Imagine going to the doctor for a checkup and routine bloodwork. The bloodwork comes back with a diagnosis of cancer. Beyond just a yes or a no, the report tells you location, its progress, and a defined treatment plan.The shock and fear wears off quickly because you caught it early and your survival rate quadruples before a single symptom surfaces -- all because of a simple blood test. Avoiding the subjective nature of reported signs and the hit-or-miss nature of biopsies has long been a pipe dream of oncologists. It now may be right around the corner.
In 2009, there was great excitement over circulating tumor cells that could be found within the blood. This type of test, however, was marketed to those patients that have already been diagnosed in order to determine the progression of the disease. The next step has arrived. In 2014, researchers discovered a test that goes deeper than the cell. Rather, these “liquid biopsies” seek signs of actual DNA, or cell-free circulating tumor DNA (ctDNA) that is shed from a tumor into the bloodstream. The advantage is that ctDNA is more than 100 times more abundant in the blood than tumor cells.
Studies are underway in China for a variety of cancers, with reports that cancer is being caught before any symptoms are reported, and at a stage where treatment can be extremely effective. In the United States, research is being conducted on advanced non-small cell lung cancer, a disease where tissue biopsies are the “gold standard” for identifying targetable mutations for treatment. In the study, researchers noted that not only was ctDNA competing with tissue biopsies, but it was also capturing clinically relevant mutations not picked up by a tissue biopsy.
While studies are still underway, the market is adjusting to make way for this revolutionary cancer test. Annual sales are forecasted to be $10 billion, and several companies are developing testing kits to hit the market this year. Companies are also researching new approaches that investigate ctDNA in urine and cerebral spinal fluid.
Currently, these tests are being developed for specific cancers, but the frontier of the liquid biopsy is wide open.It’s being hailed as a flagship technology of the federal government’s Cancer Moonshot Initiative.With more research and market investment, experts believe it’s only a matter of time before catching and treating cancer is as routine as your annual checkup.
Where Are They Now
While studies are still underway, the market is adjusting to make way for such revolutionary cancer tests. The global liquid biopsy market accounted for $634 million in 2016, and is estimated to reach $3,805 million by 2023, as several companies are developing testing kits expected to hit the market this year. It’s being hailed as a flagship technology of the federal government’s Cancer Moonshot Initiative. However, in 2016, the FDA is cited to have said that diagnostic tests such as these should be treated with caution when being used for major health decisions. The FDA does not currently oversee tests like this, but is in the process of drafting framework to regulate their use. With more research and market investment, the clinical utility of ctDNA may be accurately analyzed as the efforts remain experimental for now.