1INNOVATION FOR BIOTHERAPIES

Training

After sales service

Quality assurance

DEDICATED ACCREDITATION

PROCEDURES

ALLERGYPROGRAM

ONSITEINTERVENTION

THERAPEUTIC DRUG MONITORING

PROGRAM

HOTLINE

QUALITY CONTROL PROGRAM

AUTOIMMUNEPROGRAM

REMOTE MAINTENANCE

Autoimmunity

Allergy

Therapeutic Drug Monitoring

A NEW DIMENSION IN DIAGNOSTIC AND PATIENT MONITORING

BioCLIA™ combines for the first time autoimmunity, allergy and therapeutic drug monitoring

in one solution. BioCLIA™ is the 4th generation chemiluminescence random access analyzer

with a broad offer of high quality services.

Experience, for the first time, a comprehensive solution, not only for diagnosing but also

for monitoring patients treated by biotherapies. The fast and accurate results obtained

with BioCLIA™ are of high clinical value. They help to support therapeutic decision while

enhancing productivity and cost-effectiveness.

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FUTURE IS HERE

The solution that fits your needs

ACCURATE

Thanks to the CLIA (Chemiluminescent Immuno Assay) technology, get immediate and precise results from lower to upper titers, while avoiding further dilutions steps.

SIMPLE

Random access, fully automatized and driven by an intuitive software interface, BioCLIA™ is an easy to use solution. Therapeutic decision becomes much easier.

FAST

Instrument throughput and BioCLIA™ technology deliver results within less than an hour. The ability to keep reagents on board, the design of sample loading and the automation of daily maintenance tasks reduce the time spent in front of the instrument.

VERSATILE

Thanks to its unique menu combining therapeutic drug monitoring, autoimmunity and allergy, BioCLIA™ adapts to your needs and offers you a higher level of versatility. The Short Turn Around Time (STAT) function offers an additional flexibility in samples management.

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CHANGING DIMENSION WITH NEW TECHNOLOGIES

The 4th generation of chemiluminescence at your fingertips

ANTIGENS PRESENTATION OPTIMIZATION

In order to optimize antigen-antibody reaction, BioCLIA™ uses two different approaches:• Liquid antigens captured by particles• Already coated particlesThe choice of either technology is driven by the kind of dosage to be performed: drugs, autoantibody, IgE...

MAGNETIC PARTICLES

The use of magnetic property of particules ensures fast washing steps, without any loss of response, providing an excellent sensitivity.Miniaturization of the particles-antigen-antibody system increases incubation efficiency. BioCLIA™ offers first results within less than one hour after startup.

A CHEMILUMINESCENCE DETECTION

Detection by luminescence decreases background compared to classical methods. The combined use of high sensitivity sensors and innovative substrate formulation increases dynamic range while providing reliable results regardless the intensity of the signal.

HIGH SENSITIVITY

ADAPTABILITYRELIABLE RESULTS

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THERAPEUTIC DRUG MONITORING

As it allows to monitor the drug trough level and anti-drug antibody assay of patients treated by biotherapies, the BioCLIA™ Tracker product range offers highly valuable clinical results. It guides and strengthens therapeutic decision.The BioCLIA™ short turn around time provides Therapeutic Drug Monitoring (TDM) results before the next drug infusion.

DIAGNOSING AUTOIMMUNE DISEASES

With its menu combining both routine analyses (ENA, DNA,…) and highly specialized tests (GAD, IA2…), BioCLIA™ Autoimmunity product range is adapted to your needs and your lab’ specialization level.For the first time ever, enlarge your test menu with the automated diagnosis of type I diabetes.

A UNIQUE MENU

From diagnostic to patient monitoring with one and only instrument

DIAGNOSING ALLERGY

With a rationalized and optimized menu, the BioCLIA™ Allergy product range allows you to run the majority of allergy diagnostic tests. From screening to components identification, BioCLIA™ Allergy suits your needs.

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« THERANOSTICS: DIAGNOSTICS APPLIED

TO A SPECIFIC THERAPY »

« BIOCLIA™ TRACKER: A THERAPEUTIC DECISION SUPPORT TOOL »

« IMPROVE THERAPEUTIC RESPONSE WHILE MINIMIZING COST

AND SIDE EFFECTS »

A NEW DIMENSION FOR PATIENT MANAGEMENT: THERAPEUTIC DRUG MONITORING

A step towards personalized medicine

OPTIMIZATION OF TREATMENT BY BIOTHERAPIES AND BIOSIMILARS

Beyond simple diagnostics, theranostics provides clinicians with a tool to implement patient centric treatments. Drug and anti-drug antibodies measurement improves the efficacy of the biotherapies. It helps also to prevent therapeutic escape and the occurrence of potential side effects while reducing costs of these expensive treatments.

THERAPEUTIC DRUG MONITORING BENEFITS

Along with the patient clinical file, measuring drug trough level and anti-drug antibodies production allow clinicians to take rational therapeutic decisions:

• Optimizing the dose

• Guiding therapy after treatment failure

• Reducing treatment costs by cutting short non-effective treatment protocols

• Guiding dose de-escalation in patients in remission

• Predicting clinical response

• Decreasing the risk of allergic reactions during infusion or other adverse effects

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« TOWARDS PERSONALIZED MEDICINE TO IMPROVE PATIENT CARE »

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A NEW DIMENSION SOFTWARE AT YOUR SERVICE

Intuitive, Smart, Connected

INTUITIVE

The user friendly interface guides you through loading steps and alerts you whenever needed. Visualize your sample status and the number of available tests on board at a glance.

SMART

Each single action and event is tracked in the system’s logbook. Management of calibration and batch number tracking are directly performed with the help of an integrated barcode scanner. Thus, risk management is guaranteed.

CONNECTED

Designed according to up-to-date standards, BioCLIA™’s connection with your informatics system is seamless: direct connection or via middleware, the choice is yours.

Training

After sales

service

Quality

assurance

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THE SERVICE IN ALL ITS DIMENSION

An expertise serving your practice

SPECIALISTS AT YOUR SIDE

Wherever you are, Theradiag guarantees a highly qualified team of professionals trained for installation and maintenance of your automated solution.

QUALITY ASSURANCE

Laboratory accreditation is becoming more and more a requirement across Europe. Therefore, we develop and provide specific tools to support your quality assurance.

TRAINING

Theradiag and its partners help you to implement new techniques in your laboratory: practical training on instruments, courses in autoimmunity, therapeutic drug monitoring or allergy. Our team will listen to your specific needs and implement customized training plans.

THERADIAG AND THERAPEUTIC DRUG MONITORING

Capitalizing on its expertise in distribution, development and manufacturing of in vitro diagnostic tests, Theradiag innovates and develops theranostic tests (combining therapy and diagnostics) that improve the efficiency of biotherapies in the treatment of autoimmune and inflammatory diseases.Theradiag is thus participating in the development of customized and individualized treatments, improving their efficacy and preventing drug resistance. As a market innovator, Theradiag provides for the first time fully automated Therapeutic Drug Monitoring tests and reinforces its leading position.

HOB® AND THERADIAG, A PARTNERSHIP IN MARKETING AND DEVELOPMENT

HOB® Biotech Group is a leading manufacturer in China. It is considered a first-class global player in allergy and autoimmune in vitro diagnostics. Being both leaders in their respective fields, it appeared obvious that HOB® and Theradiag have joined their forces to co-develop BioCLIA™ reagents. Both companies share their specific market know-how and technical expertise. Carried by the quality of HOB®’s products, Theradiag is committed to be the CE representative for the BioCLIA™ product range in Europe.

THERADIAG, YOUR PARTNER HEADING TO A NEW DIMENSION

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AN EFFICIENT 3 IN 1 SOLUTION

Gather all your parameters in Therapeutic Drug Monitoring, autoimmunity and allergy on the same easy to use random access platform. The simplicity of using the instrument, the automation of maintenance tasks and the sample loading procedure ensure efficiency of your lab.

PERSONALIZED MEDICINE

Offer the Therapeutic Drug Monitoring results in less than one hour to adjust the treament immedialtely and maximize its efficacy.

RELIABLE PARTNER

Theradiag and its European partners are dedicated to help you implementing a BioCLIA™ solution in your daily practice with specific trainings and active support of your teams.

CHANGING DIMENSION

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INNOVATION FOR BIOTHERAPIES

14 rue Ambroise CroizatCS 90136 Croissy Beaubourg77435 MARNE LA VALLEE cedex 2FRANCEPhone +33(0)1 64 62 10 12Fax +33(0)1 64 62 09 66info@theradiag.com

www.theradiag.com

BioCLIA™ range – V.01/2017 - UKRead carefully the instructions for use of the product insert before use.Pictures may differ from actual products.

Reagents

HOB Biotech Group (China)

Theradiag (France)

Instrument

Rayto (China)

Shangai International holding Corp. GmbH (Germany)

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