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Avant Diagnostics Presented Data on TheraLink® Pancreatic Cancer Assay at the International Symposium on Pancreas Cancer 2016

2016-06-14 09:00 ET - News Release

SCOTTSDALE, Ariz. and GAITHERSBERG, Md., June 14, 2016 (GLOBE NEWSWIRE) -- Avant Diagnostics, Inc. (“Avant”) (OTCQB:AVDX), an innovative molecular diagnostics company, today announced that Dr. Vince Picozzi presented data on use of the Company’s TheraLink® assay in pancreatic cancer at the International Symposium on Pancreas Cancer 2016.

“The presentation of data by D. Picozzi demonstrating that information on the activation status of signaling pathways, as provided by the technology behind our TheraLink® tests, prior to adjuvant therapy could enhance current prognostic models and/or identify new pharmacological targets is an important step forward as we validate additional applications for TheraLink® beyond breast cancer,” said Glenn Hoke, PhD, incoming Chief Scientific Officer at Avant.

PRESENTATION DETAILS
Meeting: Pancreas 2016: International Symposium on Pancreatic Cancer in Glasgow, Scotland
When: Thu 9 June 2016 - Sun 12 June 2016
Abstract Title: Association of long-term survival in pancreatic cancer (PDAC) with increased proliferative and anti-apoptotic protein activation.
Authors: Vincent J. Picozzi, Corinne Ramos, Nicholas N. Hoke, Glenn D. Hoke; Virginia Mason Medical Center, Seattle, WA; Theranostics Health, Inc., Rockville, MD; Theranostics Health, Rockville, MD
Background: 5 year (yr) overall survival (OS) for resected PDAC is typically 20%. To test the potential for molecular prediction of > 5 yr OS in such patients (pts), we analyzed proteomic activation (phosphorylation) patterns in both cancer and stromal cells from initial surgical specimens prior to adjuvant therapy (Rx). 
Methods: Formalin-fixed, paraffin-embedded tissue from 40 pts (20 pts each with long-term actual disease-free OS [median 65 mo, range 26-137 mo] [LTS] and with early relapse/death < 2 yrs [STS]) with de novo resected PDAC formed the test cohort. All pts received adjuvant Rx (chemo Rx with/without chemoradiation). Laser Capture Microdissection enabled directed cancer and stromal cell isolation. Retrospective blinded protein activation analysis for both was performed via Reverse Phase Protein Array (RPPA). Differences in baseline protein signaling of LTS vs. STS were evaluated via two-way ANOVA analysis. 
Results: Analysis of > 50 signal transduction proteins (STPs) for activation (phosphorylation) showed these significant differences for LTS vs. STS in cancer cells: 1) Activation of proliferation markers Sox2/ Ki 67 were higher (p<0.0001). 2) Activation of anti-apoptotic signal transducer and activator of transcription 3 (p-STAT 3) (p=0.047) and p-SRC kinase (p=0.039) were higher. 3) Activated p-m-TOR expression was higher (p=0.021). 4) Activation of mitotic marker histone H3S10 was lower (p=0.03). In stromal cells, activation of the survival marker Mek S298 was lower (p=0.021). For other STPs, differences for LTS vs. STS (e.g. Livin, PCNA) were not seen. 
Conclusions: 1) LTS and STS of de novo resected PDAC show clear differences in cancer cell protein activation re key markers of proliferation and apoptosis (Sox2, Ki67, STAT3, SRC kinase, H3S10). 2) For stromal cells, protein activation was largely similar, but a difference in activation of one stromal protein (Mek S298) was seen. 3) For these pts, differences in protein activation prior to adjuvant Rx could enhance current prognostic models and/or identify new pharmacological targets designed to improve OS. 4) These findings require further validation: a second 60 sample validation cohort is now under analysis.

About Avant Diagnostics, Inc.
Avant is a medical diagnostic technology company that specializes in biomarker tests that are being developed and offered through its CLIA/CAP laboratory in the areas of oncology and neurology. Avant provides personalized medicine diagnostic testing capabilities through its TheraLink® Diagnostic Assays, primarily for breast cancer, to assist clinical oncologists in identifying likely responders for over 30 FDA-approved drug treatment regimens. Avant is the leading developer of proteomic technologies for measuring the activation status of key signaling pathways, with applications across several different cancer types, including breast, ovarian and pancreatic that are instrumental in the development of companion diagnostics for molecular-targeted therapies. Avant has used these proteomic technologies to support the drug development programs of many of the top biopharmaceutical companies in the world. For more information please visit www.theranosticshealth.com.

Avant is also developing OvaDx® 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.

Avant’s neurology division was recently acquired from Amarantus  Bioscience Holdings (OTCQB:AMBS) and owns the rights to MSPrecise™, a proprietary next-generation DNA sequencing (NGS) assay for the identification of patients with relapsing-remitting multiple sclerosis (RRMS) at first clinical presentation, has an exclusive worldwide license to the Lymphocyte Proliferation test (LymPro Test™for Alzheimer's disease, which was developed by Prof. Thomas Arendt, Ph.D., from the University of Leipzig, and owns intellectual property for the diagnosis of Parkinson's disease (NuroPro).

For further information, please visit www.AvantDiagnostics.com, or connect with the Company on Facebook and LinkedIn.

Forward-Looking Statements
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 10-K filed with the Securities and Exchange Commission on January 13, 2016, and other periodic reports filed with the Securities and Exchange Commission.

Investor and Media Contact:
Ascendant Partners, LLC
Fred Sommer
732-410-9810
fred@ascendantpartnersllc.com

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