SCOTTSDALE, Ariz., Oct. 07, 2015 (GLOBE NEWSWIRE) -- Avant Diagnostics, Inc. (OTCQB:AVDX) (“Avant”), an innovative in vitro diagnostics company, was notified by DOCRO, its independent clinical research organization, that it has received notification that the previously purchased specimens have been approved and are available for use in the forthcoming validation study to be used to support a pre-Submission package to the United States Food and Drug Administration (“FDA”).
Avant expects to commence the FDA validation study shortly after the completion of the ongoing calibration testing. Once the calibration testing is completed, 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 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, 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, noted, “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.”
About Avant Diagnostics, Inc.
Avant is a medical diagnostic technology company that specializes in large panel biomarker tests. Our first test, OvaDx®, is proposed for use in monitoring women diagnosed previously with ovarian cancer. OvaDx® is a sophisticated microarray-based test that measures the activation of the immune system in blood samples in response to ovarian tumor cell development. Pre-clinical research studies with OvaDx® indicate high sensitivity and specificity for all types and stages of ovarian cancer including stage IA-IV borderline serous, clear cell, endometrioid, mixed epithelial, mucinous, serous, and ovarian adenocarcinoma. Upon FDA 510(k) clearance, Avant intends to sell or license OvaDx®. Avant intends to utilize its public company stage to expand its portfolio of diagnostic tests in the future.
Safe Harbor Statement
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” among others. These forward-looking statements are based on Avant’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Avant does not undertake an obligation to update or revise any forward-looking statement except as required by law. Investors should read the risk factors set forth in Avant’s Form 8-K filed with the Securities and Exchange Commission on January 14, 2015, as amended on January 16, 2015, and other periodic reports filed with the Securities and Exchange Commission.
Contact: Avant Diagnostics Gregg Linn, 602-524-4165 President/CEO glinn@avantdiagnsotics.com www.avantdiagnostics.com Or Goal Capital Inc., Investor Relations Danny Gravelle Tel 949-305-5093 contact@goalcapital.net
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