Companion diagnostics are certain tests designed in order to predict if a person responds positively to a certain companion treatment. Companion treatment means a specific medication or drug (also known as personalized medicine) made to cure a particular ailment that may be due to the alteration in the genes (e.g.: cancer) or some serious underlying condition like asthma.
Earlier, the understanding of a disease pathobiology and aetiology was based on observations like the patient’s homeostatic imbalance and psychological changes but researchers have replaced this observation with an understanding that any disease onset and causation is a complex multicomponent process. For example, these days breast cancer has been categorized into five different subtypes and ideally, with each subtype having different therapeutic drugs. But our inability to know the exact cause of the disease, complexity, progression and effective treatment has led to an increase in healthcare costs.
Companion Diagnostics can:
- Identify patients who can benefit from a particular therapeutic action
- Identify patients who have increased risk of side effects due to a certain therapy
- Monitor the response of the patient to the treatment and adjust the side-effects by looking into the safety measures as well.
Patients with similar ailments have the chances of responding differently to the same pharmacological intervention with respect to safety outcome and efficacy. Despite the discussions going on over personalized medicines, we still see that for chronic diseases like cancer, the drug prescriptions are sometimes based on “trial and error “and not on solid biomarker data.
The present requirement is to first diagnose the exact disease and source, then provide the proper medication. Tailored for specific patients, these companion diagnostic tools are medical instruments that help the doctors to offer the right treatments and dosage to specific patients. Over the last few years, the huge development of molecular diagnostics industry and detailed research on understanding the disease mechanism has been carried out.
Invivoscribe Collaboration: Invivoscribe (manufacturers of Diagnostic products and reagents for lymphomas and leukemias), with more than two decades of validations, development and commercialization experience has now collaborated with Astellas Pharma Inc and Novartis AG to develop immune-oncology molecular diagnostics and bioinformatics software. These have the potential to be one of the powerful tools in the near future for the diagnosis and monitoring of a range of hematologic malignancies.
AstraZeneca Partnership: In May 2015, AstraZeneca entered into an agreement with Abbott healthcare company to develop companion diagnostic tests for Tralokinumab in asthmatic patients. As of now, there is no provision for diagnosing asthma through blood tests. As per the terms, agreed by both the companies, Abbott will develop the diagnostic tests that will measure serum levels of Dipeptidyl Peptidase-4 (DPP4) and Proteins Periostin which is said to be a potential predictive biomarker of IL-13 in severe asthma. In November 2017, AstraZeneca announced its third phase of development for which the results were a bit disappointing, but the research and development is still being carried out to achieve that enhanced response to tralokinumab.
Singulex Collaboration: Singulex, a next-generation immunodiagnostics company has entered into an alliance with Qiagen NV (European diagnostic specialist). Through this collaboration, QIAGEN will get an access to Singulex’s CLIA licensed laboratory and Single Molecule Counting immunodiagnostic platform which would be an add-on to QIAGEN’s molecular testing services that would help in the development of companion diagnostics for different ailments.
There has been an observed increase in the number of research collaborations around the world and this figure is only expected to rise over the next decade. With the launch of highly effective drug therapies and disease diagnostic procedures, the companion diagnostic market is set to grow at a tremendous rate, thereby enhancing the overall treatment of ailing patients.
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