Broadly speaking, a liquid biopsy is a non-invasive alternative to traditional tissue biopsy. The term liquid biopsy has become a buzzword in the healthcare sector, more specially in clinical genomics. This field is continuing to evolve and grow in near future, driven by physician adoption and payer support. This technology is initially being focused on cancer.
Limitations of Traditional Tissue Biopsy
There are two major disadvantages in retrieving biopsy samples using the traditional tissue based approach: (1) traditional biopsies might not be suitable for late stage cancer patients (metastatic tumor) due to poor physical condition of the patient (2) it provides an incomplete view of the cancer – not only are cancerous cells heterogeneous within a tumor, they mutate and change over time. A tissue biopsy would not be able to capture all of the different types of cancerous cells within a tumor site nor would it be able to track changes or resistance towards therapy over time.
Liquid Biopsy Helps Address the Pitfalls of Tissue Biopsy
Liquid biopsies take advantage of the recently discovered fact that tumors and cancerous cells can shed their genetic material into the circulating bloodstream. Liquid biopsies could provide non-invasive alternatives to traditional tissue biopsies allowing physicians to gain a systemic view of patient-specific cancers and the ability to monitor them over time.
By leveraging the recent developments in next generation sequencing technology and its ability to generate large amounts of data at low cost, researchers have found liquid biopsies as the most promising area that addresses the limitations presented by tissue biopsies in cancer diagnostics. As of now, the term liquid biopsy in general, refers to a novel, non-invasive technique used for detecting cancer biomarkers in blood, urine, or other biofluid samples. Studies have shown that liquid biopsies are effective in detecting cancer causing genomic alterations in circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), or microvesicles carrying genomic information called exosomes.
Total Addressable Liquid Biopsy Market
Liquid biopsy has the potential to impact the diagnosis, prognosis, and treatment optimization in many fields, but is initially being focused on cancer. However, the technology could, over time, expand beyond the field of cancer and pharmacogenomics into urology, infectious diseases, human leukocyte typing, and eventually could become a standard of care for annual health checks in healthy individuals as well.
Natera Inc., a fast growing diagnostics company has sized the cancer liquid biopsy commercial opportunity at $18billion, including therapeutic management and monitoring ($12billion) and screening ($6billion). Illumina views the cancer liquid biopsy market to reach $20billion by 2030.
With the rising interest in liquid biopsies, several companies have begun investing in the development of this technology. In hopes of capitalizing on the commercial prospects, established diagnostic companies and new companies alike are looking to push out liquid biopsy products within the near future.
There are about 200 players in the space currently that are looking to expand its product offering beyond sample prep to more liquid biopsy tests similar to its EGFR test for Iressa.
Roche recently received FDA approval for its cobas EGFR blood-based liquid biopsy test. To receive FDA approval Roche completed ~20 different studies (e.g., determining assay limit of detection, validating reference materials and assessing analytical accuracy.
Adaptive Biotechnologies, Biocept, Foundation Medicine, Genomic Health, Guardant Health, Illumina, Qiagen, Thermo Fisher, RainDance Technologies and Trovagene are some of the other frontrunners in this space.
Liquid Biopsy Market Outlook
Liquid biopsy remains one of the most exciting potential advances in the field of medicine today. There are at least 33 liquid biopsy clinical trials underway.
FDA's workshop on liquid biopsies in late July 2016 shows there is a strong interest in the fieldwith over 800 people registered to attend the event. However, industry stakeholders acknowledged widespread adoption of liquid biopsies will require labs to generate clinical evidence demonstrating that liquid biopsies result in improved outcomes than tissue biopsies. In addition, cost of tests, coverage and reimbursement are some of the factors that will come in to play before this new technology attains mainstream status.
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