Personalized medicine focuses on giving the right treatment to the right group of patients at the right time, based on an in-depth understanding of the patient’s medical status and specific biological criteria. It first requires establishing an assessment of the person’s medical condition using biomarkers and/or gene signatures in order to then tailor an approach to the specific characteristics of the individual’s situation. This approach includes the targeting of possible diseases and potential pathogenic agents.
The aim is to improve the chances of a beneficial patient outcome by administering more closely targeted interventions only to patients who are likely to respond (i.e. those for whom the treatment will most likely be effective), while limiting undesirable side effects. In such a way, personalized medicine, with its obligatory associated diagnostic, so called companion tests, allows each individual patient to benefit from the interventions that will be most effective for him or her, while optimizing the cost-efficacy ratio.
Personalized medicine is already being widely used in oncology. In the future, it is poised to undergo significant development in other therapeutic areas: infectious diseases, neurology, immunology, cardiology, gastroenterology, etc.
bioMérieux is committed to improving patient outcomes by using innovative and beneficial diagnostic tools. bioMérieux has created the Companion Diagnostics program which is structured to work in close partnership with pharmaceutical, vaccine and medical device companies. Its objective is to promote the use of various laboratory tests which are combined with medical interventions: “companion tests” and “complementary and supportive tests”.
- “Companion tests” are essential diagnostic tests to select those patients who are likely to show a clear benefit from an intervention for a given disease (patient stratification). In addition, they are used to identify patients with predispositions to serious side effects related to an intervention or treatment. Regulatory bodies such as the Food and Drug Administration (FDA) impose strict regulations on the development and marketing of “companion tests”, which are closely tied to the targeted therapy they accompany. bioMérieux has acquired several years of experience in this field. The Company has worked with GlaxoSmithKline (GSK), Novartis and Array BioPharma for the co-development of THxID™-BRAF, a molecular-based companion test for patients with late-stage metastatic melanoma.
- “Complementary and supportive tests” include, at bioMérieux:
- tests to determine antibiotic susceptibility (e.g. Minimal Inhibitory Concentration [MIC]) to antibiotics, such as ETEST® and VITEK® 2 products,
- tests used in clinical trials for patient stratification in order to create homogenous and uniform cohorts of patients with a similar condition, disease, or pathogen of interest.
For many years, bioMerieux has applied its partnership know-how in the field of infectious diseases to coordinate the development of the ETEST® and VITEK® 2 product ranges, in close collaboration with anti-infective pharmaceutical companies. Both these diagnostic solutions play an instrumental role in launching and safely prescribing new anti-infective agents, particularly in the context of growing antimicrobial resistance.
In addition, the tests developed by bioMérieux can be used by pharmaceutical, vaccine and medical device companies in their clinical trials investigating preventive and therapeutic interventions. In fact, many of the tests on the BIOFIRE FILMARRAY® and VIDAS® systems, as well as certain microbiology growth-based assays (RAPIDEC® CARBA NP, CHROMID®), can be used to efficiently select patients who are going to be treated with prophylactic or therapeutic monoclonal antibodies, anti-infective medications or immunomodulatory drugs.
Our partnership program
At bioMérieux, we combine our expertise in infectious diseases and targeted critical medical conditions with our experience in the field of “companion” and “complementary/supportive” tests to forge strong and innovative development and commercialization partnerships with healthcare companies. These partnerships may, for instance, be in the field of sepsis, anti-infective medicines and vaccines, and immunomodulating interventions. They rely on technologies in which bioMérieux has a long history of established expertise: microbiology, immunoassays and molecular biology.
As a pure player of in vitro diagnostics, bioMérieux fully manages the phases of development, validation, registration, global commercial deployment thereby allowing maximal market access of both the diagnostic test and the associated pharmaceutical or medical device.
All our partnerships with pharmaceutical, vaccine and medical device companies are coordinated through the Companion Diagnostics program, which provides a single point of entry to facilitate interactions with our partners.