Avant Diagnostics, an innovator in molecular diagnostics, this morning announced the start of calibration testing in preparation for the company’s validation study of OvaDx®, which will be used to support a pre-submission package to the United States Food and Drug Administration (“FDA”). Avant expects to complete the calibration testing within 30 days.
OvaDx® is a sophisticated microarray-based test proposed for use in monitoring women previously diagnosed with ovarian cancer. Pre-clinical research studies with OvaDx® indicate high sensitivity and specificity for all types and stages of ovarian cancer.
Upon completion of the testing, Avant said it intends to test the previously purchased set of ovarian cancer specimens, including serial sets obtained from women previously diagnosed with ovarian cancer, which will serve as the validation study and form the basis of the pre-submission package that will be submitted to FDA for review and comment prior to the commencement of the OvaDx® 510(k) trial.
The validation study and 510(k) trial will be conducted in a double-blinded environment supervised by independent clinical research organization DOCRO, Inc. Validation study results are expected to be published in a peer-reviewed scientific journal within six months of test completion and data analysis.
“The entire Avant team has been working tirelessly over the past few months to reach this critical milestone. We look forward to communicating to our shareholders and the markets as we move through the FDA negotiations and review of our 510(k) submission,” Gregg Linn, Avant’s CEO and president stated in the news release.
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