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Avant Diagnostics, Inc. Begins OvaDx FDA Trials and Engages Clinical Research Organization
Avant Diagnostics, Inc. Begins OvaDx FDA Trials and Engages Clinical Research Organization.
About this update from Arrayit Corp
[{"type":"text","content":"\n \n Avant \n Diagnostics, Inc. (OTCBB: AVDX) (“Avant”), a diagnostic company with \n a primary focus on the commercialization of a proprietary diagnostic \n test for the early detection of ovarian cancer called OvaDx®, is pleased \n to announce that it has engaged the professional services of DOCRO, Inc. \n (“DOCRO”) to manage the preparation and the submission of the \n pre-submission package for OvaDx® and to conduct the negotiation with \n the U.S. Food and Drug Administration (“FDA”) office for the process for \n obtaining a 510(k) clearance of the OvaDx® device intended for use as an \n aid in monitoring women diagnosed with ovarian cancer. Additionally, \n Avant purchased the necessary ovarian cancer samples required for the \n supervised, double blinded clinical validation testing data to be \n included in the pre-submission package.\n \n \n Gregg Linn, Avant’s President and Chief Executive Officer, noted, “I am \n thrilled finally to reach this milestone. Since I joined the company \n almost 2½ years ago, my goal was simply to take OvaDx® through the FDA \n submission process for ovarian cancer monitoring, seek FDA clearance, \n and most importantly, save lives.”\n \n \n About Avant Diagnostics, Inc.\n \n \n Avant Diagnostics, Inc. is a medical diagnostic technology company that \n specializes in large panel biomarker screening. Our first test, OvaDx®, \n developed in conjunction with Arrayit Corporation (OTCQB: ARYC), detects \n for pre-symptomatic ovarian cancer. OvaDx® is a sophisticated \n microarray-based test that measures the activation of the immune system \n in blood samples in response to early stage ovarian tumor cell \n development. Pre-clinical research studies with OvaDx® indicated \n high sensitivity and specificity for all types and stages of ovarian \n cancer, including stage IA-IV borderline serous, clear cell, \n endometrioid, mixed epithelial, mucinous, serous, and ovarian \n adenocarcinoma. Upon FDA 510(k) clearance, Avant intends to sell or \n license OvaDx® as a diagnostic test for women seeking greater \n wellness and for women in the elevated risk category for ovarian cancer.\n \n \n Safe Harbor Statement\n \n \n Certain statements in this press release are forward-looking within the \n meaning of...