Genetic Testing of Solid Tumor Target Therapy

Categories of Testing

Lung cancer

EGFR 29 Mutations Detection

Purpose

According to the “Global Lung Cancer Incidence Map” published by the World Health Organization (WHO) in 2018, the incidence of lung cancer in Taiwan ranks 15th in the world and 2nd in Asia. Since lung cancer has long been the number one cancer killer for a long time, how to prevent and treat it, improve the survival of lung cancer patients and improve the prognosis, has always been the most difficult and major issue in the medical industry. Studies have shown that EGFR is a common mutated gene in lung cancer and has a corresponding targeted therapy in clinical treatment. Understanding the status of EGFR gene mutations is an important indicator for clinicians to treat patients and determine medication strategies.

Leopard Gene Human EGFR Gene Mutation Detection Kit (ARMS-PCR) is licensed by the Ministry of Health and Welfare for in-vitro diagnostic reagent No. 000668, and those who meet the indications can apply for reimbursement for the accompanying test before medication.

Specification

Lung Cancer EGFR T790M Detection in Liquid Biopsy
cfDNA EGFR T790M CDx Assay

Purpose

The mortality rate of lung cancer continuously ranks first in the world, and the proportion of non-small cell lung cancer (NSCLC) accounts for about 85%. Although there are clinically targeted therapies that can be used to treat NSCLC, due to the emergence of drug resistance, it leads to relapse, resulting in poor therapeutic effect. According to statistics, about 7-23% of lung cancer patients in the West and nearly 50% of lung cancer patients in Asia carry EGFR mutations. Studies have shown that mutations at the T790M site of the EGFR gene are the key to the effect of targeted therapies and drug resistance in lung cancer patients.

Leopard Gene Lung Cancer EGFR T790M Liquid Biopsy not only assists clinicians in judging and choosing targeted therapies, but also can track the efficacy of patients’ medications, and accurately adjust and formulate the best clinical treatment guidelines for patients.

Specification

Lung Cancer EGFR L858R Detection in Liquid Biopsy
cfDNA EGFR L858R CDx Assay

Purpose

The mortality rate of lung cancer continuously ranks first in the world, and the proportion of non-small cell lung cancer (NSCLC) accounts for about 85%. Although there are clinically targeted therapies that can be used to treat NSCLC, due to the emergence of drug resistance, it leads to relapse, resulting in poor therapeutic effect. According to statistics, about 7-23% of lung cancer patients in the West and nearly 50% of lung cancer patients in Asia carry EGFR mutations. Studies have shown that mutations in the L858R allele of the EGFR gene are the key to the effect of targeted therapies use and drug resistance in patients with lung cancer.

Leopard Gene Lung Cancer EGFR L858R Liquid Biopsy not only assists clinicians in judging and choosing targeted therapies, it can also track the efficacy of patients’ medications, and accurately adjust and formulate the best clinical treatment guidelines for patients.

Specification

Lung Cancer EGFR Exon19del+L858R Detection in Liquid Biopsy
cfDNA EGFR Exon19del+L858R CDx Assay

Purpose

The mortality rate of lung cancer continuously ranks first in the world, and the proportion of non-small cell lung cancer (NSCLC) accounts for about 85%. Although there are clinically targeted therapies that can be used to treat NSCLC, due to the emergence of drug resistance, it leads to relapse, resulting in poor therapeutic effect. According to statistics, about 7-23% of lung cancer patients in the West and nearly 50% of lung cancer patients in Asia carry EGFR mutations. Studies have shown that mutations caused by the deletion of EGFR exon 19 and exon 21 (L858R) points, respectively, are the key to the effect of targeted therapies and the development of drug resistance in patients with lung cancer.

Leopard Gene Lung Cancer EGFR Exon19del+L858R Liquid Biopsy not only assists clinicians in judging and choosing targeted drugs, but also can track the efficacy of patients’ medications, and accurately adjust and formulate the best clinical treatment guidelines for patients.

Specification

Non-Small Cell Lung Cancer Targeted Therapy Gene Detection
NSCLC CDx Panel

Purpose

Leopard Gene NSCLC CDx Panel uses the Next Generation Sequencing platform to perform rapid, accurate, and one-time detection with a very small amount of puncture or postoperative paraffin-embedded specimens. This test can simultaneously detect 16 targeted therapy genes and 121 mutation alleles. Based on the clinical guidelines established by the National Comprehensive Cancer Network (NCCN), combined with the cancer diagnosis and treatment guidelines for clinicians in local medical institutions, it provides detection of genetic mutations of cancer targeted therapies approved by the FDA or ongoing clinical trials. This assay intents to assist clinicians to determine treatment strategies. It can also help to establish the background knowledge of the correlation between gene mutations and prognosis and drug responses of patients and hence providing valuable reference information for clinical precision medicine.

Specification

Lung Fusion Gene Targeted Drug Gene Detection
Lung Fusion CDx Panel

Purpose

Leopard Gene Lung Fusion Gene Targeted Therapy Gene Detection applies the Next Generation Sequencing platform to perform rapid, accurate, and one-time detection with a very small amount of puncture or postoperative paraffin-embedded specimens. This test can simultaneously detect 3 fusion genes and 40 fusion types. Based on the clinical guidelines established by the National Comprehensive Cancer Network (NCCN), combined with the cancer diagnosis and treatment guidelines for clinicians in local medical institutions, it provides detection of genetic mutations of cancer targeted therapies approved by the FDA or ongoing clinical trials. This assay intents to assist clinicians to determine treatment strategies. It can also help to establish the background knowledge of the correlation between gene mutations and prognosis and drug responses of patients and hence providing valuable reference information for clinical precision medicine.

Specification

Liquid Biopsy For Lung Cancers Genetic Testing
cfDNA Oncomine Lung CDx Panel

Purpose

The current molecular diagnostic technology for tumors needs to obtain tissue samples through surgery or puncture, which has limitations such as trauma to the patient and the inability to conduct dynamic monitoring. However, with the development of liquid biopsy technology, non-invasive detection technologies such as circulating free DNA have moved from the scientific research stage to clinical diagnosis.

In the 1940s, scientists discovered the existence of cfDNA in the blood. When normal cells metabolize and rupture in the body, they will release all intracellular substances, and DNA will also freely enter the blood from the cells to become cfDNA. Generally speaking, this kind of cfDNA will be cleared by macrophages. However, when the generation rate of cfDNA is greater than the clearance rate, it may persist in the blood. Therefore, the detection of cfDNA through blood can track cancer. The presence or absence of tumor cells and the detection of cfDNA mutations can also be used as a reference for tumor diagnosis and medication prescription.

Leopard Gene uses a high-throughput Next Generation Sequencing platform to detect key circulating tumor genes in cfDNA and scan the mutation allele where the tumors are likely to occur. Furthermore, it provides a comprehensive basis and reference for target therapy selection, dynamic efficacy monitoring, drug-resistant treatment plan adjustment and prognosis evaluation.

Specification

Colorectal Cancer

KRAS Mutation Detection

Purpose

The number of new diagnoses and deaths of colorectal cancer in the world is gradually increasing every year. In Taiwan, according to the cancer registration report of the National Health Promotion Administration of the Ministry of Health and Welfare, colorectal cancer has surpassed liver cancer and becoming the cancer with the highest annual incidence since 2006. Clinically, the co-treatment for colorectal cancer will usually combine both targeted therapy and chemotherapy.

In patients with lung cancer or colorectal cancer, the MAPK signaling pathway of cancer cells is often activated by KRA mutations. KRAS protein is a GTPase and one of the main downstream molecules of the epidermal growth factor receptor (EGFR) signaling pathway. KRAS mutations can cause abnormal cell proliferation, differentiation, and resistance to apoptosis. KRAS gene mutations are more likely to occur in the second, third, or fourth exons. According to the NCCN Cancer Guidelines, regular KRAS testing can be used to predict whether patients will develop resistance to the monoclonal antibody treatment against EGFR. Studies have shown that KRAS is a common mutated gene in colorectal cancer. There are corresponding target therapies in clinical treatment. Understanding the status of KRAS gene mutations is an important indicator for clinicians to treat patients and to determine medication strategies.

Leopard Gene applies qPCR to detect 19 key mutations in exons 2-4 of KRAS gene. Based on the detection result, it can provide targeted therapy information to assist clinicians for treatment strategies and to monitor correlation between mutations and prognosis and drug response for patients. It hence provides valuable reference information for clinical precision medicine.

Specification

BRAF V600 Mutations Detection

Purpose

The number of new diagnoses and deaths of colorectal cancer in the world is gradually increasing every year. In Taiwan, according to the cancer registration report of the National Health Promotion Administration of the Ministry of Health and Welfare, colorectal cancer has surpassed liver cancer and becoming the cancer with the highest annual incidence since 2006. Clinically, the co-treatment for colorectal cancer will usually combine both targeted therapy and chemotherapy.

The Ras-Raf-MEK-MAPK signal transduction pathway of cancer cells activates transcription factors that starts cell cycle operation and promotes cell proliferation under the induction of hormones and growth factors. BRAF is the serine/threonine kinase in the transmission pathway. The most common mutation found in BRAF is V600E. Other common mutations include V600D, V600K, and V600R. These mutations will active BRAF protein permanently and result in abnormal cell proliferation, cell resistance to apoptosis, and eventually cause cancer. Studies have shown that patients with melanoma, Papillary Thyroid Carcinoma, ovarian cancer, prostate cancer, non-small cell lung cancer and colorectal cancer have a high probability of having BRAF gene mutations. The V600E mutation is a common tracking biomarker for the prognosis and recurrence in colorectal cancer patients. Therefore, searching for drugs that block the pathway of cancer-causing BRAF gene is currently the most important research area. Studies have shown that BRAF V600 mutation is commonly found in colorectal cancer patients and has a corresponding targeted therapy in clinical treatment. Understanding the status of BRAF V600 gene mutation is an important indicator for clinicians to treat patients and to determine medication strategies.

Leopard Gene BRAF V600E mutation detection performs rapid, accurate, and one-time detection with a very small amount of puncture or FFPE specimens by Real-time PCR. This test will provide BRAF V600 mutation analysis as well as therapy information based on the result to assist clinicians for treatment strategies and to monitor correlation between mutations and prognosis and drug response for patients. It hence provides valuable reference information for clinical precision medicine.

Specification

Colorectal Cancer Targeted Therapy Gene Detection
CRC CDx Panel

Purpose

The number of new diagnoses and deaths of colorectal cancer in the world is gradually increasing every year. In Taiwan, according to the cancer registration report of the National Health Promotion Administration of the Ministry of Health and Welfare, colorectal cancer has surpassed liver cancer and becoming the cancer with the highest annual incidence since 2006. For patients with colorectal cancer, the discovery of mutation allele and effective targeted therapy can improve the survival rate of patients. Colorectal cancer associated mutation allele often has been found in KRAS, BRAF, PIK3CA, PTEN, AKT1, NRAS, SMAD4, and UGT1A1 genes. According to results of clinical trials, the above-mentioned colorectal cancer-related mutation allele have a great relationship with the sensitivity of commonly used clinical target therapies.

Leopard Gene Colorectal Cancer Gene Targeted Therapy Gene Detection applies the Next Generation Sequencing platform to perform rapid, accurate, and one-time detection with a very small amount of puncture or postoperative paraffin-embedded specimens. This test can simultaneously detect 8 target therapy genes and 79 mutation alleles. Based on the clinical guidelines established by the National Comprehensive Cancer Network (NCCN), combined with the cancer diagnosis and treatment guidelines for clinicians in local medical institutions, it provides detection of genetic mutation allele of cancer targeted therapies approved by the FDA or ongoing clinical trials. This assay intents to assist clinicians to determine treatment strategies. It can also support to establish the background knowledge of the correlation between gene mutations and prognosis and drug responses of patients and hence providing valuable reference information for clinical precision medicine.

Specification

Colorectal Cancer Genetic Testing in Liquid Biopsy
cfDNA Oncomine Colon CDx Panel

Purpose

The current molecular diagnostic technology for tumors needs to obtain tissue samples through surgery or puncture, which has limitations such as trauma to the patient and the inability to conduct dynamic monitoring. However, with the development of liquid biopsy technology, non-invasive detection technologies such as circulating free DNA have moved from the scientific research stage to clinical diagnosis.

In the 1940s, scientists discovered the existence of cfDNA in the blood. When normal cells metabolize and rupture in the body, they will release all intracellular substances, and DNA will also freely enter the blood from the cells to become cfDNA. Generally speaking, this kind of cfDNA will be cleared by macrophages. However, when the generation rate of cfDNA is greater than the clearance rate, it may persist in the blood. Therefore, the detection of cfDNA through blood can track cancer. The presence or absence of tumor cells and the detection of cfDNA mutations can also be used as a reference for tumor diagnosis and medication prescription.

Leopard Gene uses a high-throughput Next Generation Sequencing platform to detect key circulating tumor genes in cfDNA and scan the mutation allele where the tumors are likely to occur. Furthermore, it provides a comprehensive basis and reference for target therapy selection, dynamic efficacy monitoring, drug-resistant treatment plan adjustment and prognosis evaluation.

Specification

Breast cancer

Personalized BRCA test [MLPA included]
BRCA 1/2 Germline Panel

Purpose

5-9% of breast cancers come from familial inheritance. Studies have confirmed that carrying BRCA gene mutations can greatly increase the risk of breast cancer, ovarian cancer, prostate cancer, pancreatic cancer and other cancers. Leopard Genetic Testing Service performs gene sequencing for all exons of BRCA1 and BRCA2, and detects large-segment genetic mutations in BRCA genes with multiplex ligation-dependent probe amplification (MLPA) technology. The test results can be used as a reference for clinicians in diagnosis, treatment, medication, and prognosis tracking.

Specification

Breast Cancer Genetic Testing in Liquid Biopsy
cfDNA Oncomine Breast CDx Panel

Purpose

The current molecular diagnostic technology for tumors needs to obtain tissue samples through surgery or puncture, which has limitations such as trauma to the patient and the inability to conduct dynamic monitoring. However, with the development of liquid biopsy technology, non-invasive detection technologies such as circulating free DNA have moved from the scientific research stage to clinical diagnosis.

In the 1940s, scientists discovered the existence of cfDNA in the blood. When normal cells metabolize and rupture in the body, they will release all intracellular substances, and DNA will also freely enter the blood from the cells to become cfDNA. Generally speaking, this kind of cfDNA will be cleared by macrophages. However, when the generation rate of cfDNA is greater than the clearance rate, it may persist in the blood. Therefore, the detection of cfDNA through blood can track cancer. The presence or absence of tumor cells and the detection of cfDNA mutations can also be used as a reference for tumor diagnosis and medication prescription.

Leopard Gene uses a high-throughput Next Generation Sequencing platform to detect key circulating tumor genes in cfDNA and scan the mutation allele where the tumors are likely to occur. Furthermore, it provides a comprehensive basis and reference for target therapy selection, dynamic efficacy monitoring, drug-resistant treatment plan adjustment and prognosis evaluation.

Specification

Pan-Cancer

Clinical Focus Analysis Genetic Diagnosis
Oncomine 52 CDx Panel

Purpose

Clinical Focus Analysis Genetic Diagnosis (Oncomed 52) uses the high-throughput Next Generation Sequencing (NGS) platform and Oncomine™ Knowledge Base database to target 52 key tumor genes, including 988 mutation allele detection, 19 gene copy number variation analysis, 23 fusion gene variation analysis, simultaneous perform DNA and RNA detection in a single process.

In addition to providing the above-mentioned complete tumor gene mutation information, this testing service also provides drug recommendations for targeted therapies approved by the FDA, as well as information on clinical trials in 64 countries, and provides a full range of Oncomine™ analysis reports to assist clinicians in developing treatment policies for cancer patients.

Specification

Comprehensive CDx Panel for Targeted Therapy Gene Detection

Purpose

Leopard Gene Comprehensive CDx Panel for Targeted Therapy Gene Detection applies the Next Generation Sequencing platform to perform rapid, accurate, and one-time detection with a very small amount of puncture or postoperative paraffin-embedded specimens. This test can simultaneously detect 30 targeted therapy genes and 312 mutation alleles. Based on the clinical guidelines established by the National Comprehensive Cancer Network (NCCN), combined with the cancer diagnosis and treatment guidelines for clinicians in local medical institutions, it provides detection of genetic mutation allele of cancer targeted therapies approved by the FDA or ongoing clinical trials. This assay intents to assist clinicians to determine treatment strategies. It can also support to establish the background knowledge of the correlation between gene mutations and prognosis and drug responses of patients and hence providing valuable reference information for clinical precision medicine.

Specification

Frequently asked questions

The body constantly produces new cells. New cells replace old cells or heal damaged cells after injury. If body cells divide abnormally, tumors will form. These processes are controlled by certain genes. All cancers are caused by genetic damage. Damaged genes cause cells to behave abnormally and grow into tumors. There are two types of tumors, benign tumors and malignant tumors. Benign tumors do not spread to other parts of their normal boundaries; when malignant tumors develop, it may be confined to its original location, but if not treated, these cells may spread beyond the normal boundaries into surrounding tissues.
There are about 20,000 genes in the human body, and studies have pointed out that about 400 genes are highly related to cancer. If these genes undergo congenital or acquired mutations, they are likely to cause cancer.

The human genome has a total of 3 billion base pairs, and there will be a difference every 100-300 bases, which is called Single Nucleotide Polymorphism (SNP). Scientific research has shown that 90% of the differences in human genetic genes are derived from SNP genetic mutations, and “genetic testing” is to decrypt the body’s genetic code, analyze the SNP sites that determine the physique, and learn about the individual’s physique , disease risk, and then choose personalized medical care methods to achieve effective health management and realize the true essence of preventive medicine.

Cancer genetic testing is to obtain a patient’s cancer cell sample for analysis through puncture or surgery to find out whether the cancer is unique to genetic mutations or over-representation.

For diagnosed cancer patients, the purpose of genetic testing is to assist doctors in finding suitable treatments based on the genetic information of cancer cells, such as: evaluating the side effects of drugs or adjusting the dosage, thereby monitoring the patient’s prognosis, delaying the progression of cancer, and work with cancer friends to fight cancer.

General cancer treatment methods can be roughly divided into five major directions, including surgery, radiation therapy (commonly known as electrotherapy), chemotherapy (commonly known as chemotherapy), photodynamic therapy, and new biotechnology treatments (vaccine, gene therapy, RNA interference, Stem cells, etc.).

Targeted therapy is a kind of drug therapy that prevents the growth of cancer cells by interfering with specific molecules required for cancerous transformation or tumor proliferation, rather than general traditional therapy that interferes with all continuously dividing cancer cells (unstable cells).

Cancer targeted therapy mainly target key regulatory molecules of tumor molecular pathology, effectively preventing tumor growth and metastasis, and killing cancer cells with specific mutations. Taking lung cancer as an example, Yu Zhongren, superintendent of the Hsinchu Branch of National Taiwan University Hospital, said that the proportion of lung cancer patients in Asia with EGFR mutations is two or three times higher than that in Europe and the United States. This study also found that the proportion of mutations in Chinese is as high as 50%. Target drugs have a significant effect on prolonging the lifespan of lung cancer patients.

Even if the same cancer is diagnosed, not every patient may be suitable for targeted therapy. The key is whether the patient’s cancer cells have specific tumor genes. Lung cancer is one of the most serious cancers in Taiwan. In the past, physicians mostly used gender, smoking or not and histological type of cancer cell as conditions for lung cancer patients to receive targeted therapy. However, among lung cancer patients, patients with lung adenocarcinoma and epidermal growth factor receptor (EGFR) mutations must be treated with targeted therapy to be effective. Therefore, whether targeted therapy are needed, patients should first test whether they have specific genes and whether they are suitable for targeted therapy.

Thanks to the rapid progress of cancer molecular biology, more and more cancer-specific tumor genes have been discovered, helping physicians find patients suitable for treatment with targeted therapy.
  • Among patients with colorectal cancer, patients without wild-type KRAS gene mutations have a significant effect on receiving targeted therapy.
  • In patients with lung cancer whose cancer cells have epidermal growth factor receptor (EGFR) mutations, the tumor effective rate can reach 80% after receiving targeted therapy. Conversely, if the patient does not have EGFR mutations, chemotherapy should be used on the first line.
  • Among breast cancer patients, those with HER-2 overexpression are treated with targeted therapy to treat HER2-positive breast cancer. The survival rate of patients has exceeded 80% after surgery combined with targeted therapy, and early breast cancer can reach 100%.
  • Several immediate family members have had cancer, especially the same type of cancer.
  • Relatives in the family suffer from a variety of cancers, including breast cancer, ovarian cancer, colorectal cancer, prostate cancer and so on, and it is known that these cancers are related to a mutation in a specific gene.
  • Family members suffered from cancer at a very young age.
  • There are relatively rare cancers in distant relatives, but this cancer is related to a genetic mutation.
  • Have polyps or other symptoms related to hereditary cancer.
  • Gene mutations have been found in family members who have undergone genetic testing.

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