10 Reasons You Should Invest in Companion Diagnostics

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:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. therapy developers, although not required to, have started offering substantial subsidies and royalties to companies developing diagnostic kits.
9. 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.
10. 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.