THE CHALLENGE
Cancer is a leading cause of death worldwide, accounting for 7.9 million deaths (around 13% of all deaths) in 2007.* Several types of cancer appear to be more frequent due to factors such as the aging of the population, environmental conditions and lifestyle choices.
Progression of the disease depends on the type of cancer and the care patients receive, which is why an accurate assessment of the cancer type is essential.
* WHO – Cancer, Fact Sheet N°297, July 2008
OUR RESEARCH
The latest tests under development
We have chosen to focus our research on the most common types of cancer (breast, prostate, lung and colorectal cancers), as well as cancers associated with a virus (cervical cancer).
Breast cancer: the findings of clinical evaluations were recently published for the Theros Breast Cancer IndexSM, a method for the “characterization” (identification) of tumors in molecular biology, for breast cancer risk prognosis and assessment of the response to chemotherapy and hormone therapy, developed by our subsidiary, bioTheranostics.
Within this framework, we are working on the development of a diagnostic “companion” test for a new breast cancer drug undergoing clinical evaluation by Ipsen. Our test would make it possible to identify patients likely to have a positive response to this new treatment.
Colorectal cancer: our research aims to offer an alternative to the detection of occult bleeding (abnormal and invisible presence of blood in stool) and to colonoscopy (a medical exam that is difficult to practice widely and one that is not without risk for the patient).
Prostate cancer: we are working to develop new tests that will complement our tests for the measurement of prostate-specific antigen (PSA) levels. We have a license and development agreement with the German biotech company, ProteoSys, for a urine-based test. By combining this test – which detects a new biomarker – with standard screening methods, the number of biopsies performed could potentially be reduced by up to 75%.
Theranostics, a diagnostic test associated with a therapy: The profile of genes expressed by tumors can make it possible to predict the quality of a patient’s response to treatment in order to better adapt and personalize therapy. Patients are administered the most effective treatment for their individual case and treatments causing undesirable side effects or adverse events, that outweigh the expected benefit, are avoided.
With this new approach, known as theranostics, bioMérieux is devising diagnostic companion tests for new drugs, in collaboration with Ipsen, for example (see breast cancer) and in the framework of the ADNA program.
Specialized research laboratories
Fudan University Cancer Hospital – Shanghai, China: the FUCH-bioMérieux Laboratory, located in the biggest cancer hospital in China, aims to achieve the molecular characterization of breast and colon tumors in order to identify patients who would benefit from targeted treatments.
bioTheranostics, our subsidiary dedicated to theranostics - San Diego, California: bioTheranostics is specialized in molecular diagnostics for the classification of cancers and to help oncologists decide on the best treatment strategy. The company has a high complexity CLIA* certified laboratory in which the tests are performed. The laboratory accelerates the development of tests with new biomarkers:
- The CLIA lab allows early introduction of the biomarkers to the clinical community through the testing service it provides,
- Subsequently, bioMérieux is able to make the biomarkers more widely available by transferring them onto our global installed base of diagnostics systems.
*CLIA - Clinical Laboratory Improvement Amendments
DIAGNOSTICS
Surgery, radiation therapy, chemotherapy? To make the best possible decision, physicians must know exactly what type of cancer a patient has. Thanks to our tests, they can identify the tumor with a high degree of accuracy and adapt their treatment strategy accordingly.
Once the patient has begun therapy, our tests play a decisive role by allowing an early evaluation of the response to the selected treatment.
For 20 years, bioMérieux has fine-tuned the technique of using tumor markers to detect the presence of cancer with our VIDAS® system. This immunoassay platform offers several tests for the measurement of tumor markers of prostate, breast and ovarian cancer, as well as lymphomas. It is used for two applications:
- Routine screening of certain subgroups at risk in the population, since early testing ensures better patient care.
- Monitoring progression of the disease and the effectiveness of treatment. Regularly measuring the levels of certain markers makes it possible to monitor the clinical evolution of the disease (the measurement of PSA – the Prostate Specific Antigen - for prostate cancer and the measurement of CA15.3 for breast cancer).
Our wholly-owned subsidiary, bioTheranostics, offers innovative molecular tests* based on its proprietary technologies:
- Theros CancerTYPE ID®, for the classification of metastatic cancers when the origin is uncertain or unknown, can classify up to 39 tumor types and 64 cancer subtypes.
- Theros Breast Cancer IndexSM offers breast cancer prognosis assessment and treatment response prediction for chemo and hormonal therapy.
We have also launched a molecular diagnostic test for the detection of human papillomavirus (HPV), used for the prevention of cervical cancer. NUCLISENS EASYQ® HPV uses bioMérieux’s NASBA Real-Time technology. The test is based on a novel concept, which consists of evaluating the virus’s oncogenicity, i.e., its potential to cause cancer, via the direct detection of the expression of certain oncogenic viral proteins.
*Tests available only in the United States