Introduction:
A medical device and an in-vitro diagnostic help provide information regarding the safe and effective use of the corresponding drug and a biological product. These devices help identify individuals who need particular therapeutic drugs. They identify patients at increased risk for side effects of particular therapeutic drugs and help monitor their response.
What Is Companion Diagnostics?
Companion diagnostics (CDx) is a medical device or test to know a treatment's risks and side effects. It helps get information essential for the safe and effective use of a particular drug or a biological product. It is particularly used for the targeted treatment.
It helps the healthcare professional to know about the benefits of drugs, risks, or the side effects of a drug. This kind of diagnostics has been available since the late -1990s. Approximately 90 percent of the devices are used for oncology treatment. Another type is a compulsory complete blood count test before administering a drug called Clozapine for severe schizophrenia. Schizophrenia is a mental illness and the affected individual may interpret the reality abnormally.
The test considers
-
Nature of the disease.
-
Aspects of patient’s health.
-
Development of the test itself with the drug to be used.
The companion diagnostic test must be officially approved with the licensing of the drug for its use. Information about the CDx test must be included in labeling the therapeutic drug used.
Companion diagnostics are developed based on companion biomarkers. These biomarkers help to know the responses or severe toxicity. Many regulatory agencies like the United States (U.S.) Food and Drug Administration (FDA) needs CDx to approve certain targeted therapies.
Predictive biomarkers play an important role in the implementation of precision medicine. The number of US FDA-approved CDxs has increased since the development of the CDx co-development model in the late 1990s.
Companion diagnostics is an appropriate term for the class of devices. Companion term can be described as often developed alongside a specific therapeutic drug, and diagnostic is a biological assay that assesses whether the patient will benefit from the treatment.
Companion diagnostic purposes include
-
To identify genetic subgroups that may benefit from a targeted therapy.
-
To identify patients at higher risk for severe side effects because of specific treatment.
-
To identify any adverse responses so that the treatment can be modified. This helps increase the suitability and safety of the treatment.
A healthcare professional may apply a CDx test to determine whether the drug is effective for that condition. These tests can help identify the side effects to be caused and to assess the effectiveness of the treatment given. This information can be used to alter the course of treatment so that it is safe and more effective.
What Is the Difference Between Companion Diagnostics and Complimentary Diagnostics?
Complimentary diagnostics, like companion diagnostics, are medical devices or in vitro diagnostics used to effectively and safely use therapeutic products. Complimentary diagnostic is not mandatory to be used for the usage of drugs. It can be used as optional. Generally, its information is added to the therapeutic product labeling.
Companion diagnostics is a must for the effective use of therapeutic drugs, whereas complementary diagnostics gives additional information regarding giving a particular treatment to an individual.
What Is the Role of Companion Diagnostics for Oncology?
Companion diagnostics is a technique that deals with pharmacogenomics. Pharmacogenomics deals with a person's genome (full gene pattern, not just a particular gene) and helps to know how the entire genome reacts to a particular treatment. It helps to know about the effectiveness of the particular drug used, the possible risks, and benefits for that individual.
Pharmacogenomics and CDx play an important role in oncology. A healthcare professional needs to take utmost care in treating cancer patients. Individuals affected with cancer may need to be given aggressively, and at the same time, this treatment may cause serious harm and be fatal to the patient. Hence, CDx and pharmacogenomics help to know about the drug to be used and how the person reacts to the treatment. Hence, fatal and serious harm to the patient may be avoided.
What Are the Uses of Companion Diagnostics for Oncology?
Companion diagnostics play a role in the treatment of cancer patients. Pharmacotherapy varies from one person to another with similar diagnoses. The reaction of the patients to the same treatment may vary in terms of efficacy and safety.
Studies have shown that almost 75 percent of cancer patients do not respond favorably to the same treatment or drug used for cancer. Hence, for decades, personalized or precision medicine has been considered a significant part of oncology treatment. With the help of CDx, treatment effects may be predicted for a particular individual.
Continued learning about biomarkers, molecular diagnostics, and CDx has shown continued improvement in the outcome of cancer patients. Continued research has shown that cancer patients benefit from new diagnostic tests and biological and gene therapies. This, in turn, has been shown to improve survival and quality of life for those diseases that usually had poor prognoses previously.
Companion diagnostics and patient care personalization are growing fields for patient healthcare outcomes and benefits. These help reduce the risks of treatment, which is an important factor in improving patient’s experience of severe and life-threatening diseases.
Complete blood count (CBC) is a companion diagnostic test done compulsorily outside of oncology. Conducting CBC before the issue of medicine helps to make the treatment safer.
In recent years, advancements in scientific and engineering achievements have increased safety by performing CBC at the point of care. Eliminating the risks helps achieve patient treatment without any disruption.
Conclusion:
Companion diagnostics is a medical device or a test that helps to know information regarding the safety and efficacy of a drug in a particular individual. It helps transform the treatment and bring improvement in patients' health outcomes. Hence it is important to know about CDx, its uses, and its role in oncology.
