Australian diagnostics firm HealthLinx said that preliminary data from a Korean Food and Drug Administration study of its ovarian cancer diagnostic OvPlex showed that the test offers an advantage over use of CA125 alone – currently the standard biomarker test used in ovarian cancer diagnosis.
The analysis used a new diagnostic algorithm developed using data from an ongoing 1,150-patient multinational trial for OvPlex. The results suggest that OvPlex holds an advantage over CA125 alone, particularly in reducing false positives, the company said.
The preliminary analysis of the KFDA study used data from 220 patient samples. According to the company, final analysis of the KFDA trial data will occur after completion of the multinational trial and implementation of the new algorithm it is developing through that trial.
Upon completion of the trial HealthLinx plans to make a formal submission to the KFDA for regulatory approval of OvPlex. HealthLinx's partner Seoul Clinical Laboratories, which is co-funding the study, will then obtain an exclusive clinical license to distribute OvPlex in South Korea.