[Chinese pharmaceutical network technology dynamics] Companion diagnosis is an in vitro diagnostic technology associated with targeted drugs, mainly through the detection of protein and mutant gene expression levels in humans, screening the best drug users in different types of disease population, Targeted individualized care.
The same treatment is used for the same disease, and this traditional “package of treatment†approach has now been gradually replaced by “individualized careâ€. Doctors use a variety of tools to group patients into different groups and then tailor the therapy or product to their genomic information. Diagnostic testing is one such tool.
Companion diagnosis is an in vitro diagnostic technique associated with targeted drugs. It mainly selects the best drug users in different types of disease populations by detecting the expression levels of proteins and mutant genes in humans. Medical.
The reporter learned that companion diagnostics provide doctors with information that is critical to the safety and efficacy of a drug or biological product, helping doctors determine whether a particular treatment product benefits a patient beyond a potentially serious side effect or risk.
"As the mutations of unique genes in different cancers are continuously discovered and the clinical application of targeted drugs against these mutant genes, the accompanying diagnosis can help clinicians find patients with these genetic mutations, improve the efficacy and safety of targeted drugs. As well as reducing the cost of medical care, it has become a key to achieving accurate cancer treatment." Cui Tongjian, director of the Department of Oncology, Fujian Provincial Hospital, said in a recent conference on assisted diagnosis of lung cancer in Xiamen.
Accompanied by precise medical diagnosis targeted therapy = <br> <br> growing evidence that cancer is a complex diversity of disease, the patient may exhibit similar symptoms, and have the same pathological changes, which may It is caused by completely different genetic changes. Because of this heterogeneity, cancer patients with the same pathological type have a very different response rate to currently available drugs.
The existence of individual genetic differences also makes the treatment of cancer and its effects vary from person to person. "The same disease, the same treatment plan" can not meet the treatment needs of patients, individualized medical treatment has become the trend of the times. With the close cooperation between the diagnostic and pharmaceutical fields in terms of expertise and technology, concomitant diagnosis and targeted therapy have become the two most important tools for achieving precision medicine.
As the main means of personalized medicine, "targeted therapy" mainly kills malignant tumor cells through the selection of genes or molecules. This method hardly affects normal cells and has the characteristics of "high efficiency and low toxicity".
"Targeted therapy is to design a corresponding therapeutic drug at the cellular and molecular level for a well-defined carcinogenic site. The drug enters the body and specifically selects a carcinogenic site to act to inhibit the tumor cells." Shanghai Chest Hospital Zhang Jie, director of the Department of Pathology, further explained to the reporter of the Chinese Journal of Science.
As an in vitro diagnostic technology associated with targeted drugs, "concomitant diagnosis" mainly selects the best drug users in different types of disease populations by detecting the expression levels of proteins and mutant genes in humans. Individualized medical treatment.
According to the definition of the US Food and Drug Administration (FDA), companion diagnostics can determine which patients are most likely to benefit from a particular treatment product; determine which patients may have serious side effects due to treatment; monitor treatment response to adjust treatment so that Safety and effectiveness are improved.
"We have entered the era of personalized medicine, with diagnostics playing an indispensable role in providing important guidance and treatment information for the promotion of personalized medicine." Zhang Jie pointed out that accurate companion diagnostic results can be appropriate for clinical selection. Targeted drugs provide a strong basis to help patients tailor the optimal treatment regimen, making it possible for patients to achieve maximum survival benefits.
Individualized treatment of lung cancer as a typical example of <br> <br> In recent years, the incidence and mortality of lung cancer continues ranked first malignant disease, each year about 730,000 new cases of lung cancer. In the field of lung cancer diagnosis and treatment, the classification of lung cancer patients by accompanying diagnosis, thus implementing safer and more effective targeted therapy has become a typical example of precision medicine.
Cui Tongjian said that according to the pathological features of cancer cells in lung cancer, lung cancer is divided into small cell lung cancer and non-small cell lung cancer, of which non-small cell lung cancer accounts for up to 80%, mainly including lung adenocarcinoma and lung squamous cell carcinoma. About 70% of patients with non-small cell lung cancer have been diagnosed at an advanced stage and are not sensitive to chemoradiotherapy, resulting in high mortality, a median survival of only 3 months, and a five-year survival rate of only 15%.
The researchers found that a member of the insulin receptor family, degenerative lymphoma kinase (ALK), is one of the key promoter genes for non-small cell lung cancer. The ALK fusion gene is mainly found in lung cancer patients who do not smoke or smoke less, accounting for 5% of all non-small cell lung cancers. The number of new cases in China is about 35,000 per year.
At present, ALK gene variant lung cancer has been clinically proven to be a type of lung cancer with a clear molecular target, target detection technology and targeted drugs. Such patients generally benefit from targeted drug therapy with ALK inhibitors. Studies have shown that ALK-positive non-small cell lung cancer patients with targeted drug therapy have a five-year survival rate of 55%, while chemotherapy survival rate is only 12%.
Epidermal growth factor receptor (EGFR) is a "high frequency" driving gene for non-small cell lung cancer. The proportion of EGFR-sensitive mutations in Asian population is 30% to 40%, which is much higher than that in European and American countries. Currently, EGFR inhibitors are targeted therapies that prolong the survival of patients with EGFR-positive non-small cell lung cancer, and their tolerance and quality of life are higher than traditional chemotherapy.
"In Asian patients with lung adenocarcinoma, 87% of patients were found to have known driver genes, and 81% of the driver genes have clear targeted inhibitors, the most common being ALK and EGFR-driven genes. Pathologists must constantly Genetic testing and targeting from non-small cell lung cancer (lung adenocarcinoma, lung squamous cell carcinoma)." Zhang Jie said, "EGFR and ALK are high-frequency driving genes with clinical therapeutic significance. ALK has almost no early lung cancer. As long as this mutation is a very fierce cancer, it is necessary to test and treat before taking the drug."
In order to further optimize the individualized and precise treatment of non-small cell lung cancer, since 2011, the American Society of Clinical Oncology, the European Society of Clinical Oncology Annual Meeting, the National Comprehensive Cancer Network and other institutions have successively developed guidelines for the diagnosis and treatment of non-small cell lung cancer, emphasizing treatment before treatment. The importance of genetic testing, and the driving of genetic testing to guide clinical treatment programs.
China's National Health and Family Planning Commission's "Chinese Primary Lung Cancer Treatment and Treatment Regulations (2015 Edition)" also pointed out that for advanced non-small cell lung cancer, adenocarcinoma or other types of lung cancer containing adenocarcinoma, it should be routinely diagnosed. Detection of mutations such as EGFR and ALK.
“Targeted therapy is a better choice for lung cancer patients with positive mutations. Studies have shown that targeted therapy for ALK and EGFR-positive patients is superior to traditional chemotherapy and can significantly prolong patient survival. Accurate identification of ALK and EGFR-positive non-small cell lung cancer patients plays a decisive role in the selection of targeted therapeutic strategies." Cui Tongjian emphasized that the first detection, post-treatment, and the use of accompanying diagnosis to guide targeted therapy is the best diagnosis and treatment of lung cancer. Program.
Innovative companion diagnostic technology has a bright future
In addition to lung cancer, the accompanying diagnosis has also entered the field of treatment of breast cancer, melanoma, gastric cancer and other diseases, becoming an indispensable tool for oncologists. Therefore, some analysts expect that the global companion diagnostic market is expected to reach $8.73 billion by 2019.
For pharmaceutical companies, the use of companion diagnostics during drug development can also increase the success rate of the drug. Previously, a study of 676 clinical trials of 199 drug compounds showed that the failure of phase III clinical trials was the biggest obstacle to drug approval, with an overall success rate of only 28%. However, in biomarker-directed trials, the success rate can reach 62%. The researchers used data analysis to conclude that the use of companion diagnostic tests during Phase III drug development significantly increased the chances of clinical success.
According to Dr. Patricia Keegen, regulator of the FDA's Oncology Products Division, if the new drug acts on a specific gene or biological target, but the target is only present in some patients, the FDA needs to be accompanied by a diagnostic test. This test can determine which individuals will benefit from treatment and which patients will not benefit and may even be harmed. The FDA will include accompanying diagnostics in Class III equipment and will require the most stringent medical device approval procedures.
The close cooperation between pharmaceutical companies and diagnostic companies has driven innovation in some drugs and accompanying diagnostic technologies. At present, the FDA has approved a number of companion diagnostic tests introduced by Roche, Abbott, QIAGEN, DAKO and other companies, which mainly use in situ hybridization, immunohistochemistry and other methods to screen some tumor-related mutations to help doctors choose appropriate therapies.
For example, the "Guidelines for the diagnosis and treatment of ALK-positive non-small cell lung cancer in China (2015 edition)" is recommended to use the Roche diagnosis VENTANAALKIHC test for screening and concomitant diagnosis of patients with ALK fusion gene-positive non-small cell lung cancer. The positive result can directly accept crizotinib. medical treatement.
However, as far as the current situation is concerned, Cui Tongjian said that there is still a gap between China and the United States in the accompanying diagnosis and targeted therapy. "The main reason is that foreign basic research is relatively fast, and related drugs for genetic mutations will soon be developed. Can enter clinical trials. In actual clinical application, the genetic testing penetration rate in developed countries is also higher than domestic, which can reach 60%~70%. In addition, foreign patients use medical insurance, which also promotes the application of genetic testing. ."
It is gratifying that at present, the value of accompanying diagnosis has been recognized in China, and cooperation has begun to develop effective tests. At present, more and more companies are developing targeted therapeutic products. Accordingly, the development of accompanying diagnostic tests has become an important part of their new drug development strategy.
The same treatment is used for the same disease, and this traditional “package of treatment†approach has now been gradually replaced by “individualized careâ€. Doctors use a variety of tools to group patients into different groups and then tailor the therapy or product to their genomic information. Diagnostic testing is one such tool.
Companion diagnosis is an in vitro diagnostic technique associated with targeted drugs. It mainly selects the best drug users in different types of disease populations by detecting the expression levels of proteins and mutant genes in humans. Medical.
The reporter learned that companion diagnostics provide doctors with information that is critical to the safety and efficacy of a drug or biological product, helping doctors determine whether a particular treatment product benefits a patient beyond a potentially serious side effect or risk.
"As the mutations of unique genes in different cancers are continuously discovered and the clinical application of targeted drugs against these mutant genes, the accompanying diagnosis can help clinicians find patients with these genetic mutations, improve the efficacy and safety of targeted drugs. As well as reducing the cost of medical care, it has become a key to achieving accurate cancer treatment." Cui Tongjian, director of the Department of Oncology, Fujian Provincial Hospital, said in a recent conference on assisted diagnosis of lung cancer in Xiamen.
Accompanied by precise medical diagnosis targeted therapy = <br> <br> growing evidence that cancer is a complex diversity of disease, the patient may exhibit similar symptoms, and have the same pathological changes, which may It is caused by completely different genetic changes. Because of this heterogeneity, cancer patients with the same pathological type have a very different response rate to currently available drugs.
The existence of individual genetic differences also makes the treatment of cancer and its effects vary from person to person. "The same disease, the same treatment plan" can not meet the treatment needs of patients, individualized medical treatment has become the trend of the times. With the close cooperation between the diagnostic and pharmaceutical fields in terms of expertise and technology, concomitant diagnosis and targeted therapy have become the two most important tools for achieving precision medicine.
As the main means of personalized medicine, "targeted therapy" mainly kills malignant tumor cells through the selection of genes or molecules. This method hardly affects normal cells and has the characteristics of "high efficiency and low toxicity".
"Targeted therapy is to design a corresponding therapeutic drug at the cellular and molecular level for a well-defined carcinogenic site. The drug enters the body and specifically selects a carcinogenic site to act to inhibit the tumor cells." Shanghai Chest Hospital Zhang Jie, director of the Department of Pathology, further explained to the reporter of the Chinese Journal of Science.
As an in vitro diagnostic technology associated with targeted drugs, "concomitant diagnosis" mainly selects the best drug users in different types of disease populations by detecting the expression levels of proteins and mutant genes in humans. Individualized medical treatment.
According to the definition of the US Food and Drug Administration (FDA), companion diagnostics can determine which patients are most likely to benefit from a particular treatment product; determine which patients may have serious side effects due to treatment; monitor treatment response to adjust treatment so that Safety and effectiveness are improved.
"We have entered the era of personalized medicine, with diagnostics playing an indispensable role in providing important guidance and treatment information for the promotion of personalized medicine." Zhang Jie pointed out that accurate companion diagnostic results can be appropriate for clinical selection. Targeted drugs provide a strong basis to help patients tailor the optimal treatment regimen, making it possible for patients to achieve maximum survival benefits.
Individualized treatment of lung cancer as a typical example of <br> <br> In recent years, the incidence and mortality of lung cancer continues ranked first malignant disease, each year about 730,000 new cases of lung cancer. In the field of lung cancer diagnosis and treatment, the classification of lung cancer patients by accompanying diagnosis, thus implementing safer and more effective targeted therapy has become a typical example of precision medicine.
Cui Tongjian said that according to the pathological features of cancer cells in lung cancer, lung cancer is divided into small cell lung cancer and non-small cell lung cancer, of which non-small cell lung cancer accounts for up to 80%, mainly including lung adenocarcinoma and lung squamous cell carcinoma. About 70% of patients with non-small cell lung cancer have been diagnosed at an advanced stage and are not sensitive to chemoradiotherapy, resulting in high mortality, a median survival of only 3 months, and a five-year survival rate of only 15%.
The researchers found that a member of the insulin receptor family, degenerative lymphoma kinase (ALK), is one of the key promoter genes for non-small cell lung cancer. The ALK fusion gene is mainly found in lung cancer patients who do not smoke or smoke less, accounting for 5% of all non-small cell lung cancers. The number of new cases in China is about 35,000 per year.
At present, ALK gene variant lung cancer has been clinically proven to be a type of lung cancer with a clear molecular target, target detection technology and targeted drugs. Such patients generally benefit from targeted drug therapy with ALK inhibitors. Studies have shown that ALK-positive non-small cell lung cancer patients with targeted drug therapy have a five-year survival rate of 55%, while chemotherapy survival rate is only 12%.
Epidermal growth factor receptor (EGFR) is a "high frequency" driving gene for non-small cell lung cancer. The proportion of EGFR-sensitive mutations in Asian population is 30% to 40%, which is much higher than that in European and American countries. Currently, EGFR inhibitors are targeted therapies that prolong the survival of patients with EGFR-positive non-small cell lung cancer, and their tolerance and quality of life are higher than traditional chemotherapy.
"In Asian patients with lung adenocarcinoma, 87% of patients were found to have known driver genes, and 81% of the driver genes have clear targeted inhibitors, the most common being ALK and EGFR-driven genes. Pathologists must constantly Genetic testing and targeting from non-small cell lung cancer (lung adenocarcinoma, lung squamous cell carcinoma)." Zhang Jie said, "EGFR and ALK are high-frequency driving genes with clinical therapeutic significance. ALK has almost no early lung cancer. As long as this mutation is a very fierce cancer, it is necessary to test and treat before taking the drug."
In order to further optimize the individualized and precise treatment of non-small cell lung cancer, since 2011, the American Society of Clinical Oncology, the European Society of Clinical Oncology Annual Meeting, the National Comprehensive Cancer Network and other institutions have successively developed guidelines for the diagnosis and treatment of non-small cell lung cancer, emphasizing treatment before treatment. The importance of genetic testing, and the driving of genetic testing to guide clinical treatment programs.
China's National Health and Family Planning Commission's "Chinese Primary Lung Cancer Treatment and Treatment Regulations (2015 Edition)" also pointed out that for advanced non-small cell lung cancer, adenocarcinoma or other types of lung cancer containing adenocarcinoma, it should be routinely diagnosed. Detection of mutations such as EGFR and ALK.
“Targeted therapy is a better choice for lung cancer patients with positive mutations. Studies have shown that targeted therapy for ALK and EGFR-positive patients is superior to traditional chemotherapy and can significantly prolong patient survival. Accurate identification of ALK and EGFR-positive non-small cell lung cancer patients plays a decisive role in the selection of targeted therapeutic strategies." Cui Tongjian emphasized that the first detection, post-treatment, and the use of accompanying diagnosis to guide targeted therapy is the best diagnosis and treatment of lung cancer. Program.
Innovative companion diagnostic technology has a bright future
In addition to lung cancer, the accompanying diagnosis has also entered the field of treatment of breast cancer, melanoma, gastric cancer and other diseases, becoming an indispensable tool for oncologists. Therefore, some analysts expect that the global companion diagnostic market is expected to reach $8.73 billion by 2019.
For pharmaceutical companies, the use of companion diagnostics during drug development can also increase the success rate of the drug. Previously, a study of 676 clinical trials of 199 drug compounds showed that the failure of phase III clinical trials was the biggest obstacle to drug approval, with an overall success rate of only 28%. However, in biomarker-directed trials, the success rate can reach 62%. The researchers used data analysis to conclude that the use of companion diagnostic tests during Phase III drug development significantly increased the chances of clinical success.
According to Dr. Patricia Keegen, regulator of the FDA's Oncology Products Division, if the new drug acts on a specific gene or biological target, but the target is only present in some patients, the FDA needs to be accompanied by a diagnostic test. This test can determine which individuals will benefit from treatment and which patients will not benefit and may even be harmed. The FDA will include accompanying diagnostics in Class III equipment and will require the most stringent medical device approval procedures.
The close cooperation between pharmaceutical companies and diagnostic companies has driven innovation in some drugs and accompanying diagnostic technologies. At present, the FDA has approved a number of companion diagnostic tests introduced by Roche, Abbott, QIAGEN, DAKO and other companies, which mainly use in situ hybridization, immunohistochemistry and other methods to screen some tumor-related mutations to help doctors choose appropriate therapies.
For example, the "Guidelines for the diagnosis and treatment of ALK-positive non-small cell lung cancer in China (2015 edition)" is recommended to use the Roche diagnosis VENTANAALKIHC test for screening and concomitant diagnosis of patients with ALK fusion gene-positive non-small cell lung cancer. The positive result can directly accept crizotinib. medical treatement.
However, as far as the current situation is concerned, Cui Tongjian said that there is still a gap between China and the United States in the accompanying diagnosis and targeted therapy. "The main reason is that foreign basic research is relatively fast, and related drugs for genetic mutations will soon be developed. Can enter clinical trials. In actual clinical application, the genetic testing penetration rate in developed countries is also higher than domestic, which can reach 60%~70%. In addition, foreign patients use medical insurance, which also promotes the application of genetic testing. ."
It is gratifying that at present, the value of accompanying diagnosis has been recognized in China, and cooperation has begun to develop effective tests. At present, more and more companies are developing targeted therapeutic products. Accordingly, the development of accompanying diagnostic tests has become an important part of their new drug development strategy.
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