Cancer diagnostics based on measuring biomarkers in tissue samples has already in the past decade provided revolutionary advances in diagnosis, prognosis, and therapy selection. A major drawback of the tissue-based approach centers on the need for invasive surgical procedures in sample collection, which in a great many instances preclude following the progression or regression of disease during therapy.

In recent years, an impressive number of cancer biomarker researchers have turned their attention to the analysis of markers present in biological fluids, which can be collected with minimal invasiveness and permit following the disease over time. This highly dynamic field has come to be called liquid biopsy. In the past few years a significant and growing number of startups and several major companies have taken up the challenge of commercializing and offering liquid biopsy products and services to the market

These procedures, for the most part, query blood samples for information to be gleaned from circulating tumor cells (CTCs), circulating tumor DNA (ctDNA) fragments, and extracellular vesicles (EVs). CTCs have the longest history as subjects for liquid biopsy. Indeed, one decade-old commercial product has already garnered FDA approval for in vitro diagnostic use. Circulating tumor DNA, a more recent entry on the liquid biopsy scene, is fast becoming an alternative or adjunct to CTC assays. EVs are the newest and least developed of the three liquid biopsy sample sources, and while highly promising, their ultimate value has yet to be fully established.

The report delves deeply into recent progress and emerging trends in this highly dynamic area of research and commerce. Following an introductory chapter that sets the stage for what is to follow, Chapter 2 provides a survey of historical and evolutionary aspects of liquid biopsy, and provides required background and definitions helpful in understanding subsequent material. Chapter 3 covers basic research activities arranged according to the three aforementioned analyte classes (CTCs, ctDNA, and EVs).

CTCs, the first such entities on the liquid biopsy scene, have accounted for much of what’s been learned to date. However, the relative ease of isolating cell-free DNA has quickened research activity in this field, and ready access to ctDNA has provided important insights that enhance and complement those derived from CTCs. EVs, though a recent arrival on the liquid biopsy scene, are rising rapidly in importance based on their perceived ability to add yet another important perspective to cancer diagnostics.

Chapter 4 examines commercial activity in the field, including brief profiles of relevant companies and status of current and forthcoming product offerings. Companies active in CTCs include AdnaGen, Angle, ApoCell, Biocept, Biofluidica, Clearbridge Biomedics, Cynvenio, Cytolumina, CytoTrack, Diagnologix, Epic Sciences, Fluxion Biosciences, iCellate, Janssen Diagnostics, Qiagen, Rarecells SAS, Silicon Biosystems, and SRI International. Biocept and Cynvenio exemplify companies that augment their CTC assays with ctDNA analysis.

Companies focused on ctDNA include Agena Bioscience, Boreal Genomics, Chronix Biomedical, Genomic Health, Guardant Health, Inivata, Molecular MD, Myriad Genetics, Natera, Personal Genome Diagnostics, Sysmex Inostics, and Trovagene. Those active in the EV segment include Exosome Diagnostics, Exosome Sciences, and HansaBiomed OU.

Chapter 5, which deals with market dynamics in the liquid biopsy space, includes commentary on the competitive environment, market size estimates and five-year revenue projections, tabulation and discussion of deal activity, and results from a market survey of more than 100 individuals active in the field.

Chapter 6 of the report examines some emerging trends that may affect the future development, acceptance, and market growth of liquid biopsy. Of particular interest are trends in government regulation that could possibly limit growth of the field, and even in the overall molecular diagnostics market. The report also discusses issues surrounding the relative merits of the three categories of liquid biopsy samples, and ways in which they may be competitive or complementary. Finally, the chapter examines important trends relevant to cancer drug resistance and metastasis.

The final chapter contains transcripts from extended interviews with six individuals who are highly knowledgeable in the liquid biopsy field.

These are:



Nicholas Dracopoli, Ph.D., Vice President Oncology Translational Research, Janssen Pharmaceuticals
Paul Dempsey, Ph.D., Chief Scientific Officer, Cynvenio Biosystems
Johan Skog, Ph.D., CSO and Founding Scientist, Exosome Diagnostics
Lidia Sambucetti, PhD, Sr. Director of Cancer Biology, and Ted Ira, Director of Sales, SRI Biosciences Div.
Harry Glorikian, Life Sciences Consultant