Diagnosis Kit for Leishmaniasis.

1. Diagnosis Kit for Leishmaniasis

2. 10 years of collaborative research

3. Parasite
sandfly
“Increasingly, there is evidence that clinical cases of leishmaniasis
represent the tip of an ‘infection iceberg”
www.eurosurvaillance.org, Sept. 2013
PROBLEM

4. 1.4 M infected people every year*; 25 000 human deaths every year*
Now spreading due to global warming
* Jan 2014
PROBLEM

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

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

7. 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

8. An innovative combination
of several proteins …
Quantitative
Electronic Reader
Probe
LEVDS
SOLUTION

9. Quantitative
Electronic Reader
“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 negativesProbe
LEVDS
SOLUTION

10. • 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

11. 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

12. • Anabela Cordeiro da Silva (FFUP/IBMC/i3S)
• Célia Gomes Amorim (FFUP/ IBMC/i3S)
…“over 20 years of cumulative experience in research”
TEAM

13. Winner of the Grand Prix - 10th Edition of National Inovation Contest
AWARD

14. INCENTIVES FOR INNOVATIVE
AVISO SI-47-2015-33-
Incentive Scheme for Research and Technological Development (R & TD)
Projects Co-Promotion

15. 20222021202020192018201720162002 …
ROADMAP
R&D + Proof of Concept

16. 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
20222021202020192018201720162002 …
R&D + Proof of Concept
ROADMAP

17. LEISH KIT FOR HUMANS *
20222021202020192018201720162002 …
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

18. EXIT STRATEGY