Clinicians have been conducting biopsies for a long time, for diagnosing and managing cancer, as genetic profile of tumor is analyzed through biopsy. Tissue biopsy is a traditional biopsy technique which is a time consuming and lengthy procedure, and cannot be performed routinely. Liquid Biopsy is a next generation cancer test which is an alternative to tissue biopsy. It helps in early detection of various cancers such as Breast Cancer, Ovarian Cancer, Prostate Cancer and Colon Cancer as it detects mutations in fragments of tumor DNA and tumor cells.
Liquid Biopsy is recommended for monitoring treatment response, genetic changes and resistance mechanisms in the tumor. It provides complete genetic information of genes such as Epidermal Growth Factor Receptor (EGFR) and Serine/threonine-protein kinase (BRAF) expressed on various cancer cells. It is based on Polymerase Chain Reaction (PCR) amplification or Next-Generation Sequencing (NGS) technology, and involves analysis of genetic markers such as Cell Free DNA (cfDNA) and Circulating Tumor Cells (CTCs) for tumor detection. It also detects more than two mutations that can occur in some cancers such as Melanoma and Lung Cancers, which is an advantage over tissue biopsy as the latter fails to detect two to four genetic mutations.
The process involves three step procedure including phlebotomy, separation of plasma cells from blood, isolation of cfDNA and analysis of cfDNA. It provides high positive predictive value, is safe and easy to perform and provides complete tumor genetics of a patient.
Several liquid biopsies tests have been approved. Among them, Cell Search test developed by Veridex was the first liquid biopsy screening test to be approved in China in 2012 for diagnosis of Breast Cancer. In 2015, CancerIntercept developed by Pathway Genomics was approved. Recently, Cobas EGFR Mutation Test V2 developed by Roche was approved by USFDA in 2016 for diagnosis of Non-small cell lung cancer (NSCLC). Several Companies such as San Diego, OncoCyte Corp, Myriad Genetics and Veracyte are developing liquid biopsy tests, while IIlumina, Guardant Health and Inivata are raising funding for the development of liquid biopsy tests.
Insight by: Diksha Wadhwa
DelveInsight Business Research