Avant Diagnostics, Inc. Begins OvaDx FDA Trials and Engages Clinical Research Organization
15 Abril 2015 - 7:00AM
Business Wire
Avant Diagnostics, Inc. (OTCBB: AVDX) (“Avant”), a diagnostic
company with a primary focus on the commercialization of a
proprietary diagnostic test for the early detection of ovarian
cancer called OvaDx®, is pleased to announce that it has engaged
the professional services of DOCRO, Inc. (“DOCRO”) to manage the
preparation and the submission of the pre-submission package for
OvaDx® and to conduct the negotiation with the U.S. Food and Drug
Administration (“FDA”) office for the process for obtaining a
510(k) clearance of the OvaDx® device intended for use as an aid in
monitoring women diagnosed with ovarian cancer. Additionally, Avant
purchased the necessary ovarian cancer samples required for the
supervised, double blinded clinical validation testing data to be
included in the pre-submission package.
Gregg Linn, Avant’s President and Chief Executive Officer,
noted, “I am thrilled finally to reach this milestone. Since I
joined the company almost 2½ years ago, my goal was simply to take
OvaDx® through the FDA submission process for ovarian cancer
monitoring, seek FDA clearance, and most importantly, save
lives.”
About Avant Diagnostics, Inc.
Avant Diagnostics, Inc. is a medical diagnostic technology
company that specializes in large panel biomarker screening. Our
first test, OvaDx®, developed in conjunction with Arrayit
Corporation (OTCQB: ARYC), detects for pre-symptomatic ovarian
cancer. OvaDx® is a sophisticated microarray-based test that
measures the activation of the immune system in blood samples in
response to early stage ovarian tumor cell development.
Pre-clinical research studies with OvaDx® indicated 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® as a diagnostic test for women seeking
greater wellness and for women in the elevated risk category for
ovarian cancer.
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.
Avant DiagnosticsGregg Linn,
480-478-6660President/CEOglinn@avantdiagnsotics.comorConsultant for
Avant DiagnosticsSteven Scott, 617-448-1300sscott@scottgrp.com
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