The possibility of diagnosing cancer from a simple blood draw has gripped the attention and financial resources of venture capitalists nationwide. While there has been progress, no one has reached the ultimate goal — identifying early-stage cancer in blood drawn from a patient who appears healthy.
A new article in STAT explores the science and industry driving the race for the liquid biopsy. Here are five things to know about liquid biopsy research.
1. Excitement: While surgical biopsies are the norm, they are invasive and expensive. The need for simpler and more efficient processes has catalyzed some 38 companies in the U.S. to work on creating liquid biopsies. In a 2015 report, investment bank Piper Jaffray valued the potential market for liquid biopsies at $29 billion just in the U.S., according to STAT.
2. Drama and setbacks: Creating a safe and effective liquid biopsy has proved to be a challenging task. In 2013, liquid biopsy startup On-Q-ity from Waltham, Mass., folded. Last fall, regulators reprimanded San Diego-based Pathway Genomics for putting out a biopsy kit that could purportedly screen healthy individuals for incipient signs of cancer. According to STAT, the Food and Drug Administration categorized the kit as "a high risk test that has not received adequate clinical validation and may harm the public health."
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3. Different paths: While most researchers are looking for fragments of tumor DNA in the blood, the STAT article focuses on bioengineer Mehmet Toner, PhD, and geneticist Daniel Haber, MD, PhD, who are taking an alternate course in search of the liquid biopsy. The duo, working from Massachusetts General in Boston, is looking for whole tumor cells in the blood. The process is expensive and time-consuming but the two believe whole cells contain valuable information. Dr. Haber told STAT that a fragment from a dying tumor cell "doesn't tell me anything about the biology of the living tumor."
4. Validation: Dr. Haber's and Dr. Toner's research went through a seminal shift when they decided to filter out the healthy blood components to make the search for tumor cells easier. This led to a $30 million investment from Johnson & Johnson and the creation of the iChip. The chip is made of thin, lightweight plastic etched by a laser with microfluidic grooves that slowly collect whole cancer cells as blood filters through.
5. More approaches: Another novel approach has also shown promise: Detecting tumor mutations via DNA, RNA and proteins extracted from tiny vesicles called exosomes that are ejected by living cells. Cambridge-based Exosome Diagnostics has received $60 million in investor funding and has already released a lung cancer liquid biopsy to detect tumor mutations in those exomes. The company has three other tests slated for release this year, according to STAT.
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