After the DOCRO/Avant/Arrayit/Tainsky summit, Avant put out a PR
Avant Diagnostics Inc. Commences OvaDx(R) Ovarian Cancer Test Calibration in Preparation for FDA Submission
Avant Diagnostics, Inc. September 24, 2015 10:24 AM
SCOTTSDALE, Ariz., Sept. 24, 2015 (GLOBE NEWSWIRE) -- Avant Diagnostics, Inc. (AVDX) ("Avant"), an innovative molecular diagnostics company, began calibration testing in preparation for the validation study of OvaDx(R), which will be used to support a pre-Submission package to the United States Food and Drug Administration ("FDA").
Avant expects to have the calibration testing completed within 30 days. Once the calibration testing is completed, Avant plans 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(R) 510(k) trial. The OvaDx(R) microarray test is intended for use 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.
Gregg Linn, Avant's Chief Executive Officer and President, noted, "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."
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