It is estimated that around one million people are diagnosed with cancer every year, and almost one in every two people has cancer during their lifetime. With the help of technology, the diagnosis and treatment of cancer have advanced. Cancer genomic medicine is also advanced testing, enabling more effective and efficient diagnosis, treatment, and prevention. This test is receiving increasing interest from every corner of the world. Comprehensive genomic profiling (CGP) is also known as biomarker testing or tumor profiling. This is a process of cancer sequencing using a single test to access hundreds of cancer-relevant genes and detect genomic mutations known to drive cancer growth. With the help of this testing, the modifications in cancer’s DNA are identified. It helps doctors determine a targeted therapy, immunotherapy, or clinical trial best for the cancer patient. It is a US-FDA approved test now available in some hospitals in India.
US FDA has approved the FoundationOne®CDx, FoundationOne®Liquid CDx, and FoundationOne®Heme under the comprehensive genomic profiling (CGP) test. This is the first test to analyze more than 300 genes and multiple genomic signatures to optimize patient care. In this article, we will discuss these three types of testing and their benefits for cancer treatment.
- FoundationOne®Liquid CDx
FoundationOne®CDx- FoundationOne®CDx test is used for comprehensive genomic profiling. This test helps in finding information about your tumor’s DNA. With the help of this test, a personalized cancer treatment plan can be given to the patient. This test is best suited for late-stage cancer patients.
Comprehensive genomic profiling (CGP) — also known as biomarker testing or tumor profiling — is a method of cancer sequencing using a single test to access hundreds of cancer-relevant genes and detect genomic mutations known to drive cancer growth. The mutation in your cancer’s DNA may help your doctor identify a targeted therapy, immunotherapy, or clinical trial right for you.
FoundationOne CDx is a next-generation sequencing-based in vitro diagnostic tool that detects substitutions, insertions, deletion alteration, and copy number alterations in 324 genes. This diagnostic can also distinguish gene rearrangements and genomic signatures, including microsatellite instability (MSI) and tumor mutational burden.
The device uses formalin-fixed, paraffin-embedded tumor tissue specimens to identify these genomic signatures. Additionally, FoundationOne CDx is a prescription-only diagnostic, and its intended use is for patients who may benefit from treatment with specific therapies.
FoundationOne®Liquid CDx- FoundationOne®Liquid CDx is a complete genomic profiling test that examines more than 300 cancer-related genes and multiple genomic signatures from a single blood draw to help make informed treatment decisions for all solid tumor cancers. FoundationOne®Liquid CDx is mainly prescribed in metastatic cancers, i.e., at stage IV of the disease. US FDA has approved the FoundationOne®Liquid CDx, a comprehensive genomic profiling (CGP) test. This is the first test to analyze more than 300 genes and multiple genomic signatures to optimize patient care. Cancer is a disease of the genome. Most tumors harbour a collection of genomic modifications that may dominate their clinical behavior and treatment response.
Blood-based biomarker testing options like FoundationOne®Liquid CDx can help expand access to genomic insights in patients with advanced cancer compared to a tissue biopsy, which may not be an option for many patients due to tumours location and patient health status. FoundationOne®Liquid CDx is a single non-invasive test based on Next Generation Sequencing technology that gives access to genomic information of over 300 genes. The report also provides information about the biomarker signatures microsatellite instability (MSI) and blood tumor mutational burden (bTMB) to support informed decision making for targeted and immunotherapies.
FoundationOne®Heme- FoundationOne Heme is FDA-approved companion diagnostic. It analyzes guideline-recommended genes from a simple blood draw. It is the only FDA-approved blood-based test to diagnose over 300 genes, making it the most inclusive FDA-approved liquid biopsy. This test reports blood tumor mutational burden (bTMB), microsatellite instability-high (MSI-H), and tumor fraction values. With more targeted therapy options, comprehensive genomic profiling with FoundationOne Heme can help guide treatment strategies and help predict patient benefits across multiple cancer indications.
FoundationOne Heme is a comprehensive genomic profiling (CGP) test combining DNA and RNA sequencing for patients with hematologic malignancies, sarcomas or solid tumors where RNA sequencing is desired. FoundationOne Heme detects known, novel, and complex fusion events and other common genomic alterations (substitutions, indels, and CNVs). Physicians can use this laboratory-developed test (LDT) to identify potential targeted therapy options, detect alterations in prognostic genes, and sub-classify sarcoma diagnoses.
The total disease burden of cancer in India is anticipated to increase significantly from about 1 million new cases in 2012 to more than 1.7 million per year by 2035. It is increasingly essential to shift towards new treatment approaches like personalized medicine with such an alarming trend. This new treatment is expected to bring some changes in the way treatment is done.