Although Arrayit had previously said it would pursue 510(k) clearance for OvaDx, Schena told PGx Reporter this week that the company chose the PMA path in order to prove that the technology platform for OvaDx could "pass muster in a rigorous clinical trial," and differentiate the test in the marketplace.
While the pre-market approval route is more stringent than the 510(k) pathway and is for devices with the highest risk to patients, the company said it would be the most appropriate strategy for its ovarian cancer test.
Results from the 94-subject study suggest that the test could be useful in screening high-risk patients for ovarian cancer and possibly even as a screening diagnostic for the general population, a Georgia Tech researcher said.
The trial will study samples from 1,150 patients in Australia and the UK to explore the utility of adding two protein biomarkers to the test to improve its sensitivity and specificity, Nick Gatsios, HealthLinx managing director, told ProteoMonitor.
The Sunnyvale, Calif.-based array company said its growth has been "frustrated" by a lack of capital and inability to meet orders, and that it expects to close one or more rounds of financing during the second quarter of this year.