compact biophotonic platform for drug allergy … · 2018-12-10 · compact biophotonic platform...

1
COMPACT BIOPHOTONIC PLATFORM FOR DRUG ALLERGY DIAGNOSIS (COBIOPHAD) Estrella Fernández 1 , Teresa Molina-Jiménez 1 , Sergi Morais 1,2 , Luís A. Tortajada-Genaro 1,2 , Rosa Puchades 1,2 , Ángel Maquieira 1,2 Instituto Interuniversitario de Investigación de Reconocimiento Molecular y Desarrollo Tecnológico (IDM) 1 Universitat Politècnica de València-Universitat de València. Camino de vera s/n, 46022 Valencia. 2 Departamento de Química, Universitat Politècnica de València. Camino de vera s/n, 46022 Valencia. E-mail: [email protected] Acknowledgements The COBIOPHAD Project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 688448. It is an initiative of the Photonics Public Private Partnership (www .photonics21.org) References [1] M. Blanca, A. Romano, M. J. Torres, J. Fernandez, C. Mayorga, J. Rodriguez, P. Demoly, P. J. Bousquet, H. F. Merk, M. L. Sanz, H. Ott, M. Atanaskovic. Update on the evaluation of hypersensitivity reactions to betalactams. Allergy. 2009, vol. 64, 183-193. [2] M. J. Torres, A. Romano, G. Celik, P. Demoly, D. A. Khan, E. Macy, M. Park , K. Blumenthal, W. Aberer, M. Castells, A. Barbaud, C. Mayorga, P. Bonadonna. Clinical and Translational Allergy. 2017, vol. 7, 1-13. COBIOPHAD is organized on seven Work Packages WP1 comprises the development of the hardware, firmware and software of the biophotonic device based on Optical Disc Drive. WP2 is focused on the design and manufacturing of disc prototypes, based on a centrifugal microfluidic system for fully automated the assay. WP3 addresses the collection of human blood samples, synthesis of structural determinants and high- affinity anti-IgE. WP4 aims at the integration of the components and evaluation of the analytical performance of the reagents, disc and reader. GOLD STANDARD: in vivo skin tests & provocation tests Good specificity (98-100%) Invasive Time consuming Low sensitivity (61-70%) High rate of false diagnosis with critical consequences: risk of mortality Uncomfortable for patients CURRENT ALTERNATIVE: in vitro diagnostic methods (IVD) Minimally invasive Developed with bulky autoanalyzers, based on classical technologies Low sensitivity (< 40%) High detection threshold (>0.2kU/L) Only for 5 BLCs False positive and negative results Expensive (test: 30/allergen) Quick & cheap IVD tests for specific IgEs / BLC hypersensitivity: highly demanded solution to guarantee safe and sure diagnostics COBIOPHAD is developing an innovative IVD solution based on compact disc technology for diagnosis of IgE-mediated drug allergies Current state 400um WP1: DETECTOR WP2:PLATFORM WP3: ASSAY WP4: INTEGRATION WP5: VALIDATION AND PRE-INDUSTRALIZATION MARKET TECHNOLOGICAL INNOVATION WP6: IP & DISSEMINATION WP7: COORDINATION Low-cost device (detector manufacturing cost ~300 ) • Low-cost consumables (~1 per disc and ~0.3 /allergen in reagents) • Autonomous, robust • Broad range of scenarios: emergency and critical care units, allergy departments COBIOPHAD specifications: • Sensitivity (80%) and detection limit below 0.1 kU/L • High specificity ( 98%) simultaneous response to 10 BLCs • Multiplexing capability (up to 10 samples per BLC or BLCs per disc) • Rapid, 30 minutes maximum total analysis time Hypersensitivity to Beta-Lactams (BLCs) BLCs antibiotics are the most dispensed in EU 50% or more of the total antibiotics consumption Affects 2.5 million people in EU and causes 47% of drug anaphylaxis Public health problem Erroneous allergy diagnosis, wrong treatment High costs of drug allergy diagnosis (~ 500 /drug) Hospitalization: 1750-4500 /patient

Upload: others

Post on 10-Jun-2020

5 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: COMPACT BIOPHOTONIC PLATFORM FOR DRUG ALLERGY … · 2018-12-10 · COMPACT BIOPHOTONIC PLATFORM FOR DRUG ALLERGY DIAGNOSIS (COBIOPHAD) Estrella Fernández1, Teresa Molina-Jiménez1,

COMPACT BIOPHOTONIC PLATFORM FOR DRUGALLERGY DIAGNOSIS (COBIOPHAD)

Estrella Fernández1, Teresa Molina-Jiménez1, Sergi Morais1,2, Luís A. Tortajada-Genaro1,2, Rosa Puchades1,2, Ángel Maquieira1,2

Instituto Interuniversitario de Investigación de Reconocimiento Molecular y Desarrollo Tecnológico (IDM)1Universitat Politècnica de València-Universitat de València. Camino de vera s/n, 46022 Valencia.

2 Departamento de Química, Universitat Politècnica de València. Camino de vera s/n, 46022 Valencia.E-mail: [email protected]

Acknowledgements

The COBIOPHAD Project has received funding from the European Union’s Horizon 2020

research and innovation programme under grant agreement No. 688448. It is an initiative of

the Photonics Public Private Partnership (www.photonics21.org)

References

[1] M. Blanca, A. Romano, M. J. Torres, J. Fernandez, C. Mayorga, J.

Rodriguez, P. Demoly, P. J. Bousquet, H. F. Merk, M. L. Sanz, H. Ott, M.

Atanaskovic. Update on the evaluation of hypersensitivity reactions to

betalactams. Allergy. 2009, vol. 64, 183-193.

[2] M. J. Torres, A. Romano, G. Celik, P. Demoly, D. A. Khan, E. Macy, M.

Park , K. Blumenthal, W. Aberer, M. Castells, A. Barbaud, C. Mayorga, P.

Bonadonna. Clinical and Translational Allergy. 2017, vol. 7, 1-13.

COBIOPHAD is organized on seven Work Packages

NOW FUTURE (COBIOPHAD)

WP1 comprises the development of the

hardware, firmware and software of the

biophotonic device based on Optical Disc Drive.

WP2 is focused on the design and

manufacturing of disc prototypes, based on a

centrifugal microfluidic system for fully

automated the assay.

WP3 addresses the collection of

human blood samples, synthesis of

structural determinants and high-

affinity anti-IgE.

WP4 aims at the integration of the

components and evaluation of the

analytical performance of the reagents,

disc and reader.

GOLD STANDARD:in vivo skin tests & provocation tests

• Good specificity (98-100%)• Invasive• Time consuming• Low sensitivity (61-70%)• High rate of false diagnosis with critical

consequences: risk of mortality• Uncomfortable for patients

CURRENT ALTERNATIVE:in vitro diagnostic methods (IVD)

• Minimally invasive• Developed with bulky autoanalyzers, based

on classical technologies• Low sensitivity (< 40%)• High detection threshold (>0.2kU/L)• Only for 5 BLCs• False positive and negative results• Expensive (test: 30€/allergen)

Quick & cheap IVD tests for specific IgEs / BLC hypersensitivity: highly demanded

solution to guarantee safe and sure diagnostics

COBIOPHAD is developing an innovative IVD solution based on compact disc technology

for diagnosis of IgE-mediated drug allergies

Current state

400um

WP1: DETECTORWP2:PLATFORMWP3: ASSAYWP4: INTEGRATION

WP5: VALIDATION ANDPRE-INDUSTRALIZATION

MARKETTECHNOLOGICAL INNOVATION

TRL4 TRL7

WP6: IP & DISSEMINATIONWP7: COORDINATION

• Low-cost device (detector manufacturing cost ~300 €)

• Low-cost consumables (~1 € per disc and ~0.3 €/allergen in

reagents)

• Autonomous, robust

• Broad range of scenarios: emergency and critical care units, allergy

departments

COBIOPHAD specifications:

• Sensitivity (80%) and detection limit below 0.1 kU/L

• High specificity ( 98%) simultaneous response to 10 BLCs

• Multiplexing capability (up to 10 samples per BLC or BLCs per

disc)

• Rapid, 30 minutes maximum total analysis time

Hypersensitivity to Beta-Lactams (BLCs)

BLCs antibiotics are the most dispensed in EU

50% or more of the total antibiotics consumption

Affects 2.5 million people in EU and causes 47% of drug anaphylaxis

Public health problem

Erroneous allergy

diagnosis, wrong

treatment

High costs of drug

allergy diagnosis

(~ 500 €/drug)

Hospitalization:

1750-4500 €/patient