Future Diagnostics Solutions

Future Diagnostics has over 15 years of experience in quantitative Point-of-Care (POC) test developments on several devices/technologies. For this reason, Future Diagnostics is the obvious choice to assist companies with POC test- and platform developments. You can benefit from our POC knowledge on whole blood, dry-chemistry, nano-technology, and magnetic beads.

Point-of-Care

Point-of-Care testing is a fast growing specialty within the in vitro diagnostics market. POC tests decrease turnaround time (TAT) and therefore improves patient care by near-patient testing. You can think about rapid diagnosis at the emergency rooms or operating theaters at hospitals, medical specialist's offices, general practitioner's offices or in the ambulance. No more delays in treatment decision making and at the same time no unnecessary anxiety for patients. Besides efficiency, technologies improve fast on precision, reliability and accuracy. In conclusion, the right POC device can deliver lab-equivalent results within 8 - 30 minutes.

Devices
Future Diagnostics develops quantitative Point-of-Care Tests on devices of a customer's choice. Nevertheless, if the customer is in doubt on choosing the best POC device for their test, our advice is considered valuable. Based on the customer's wishes and requirements, we give an independent and well thought out advise on choosing the best device for their test.

Critical Parameters
Besides support on choosing a POC device, Future Diagnostics provides support on making important decisions on critical parameters to start a successful Point-of-Care test development. Critical parameters that may affect the success of a test are e.g. reagents and materials. Critical parameters are optimized by continuously monitoring ongoing processes during developments. Active monitoring of critical parameters enables a final precision that is equal compared to the large analyzers in the central laboratories.

Whole Blood
In general, Point-of-Care tests require only a single drop of biological samples, such as whole blood, saliva or urine. Very low concentrations (pico molar) target substances are measured in a matter of minutes. We are able to convert whole blood immediately to plasma within the cartridge. This is based on the long lasting experience we have on the handling of blood and the usage of filters.

Dry Chemistry
Point-of-Care tests based on dry chemistry are realized by a cutting-edge technology. It eliminates the usage of liquid reagents within a Point-of-Care device by applying dry reagents onto the POC cartridge. One advantage of dry chemistry is that dilution of the biological sample is prevented, since 'wet' solutions are omitted. Drying reagents on cartridges and at the same time keep the reagent's features are special skills of our assay developers. Equally important, the dried reagents on the cartridge need to have the ability to get reconstituted within seconds. This is another way of making pico molar sensitivity possible with POC applications.

Nano-Technology
Nano-Technology is the engineering of functional systems with novel properties at nanoscale. Building POC assays from the bottom up with atomic precision is what our assay developers do best.

Beads
The beads used in Point-of-Care tests are in general smaller than 1 micrometer in diameter. They are coated with antibodies or analytes that capture the target molecules. We work with numerous commercially available beads (also called particles or microspheres). We evaluate and select the most optimal beads to use. Magnetic- or gold beads are preloaded into the cartridge. They automatically disperse into the sample as the cartridge fills with the applied biological sample.

Future Diagnostics develops full IVD immunoassays on demand and offers flexible support in feasibility & optimization, verification & validation projects, and technical transfer to manufacturing for third parties.

Our exploratory phase teams run projects for conjugation, biomarker qualification, benchmarking and bead selection/coating to withstand the golden standard in the market on a daily basis.

The development of an immunoassay involves choosing a format, gathering the right components, and constructing a good working protocol. Optimization of assays takes systematically adjusting and testing all components and variables to ensure results are robust and accurate. The immunoassay formats provide different levels of specificity, sensitivity, simplicity, and speed. They also require different numbers and varieties of components. When we develop an immunoassay from scratch, this is often because the target of interest is a “new” biomarker, in which case a known pair of antibodies may not be available. Searching and matching for the right antibodies may be required.

Expertise and Experience

Future Diagnostics is strongly familiar with various types of immunoassays, such as:

• ELISA
  
• EIA
  
• CLIA
  
• Automated Platform based assay
  
• Paramagnetic particle based assay
  
• Microarray assays
  
• Multiplex bead assay
  
• Point of care assays
  
• Microfluidic assays
  
• Enzyme multiplied immunoassay technique (EMIT)
  
• Turbidimetric assays
  

Future Diagnostics is highly experienced in using the following tracers:

• Acridinium Ester
  
• Alkaline Phosphatase (AP) (Colorimetric and Chemiluminescent)
  
• Bioluminescence
  
• Fluorescence
  
• Horseradish Peroxidase (HRP) (Colorimetric and Chemiluminescent)
  
• Isoluminol
  
• Colloidal (nano) Gold Particles

Our Manufacturing Site is there to give you Convenience and Peace of Mind.

Because we know how important it is for you to reach your return on investment (ROI), we do not limit our services to assay development. We use our professional knowledge and capabilities to support you in the next step...manufacturing.

Even without the development phase there are numerous benefits if you outsource IVD manufacturing to us:

• We make your production(s) conform high quality standard.
  
• We make the technical transfer from development to production and tackle possible problems in upscaling
  
• We make all the manufacturing documentation according your request and regulations, to save you time.
  

We keep an eye on quality by working according to Quality Control and Quality Assurance Procedures that are based on ISO 13485 and cGMP requirements for 21 CFR part 820.

Manufacturing services we offer:

• Full immunoassays (e.g. ELISA, EIA, CLIA)
  
• Solutions (e.g. buffers)
  
• Small scale bead coating
  
• Microtiter plate coating
  
• Lyophilization of kit components, also accuspheres
  
• Product filling, capping and labeling
  
• Final kit box-packaging
  

Future Diagnostics develops full IVD immunoassays on demand and offers flexible support in feasibility & optimization, verification & validation projects, and technical transfer to manufacturing for third parties.

Our exploratory phase teams run projects for conjugation, biomarker qualification, benchmarking and bead selection/coating to withstand the golden standard in the market on a daily basis.

The development of an immunoassay involves choosing a format, gathering the right components, and constructing a good working protocol. Optimization of assays takes systematically adjusting and testing all components and variables to ensure results are robust and accurate. The immunoassay formats provide different levels of specificity, sensitivity, simplicity, and speed. They also require different numbers and varieties of components. When we develop an immunoassay from scratch, this is often because the target of interest is a “new” biomarker, in which case a known pair of antibodies may not be available. Searching and matching for the right antibodies may be required.

Expertise and Experience

Future Diagnostics is strongly familiar with various types of immunoassays, such as:

• ELISA
  
• EIA
  
• CLIA
  
• Automated Platform based assay
  
• Paramagnetic particle based assay
  
• Microarray assays
  
• Multiplex bead assay
  
• Point of care assays
  
• Microfluidic assays
  
• Enzyme multiplied immunoassay technique (EMIT)
  
• Turbidimetric assays
  

Future Diagnostics is highly experienced in using the following tracers:

• Acridinium Ester
  
• Alkaline Phosphatase (AP) (Colorimetric and Chemiluminescent)
  
• Bioluminescence
  
• Fluorescence
  
• Horseradish Peroxidase (HRP) (Colorimetric and Chemiluminescent)
  
• Isoluminol
  
• Colloidal (nano) Gold Particles

Immunoassays Services

Bioanalytical Assays Services

Bioanalysis Services

Pharmacology & Toxicology Services

Project Management & Consulting Services

Clinical Hematology Services

Clinical Laboratory Services

Clinical Research Services

Protein Expression Services

Protein Services

Biochemistry & Molecular Biology Services

Biology Services

Business & Legal Consulting Services

Marketing, Business Development & Commercialization Services

Formulation & Manufacturing Services

Medical Devices & Diagnostics Services