Biomedical Diagnostics: Release of the First Evaluation Data of LISA TRACKER Kits Used By 3 Hospital Centres for the Monitoring of Patients Affected by Auto-Immune Diseases and Treated with Anti-TNFa

Paris, December 20th, 2010: Biomedical Diagnostics has released the first evaluation data for LISA TRACKER kits carried out by 3 hospital centres in Rheumatology. This innovative tool allows the clinicians to identify, at various moments of the treatment, a possible resistance with the medicine and to optimize the patients’ management (treatment and follow- up) over time.

The first results of evaluations presented to the 23rd Congress of the French Society of Rheumatology are very encouraging and allow considering a regular use of LISA TRACKER kits in the management of auto-immune diseases treated by anti-TNFa.

Identify resistance with anti-TNFa treatment and optimize patients’ management in the long-term Biomedical Diagnostics, company dedicated to the development and to the marketing of innovative in vitro Diagnostic (IVD) products, is specialized in particular in the auto-immune diseases. This recognized expertise allowed Biomedical Diagnostics to provide LISA TRACKER kits, the first CE marked tests. These kits allow physicians to benefit from additional biological parameters, within a few hours and from a simple blood sample, thanks to concomitant dosages of:

· Circulating TNFa;

· Prescribed anti-TNFa;

· Anti-drug antibodies (ADAb) responsible for neutralizing the drug when they are developed by the patient.

Associated with a regular clinical evaluation, this diagnostic test becomes a real theranostic tool allowing:

· to better profile responders to treatment;

· to optimize the treatment of patients affected by chronic auto-immune diseases and treated by anti- TNFa;

· and to improve the patients’ management in the long term.

LISA TRACKER diagnostic tests are specific for each anti-TNFa (Infliximab, Adalimumab, Etanercept and soon Certolimumab pegol and Golimumab)

Resistance to anti-TNFa treatment within the framework of auto-immune diseases such as Rheumatoid Arthritis

We count at present, in seven bigger industrial nations, 9,3 million persons affected by an articular disease such as Rheumatoid Arthritis or Ankylosing spondylitis and 2,1 million persons affected by a digestive disease, mainly Crohn Disease.

Several treatments, among which monoclonal antibodies such as anti-TNFa, are prescribed to reduce the symptoms of these severe and chronic auto-immune diseases which have a major impact on the quality of life of patients and their circle of acquaintances.

Nevertheless a certain number of patients present, in the course of treatment, a resurgence of the symptoms which can lead to additional irreversible articular damages. This change of the therapeutic response can be linked to various causes. However it is recognized that patients can develop an immunization, that is to say antibodies against the prescribed drug (ADAb) which neutralize, in most of the cases, the therapeutic effect of the anti-TNFa.

“The simultaneous consideration of 3 additional biological information, at various moments of the treatment, represents a significant improvement in the monitoring of patients affected by auto-immune diseases and treated by anti-TNFa. Thanks to this diagnostic tool, we hope to take part and to facilitate the necessary implementation of a personalized treatment for every patient ", indicates Michel Finance, Chief Executive Officer of Biomedical Diagnostics.

Communication on the first experiences on the use of LISA TRACKER kits in hospital centres at the 23rd Congress of the French Society of Rheumatology on November 30th in PARIS

The hospital centres of La Pitié Salpétrière (Dr Makoto MIYARA, Dr Lucile MUSSET), Bordeaux (Pr Christophe RICHEZ and Pr Patrick BLANCO) and Kremlin-Bicêtre / Clamart (Pr Dominique Emilie, Pr Corinne MICELI and Dr Fabien VINCENT) implemented the dosages with LISA TRACKER kits and correlated the results to clinical data of some of their patients in Rheumatology.

Professor Xavier Mariette, Chief of the Rheumatology Department at the Kremlin-Bicêtre Hospital, mentions the importance of the dosage of these medicines and in this particular case of anti-TNFa, in the monitoring of patients treated by anti-TNFa in the long term. “It is the topic which is going to become critical in the management of treatments by biological medicines in inflammatory diseases ".

“The biological antibodies took a considerable importance in the treatment of inflammatory diseases. That is why the first results of evaluation of LISA TRACKER kits in hospital centers are particularly encouraging. They demonstrate that the detection of ADAb put in perspective with the dosages of TNFa and anti-TNFa, can help us to adjust the treatment of the patients in order to make it more effective ", concludes Pr Mariette.

About Biomedical Diagnostics (BMD):

More than twenty years of presence in the in vitro Diagnostics (IVD) market makes today BMD a company recognized in the domains of development, manufacturing and marketing of innovative IVD products. This expertise allows among others the company to develop and to propose a complete offer especially based on the Luminex technology for the diagnosis of auto-immune diseases.

Today, BMD has the ambition to position itself as one of the first French distributors of innovative IVD products. BMD is one of the leaders in Auto-Immunity on the French market and asserts itself as a leading European actor for the development and the production of kits through an active strategy of partnerships with pharmaceutical companies. The company is based in Marne la Vallée and counts about fifty employees.

For further information on BMD, please visit our website: www.bmd-net.com.

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