Mayo Clinic Partners With Companies In Emerging ‘Liquid Biopsies’ Market

Mayo Clinic Partners With Companies In Emerging ‘Liquid Biopsies’ Market

Detecting cancerous tumors from blood samples is the goal of Illumina and Exact Sciences.

One of the newest and perhaps most commercially promising arenas in cancer research is the potential of “liquid biopsies,” in which advanced genetic sequencing is used to detect the presence of early-stage tumors via simple blood samples, rather than from tissue samples as is required in traditional biopsies.

If such a technology could be perfected, it would truly revolutionize medical science’s ability to detect cancer in its earliest stages through widespread screening, dramatically reshaping cancer diagnosis and significantly reducing the number of patients who die from late-stage forms of cancer each year.

The Mayo Clinic and its deep research expertise in genomics is at the forefront of what some estimate could ultimately be a $200 billion liquid biopsy market partly through its close ties with a pair of companies: San Diego-based Illumina Inc. (NASDAQ: ILMN) and Exact Sciences (NASDAQ: EXAS) of Madison, Wisconsin.

Illumina made headlines a year ago when it spun off a new startup—Grail Inc., of Menlo Park, California—with an eye-popping $100 million Series A financing. 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 circulating tumor nucleic acids (ctDNA) in blood. Detecting cancer at the earliest stages 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.

This promise was enticing enough to land a star-studded cast of initial investors including Illumina itself (retaining a 50-percent ownership stake), ARCH Venture Partners, Bezos Expeditions, Bill Gates and Sutter Hill Ventures.

Among Grail’s scientific advisers is Dr. Minetta C. Liu, a Mayo associate professor of oncology, whose expertise is in isolating and analyzing circulating tumor cells, cell-free DNA (cfDNA), and other blood components measured in liquid biopsies. Grail claims that if the detection of such circulating tumor DNA indeed becomes the definitive way of sniffing out stage 1 cancers, it could translate into a liquid biopsy market of between $100 billion and $200 billion.

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 non-cancer participants using a ‘high-intensity’ (ultra-broad and ultra-deep) sequencing approach” designed by parent firm Illumina, a company that also has a significant relationship with Mayo.

For instance, Illumina and Mayo Medical Laboratories revealed in November that they will deploy Illumina’s BaseSpace Clarity LIMS product in specific Mayo labs to provide pilot testing of the tool, which is an information management system for genetic sequencing labs that provides “comprehensive workflow tracking and integration.”

Mayo and Illumina also partnered in 2015 on a San Francisco-based startup called Helix, through which consumers can pay to have their genome sequenced from a saliva sample. That company also garnered $100 million in initial funding, partly coming from Mayo Clinic Ventures.

Mayo’s other major link into 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 (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. It projects the liquid biopsy market at $13 billion by 2030 and touts its “epigenetics” methodology, which it claims is more precise and less costly than next-generation sequencing.

Led by research performed by Mayo medical professor Dr. David Ahlquist, Exact says it has discovered accurate methylation markers for lung, pancreatic and liver cancer.