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Diagnosis Kit for Leishmaniasis
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10 years of collaborative research
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Parasite
sandfly
“Increasingly, there is evidence that clinical cases of leishmaniasis represent the tip of an ‘infection iceberg”
www.eurosurvaillance.org, Sept. 2013
PROBLEM
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1.4 M infected people every year*; 25 000 human deaths every year*
Now spreading due to global warming
* Jan 2014
PROBLEM
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5
Manufacturer Product name Bound
Antigen
Application Time Leishmaniasis
type
Test Web site
Bio-Rad Laboratories DiaMed-IT LEISH rK39 Human na Visceral L. IC http://www.diamed.com.br/cmi/Pagina.aspx?306
CTK Biotech, Inc OnSite Leishmania Ab Rapid Test rK39 Human 15 min Visceral L. IC http://www.grupolabca.com.mx/laboratorios%20clinicos/pruebas%20rapidas/ct
k%20inserts/R0122C.pdf
Span Diagnostics, Lda Crystal KA (Kala azar) rKE16 Human 15 min MucoCutânea IC http://www.dpcleb.com/product/view/204
InBios International Inc Kalazar Detect™ rK39 Human 10 min Visceral L. IC http://www.inbios.com/rapid-tests/kalazar-detect
InBios International Inc Canine Visceral Leishmaniasis Dipstick* rK39 Dog na Visceral L. IC http://www.inbios.com/veterinary-reagent-controls/canine
Vtrade Anigen Rapid Leishmania Ab Test Kit na Dog 20 min Visceral L. IC http://www.vtrade.be/nl/main/gamma/rapid-tests/test-rapide-kitvia-v600920-
leishmaniose-eng.pdf
BIONOTE Anigen Rapid Leishmania Ab Test Kit na Dog 20 min Visceral L. IC http://www.bionote.co.kr/ANIMAL/ENG/Production/canine.asp?LT=2&MODE=V
&bIdx=165&bcIdx=9&P=2&BLT=L&PC=20&gAIdx=&gSearchText=
Virbac Animal Health Speed Leish K Kinesin
Capture
Complex
Dog 20 min Visceral L. IC http://en.bvt.fr/p-bvtfrpuben/display.aspx?srv=p-
bvtfr&typ=pub&lang=en&cmd=view&style=styles/specie.xsl&select=PRODUCT%5
B@ID$eq$PRODUCT_98%5D
Bio-
Manguinhos/Fiocruz
DPP® Canine Leishmaniasis rK39 Dog 15 min Visceral L. IC https://www.bio.fiocruz.br/en/index.php/products/ivd-tests/rapid-tests/dppr-
canine-leishmaniasis
Biogal, Galed Labs. ImmunoRun na Dog 5-20 Visceral L. IC file:///C:/Users/camorim/Downloads/ircli155.01.12.11%20(2).pdf
Quicking Biotech Canine Leishmania Antibody Test HRPO
Conjugate
Dog 10 min Visceral L. IC http://en.quicking.cn/Products/Pet/Canine/Enquicking12.html
EcoDiagnóstica Leishmania Ab na Dog 10 min Visceral L. IC http://www.ecodiagnostica.com.br/produto/leishmania-ab
PROBLEM
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6
.....but only some of the antibodies can be detected by the existing diagnostic kits, drawbacks:
• 40% false results •Individuals without clinical signs are not detected
PROBLEM
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Diagnostic kit
.....but only some of the antibodies can be detected by the existing diagnostic kits, drawbacks:
• 40% false results •Individuals without clinical signs are not detected
PROBLEM
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An innovative combination of several proteins …
Quantitative Electronic Reader
Probe
LEVDS
SOLUTION
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Quantitative Electronic Reader
9
“I think that what is really important, is to have a quantitative kit” ; Luis Cardoso, PhD (Opinion Leader, Veterinary School in the endemic northern region of Portugal)
…able to reduce 10x the false negatives Probe
LEVDS
SOLUTION
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• Regulatory hurdles : Shorter Independent certification Easier authorization of ethical committees Simpler requirement to Infarmed • Shorter time to market • Earlier revenues help the funding of the development of the solution for humans
“Disease can be controlled if infected dogs are identified” (WHO, 2014)
Pet dogs
LEVDS
MARKET
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30M South of Europe
Total pet dogs 223M India 10 M
Brazil 36 M
Europe 66 M
There are 2.5 M dogs in Europe already infected ; 2 M vaccine shots
Entry market
MARKET
15M dogs with Veterinary Care
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• Anabela Cordeiro da Silva (FFUP/IBMC/i3S)
• Célia Gomes Amorim (FFUP/ IBMC/i3S) …“over 20 years of cumulative experience in research”
TEAM
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Winner of the Grand Prix - 10th Edition of National Inovation Contest
AWARD
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INCENTIVES FOR INNOVATIVE
AVISO SI-47-2015-33-
Incentive Scheme for Research and Technological Development (R & TD)
Projects Co-Promotion
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2022 2021 2020 2019 2018 2017 2016 2002 …
ROADMAP
R&D + Proof of Concept
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McS
Regulatory Approvals Business Partnerships
Market Development
Market Development
Launch Product PT, SP, FR, IT
Launch Product BR
Previous research investment
450K€ 300K€ 1 M€
Product develp
2022 2021 2020 2019 2018 2017 2016 2002 …
R&D + Proof of Concept
ROADMAP
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LEISH KIT FOR HUMANS *
2022 2021 2020 2019 2018 2017 2016 2002 …
ROADMAP
McS
Regulatory Approvals Business Partnerships
Market Development
Market Development
Launch Product PT, SP, FR, IT
Launch Product BR
Product develp
R&D + Proof of Concept
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EXIT STRATEGY
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