Currently marketed for research use by Biofluidica, the test's microfluidic channels use specific cancer antibodies to detect capture circulating tumor cells.
The ctDNA assay will be used to select patients for Phase 3 of Five Prime's registrational trial investigating bemarituzumab in gastric cancer patients.
The company has highlighted the study as evidence that its test would outperform Roche's FDA-approved liquid biopsy assay if implemented in the clinic.
The company's test boasted strong sensitivity and specificity for a range of different alterations in clinical and contrived samples, particularly for low-allele frequencies.
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.
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.
