I N N O VAT I V E
DIAGNOSIS AND
PA R T N E R S H I P S
FOR ALL

1INTRODUCTION& BACKGROUNDFIND, THE GLOBAL ALLIANCE FOR DIAGNOSTICSS E E K S T O E N S U R E E Q U I TA B L E AC C E S S T O
RELIABLE DIAGNOSIS AROUND THE WORLD
We connect countries and communities, funders, decisionmakers, healthcare
providers and developers to spur diagnostic innovation and make testing an
integral part of sustainable, resilient health systems

Established in 2003 as a productdevelopment & delivery partnership
Co-convener of the Access to COVID-19Tools (ACT) Accelerator Diagnostic Pillar
WHO Collaborating Centre for Laboratory
Strengthening & Diagnostic Technology
Evaluation
WHO SAGE-IVD member
ISO-certified quality management system
for IVD clinical trial

2021 STRATEGY: EXPECTED IMPACT
Save 1 million lives

Save US$1 billion

Empower 10+ countries

through accessible,
quality diagnosis

in healthcare costs topatients and health systems

with diagnostic data to inform
policy and care3

UNADDRESSED DIAGNOSTIC GAPSARE MASSIVE~50% of patients
do not get diagnosed
63%
46%

56%

61%

35%
5%
TB

9%14%

6%

9%

Diagnostic gap
Treatment gap

HIVHepatitis C

Diabetes

Basic diagnostic capacity
is available in only 1% of primarycare clinics and 14% of hospitals
in some LMICs1

Hypertension

Appropriate tests do not exist for 60%
of infectious agents with outbreakpotential2 and 50% of the top 20
diseases responsible for most lives lost3

1 Leslie et al. Bull World Health Organ 2017;95:738–748, http://dx.doi.org/10.2471/BLT.17.191916.
243

Kelly-Cirino et al. BMJ Glob Health 2019;4:e001179. doi:10.1136/bmjgh-2018-001179
Pai et al. Analysis from Global Burden of Disease Report 2020

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2C O N T E X T:
KEEPING THE
P RO M I S E

Keeping thePromise:
Product Development Partnerships’
Role in the New Age of HealthResearch and Product Development
LOGO

Building Partnerships
Creating Solutions
Saving Lives

1. PDPs are theglobal leaders
in developing
new healthtechnologies
where lack of
traditional
marketincentives havestalled progress• Since 2010, this coalition of PDPs havedelivered 66 new health technologies—
treatments, vaccines, diagnostics,
vector controls, and devices.
• Products have reached more than 2.4billion people, mostly in LMICs• Highlights include:o First ever drug approved for treatment ofhighly drug-resistant forms oftuberculosiso Single dose treatment to prevent relapseof P. vivax malariao First all-oral cure for all stages of
sleeping sickness.

• Advances are concentrated in diseasesof poverty where investment andinnovation have long been stagnant;market forces don’t drive innovation inthese fields

PDPs DELIVERINNOVATION
Many PDPs wereestablished aroundthe turn of thecentury. This past
decade has seen thefruits of previous
investment.
Products
developed andmarketed by PDPs
featured in thereport2. PDP pipelines
are robust andpoised todeliver asignificant
number ofinnovativetechnologies inthe near-term

 PDPs featured in the report have morethan 375 potential new technologies intheir pipelines
o Approximately 25% of those products inlate-stage development.

 Portfolios are built through diverse
partnerships – across sectors andgeographies
 Products in development stand toimpact some of world’s oldest anddeadliest diseases, including those that
disproportionately impact women andchildren

PDPs FEATUREDIN THE REPORTHAVE MORE
THAN375
POTENTIAL NEWTECHNOLOGIESIN THEIRPIPELINES

3. PDPs achieve
impact bydevelopingproducts
appropriate forthe people andcontexts in which
they will be used

 PDPs closely engage with local
communities, care providers,
researchers, and policy makers toensure they are designing products foruse in the settings where they are
most needed

PRODUCTSDEVELOPED BY
PDPs FEATUREDIN THE REPORTHAVE REACHED Attributes to enable use in lowresource settings are prioritized

2.4+ BILLION

 This is the first step to drivingwidespread and equitable access toPDP-developed products

AROUND THE

PEOPLEWORLD3PA R T N E R S H I P W I T H
G H I T & J A PA N E S E
PA R T N E R S

E S TA B L I S H E D T R AC K R E C O R D W I T HJ A PA N E S E PA R T N E R S

Recent/ongoingcollaborations

Tests listed in FINDCOVID-19 test directory

11SPOTLIGHT ON TB

F U J I F I L M S I LVA M P T B L A M PAV E D T H E W AY T O A N E W G E N E R AT I O N
OF POINT-OF-CARE TB TESTSPLHIV (5 cohorts, n=1595)

FujiLam
AlereLAM

Sn [95% CI]

Sp [95% CI]

70.7 [59.0 – 80.8]
34.9 [19.5 – 50.9]

90.9 [87.2 – 93.7]
95.3 [92.2 – 97.7]

HIV uninfected patients (n=372)
FujiLAM
AlereLAM

Sensitivity (95% CI)
53.2% (43.9 to 62.2)
10.8% (6.3 to 18.0)

Specificity (95% CI)
98.9% (96.7 to 99.6)
92.3% (88.5 to 95.0)

Third generation LAM tests now indevelopment, finally putting accurate,affordable and accessible POC testing for TBwithin reachSource: Broger et al. J Clin Invest 2020; Broger et al, PLOS Med 202012SPOTLIGHT ON SCHISTOSOMIASISJ A PA N E S E C O L L A B O R AT I O N P I V O TA L T O A D VA N C I N G R A P I D T E S T ST H AT W I L L S U P P O R T S C H I S T O S O M I A S I S C O N T R O L & E L I M I N AT I O NSUPPORTING NATIONAL PROGRAMMES TO MONITOR THE IMPACT OF MASS DRUG ADMINISTRATIONCAMPAIGNS AND PRECISION MAPPING EFFORTS
GHIT grant approved July 2020
Consortium of 8 partners
In 2021, first field evaluations ofprototype in Kenya and the Philippines(led by NUITM) yielded very
encouraging results
Further development of the CAA RDT isrequired to meet the sensitivity targets,with a final field evaluation required
prior to design-lock and transfer tomanufacturing – planned for Q2/3 2022
FIND in collaboration with GHIT andthe Merck Global Health Institute aredeveloping an access strategy for theCAA RDT
Circulating anodic antigens (CAA) are secreted by all species of schistosomes that are of public health importance, making it a particularly suitable target forschistosomiasis diagnostics. A laboratory-based test for CAA is available; however, in order to achieve optimal sensitivity, the test requires complex sample processing
s t e p s a n d a r e a d e r f o r d e t e c t i o n . T h i s p r o j e c t a i m s t o b r i n g C A A t e s t i n g o u t o f t h e l a b o r a t o r y a n d i n t o c o m m u n i t y s e t t i n g s , by d e v e l o p i n g i t i n t o a n R D T .
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SPOTLIGHT ON BURULI ULCER

GHIT INVESTMENT SUPPORTING DEVELOPMENT OF THE FIRST-EVER
RAPID TEST FOR BURULI ULCER
With partners we have developed the first-everRDT for Buruli ulcer, made possible byleveraging two innovations: monoclonal
antibodies specific for mycolactone; andmagnetic plasmonic nanoparticles
An RDT for Buruli ulcer will be key to:

WHO DTAG highlights Buruli ulcer
as one of the 4 skin-NTDs thaturgently needs new diagnostics tofacilitate treatment
Early, accurate diagnosis and treatment canprevent painless infections becoming deepulcers that lead to permanent disability•

Meet the WHO NTD 2030 targets•

Enhance diagnosis at primary health centres andcommunity levels•

Reduce turnaround time for result confirmation(1 hour instead of 1+ weeks)•

Improve early treatment following earlyconfirmation•

Improve treatment monitoring and test of cure
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F U T U R E O P P O R T U N I T I E S & P O T E N T I A L C O L L A B O R AT I O N S

A C C E L E R AT E D B Y C O V I D - 1 9 A D VA N C E S

CAD, artificial intelligence & machine learning
Quality diagnosis in areas without specialist healthcare workers

Mobile devices & connectivity
Reach the hard-to-reach; enable real-time monitoring ofhealth status

Next-generation technologies (genomics, CRISPR)
Sequencing for disease surveillance and rapid response

Wearables & home-use tools
Self-monitoring, early detection and ambulatory management

Manufacturing & tech transfer for LMICs
Build on COVID-19 capacity to enable affordable and accessible
tests for NTDs, TB and malaria

15154COVID-19 &DIAGNOSTICS

AC T- AC C EL ER ATOR DI AG N OS TI C S PI L L A R I S

W O R K I N G T O H A R N E S S I N N O VAT I O N , S E C U R E
ACCESS & DEPLOY AFFORDABLE, QUALIT Y POINTOF-CARE TESTSTo break chains of transmission
To enable targeted public healthinterventions and treatment
To inform epidemiological surveillance

To detect novel variants

Gradual roll-out of vaccines and continued threat of novel variants mean thatwidespread, affordable, and accurate testing remains critical to global COVID-19 response
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SPEED OF COVID-19 ANTIGEN RDT INTRODUCTION HAS BEEN
U N P R E C E D E N T E D C O M PA R E D W I T H A N Y O T H E R R D T
Early January 2020:
Genetic sequencing
sharedMid September 2020:
WHO releases interim
guidance on the use ofrapid antigen tests

October 2020:
Countries start using rapid
antigen tests in healthcare
settings and beyond, togetherwith PCR

January 2021:
FIND/Unitaid announce first
EOI agreement: with PMC,bringing Ag RDTs price down
to US$2.50 per test

Within 6 months ofEUL listing: over 30
million Ag RDTs
have beenprocured across Dx

Dec 2019:
Cluster of "pneumonia
of unknown cause"
identified in Wuhan

July 2020:
FIND/Unitaid issue EOI tobring lower cost Ag RDTs
with regionalized
manufacturing to LMICs

Early 1990s
Example: malaria
RDT timeline

End September 2020:
WHO issues EUL: first rapid
point-of-care reader-free Ag test1
120m volume guarantee forLMICs announced under ACT-A1999Emergence of malaria RDTs intolargely unregulated markets and withuncertain performance

November 2020:
WHO issues EUL: first rapid
point-of-care reader-free Ag testwith easier sample collection(nasal)2

Early 2000s

WHO first meeting on
rapid diagnostic
testing

Rapid expansion in
number of products

Source: 1. SD Biosensor STANDARD Q COVID-19 Ag Test; 2. Abbott Panbio COVID-19 Ag Rapid Test Device(NASAL); 3. Global Fund, GDF/StopTB, PAHO, UNDP, Unicef, WHO; https://extranet.who.int/pqweb/vitrodiagnostics/coronavirus-disease-covid-19-pandemic-%E2%80%94-emergency-use-listing-procedure-eul-open;
Cunningham J, et al. Malar J 2019;18:387. All accessed 15 March 2021

2002
Development of coordinatedeffort to quality control RDTs
pre- & post-purchase

Supply Consortium
partners only3

2018
WHO requirement for RDTs
to be pre-qualified

ACT-A, ACT-Accelerator; Ag, antigen; EOI, expression of interest;
EUL, emergency use listing; LMIC, low- and middle-income countries;
P C R , p o l y m e r a s e c h a i n r e a c t i o n ; P M C , P r e m i e r M e d i c a l C o r18
poration;
RDT, rapid diagnostic test

LESSONS FOR THE FUTURECRITICAL NEED FOR A QUICKER RESPONSE
30January

3April4AprilWHOdeclares
PHEIC

64 days: First
real-time PCR
test granted
WHO EUL

65 days: WHO
reports 1 million
confirmed
COVID-19 cases

9May

2
September

22
September

25
November

31
December

100 days after
WHO declared
PHEIC

216 days: WHOapproves
dexamethasone
as the first
COVID-19
therapeutic

236 days: First
rapiddiagnostic test
for COVID-19
granted WHO
EUL

300 days after
WHO declared
PHEIC

336 days: WHO
issued its first
EUL for a COVID19 vaccine

2020

Day 1

WHO declares PHEIC earlier

Day 100

Accurate and approved rapid
diagnostic tests
An initial regimen of therapeutics
Vaccines ready to be produced
at scale

EUL, emergency use listing procedure; PCR, polymerase chain reaction; PHEIC, public health emergency of international concern.
G7 100 Days Mission to respond to future pandemic threats.
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/992762/100_Days_Mission_to_respond_to_future_pandemic_threats__3_.pdf

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TH ANK YOU..and the many
partners and other
donors who makethe work of FIND
possible21