A year ago, we reported that the liquid biopsy market got off to big start in 2016. Now, the field is hotter than ever, with new investments, partnerships, and initiatives toward making liquid biopsies a standard of care. 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.
MD ANDERSON, GUARDANT HEALTH AIM TO MAKE LIQUID BIOPSY A STANDARD OF CARE
MD Anderson Cancer Center and Guardant Health formed a multiyear partnership designed to accelerate comprehensive liquid biopsy (CLB) technology into the standard of care in cancer treatment. Guardant Health will help MD Anderson build multiple onsite liquid biopsy centers, enabling development of novel noninvasive assays using Guardant Health’s digital sequencing technology. First-of-their-kind interventional clinical utility studies, designed to demonstrate how CLB can improve patient outcomes across multiple types and stages of cancer, will be jointly funded. The two institutions also will work together on CLB clinical utility studies designed to support incorporation of CLB testing into national guidelines and adoption as a national standard of care.
“Liquid biopsies are far less invasive than traditional biopsies, a development that not only benefits our patients through a simplified diagnostic procedure but also by significantly enhanced analysis of samples taken,” said Stanley Hamilton, MD, professor of Pathology and division head of Pathology and Laboratory Medicine at MD Anderson. “This unique partnership will greatly contribute to bringing liquid biopsies to the forefront of cancer care. We have already seen in the medical literature the impact this technology can have on patients, and we anticipate this agreement will drive broader access for our patients in the future.” [MD Anderson News Release, 1/31/2017]
MAYO CLINIC PARTNERS WITH COMPANIES IN LIQUID BIOPSIES MARKET
The Mayo Clinic is aligned with a pair of companies for which the goal is detecting cancerous tumors from blood samples: San Diego-based Illumina Inc. and Exact Sciences of Madison, WI [Twin Cities Business, 1/18/2017]. Illumina made headlines a year ago when it spun off a new startup (aptly named Grail Inc., of Menlo Park, CA) with an eye-popping $100 million Series A financing. Initial investors included Illumina (retaining 50% ownership), ARCH Venture Partners, Bezos Expeditions, Bill Gates, and Sutter Hill Ventures. Grail is in essence a cancer moonshot because its goal is a grand one: nothing less than completely changing the cancer-fighting landscape.
Its stated mission is to develop a “deep-sequencing” pan-cancer screening test by directly measuring ctDNA in blood. Cancer is usually the most treatable when it is detected in its earlier stages; as such, early detection dramatically increases long-term survival. Hence, the successful development of a pan-cancer screening test for asymptomatic individuals would make “the first major dent in global cancer mortality,” the company says. Grail claims that if the detection of ctDNA indeed becomes the definitive way of detecting stage 1 cancers, it could translate into a liquid biopsy market of between $100 billion and $200 billion.
Now, Grail is seeking to raise more than $1 billion in a new funding round to advance development of its specialized early detection cancer test. The new financing would help Grail refine and validate its technology by running a number of large-scale clinical trials in which it is expected to sequence hundreds of thousands of patients. Successful results from these studies could lay the groundwork for a noninvasive alternative to traditional tissue biopsies. No specific investors were named in Grail’s statement, but the venture expects to complete this financing before the end of the first quarter this year.
The relationship between Mayo and Grail was further solidified in December when Mayo was tapped to collaborate with the startup on its very first clinical study: the Circulating Cell-free Genome Atlas (CCGA). The study is being conducted to aid in the development of its blood test. Grail says the CCGA study “will characterize the landscape of cell-free DNA profiles in individuals with cancer and in healthy noncancer participants using a ‘high-intensity’ (ultra-broad and ultra-deep) sequencing approach” designed by parent firm Illumina.
Mayo’s other major link to the liquid biopsy market is through its equity stake in and close research collaboration with Exact Sciences, maker of the Cologuard stool-sampling kit for detection of colorectal cancer. With the emergence of blood sampling as perhaps the dominant way to screen for cancer in the future, Mayo and Exact have announced they are expanding their proprietary DNA methylation approach (i.e., turning genes on or off) to cover more kinds of cancer and have made progress in identifying new cancer biomarkers.
In an investor presentation for the J.P. Morgan Healthcare Conference held January 12 in San Francisco, Exact said its goal is to “extend the Cologuard platform to the next generation of liquid biopsy cancer diagnostics” by leveraging its research collaboration with Mayo. Exact claims its epigenetics methodology is more precise and less costly than next-generation sequencing. Exact says it has discovered accurate methylation markers for lung, pancreatic, and liver cancers.
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, including the average-risk noninvasive prenatal testing, cancer monitoring, and organ transplantation surveillance segments. According to its analysis, Liquid Biopsy Research Tools, Services and Diagnostics: Global Markets, the global liquid biopsy market, which totaled $1.6 billion in 2015, is growing at a five-year compound annual growth rate (CAGR) of 22.3%. At this pace, its value will be nearly $4.5 billion by 2020.
The cancer lipid biopsy market, the fastest-growing segment with a five-year CAGR of 36.2%, was $414.5 million in 2015 and should reach $1.9 billion by 2020. The global noncancer market for liquid biopsies (reproductive health and organ transplant diagnostics) totaled $1.2 billion in 2015. Growing at a five-year CAGR of 15.7%, this larger segment should reach $2.5 billion by 2020. Growing support by the medical communities is helping to drive this growth for the liquid biopsy market.