caixa empreender award 2016| health - vitacontrol (cohitec)
TRANSCRIPT
Diagnosis Kit for Leishmaniasis
10 years of collaborative research
Parasite
sandfly
“Increasingly, there is evidence that clinical cases of leishmaniasis represent the tip of an ‘infection iceberg”
www.eurosurvaillance.org, Sept. 2013
PROBLEM
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
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
An innovative combination of several proteins …
Quantitative Electronic Reader
Probe
LEVDS
SOLUTION
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
• 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
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
• Anabela Cordeiro da Silva (FFUP/IBMC/i3S)
• Célia Gomes Amorim (FFUP/ IBMC/i3S) …“over 20 years of cumulative experience in research”
TEAM
Winner of the Grand Prix - 10th Edition of National Inovation Contest
AWARD
INCENTIVES FOR INNOVATIVE
AVISO SI-47-2015-33-
Incentive Scheme for Research and Technological Development (R & TD)
Projects Co-Promotion
2022 2021 2020 2019 2018 2017 2016 2002 …
ROADMAP
R&D + Proof of Concept
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
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
EXIT STRATEGY