Companion diagnostics are diagnostic tests that provide information to guide the use of a corresponding therapy. These days, the ‘one therapy fits all’ approach to medicine has been demonstrated to be insufficient. Trial and error is often used to select a therapy for a specific person. Companion diagnostics aim to eliminate this by identifying patients who will particularly benefit from or, in contrast, be at an enhanced risk from a certain therapy, and also to monitor treatment response.
Here are ten reasons you should put resources into companion diagnostics:
- The FDA may not approve some therapies without a companion diagnostic, or may require one to be created subsequently in which case time is of essence.
- Companion diagnostics allow dosage to be tailored to a specific patient by monitoring treatment response. This prevents over or under dosing and improves clinical results.
- Eliminating the trial and error factor when choosing which treatment for a particular patient saves time, money and lives. It also reduces the risk of malpractice suits being filed if the ‘wrong’ therapy is given.
- Companion diagnostics allow the selection of subjects most likely to be helped by clinical trials and can thus speed a therapy through review and approval.
- The system also facilitates the approval of therapies which might only help a small number of patients. By identifying therapies that help people with, for example, a specific mutation, these therapies can be brought to market faster and save lives.
- In some cases, adding a companion diagnostic can broaden the use of a therapy. For example, Gleevec, a therapy used for chronic myeloid leukemia, was initially approved only for later stages. However, the introduction of a diagnostic allowed its approval for some patients in early stages of the disease.
- The use of companion diagnostics may prevent therapy recall by identifying individuals who are likely to have a severe reaction, allowing the therapy to continue being used by the majority of patients.
- therapy developers, although not required to, have started offering substantial subsidies and royalties to companies developing diagnostic kits.
- Insurance companies and other payers may introduce a requirement for diagnostic tests before paying for therapies that are known to only benefit a subset of patients or for those that could have severe side effects.
- In the future, genome screening using computers may allow a doctor to select from a ‘library’ of therapies to get the best results for their patient, reducing costs substantially.
Personalized medicine is part of todays healthcare, and companion diagnostics are an important part of it.