Future Diagnostics company overview

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Table of contents

• Introduction • Company overview • Assay Development • Manufacturing Services • Quality Management • How we handle projects • Contact

20 May 2015 General Presentation 2

Introduction


Why?

Because we are professionals, with passion for the Life Science industry.

We want to improve health with innovations in diagnostics.

How?

Over 90 skilled employees with 12 Senior-level Scientists on board.

From a modern lab in the Health Valley of the Netherlands.

What?

IVD development, Biomarker qualification, Companion diagnostics, Validation (technical & clinical)

Pilot Productions and Manufacturing.

Company overview


Since 1997, Future Diagnostics has been delivering expert assay development services to the medical diagnostics and device industries. With over 90 employees, our expertise includes a wide array of disease areas and detection technologies. We developed more than 150 high quality in vitro diagnostics (IVD) products for our multinational customers. Our well-established reputation as an independent and reliable partner confirms our vision of integrity, customer service, sensitivity and collaboration.

Amsterdam

Brussels

Dusseldorf

Wijchen

Company overview Modern Facility (3500 m2)

We develop high-quality assays for…

• to the medical diagnostics and device industries.

• Global IVD companies as extension of their internal R&D.

• Innovative companies that require support to bring novel IVD products to market.

• Biopharmaceutical companies seeking expertise for companion diagnostics.

Assay Development When your targets are set, we exceed.


We have a profound experience across Disease Areas & Technologies

Experience


Bone Metabolism 17

Infectious Disease 27

Tumor Markers 12

Fertility 16 Diabetes

7

Cardiovascular 34

Endocrine 21

Autoimmune 7

Veteranary 4

Other 23

Full development / Validations / Feasibility & Research / Government funded programs / Point of Care

cases results Resolved high background by design of effective assay buffer formulations for automated CMV IgM assay

Endocrine Resolved LoD and precision for iPTH by introducing new bead into MFG

Infectious Disease Resolved high background by changing assay configuration resulting in one of the best automated assays for Syphilis on the market

Infectious Disease Development of High Sensitive HIV Combo on microarray slide

Veterinary Development of Sensitive homogeneous assay for detection of Progesteron in Cow milk

Infectious Disease Development of sensitive HIV combo ELISA

Fertility Development of sensitive FT3 ELISA

Endocrine Development of several sensitive iPTH assays on automated platforms

Bone Metabolism Development and automation of ELISA for Vit D using new developed release reagent

Tumor Markers Antibody screening and development of two sensitive TBI marker assays

Bone Metabolism Development of high throughput 25OH-vitamin D assay

Experience


Experience



cases results LoB/LoD determination of 25 existing assay to update filing and IFU

Other Validation of new automated analyzers

Validation of free-PSA assay on three analyzer types

Sample collection device study for updating technical file and IFU

Other Stability studies on Customer Calibrators (Real time)

Validation of new developed assay on three analyzer types

Validation of FOB assay on two analyzer types

Validation of FIT assay on two analyzer types

LoB/LoD determination of 25 existing assay to update filing and IFU

Other Validation of new automated analyzers

Validation of free-PSA assay on three analyzer types

Experience



cases results Evaluation of new magnetic particles for several vendors

Bone Metabolism Introducing new formulation for release of 25OH-VitD from DBP

Feasibility of accusphere technology for stabilizing cytokine standards

Feasibility of combined enzymatic and immunoassay for detection of VASP on an automated platform

Combining beads and conjugation chemistries to improve performance and reduce costs of automated cell isolation method

Bone Metabolism Feasibility of total 25OH-Vit D on PoC Platform

Feasibility and Optimization of Neonatal screening assay

Development of Aldosterone conjugate

Feasibility of immunoassays for detection of Everolimus and Creatinine

Feasibility of immunoassay for detection of LPS

Experience



cases results program Biomax. Innovative microparticle based assay techniques

program for development of Norovirus detection system

program Osteoclasts. Early markers and mediators in bone erosion

program – Non invasive detection of Coeliac disease

program Ultraplacad. Development of ultrasensitive non-PCR serum based detection methods for tumors

Experience



cases results Feasibility of iPTH and cTnI on acoustic wave detection system

Development of multiple assays on Philips Magnotech handheld device

Feasibility of VitD, cTnI, PSA for CLAROS 1 platform

Feasibility of HbA1C on PoC platform

Feasibility of cTnI on PoC piezo detection technology

bHCG as model system for feasibility of use of Q-dots in LF

Model assay on Micro Fluidics platform

Developed skills and experience in:


Experience

Isoluminol Synthesis and purification of Luminol-NHS in collaboration with specialized supplier, according to Future Dx specifications Conjugation and purification of antibody Development of the Assay within the required quality and specifications Chemiluminescence reaction triggered with licence-free Catalyst

• Isoluminol

• Horseradish Peroxidase (HRP)

• Acridinium Ester

• Alkaline Phosphotase (ALP)

• Bioluminescence

• Turbidimetric Assays

• Colloidal (nano) gold particles

• Homogenous immunoassay

• Biotin conjugation



Experience

Horseradish Peroxidase (HRP) Commonly used reporter molecule in IVD for colorimetric and chemiluminescent detection. Conjugation to antibody/antigen done by Future Dx using a hetero bi-functional conjugation method. Conjugation method will be optimized to meet the assay specific optimal performance. Customer’s preferred conjugation method can be implemented if requested. Detection with ready to use TMB (and stop solution) for read-out in any common platee reader at 450nm Detection with chemiluminescence substrate for read-out in Chemiluminescence plate reader (We use Berthold Centro XS3)

• Isoluminol




• Bioluminescence







Experience

Acridinium Ester Most commonly used reporter for chemiluminescence detection in IVD (Centaur, Architect, iSYS) Enhanced AE molecules are restricted by patents Conjugation to antibody/antigen using AE-NHS Chemiluminescence triggers are licence-free formulations

• Isoluminol




• Bioluminescence







Experience

Alkaline Phosphatase (ALP) Reporter molecule used for enzymatic and chemiluminescence detection Conjugation to antibody/antigen done by Future Dx using a hetero bi-functional conjugation method. Conjugation method will be optimized to meet the assay specific optimal performance Customer’s preferred conjugation method can be implemented if requested Detection with ready to use PNPP for read-out in any common plate reader at 405nm Detection with chemiluminescence substrate for read-out in Chemiluminescence plate reader (Future Dx uses Berthold Centro XS3)

• Isoluminol




• Bioluminescence







Experience

Bioluminescence Widely used reporter molecules Conjugation to antibody/antigen method depends on Fluorescent molecule used High quantum yield solutions (such as Q-dots) ensure high sensitivity and stable light emission Used as reporter molecule in Luminex, Evalution, Bioplex and VIDAS Availability of molecules with different emission wavelengths for use in multiplex assays

• Isoluminol




• Bioluminescence







Experience

Turbidimetric Assays Commonly used for (rapid) clinical chemistry assays Single step assay. Latex particle size and brand will be chosen to give optimal performance. Conjugation of antibody/antigen will be optimized. Future Dx has an AU680 analyzer available for development of Turbidimetric assays

• Isoluminol




• Bioluminescence







Experience

Colloidal (nano) gold particles Commonly used in Lateral flow and microarrays. Sensitivity can be enhanced with silver reagent No additional trigger/substrate needed for signal generation

• Isoluminol




• Bioluminescence







Experience

• Isoluminol




• Bioluminescence





Homogenous immunoassay Future Dx has experience in development of Homogenous immunoassays using Enzyme Multiplied Immunoassay Technique (EMIT) and Apoenzyme Reactivation Immunoassay System

EMIT principle ARIS principle



Experience

Biotin conjugation Biotin – Streptavidin is widely used to bind 1) antibody to a solid phase, b2) to bind reporter molecule to tracer antibody/antigen Future Dx uses standard (Sulfo-)NHS-biotin chemistry. If needed other chemistry can be used. Spacerlength 13 - 30 Å will be optimized to meet maximal performance.

• Isoluminol




• Bioluminescence





We know how important it is for you to quickly reach your target Return On Investment.

We understand that your project does not end after the development.

We put your product on the ‘fast track to market entry’.

Manufacturing Services to give you Convenience and Peace of Mind

To make your product to your high quality standards.

To be focused on speed to market after product development.

To share the lean production benefits you expect:

FDA-registered production facility

Small-to-medium scale pilot and commercial production capabilities

Fully compliant with regulatory requirements for IVD products

Manufacturing Services

Bulk production capacity up to 200 lt.

Lyophilizing capacity of 1,5m2, 20 lt. of liquid

Vial printing equipment

MTP coating equipment

Accusphere production technology

Finished product kit-box packaging, labeling and distribution

Bulk production of e.g. buffers, coated beads, conjugates

Manufacturing Services


On-Site Manufacturing Benefits

Manufacturing documentation and labeling in your format

Smooth transition from R&D to MFG

Products readily available for clinical trials

Quality Management


The quality improvement cycle as ongoing process

ISO 9001: As certified organization we have integrated Quality Management System requirements (QMS) into all areas of the business. ISO 13485: specifies requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet the applicable customer requirements and regulatory requirements to medical devices and related services. This approach permits us to guarantee quality control through laboratory analysis and the traceability of our products, which corresponds to regulatory demands.

Your assay, your platform, your specifications .

Our Assay Development Cycle delivers your project faster than the

industry standard.

So your assay is brought to market and commercialized faster.

How we handle projects


Contact information


Future Diagnostics Nieuweweg 279 6603 BN Wijchen The Netherlands

Mr. Gregg Mayer SVP, Corporate Strategy

Phone: +1.617.642.0322

[email protected]

Mike Martens Managing Director, PhD

Phone: +31 (0)24 64 52 900

[email protected]

Jochem van Woezik Director Program Management

Phone: +31 (0)24 64 52 900

[email protected]

Ernst Lindhout Director of R&D, PhD

Phone: +31 (0)24 64 52 900

[email protected]

www.future-diagnostics.com

http://future-diagnostics.com/



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