MARCY L'ETOILE, France, Nov. 17 bioMerieux has signed an agreement with GlaxoSmithKline to develop a predictive test to help clinicians select the most appropriate treatment for different segments of breast cancer patients. This test, based on emerging biomarkers, will be intended for use in both adjuvant and metastatic breast cancer settings, subject to regulatory approvals. Over 500,000 new cases of breast cancer are diagnosed each year in the US and Europe alone and predictive tests have been shown to improve outcomes for these patients.
"This new collaboration is a significant milestone in our theranostics strategy," said Stephane Bancel, bioMerieux Chief Executive Officer. "Working with GSK, we hope to achieve an important breakthrough in breast cancer care, helping oncologists to determine the most appropriate treatment as early as possible to give a significant number of breast cancer patients the chance for a better outcome."
The development of this new test will be co-funded by both companies and will leverage their complementary expertise. GSK, a world leader in oncology therapeutics, will bring its extensive experience in the field of cancer and conducting clinical studies and will also facilitate access to samples from several clinical trials under the collaboration.
The new test will be developed by bioMerieux's global R&D team, including its subsidiary, bioTheranostics, which has a high complexity laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). The bioTheranostics team has expertise in molecular oncology diagnostics, with its THEROS CancerTYPE IDŪ test for identifying metastatic cancers of uncertain or unknown origin and THEROS Breast Cancer Index(SM) test for predicting breast cancer recurrence risk.
Following clinical evaluation, the test will be launched by bioTheranostics in its CLIA-certified laboratory, after which an in vitro diagnostic kit will be developed by bioMerieux and introduced to the global market leveraging the resources of bioMerieux and the collaboration.
A theranostic is a diagnostic test that helps clinicians make the right therapeutic decision for the right patients, enabling a more personalized approach to medicine.
bioMerieux is partnering with pharmaceutical companies, biotech companies and payers to develop theranostic tests which:
The company's theranostics strategy focuses on infectious diseases and cancer. bioMerieux has made a sustained investment in high medical value biomarkers through in-house R&D programs, research collaborations and the aggressive pursuit of licensing opportunities. With distribution in over 150 countries, bioMerieux has the experience of bringing hundreds of diagnostics to global markets over the past 45 years.
bioMerieux has a dedicated theranostics division based in the U.S. in Cambridge, Massachusetts and backed by an extensive global network.
Theranostics development also leverages bioMerieux's unique hybrid business strategy: the high complexity CLIA lab of its subsidiary, bioTheranostics, allied with bioMerieux's global IVD business, supports aggressive development timelines while ensuring test availability wherever the drug is sold.
Advancing diagnostics to improve public health
A world leader in the field of in vitro diagnostics for over 45 years, bioMerieux is present in more than 150 countries through 39 subsidiaries and a large network of distributors. In 2008, revenues reached euro 1.111 billion with 84% of sales outside of France.
bioMerieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Our products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.
bioMerieux is listed on the NYSE Euronext Paris market (Symbol: BIM - ISIN: FR0010096479).
Other information can be found at www.biomerieux.com.
> empower physicians with high-medical value testing for science-driven treatment decisions; > improve patient outcomes and patient safety by identifying patients who won't respond to a drug or who will experience an adverse event; > increase the efficiency of drug development, helping pharmaceutical companies by pinpointing those patients most likely to benefit from the new drug; > positively impact health economics, helping physicians select optimal and cost effective therapy.