Avant Diagnostics (AVDX): Trials and Tribulations
Recently, in Avant Diagnostics set to exploit new opportunities in the laboratory testing market (http://dtn.fm/hg8TK), we reported that ‘OvaDx is now undergoing 510K trials.’ It seems we jumped the gun. We reached out to Avant’s CEO, Gregg Linn, to get clarification on our report and he confirmed that the OvaDx approval process hasn’t reached the 510K trial stage yet. Avant has been engaged in the calibration testing and validation study phases regarding OvaDx and it expects the 510K trials to commence this year. In September 2015, Avant began calibration testing in preparation for the validation study of OvaDx, which will…