What Are Concomitant Drugs?

Companion diagnostics (CD) is an in vitro diagnostic technique that provides information about a patient's response to a specific treatment, helps identify the patient population that can benefit from a treatment product, and improves treatment prognosis And reduce health spending. In addition, companion diagnostics can help determine the population of patients most likely to respond to a therapeutic drug. At present, the companion diagnostic market is still in its infancy.

Companion diagnostics (CD) is an in vitro diagnostic technique that provides information about a patient's response to a specific treatment, helps identify the patient population that can benefit from a treatment product, and improves treatment prognosis And reduce health spending. In addition, companion diagnostics can help determine the population of patients most likely to respond to a therapeutic drug. At present, the companion diagnostic market is still in its infancy.

Chinese name

Companion diagnosis

Foreign name

CompanionDiagnostic

Companion diagnostic function

This test can be performed before and after the drug is marketed, and its main purpose is to improve the treatment of individuals. The goal is to feed the data back into physical therapy and guide the development of medications and rational treatment plans. [1] ^[1]

To understand which patients can benefit from targeted drug therapy, or which patients cannot receive targeted drug therapy, the FDA (United States Food and Drug Administration) and drug and device manufacturers will "develop certain tests" and call them " Companion diagnostics. "

In terms of indications, the companion diagnostic market can be subdivided into oncology, cardiovascular disease, central nervous system, inflammation, and virology. Among them, oncology is the disease field with the highest revenue in the companion diagnostic market. Currently, a number of companion diagnostic kits have been developed for the detection of various types of cancer biomarkers. The main driving force of this market segment is targeted drug development Growth requires the development of corresponding companion diagnostic kits.

Divided from the technical level, the companion diagnostic market can be subdivided into immunohistochemistry and molecular diagnostics. Among them, molecular diagnostics will become the fastest growing and highest revenue generating area, mainly due to the widespread use of real-time PCR, in situ hybridization, and next-generation sequencing technologies. Other factors driving market growth, including advances in molecular diagnostic technology, have led to more accurate and precise diagnostic results, and the application of these methods has also reduced testing costs.

Companion diagnostic history

The road to companion diagnostics began with the FDA-approved anticancer drug Herceptin in 1998. Herceptin is a humanized monoclonal antibody that targets the extracellular domain of the HER-2 receptor tyrosine kinase. It expands HER-2 in about 20% of invasive breast cancers.

In 1998, Herceptin (Trastuzumab) and a "concomitant diagnostic" test called HER-2 overexpression were approved by the FDA.

Companion diagnostic developments

With the development of scientific knowledge, multiple companion diagnostics combined with practically applied therapies make testing more complex.

Co-development of drug-companion diagnostics is receiving increasing attention from the global pharmaceutical community

Because the Drug-Companion Diagnostic test is designed to work with a specific drug, its development requires close collaboration between the FDA Device Center and experts to conduct evaluation tests to determine if it can be approved, and the FDA Drug Center needs to evaluate the drug To decide whether to approve.

There are now 19 advertised / approved drugs that accompany diagnostic tests. And most drugs have passed companion diagnostic tests.

In August 2014, the FDA announced several important new measures, including the recent release of a guidebook on "conpanion diagnostic (CD)" and the requirement that the U.S. Congress propose and issue a "Lab Development Diagnostic Test ( Laboratory diagnostic test (LDT) ".

First, the FDA has indicated that the final version of the Companion Diagnostic Guidelines is in the final revision stage and will be announced shortly. At present, companion diagnostic tests are often used to discover some types of cancer caused by genetic mutations. The companion diagnostic guidelines will be used to review and decide on the approval or rejection of companion diagnostics.

In the early stages of drug development, the Guide can help identify which patients require companion diagnostic tests, thereby guiding companies to develop a companion diagnostic test plan while developing drugs. The ultimate goal of the Guide is to enable critically ill patients to get early treatment with some effective and innovative drugs. As early as 2011, the Guide was published in the form of a draft and solicited opinions and suggestions from all walks of life.

Second, in accordance with the requirements of the FDA Safety and Innovation Act, the FDA communicated the purpose and significance of strengthening LDT supervision with members of Congress and urged Congress to draft a bill on the LDT regulatory framework as soon as possible. LDT is designed, manufactured and used in a separate laboratory, which includes genetic tests and tests used by other medical experts to guide drug treatment. Previously, the FDA had conducted a sample review of all tests performed directly on patients, including LDT and traditional diagnostics.

"Determining whether doctors and patients are in contact with safe, accurate, and reliable diagnostic tests is a top priority for the FDA," said FDA Commissioner Dr Margaret A. Hamburg. "Inaccurate test results may lead patients to seek unwanted Treatment methods, or delay or even completely discontinue treatment. These measures announced today are the FDA's commitment to strengthen the 'individualized medication', which rely on accurate and reliable diagnostic tests to design the correct and effective treatment for different patients Method."

"The companion diagnostic guidebook is the FDA's commitment to strengthen individualized medication. It relies on accurate and reliable diagnostic tests to design correct and effective treatments for different patients," said Dr. Margaret A. Hamburg, FDA director. ^[2]