Liquid biopsy is rapidly gaining traction as a supplement or alternative to tissue biopsy. Earlier this year, we noted that liquid biopsies continue to draw investments, and efforts prevail to establish the technique in mainstream medicine. Liquid biopsies have been likened to a Holy Grail of cancer treatment. By means of a simple blood draw, liquid biopsies aim to replace needle biopsies of solid tumors, which can be expensive for the healthcare system as well as painful for patients. For diagnosis of cancer, liquid biopsies could spare some of the risky tissue biopsies and reduce reliance on computed tomography scans, which must be limited because of the danger posed by overexposure to radiation.
Liquid biopsies are a sequencing-based technology used to screen blood for tiny fragments of genetic material released by cancer tissue, known as circulating tumor (ct) DNA. Liquid biopsies can detect cancers very early—even before the onset of symptoms—using just a few drops of blood. Not only can blood be taken at the point of care, but successive blood draws can be easily done to monitor disease progression and to direct treatment. The promise of a liquid biopsy is to provide a cheaper, less invasive way to track how a cancer is mutating or responding to treatment.
The following paragraphs provide updates on companies that we previously described as luminaries in the liquid biopsy field.
LIQUID BIOPSY COMPANY (APTLY NAMED "GRAIL") HITS $1 BILLION IN FUNDING AND PASSES EARLY TEST
In January 2016, GRAIL was spun out from DNA sequencing technology company Illumina Inc., with the aim to use a simple blood draw to detect early-stage cancer before symptoms are even visible. GRAIL was formed with $100 million in investments from Illumina and others, including Amazon founder Jeff Bezos and Microsoft co-founder and philanthropist Bill Gates. By March 2017, the company said it had raised more than $900 million in financing.
An early-stage trial of GRAIL’s liquid biopsy showed that it was able to detect at least one cancer mutation in most of the patients with advanced cancers included in the study. GRAIL’s test scans blood samples for mutations in 508 genes, reading each region of the genome some 60,000 times. The company says the process yields 100 times more data than other liquid biopsy approaches.
For the feasibility study, researchers from Memorial Sloan Kettering and GRAIL analyzed tissue and blood samples from 124 patients with metastatic breast, lung, and prostate cancers to determine if the blood test detected mutations that were identified in separate tests from tissue biopsies. In 89% of patients, at least one genetic change detected in the tumor was also found in the blood. The findings were presented in June 2017 at the American Society of Clinical Oncology meeting in Chicago.
LIQUID BIOPSIES SPARK AN EXPLOSION OF INTEREST AND FUNDING
GRAIL was joined by several other ventures at about the same time, including Inivata Limited, Exosome Diagnostics, and Guardant Health Inc.
Inivata is using ctDNA analysis to improve personalized healthcare in oncology. Upon its inception, Inivata said its test is designed to provide oncologists with clinically actionable genomic information to guide therapy selection, monitor treatment progress, and detect new mutations as they emerge. Also at the June 2017 American Society of Clinical Oncology meeting, Inivata presented new clinical data from a collaboration with Dana-Farber Cancer Institute.
In this retrospective, blinded validation study in patients with non–small-cell lung cancer, Inivata’s InVision ctDNA liquid biopsy analysis was more sensitive than droplet digital PCR, assessing ctDNA with high specificity and quantitative concordance. In a subset of cases, serial use of InVision was able to detect the emergence of competing resistance mutations, creating an opportunity for osimertinib-based targeted therapy combinations to be monitored in patients with non–small-cell lung cancer.
In August, Exosome Diagnostics announced the launch of the MedOncAlyzer 170, the first liquid biopsy pan-cancer panel that simultaneously interrogates exosomal RNA and ctDNA in a single assay. The MedOncAlyzer 170 is a targeted panel for tumor profiling that identifies clinically actionable and functionally important mutations across multiple cancer types starting from a small volume of patient blood or plasma.
Because it interrogates information on both RNA and DNA, the MedOncAlyzer has a higher sensitivity compared to ctDNA assays when profiling early- and late-stage cancers in plasma, said the company, adding that ctDNA-only solutions achieve their most accurate measurements in late-stage cancers. The MedOncAlyzer is balanced to produce accurate, highly sensitive identification of rare variants through all stages of disease progression and treatment, including RNA variants that cannot be seen on ctDNA.
In May, Guardant Health announced that it had raised $360 million from investors, with the goal of deploying its test in 1 million people over the next five years. That brings the total amount Guardant has raised to $550 million. Guardant, founded in 2012, is developing the Guardant360 (introduced in 2014), a test that looks for tumor DNA (for almost every type of cancer) that is shed into the bloodstream.
In a paper published in October 2017 in Clinical Cancer Research, researchers from the University of California, San Diego Moores Cancer Center showed that response to treatment with a checkpoint inhibitor–based immunotherapy correlated with the number of genomic alterations detected by the Guardant360 assay. Although some patients with solid tumors respond dramatically to checkpoint inhibitors, many do not. The University of California, San Diego investigators have demonstrated that the Guardant360 assay may be able to noninvasively identify patients who benefit most from these drugs.
DIAGNOSTIC EFFICACY OF LIQUID BIOPSY HAS MARKET BOOMING
Demonstration of its clinical utility in several key applications has spurred soaring growth in the market for liquid biopsy diagnostics. BCC Research revealed that this industry is poised to break into multiple applications. According to its analysis, Liquid Biopsy Research Tools, Services and Diagnostics: Global Markets, the global liquid biopsy market, which totaled an estimated $1.5 billion in 2017, is growing at a five-year compound annual growth rate (CAGR) of 24.2%. At this pace, its value will surpass $4.5 billion by 2020.
The global cancer lipid biopsy market, the fastest-growing segment with a five-year CAGR of 52.4%, was worth an estimated $229.3 million in 2017 and should reach nearly $1.9 billion by 2020. The global noncancer market for liquid biopsies (reproductive health and organ transplant diagnostics) totaled $1.3 billion in 2017. Growing at a five-year CAGR of 15.2%, this larger segment should reach $2.6 billion by 2020.
In cancer, liquid biopsy is gaining significant market traction. Payors are being influenced by mounting clinical data that support the use of liquid biopsy, and an emerging tissue-agnostic labeling strategy for cancer drugs is driving the use of liquid biopsy companion diagnostics. Key growth sectors in the liquid biopsy cancer market include tests for lung cancer, pan-cancer tests that detect recurrence, and tests that provide real-time assessment of disease progression. In addition, liquid biopsy is a key tool for assessing whether a patient is taking the right drug.
In the noninvasive prenatal testing market, liquid biopsy has achieved significant penetration in the high-risk pregnancy segment and is moving into the low-risk sector. Another high-potential growth area for liquid biopsy is organ transplantation. In this market, there is a strong need for noninvasive diagnostics that can detect the early onset of organ rejection.
“The liquid biopsy industry is dynamic and gaining substantial traction in its three main clinical market segments. Circulating cell-free DNA is fast emerging as the predominant biomarker for liquid biopsy,” said BCC Research analyst, John Bergin. “This industry is undergoing exceptional growth and promises to transform medical treatment and surveillance strategies.”
LIQUID BIOPSY RESEARCH TOOLS, SERVICES AND DIAGNOSTICS: GLOBAL MARKETS
BCC Research’s new study examines liquid biopsy technologies, applications, industry subsegments, biomarker technologies, major funding initiatives, patents and companies. The market sizes for liquid biopsy diagnostics are given for the years 2015, 2016, 2017 (estimated), and 2020. For more, see also Liquid Biopsy Research Tools, Services and Diagnostics: Global Markets.