingexpertsspecifically focusedonsuchissuestoensureweareattheforefront drivinginternationalregulatoryrequirements,aswellas implementingthoserequirementsforClientssotheymay streamlinetheproductdevelopmentprocessandbe equippedwiththenecessarytoolsforsuccess."

ComplexitiesontheWay

Today,NAMSAhassignificantopportunitiesinthegrowing MedTechCROspace.Manyoftoday'schallengesare similartothoseseeninmostareasoftheglobalMedTech market,whichincludehighdemand(manyCOVID-19 related),limitedglobalcapacity,supplychainconstraints andalimitedpoolofqualifiedtalent.

Additionally,thegrowingcomplexityofbothmedical devicesandtestingthatisrequiredtosuitablyaddress safetyandefficacyinachangingregulatoryenvironment meansthatcapacityisacriticalmanagementpoint.The complexityoftestingcandemandmoreresourcesandtime; forexample,chemicalcharacterizationtodayidentifiesfar morechemicalentitiesthanthebasicscreensconducteda merefiveyearsago.

ANoteWorthRemembering

WhenDr.Berthouxwasaskedabouthisadvicetobudding entrepreneurs,hesuggested,"Investinmulti-disciplinary educationandspendtimeunderstandinghowallofthe varioustestingmodalitiescontributetotheoverall understandingofsafetyandefficacy."

Hefurtherassertedthatthisshouldalsobebalancedbya rock-solidfoundationinunderstandingtestingguidanceand howtheregulatorydecision-makingprocessisachieved.It isimperativetounderstandthatregulatorybodiesneed high-qualitydataandinsightfulanddetailedanalysisofthat data.

London Medical Laboratory

Overthepastseveralyears,wehavewitnesseda paradigmshiftinthewaypharmaciesand laboratoriesoperateinordertocatertothe changingdynamicneedsofthehealthcarespace.Thisshift hasresultedinthere-evaluationofthetraditionalchannel ormultichannelmodelandupgradingittoaclinical omnichannelapproachthatwillseamlesslyintegrate variousdistributionmediums.

Andthat'sexactlywheretheclinicalmarketdisruptor, LondonMedicalLaboratory,enterstocombatthe healthcareindustrythroughitstechnologicallyadvanced bloodtestingapproach.Theorganizationhasintroducedthe omnichannelapproachtobloodtesting,whichisrudimental intheUK'sclinicalhistory.Throughitswiderangeoflifesavingfinger-prickbloodtestingkits,theorganization guaranteesreliabilityandexcellencetoitscustomers.

SpearheadingthisinnovationisLML'sCo-founderand JointCEO,FlaviaAraujo-Rankin. Shebelievesaccessto bloodtestscansavemanylives.Hence,Flaviaisworking towardsthemissionofmakingbloodtestingeasily accessibleinordertoimprovetheUK'shealthstatistics.

Weat Insights Care gotanopportunitytointerviewFlavia. SheoratesaboutLMLandhowitsomnichannelapproach providesafastandeasywayforpeopletostarttaking chargeoftheirhealth.

Below are the interview highlights:

PleasebriefouraudienceaboutLondonMedical Laboratory.Kindlytellusthesourceofinspirationfor startingamedicalandclinicallaboratory.

LondonMedicalLaboratory(LML)isamarketdisruptor, buildingonthebenefitsofnewdirect-to-consumer(D2C) opportunities.In2016IfoundedLML,togetherwithmy husband,withtheintentionofitbecomingtheUK'sfirst laboratorytotakeatrulyomnichannelapproachtoprovide testingservicesdirectlytothepatients.

Assurance of Reliability and Excellence

Weworkwithanationwidenetworkofpharmaciesand clinicsofferingeverymethodthereistogetbloodtests done.Weprovidephlebotomytrainingtoalloursitesso thatanyonecanhavetheirbloodtakenandcourieredback toourlaboratoryandprocessedovernight.Thismeansthat anyoneanywhereintheUKcanhavetheirresultssentback tothemthenextdaywithadoctor'scommentaryattached!

Wealsoprovideawiderangeoflife-savingfinger-prick bloodtestingkits,whichcanbepurchasedonline,oroffthe shelfwithresultssimilarlyreturnedthedayofarrivalinour laboratory.Becauseweareverticallyintegratedandown theentirepathway,weareabletoguaranteereliabilityand excellentcustomerservice.LML'smissionistomakeblood testingeasilyaccessibleandimproveourcountry'shealth statistics.Accesstobloodtestscansavelives.

NHSwaitingtimesforbloodtestsarecontinually increasing.There'scurrentlyan18+weekswaitfornonurgentcases,andthatrisesto21weeksinLondon.LML canreducetheworkloadonGPsbybothundertaking traditionalbloodtestsorderedbysurgeriesandby providingteststocustomersdirectly Thisfeedsintothe growingtrendforindividualstotakegreaterresponsibility fortheirownwell-beingandhealthcare.

ThekeytoLML'slong-termgrowthstrategyisthe continuousdevelopmentoftheD2Copportunityforboth bloodtestsandinfectiousdiseases.Ourclinicaltesting serviceprovidesclientsandcustomerswithaone-stop solutiontoimprovetheirpeople'swellness.

Whetherpeopleareconcernedabouttheirhealth,simply curious,orperhapsaremanaginganexistingcondition, bloodtestsprovideafastandeasywayforthemtostart takingchargeoftheirhealth.

Flavia,kindlybriefusaboutyourselfandshedsome lightonyourjourneyinthemedicalproductand developmentniche.

PreviouslyIcreatedandmanagedarangeofsuccessful businessesintheUnitedKingdom,BrazilandAustralia,in retail,import/export,andeducation.Whenoneofmy childrendevelopeddiabetes,Irealizedtherewasanotable lackofaccesstorapid,continualbloodtestingtokeep familiesfullyinformed.

Outofnecessitycameinvention.Myhusband,DrSeth Rankin,hadextensiveexperienceinboththeNHSand privatehealthcare.Hespentmanyyearsworkingin internationalmedicalassistance,thenasthemanaging partnerofalargeNHSgeneralpractice.Whenwerealized thehugeneedfordirect-to-consumerbloodtests,Isawhow Seth'smedicalexpertiseandmybusinessexperiencecould revolutionizethehealthcaremarket.

Myfamily'sexperiencealsoshapedLML'scorevalue,that everytestisaperson.Behindeverymedicaltestisafellow humanwhodeservesourverybest.Theirlivesmaydepend onit.ThisisthecoreofwhatLMLbelievesin.

TellusmoreabouttheservicesthatmakeLondon MedicalLaboratorystandoutfromthecompetition.

LMListhefirstomnichannelbloodtesting,diagnosticand healthcheckbusinessintheUK.Weofferphlebotomy

servicesinfranchisedHighStreethealthcheckshops, licensedpharmacies,andfinger-prickbloodtestsdirectto customersorderedonlineandsentthroughthemail.

Ourconvenientdirect-to-customerfinger-prickself-testing kitsgivepeopleeasyaccesstobloodteststhatpeoplecan dointhecomfortoftheirhomesandpostthesamplesback tous.Ourtestscoverawiderangeofconditions,from cholesterolandthyroidprofilesthoughtofertilityandheart health.

OurHighStreetservicesarealsogrowingrapidly.Wenow offerbloodtestsinmanypharmaciesandhealthstores acrosstheUK,includingapartnershipwithHolland& Barrett.Bloodsamplesusuallytakenomorethanten minutes,andpatientsusuallyreceivetheirresultsthenext workingday

Whatisthecurrentscenarioofthemedicalproduct developmentandtestingindustry?

Intermsofbloodtesting,theseareexcitingtimes,bringing testsdirectlytopatientsanddevelopingtestsforaneverwiderrangeofconditions,fromdiabetestoheartdiseaseor erectiledysfunction,usingthelatestadvances.

Our convenient direct-to-customer finger-prick self-testing kits give people easy access to blood tests that people can do in the comfort of their homes and post the samples back to us.

Flavia Araujo-Rankin Co-founder, and Joint CEO

Whatisyouropiniononhealthcareproviders'aligning theirofferingswithnewertechnologicaldevelopments, especiallywhenitcomestocateringtothedynamic needsofthehealthcaresector?

LMLwasfoundedonthebeliefthatthelatesttechnological developmentsinbloodtestingareakeypartoftheevolving healthcarespace.It'sonlythroughthegrowthinonline technologythatLML'srevolutionaryomnichannelblood testservicescouldexist.

Inmanycountries,privateroutinehealthchecksandblood testsareregularlyconducted,butthisislesscommoninthe UK.Forexample,thereareasmanyasonemillionpeople inourcountrywithundiagnosedtype2diabetes.Asimple bloodtestcancategoricallyletthemknowwhetherthey haveitornot.Knowingwilladdyearstotheirlives!

Whatadvicewouldyouliketogivetothebudding entrepreneursandenthusiastsaspiringtoventureinto themedicalproductanddevelopmentniche?

ComeandworkforLML!Asweexpandintonewareas,in termsofbothhealthcareandlocations,wearealways lookingtodevelopnewtalent.

CreatingLMLwasalotofhardbutrewardingwork.Itwas difficultatthebeginningandtookalotoftimeand investment.Inthepastthreeyears,wehavegrown tremendouslyfromonlyeightpeopletoover150staffwith sixLMLbranches–andmoreareontheway!

Withsomanyadvancesintechnology,workingin healthcareisveryexcitingandfulfilling.Workhard,find goodpeopleandensureyoufocusondevelopingproducts

customerswillbuy.Focusonthecommongoal–toimprove people'shealthandhavefundoingit.

HowdoyouenvisionscalingLondonMedical Laboratory'sservicesandoperationsin2022and beyond?

Therehasbeenasignificantriseinpatientawareness regardingself-testing.Millennialshavebecomethe "wellnessgeneration,"andtheincreasingelderlypopulation needsbetteraccesstotesting.

JustasconsumersabandonedtheHighStreetforonline storesduringthepandemic,somanylookedforeffective alternatives,suchasregularbloodtesting,toavoidGP surgeriesduringtheheightoflockdowns.Peoplerealize howeffectiveandreassuringregularbloodtestscanbe,and weareconstantlyintroducingnewteststogivepeoplea comprehensivepictureoftheircurrenthealth.

Wearecurrentlyexpandingrapidlyandhaveplentyofideas forthefuture.Wearescalingupourrangeoftestsrapidly, fromnewcomprehensiveallergyteststoawiderrangeof hormoneteststobeeasilyavailableinhighstreetshopsso thateveryonehasquickandeasyaccesstobloodtestsand generalhealthchecks.

Weareinvolvedwithmanyorganizations'staffhealthcare programs,andwe'remakingourtestsavailableinaneverincreasingrangeofpharmacies,healthfoodstores,etc.

LMLisactivelylookingfornewpharmacypartnersacross theUKwhowanttoaccessthesenewservices.Myultimate visionisforbloodtestingtobeavailableineverypharmacy andhealthcareshopthroughoutthecountry,enabling peopletotakechargeoftheirhealth.

The Potenal Impact of

Diagntic Capabilies

Itisknownthatpatientscanlivehealthierandlonger

livesiftheprogressionofthediseaseisprevented, delayedorreversedbytimelydiagnosisand appropriateclinicaltreatment.Diagnosticsprovideuseful informationtopatients,enablingthechoiceofappropriate treatment,helpinghealthprofessionalstochoose appropriatepreventivemeasures,andprovidingimportant prognosticinformationthatcanoptimizetreatmentoptions andcare.

Diagnosticinformationcanalsoenableinformedchoices about,forexample,reproduction,nutritionandlifestyle changes.Inaddition,diagnosticinformationcanhelpavoid orshortenhospitalizations,reduceinappropriatedruguse, orshortenthedurationofsickleave,bringingeconomic valuetocostcontainmentandcontributingtobetterhealth outcomes,ultimatelyleadingtomoreeffectivedruguse resources.

Unliketherapy,whosedirectclinicaleffectscanoftenbe directlydemonstrated,diagnosticsprovideinformationthat indirectlyaffectspatientcareandtheeconomicefficiencyof healthsystems.Evidenceshowingthefullpotentialof

diagnosticdataisoftenmoredifficulttoproducethan providingsuchevidencefortherapeuticagentsandmay requireadifferentapproach.

Let's dive into the potential impact of diagnostic information beyond traditional cost-effectiveness measures, encompassing both the value of the information and the improvement in quality of life resulting from this information acquisition.

ImpactforHealthcareProfessionals

Diagnosticinformationprovidesvaluetohealthcare professionalsbydirectlyguidingappropriatetreatment decisionsandrelatedclinicalbehavior.Diagnosticsproduce data(suchasbloodsugarlevels,thepresenceofan infectionoracardiacoroncologicalsignatthegenetic level)thatcanbetransformedintoinformation(data)and thussupportclinicaldecisions.

Forexample,bloodglucosevalues(obtainedfroma laboratoryorcareorbloodglucosemeter)canberecorded andsharedwithhealthcareprovidersinrealtimetoadvise onappropriatetreatmentactions(suchaschanginginsulin therapy).Thismaynotonlyleadtothepatient'sdesired healthbutmayalsoavoidtheneedforsubsequentormore invasivetests,sideeffectsand/ordelaysinimplementing thebestpossibletreatment.

Effectivenesscanalsobeincreasedbasedoninformed decisions: selectingagroupofpatientswhoarelikelyto benefitfromaparticulartreatment.Anotherexampleisthe rapiddetectionofasignofacutecoronarydisease,which allowsrapididentificationofapatient'srisk,followedby rapiddiagnosticprocessingand,ifnecessary,theinitiation oflife-savingmeasures.

ForPatients,FamiliesandCaregivers

Fromtheperspectiveofthepatientandfamily,diagnostic informationhasvalueboththroughthepromotionof clinicalbenefitandthevalueofknowledge.

Clinicalbenefitcomesfrompost-testdecisionsabout patientcare.Thesetreatmentdecisionsaffectthehealthof patients.Therefore,thediagnosticinformationcanhave clinicalandmedicalutility.Itdependsoncontextualfactors ofthehealthpathway,includingaccesstotreatmentafter diagnosticinformation,effectivenessoftreatmentand managementstrategiesfor diagnosedconditions,standards ofcare,prevalenceandothercondition-specific

characteristics,andindividualexperience,whichinterprets andusesinformation.Assessingtheclinicalutilityof diagnostictestsrequiresanintegratedapproachthat considersallcontextualfactorsandmultipleoutcomes, includinginteractionsandeffectsonsubsequent interventionsinthetreatment.Thismayrequire mathematicalorsimulationmodellingofthese relationships.

Regardingthevalueofknowledge,forexample,patients canhavegreaterpeaceofmindiftheyknowthattheyhave adiseaseornotandcanbenefitfromtreatmentifitis available.Patientsorparentsofyoungpatientscanget valuefrominformationabouttheir(child's)healthstatus, disease,orprognosis,regardlessofwhetherthis informationwouldinfluencetreatmentdecisions.In addition,knowingtheriskorpossibilitiesofadiseasecan enableinformeddecisions.

ForHealthSystemsandInstitutions

Theinformationprovidedbydiagnostictechnologiescan haveasignificantimpactonhealthcaresystemsand healthcarefacilities.Diagnosticinformationcansupport costsbyidentifyingpatientsinearlystagesofchronic diseaseoratriskfordisease(eg,diabetes,cancer).Timely preventiveandtherapeuticinterventionscanthenbe implementedtoreducetheriskandrateofdisease progressionandthelong-termcostsofchronicdiseasecare anddisability.Diagnosticinformationcanalsoleadtoearly diagnosisofacuteconditionssuchasheartattacks,thereby reducinglostlivesanddisability-relatedoutcomes.

WrappingUp

Theeffectsoftestingonlifeexpectancy,numberofdiseases detected,health-relatedqualityoflifeandhealthcarecosts aregenerallyconsideredintraditionalhealtheconomic evaluations(cost-effectivenessorcost-effectiveness analyses).Thisisbasedontheimportanceofthese characteristics,theexistenceofsystematicapproachesto measurethem,andadviceontheirvaluetosociety(e.g. throughliquidityorcost-effectivenessthresholds).

However,someimportantdiagnosticrelatedattributesmay notbedirectlyrelatedtohealth-relatedqualityoflifeor costs,andthereforeareoftennotincludedinstandard healtheconomicevaluationtests.

-SaloniAgrawal

Equipping Diagnosis with Trust P23 Labs

Trust–isastrongyetdelicateemotion.Aslongasit takestogetbuilt,ittakeslessthanhalfofthattime forittoturnfragile.

Therefore,anobviousquestiontoindividualsaswellas organizationsis,“what builds trust and how can one maintain it throughout?”

Answeringthis,theresearchliteraturesuggeststhattrust getsbuiltbyethicsandleadershipqualitiesimbibedbythe leaderoftheorganizationalongwithotherattributesof honesty,psychologicalsafety,respect,andothers.

Thiscomponentoftrustgetsveryimportantinthe healthcarenichewhereapatientputshislifeentirelyinto thehandsofthedoctor Andespeciallyatthefirstlevelof diagnosis,whichisdonebymedicalandclinical Laboratorieswhoseaccurateresultshelpthedoctorto arriveatareliablesolution,strengtheningthetrust.

PayingutmostattentiontothisvalueisSavannah’sP23 Labs,whichisfocusedonimprovingtherelationshipand trustbetweenthehealthcaresystemandminoritygroups, whohavehistoricallybeenmistreatedandmisrepresented throughoutmedicalhistory.

Thistrusthasbeenmultipliedbythepivotalroleplayedby thelaboratory’sleaders–itsMedicalDirector-Dr. BernadetteM.Mandes-Wildemore,MD,andCEO,Dr. TiffanyMontgomery,whosepassionforhelpingand servingtheunderservedhasplacedthelaboratoryamong themosttrustedintheindustry.

Without further ado, let’s go through their journey in the following interview:

Pleasebriefouraudienceaboutyourorganization. Kindlytellusthesourceofinspirationforstartinga medicalandclinicallaboratory.

P23LabsisaBlack-ownedhighcomplexitymolecular diagnosticlaboratoryheadquarteredinSavannah,GA.

Wewerebornfromadrivetoimprovetherelationshipand trustbetweenthehealthcaresystemandminoritygroups, whohavehistoricallybeenmistreatedandmisrepresented throughoutmedicalhistory.Wehave3clinicallabs operatinginSavannah,GA,HiltonHead,SC,and Guaynabo,PuertoRico.

P23Labsoffersafullsuiteofmoleculardiagnostictests thatalsoincludeCOVID-19,respiratorypathogenprofiles, andotherinfectiousdiseasesrapidlyidentifiedviaourstateof-the-artmolecularmethods.

Sinceopening,wehaveprocessedover1.2milliontestsand servedhigh-profileclientsacrossthecountry.Thetestsare primarilyfocusedontheindividual,withmanyofthem

“

“ We see a need for health and fitness backed by science, which is why we have launched our P23 Health Membership program.

basedontheperson’sDNAandtheRNAofthetargeted infectiousdisease.P23LabsemploymethodslikePCR, MassArray,GeneticSequencingandELISAtoprovidethe bestavailable,state-of-the-artactionableresults.This allowseducatingandempoweringpatientsandpartnering withprovidersforthebestoutcomes.

Briefusaboutthefeaturedpersonandshedsomelight ontheirjourneyinthemedicalproductand developmentniche.

OurlaboratorymedicaldirectorisDr.BernadetteM. Mandes-Wildemore,MD,andourCEOisDr.Tiffany Montgomery,Ph.D.Dr.Montgomerycompletedpopulation healthanddiseasedoctoralstudiesinHonduras,which culturedherloveofhelpingtheunderserved.Shehasa MasterofPublicHealthandBachelorofSciencefromUSbasedandaccreditedschools.

Tellusmoreabouttheservicesthatmakeyour organizationstandoutfromthecompetition.

Whenitcomestocompetition,themajorityofour competitorsprovidelaboratorytestingfordoctorsurgeries,

hospitals,etc.Weareputtingcontrolinthehandsofour patientsandprovidingaccesstohealthtestingoutsideof theirhealthcareplans.Whethertheyarelookingfor informationontheirgeneticmakeup,testingforinfectious disease,orotherhealth-relatedissues,wecanworkwith them.Wearealsohelpingemployersprovideaccessto healthtestingtotheiremployeesbeyondCOVID-19tests. WeworkwithlargecorporationstoprovideSafe-IDtesting –topreventcommonillnessesfromspreadingrapidly throughgroupswhoworkcloselytogether

Whatisthecurrentscenarioofthemedicalproduct developmentandtestingindustry?

Themedicalproductdevelopmentandtestingindustryis seeinghugegrowth.Astheworldbecomesmoreconnected, weareseeingdevelopmentsinthewayofphysicalhealth applications,betterqualitydatacommunicationand ultra-tailoredpreventativemeasures.P23recognizesthese trendsandisall-inwhenitcomestopersonalized, preventativehealthcare.

Whatisyouropiniononhealthcareproviders’aligning theirofferingswithnewertechnologicaldevelopments, especiallywhenitcomestocateringtothedynamic needsofthehealthcarespace?

Ashealthcareproviders,youhavetoadapttowhatthe marketneeds.Todayitisn’tone-size-fits-all,andweare seeingmoreandmorethatourcustomerswanttobein controloftheirhealthandwellness.Westartedasa moleculardiagnosticslaboratory,andwhilewecontinueto seegreatsuccessinthatarea,werecognizetheneedsofour marketandever-evolvingindustry.Ithasallowedusto analyzeanddiversifyourproductofferingstomeetthe needsweareseeinginthehealthcarespace.

Whatadvicewouldyouliketogivetothebudding entrepreneursandenthusiastsaspiringtoventureinto themedicalindustrythatyouarecateringto?

There’senoughroomforallofus.We’reluckytobeina growingindustry,withestimatedmarketsizeofover $800bn($10trillionglobally).Findyournicheandchase

yourdreams.We’reinthebusinessofhelpingpeoplelive theirhealthiest,longestlife,andifyouaretoo,wethink that’samazing(andwouldlovetocollaborate).

Howdoyouenvisionscalingyourorganization’s servicesandoperationsin2022andbeyond?

Scalingourbusinessandoperationsisdefinitelyabalance betweenourvision,customerdemandandmarket forecasting.WehavebigambitionsforP23,andweare luckytohaveateamthatwillworkwithustogetthere.We seeaneedforhealthandfitnessbackedbyscience,whichis whywehavelaunchedourP23HealthMembership program.Itissplitinto4differentprograms,thebenefitsof eachprogressingwiththepricepoint.

Giveusafewtestimonialsfromyourclientsandawards orrecognitionthataccuratelyhighlightyour organization’spositioninthemarket.

“Thepremiercustomerservice! Theyalwaysgoaboveand beyond.”

“WewereofthefirsttocontractP23sCOVID-19testing solutionoverayearago. P23,Dr.Montgomeryandher amazingteamhaverelentlesslyservedourclientsthatare verydemandingandrequirewhitegloveserviceswith expeditedtestingneeds.P23didagreatjob.”

“WehaveworkedwithP23fromthebeginningofthe pandemic.Wehaveworkedinthetrencheslateintothe nighttoenablePCRtestingforourmutualclients,andP23 hasprovidedagreatservicetousandourconsumer clients.”

“Thecustomerservicewasamazing.Ifeltvery comfortable.Iwasinandout,fasttestingandresults.”

“Thecompanyisamazing.Mytestresultscamebackright away,andthecustomerservicewasoutstanding.Will alwaysusethiscompany.”

Inadditiontobuildingtrustandprovidingworldclass services,isthereanythingelseyouthinksetsP23Labs apartfromthecompetition?

Wehaveactivelyengagedinphilanthropicendeavorsto careforPOCIgroups,includingdiagnostictestingfor COVID-19forthosewhostruggledtogainreliableaccess totesting,aswellasmakinggenerouscontributionsto Black-ownedgrassrootscharities.

Laboratory S ystems Integ ration of IT into

Laboratorysystemsinusetodayarenotdesignedfor

system-wideintegration.Theyarebuiltbyvendors anddeveloperstoperformspecifictasks,and connectionstoothersystemsareeithernotconsideredor avoidedforcompetitivereasons.Ifwewanttoconsiderthe possibilityofbuildingintegratedsystems,thefollowingfive elementsarenecessary:

Education

Installationsequippedwithintegratedsystemsarebuiltby trainedpeople.Buttheeducationalissuesdonotendthere. Laboratorymanagementmustunderstanditsrolein technologymanagement.Itisnotenoughtounderstand scienceandpeoplemanagementasitwas30or40years ago.Managersmustunderstandhowtheworkisdoneand whattechnologyisusedinit.Effectiveuse/abuseof technologycanhaveasmuchimpactonproductivityas anythingelse.Sciencemustalsobeadaptedforadvanced laboratorytechniques.Whendevelopingmethods,the implementationofthemethodshouldbeconsidered-can thistechnologybeautomated?

ObligationofUserCommunity

Vendorsanddevelopersdonotintendtoprovideintegration capabilitiesunlessrequestedbytheusercommunity Vendorsmustspendresourcestomeetintegration requirements,andtheywillnotdosounlessthereisaclear marketneedandusersarepushingthemtomeetthatneed. Ifwecontinuewith"businessasusual"practiceswherewe negotiatethingsandareunhappywiththeoutcome,where istheincentiveforvendorstospenddevelopmentmoney?

Theoptionsare:buyonlyproductsthatmeetyour integrationneeds,useresourcestointegratesystemsthat arenotdesignedforitorkeepyourlabsrunningtheway theyhavebeenforthelast30years-bitbybit. Improvements.

Standards

Thecreationofintegrablesystemsdependsmainlyontwo elements:standardizedfileformatsand communication/connectionsystemsthatallowonevendor's softwaretocommunicatewithanother'ssoftware.

FileFormatStandards-Deviceoutputmustbeinan industry-standardfileformatthatallowsittobeusedwith anysuitableapplication.Thestructureofthisfileformat mustbepublishedandcontaininstrumentoutputandother relatedinformationsuchasdate,time,deviceID,sampleID readbybarcodeorothermechanism,instrument parameters,etc.

Ideally,thestandardformatwouldbetheinstrument engineeringformat.Thedatacollectedbythedevicewould beinthisformatandwouldbecompletedandusedbyeach provider.Infact,itwouldbepossiblefortheinstrumentto haveacircuitboardthatwouldactasanetworknode.It wouldcollectandstoredevicedataandtransferitto anothercomputerforlong-termstorage,analysisand reporting,separatingdatacollectionanduse.Asimilar situationcurrentlyexistswithequipmentsuppliersusing onlinedataacquisitionmodules.

CommunicationStandards

Developersandvendorsdesignsoftware independently-thesoftwareworksasifnothingelseexists

andisself-sufficientforallcriticaltasks.Thisisa reasonablepointofviewbecauseitmaybetrue.Thereisno standardlaboratorysoftware.Itisalsotruethatsoftware existsandworkswithothersoftware,anditmaybe necessarytoexchangedataelements.Weneedastandard forcommunicationbetweentasks.TheemergenceofELNs onlyaddstothecomplexity.Filescanbe imported/exported,butifwewantintegration,weneed communicationbetweenelements.Thisincludessample preparationmodulesaswellaslargeinstrumentdata systems,LIMSandELNs.SomevendorsusePDFfilesasa dataexchangemedium.Whilethisworks,it'snotanideal situationforscheduledmessages.

ModularSystems

Theprecedingparagraphstatesthatvendorsmustassume thattheirsoftwarecanoperateinaparticularenvironment toensurethatallnecessaryfacilitiesareavailabletomeet userneeds.Thiscanleadtoduplicationofactivities.Both themulti-userinstrumentinformationsystemandtheLIMS requireatemplatelogin.Withbothsystemsinthelab,you havetwoexamplesofloginsystems.Theproblemcanbe madeworsebyaddingadditionalmulti-instrument packages.

WhereDoWeGoFromHere?

Atsomepoint,thedescribedactionsmustbeperformed. Untilnow,laboratoriestietheresultsoftheirworkto productsandformatsoverwhichtheyhavelittlecontrol. Theuseofproprietaryfileformatsthatlimitworkingwith companydatashouldbereplacedbyindustry-standard formatsthatgiveuserstheflexibilitytoworkwithany producttheychoose.

Overcomingobstaclestotheintegrationoflaboratory systemsrequiresachangeinthemindsetoflaboratory managementandpeopleworkinginlaboratories.This changewillbringasignificantdifferenceintheway laboratorieswork,whichwillincreaseproductivity, improvetheworkenvironmentandimprovethereturnon investmentmadeinthecompany'slaboratoryoperations. Waitingforchangeswillnotbringthenecessaryresults. Theusercommunityneedstotaketheleadandcome togetherandprovideguidancetodevelopers.

-SaloniAgrawal

Ali M. Alaouie, PhD Director of Product and Technical Support UTAK Laboratories Inc.

UTAK

Facilitating Wide Range of Comprehensive Stock and Custom Quality Controls to the Healthcare World

LaboratoriesInc.

Providingreliablepatientresultsandensuringutmost patientsafetyhasbeenoneofthemosthighly discussedconcernsinlaboratorymedicine.

Inthemodernhealthcaresetup,whilelaboratorymedicine hasbecomeacost-effectivesolutiontobuildingchronic illnesses,errorsinpatients'managementandinaccurate diagnosticmeasureshavecausedseriousharmtopatients.

Onsuchanote,theJournalofLaboratoryandPrecisionin theyear2022pointedoutthatthereliabilityofaresulthas beenattributedtoitsanalyticalprocesses,whichcalledfor additionalattentionandconsideration.

Inordertominimizetheseerrors,severalclinical laboratoriestodayaretakingresponsibilityforthe developmentandimplementationofprocessesthat emphasizequalitycontroloftheservicesandproducts offeredtopatients.

Oneofthecompanies,UTAKLaboratoriesInc. through itsimplementationofthelatestscientificadvancementsand highindustrystandards,hasmaintainedqualitycontrol measures,furthersupportinglabswiththematerialsthey requiretoprioritizepatientsafety

InsightsCarerecognizesthecompany’spotentialby speakingwithAliM.Alaouie,theDirectorofProductand TechnicalSupportatUTAK

Below are the highlights of the interview

Pleasebriefouraudienceaboutyourorganization. Kindlytellusthesourceofinspirationforstartinga medicalandclinicallaboratory.

Foundedin1973,UTAKhasbeensourcing100%REAL humanmatricesandthepurestdrugspossibletoprovide labswiththecontrolstheyneedforeverykindofanalysis.

AtUTAK,we’reproudtocallourselves“controlfreaks,” butnotinthewayyoumightthink.That’sbecauseour obsessionliesnotintakingcontrolbutingiving control—tothetestinglabsthatneedthefinestquality controlmaterialsfortheirclinicalandforensictoxicology testmethods.Ourclose-knitgroupofControlFreakscrafts thequalitycontrolstheselabsdependuponforeverykind ofanalysis,includingawiderangeofcomprehensivestock controlsin100%REALhumanurine,serum,blood,and more,aswellasstartingmatricesforlaboratoriesseekingto developin-housequalitycontrolmaterial.Wealsocreate customcontrolsolutionstosupportthenewmethodsand ground-breakingresearch.

Weoriginatedthemanufacturingofcomplex,personalized qualitycontrols,makingcontrolsthatnooneelsecould. Andwe'restilldoingittoday

Tellusmoreabouttheservicesthatmakeyour organizationstandoutfromthecompetition.

CustomQCsince1973.Wehavemadeover10,000custom qualitycontrolsinthelast10years.Withourcustom controlsolutions,youchoosetheanalytes,youchoosethe matrix,youchoosetheform,youchoosethesize….We giveyoucontrol.

Whatisthecurrentscenarioofthemedicalproduct developmentandtestingindustry?

Technologicaladvancement,particularlyinanalytical instrumentationwithrespecttoselectivity,sensitivity, specificityanddetectionlimits,enablesscientifictestingto extendintomuchbroaderareasofmedicaland/orforensic interest.Moreover,thescopeoftestingwithinaparticular subdisciplinecanalsoexpand.Duringinstrumental analysis,qualitycontrolmeasuresnecessitatetheuseof referencematerialtoensurereliabilityoftestmethodsand integrityoftestresults.Accordingly,sincetestingand

One of a Kind Leader

Ali M. Alaouie, PhD, is the Director of Product and Technical Support at UTAK. Ali is an experienced research scienst with a diverse scienfic, technical, and administrave background. He oversees the R&D, Quality, Regulatory, and Customer Service Departments at UTAK Laboratories. Prior to that, he was the Manager of the Breath Tesng Unit at the New Jersey State Police Office of Forensic Sciences and has contributed to a number of peer-reviewed publicaons across mulple scienfic fields.

productdevelopmentarecoupledtoeachother,growthin testingcapabilitiesleadstoincreaseddemandformedical productdevelopment.

Whatisyouropiniononhealthcareproviders'aligning theirofferingswithnewertechnologicaldevelopments, especiallywhenitcomestocateringtothedynamic needsofthehealthcarespace?

Onafundamentalbasis,anyeffortleadingtoimprovingthe qualityoflifeandsavinglivesisalwayswelcomenews.In parallel,technologicaldevelopmentsinthefieldalways invitethequestionofmassdatagenerationandhandling. Upfronttransparencywithrespecttodatamanagement effortsandassociatedrisksistheeasyanswer

Whatadvicewouldyouliketogivetothebudding entrepreneursandenthusiastsaspiringtoventureinto themedicalindustrythatyouarecateringto?

Atfirst,theviabilityofnewproductsorservicesmustbe conductedthroughmarketresearch.Ifventuringintothe medicalindustryisdecided,thenplanningandassemblinga coresupportteamofsubjectmatterexpertsbecomesvital. Identifyingexpertswithworkingexperienceinregulatory affairs,accreditation,qualitymanagementand scientific/clinicalresearchisessential.Itisimportantfor entrepreneurstounderstandthatthemedicalindustryis heavilyregulated,wherebyrequirementscanvary substantiallyfromonecountrytoanother

Howdoyouenvisionscalingyourorganization's servicesandoperationsin2022andbeyond?

UTAK’svisionforthefuturecentersarounditscore missionofcontributingtopublicsafetyandpublichealth. Sinceinception,UTAKhasplayedakeyroleinthe manufacturingofmedicaldevices(qualitycontrols)tobe utilizedinlaboratorysettingsencompassingforensic sciencetohealthcare.Overthepastyear,UTAKhas devotedconcertedeffortandresourcesintothe establishmentofanactiveR&Ddepartmentwiththeintent ofbroadeningitscontributionstopublicsafetyandpublic healththroughin-houseresearchinitiativesaswellas externalcollaborativeefforts.Operationally,werealizethat ourcontinuedsuccessisdependentonqualityproductsand

UTAK’s vision for the future centers around its core mission of contributing to public safety and public health.

apositivecustomerexperience.Inlinewiththatrealization, maintainingactiveISOaccreditationforourQuality ManagementSystemisonewayofcommunicatingour commitmenttoensuringbothfunctionsarebeingmet.

Giveusafewtestimonialsfromyourclients,andawards orrecognitionthataccuratelyhighlightyour organization'spositioninthemarket.

UTAKproductscontinuetomaintainstrongcitationinhigh levelscientificresearchasevidencedbypeer-reviewed publicationslike,“Assessmentofgadoliniumandiodine concentrationsinkidneystonesandcorrelationwith contrastagentexposure,stonematrixcomposition,and patientdemographicfactors-ScienceDirect”.

Additionally,belowisatestimonialfromaclient:

Ourlaboratorywasrunningan“In-housedeveloped” fractionated25-OHVitaminDtestonourLC/MSMS system.Weweremakingourownstandardsanditwasvery laborintensive.Weneededaprecisebuteconomical solution.UTAKwasabletomanufactureacustomsetofsix controlsthathadbeenvalidatedbyathirdparty,whichwe coulduseforcalibrators.Theyevenwereabletopackage theminvialsthatwesuppliedtouseatourpipettingstation, sotherewasnoneedtotransferthemforusebythestaff.

—DebraSwigart,QuestDiagnostic