Avant Diagnostics, an innovative in vitro diagnostics company, today told investors that the previously purchased specimens have been approved and are available for use in the upcoming validation study to be used to support a pre-Submission package to the United States Food and Drug Administration (“FDA”).
Avant anticipates that the FDA validation study will start shortly after the ongoing calibration testing is completed. Upon completion, Avant intends to test the previously purchased set of ovarian cancer specimens, including serial sets obtained from women diagnosed previously 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 OvaDx® microarray test is designed to be used as an aid in monitoring women diagnosed previously with ovarian cancer. The validation study and 510(k) trial will be conducted in a double-blinded environment supervised by DOCRO, Inc., an independent clinical research organization. The results from the validation study are expected to be published in a peer-reviewed scientific journal within six months of test completion and data analysis; however there can be no assurance that such publication will be completed within this time frame.
Gregg Linn, Avant’s Chief Executive Officer and President, stated, “Avant continues to make steady progress towards its goal of obtaining FDA 510(k) clearance for OvaDx®. We intend to periodically communicate with our shareholders and markets as we progress through the FDA negotiations and through FDA’s review of our 510(k) submission.”
For more information, visit www.avantdiagnostics.com
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