US slower than Europe, emerging markets in liquid biopsy adoption

Blood-based cancer tests have market, but more evidence may be needed to verify validity and utility.

From left: Shoshannah Roth, Michael Nall, Rob Dumanois, Eugean Jiwanmall

One of the most cutting-edge trends in oncology diagnostics is liquid biopsy, which enables the use of a blood test to guide cancer treatment rather than having to extract tumor tissue. But the United States has not been as quick as some of its peers in adopting it, said several members of a panel Thursday morning at MedCity CONVERGE.

The panel, “Liquid Biopsy and Gene Testing vs. Reimbursement Hurdles,” featured ECRI Institute assistant director of health technology assessment and information services Shoshannah Roth as moderator. The panelists were Rob Dumanois, manager for reimbursement strategy at Thermo Fisher Scientific; Eugean Jiwanmall, senior research analyst for medical policy and technology evaluation at Independence Blue Cross; and Michael Nall, CEO of Biocept. CONVERGE, taking place in Philadelphia, concludes Thursday.

On the one hand, Dumanois said, there are no markets in which liquid biopsy has ubiquitously replaced tissue biopsy. At the same time, it does appear to be moving into the market at a faster pace in Europe and Canada than in the US. Another case of faster adoption ex-US is in China, Nall said. There, patients typically pay for cancer treatment out of pocket and are thus keenly interested in finding out how well their therapies are working, given that the amount of circulating tumor DNA is expected to decrease when the cancer is responding to treatment. Meanwhile, he said, patients in Latin America undergo liquid biopsy in the front line, subsequently having a tissue biopsy done if the liquid biopsy produces a negative result.

Despite unevenness in the rapidity of adoption, panelists brought up cases where liquid biopsy would have significant utility. Nall mentioned the anecdote of a woman with HER2-positive breast cancer that had metastasized to her bones. Because of the metastases, she would require bone biopsy that itself would require bone decalcification in order to make slides. But through a liquid biopsy, Biocept was able to determine the woman’s HER2 status, and since then she has been taking Roche’s HER2-targeting drug Herceptin (trastuzumab) and is in remission. Lung cancer also represents an unmet need due to both the potential shortage of tissue needed to get a full sense of a tumor’s genome and concerns about the possibility of collapsing the patient’s lung during the process of collecting tissue, he said.

However, skepticism remains among US payers, which desire to see more clinical trial evidence to support liquid biopsy to support reimbursement. Jiwanmall pointed out that the evidence can come from either randomized controlled trials or from sufficiently large observational studies. He pointed to a joint review by the American Society of Clinical Oncology and the College of American Pathologists released in March stating that despite 77 studies supporting the use of liquid biopsy, more evidence was needed to establish appropriate and effective use in the clinic. Despite the limitations and risks associated with tissue biopsy in lung cancer, liquid biopsy still has to show that it works better, he said. “Whatever is the established way of doing things, you have to outperform that from a clinical perspective in the right quantity or quality of studies to say that you are better,” he said.

Photo: Alaric DeArment, MedCity News