Molika Ashford covers personalized medicine and molecular diagnostics for GenomeWeb.
An impetus for the review included the fact that companies are advertising and promoting liquid biopsy in areas where the technology has not yet proven its clinical utility.
The decision, which the company said was made for business and financial reasons, raises questions about the viability of such tests in the face of reimbursement uncertainly.
The company aims to shore up its core nCounter platform business with new consumables, as it continues to work on new technologies and explore clinical translation.
A study reported this week that measuring changes in the numbers of specific circulating tumor DNA mutations can rapidly identify breast cancer patients who will have better outcomes.
The company is collating data on physician decision-making from early-access users, and believes that it can make a strong case for clinical utility of the test.
With multiple independent biomarkers, and potential combinations that may require even more subtyping, diagnostics to guide immunotherapy appears to be getting more complicated.
Although a draft guidance last month recommended against use of molecular tests to guide chemotherapy, the group's finalized decision is subject to price negotiation and other adjustments.
The company expects to be able to offer at least one test commercially by the end of this year or early next, with research now starting on two others.
Adam Wolfberg argued that while corporate conflicts are widely discussed, physicians also have financial conflicts that can bias them against new technology.
The company publicized some of the first data that speaks directly to the sensitivity and specificity of its circulating tumor cell-based colorectal cancer test, which it plans to now bring to the US market.