Avant Diagnostics (OTCQB: AVDX), a biotechnology company focused on the development of oncology based diagnostics, and Amarantus Diagnostics, a wholly-owned subsidiary of Amarantus BioScience Holdings, Inc. (OTCQX: AMBS), today announced that the companies have jointly entered into a letter of intent for Avant to acquire Theranostics Health Incorporated ("THI"), adding key CLIA laboratory and intellectual property capabilities to Avant and Amarantus' previously announced diagnostics merger. Theranostics currently generates over $1.5M in services revenue from some of the world's leading biopharmaceutical companies, including 7 of the top 10 pharmaceutical companies by revenue.
Avant Diagnostics, Inc. (AVDX) is a medical diagnostic technology company that specializes in large panel biomarker screening. The company's first test, OvaDx®, is a sophisticated microarray-based test designed to detect pre-symptomatic ovarian cancer by measuring the activation of the immune system in blood samples in response to early stage ovarian tumor cell development.
In clinical development, OvaDx has 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 approval, Avant plans to offer its diagnostic product as an elective test for women seeking greater wellness, as well as those in the elevated risk category for ovarian cancer.
OvaDx is also expected to be used by doctors to advance the forefront of ovarian cancer treatment, promoting the utilization of improved surgical options and more effective chemotherapies by serving as a supplement to existing tests, such as CA-125, OVA1® and transvaginal ultrasound. In this way, Avant's innovative product will promote earlier diagnoses and, as a result, improved survival rates for patients with ovarian cancer.
As it continues to seek FDA approval for its groundbreaking diagnostic technology, Avant is poised to promote considerable growth in the ovarian cancer market, addressing what is currently the most deadly cancer of the female reproductive system. The company will lean on the industry experience of its management team in order to continue positioning itself for long-term success in the medical diagnostic market.
- Developing Specialized, Cutting-Edge Medical Tests
Advancing First-of-its-Kind Panel Biomarker Screening Test
Detecting Pre-Symptomatic Ovarian Cancer Faster Than Ever
Progressing on Goal to Obtain FDA 510(k) Clearance for OvaDx®
The market's first large panel biomarker screening test for 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.
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 approval, Avant Diagnostics will offer OvaDx® as an elective test for women seeking greater wellness and for women in the elevated risk category for ovarian cancer. OvaDx® will be used by doctors to advance the forefront of ovarian cancer treatment including improved surgical options, more effective chemotherapies, and to supplement existing tests including CA-125, OVA1® and transvaginal ultrasound.
Clinicians will appreciate the following features of this product:
- Market's first large panel screening test for ovarian cancer
Use an elective screen for women seeking greater wellness
Screen women at elevated risk for ovarian cancer
High sensitivity and specificity for all types and stages of ovarian cancer
Identifies stage I, II, III and IV disease markers in patient samples
Detects stage IA disease markers with ~80% sensitivity and 100% Specificity
Detects borderline serous, clear cell, endometrioid, mixed epithelial, mucinous, serous, and ovarian adenocarcinoma in patient sera
Multi-plexed microarray assay reads approximately 100 proteomic biomarkers
Proteomic panel provides definitive real-time test results
Microarray format reduces serum requirement to 0.1-0.25 ml per sample run
Arrayit Diagnostics' blood cards can also be used for sample collection
Fluorescence detection ensures high signal detectivity
Test controls eliminate experimental false positives and false negatives
High-throughput format scales to any number of patient samples
Automated process permits large-scale (e.g. 1,000,000 sample+) screening
Supplement OVA1® and other multi-analyte tests
Supplement single marker tests including cancer antigen 125 (CA-125) and human epididymis protein (HE4)
Supplement genetic tests including BRCA1 and BRCA2
Supplement imaging techniques including transvaginal ultrasound, computerized tomography (CT) scans and X-rays
Screen patient sera from breast, cervical, uterine and other cancer patients
Test samples from patients with ovarian cysts and other benign conditions
The Dire Need for Early Detection of the "Silent Killer"
Ovarian cancer is the 11th most common cancer among women and the fifth-leading cause of cancer-related death among women. According to the Centers for Disease Control, Ovarian cancer causes more deaths than any other cancer of the female reproductive system, but accounts for only about 3% of all cancers in women. When ovarian cancer is found in its early stages, treatment is most effective.
Often called "the silent killer," however, ovarian cancer is rarely caught early. Many times there are no symptoms until the disease has progressed to advanced stages. About 20% of ovarian cancers are found at an early, localized stage, and 94% of those patients live longer than five years after diagnosis, according to the American Cancer Society.
While regular women's health exams, knowledge of symptoms and risks, and screenings can be important ways to detect ovarian cancer, there is much research being done to develop new tests to accurately diagnose the disease at an early stage.
Avant Diagnostics' progression toward FDA approval and commercialization of OvaDx® is spearheaded by a management team with a rich history of experience in executive leadership, accounting, corporate sales, marketing and financing for numerous industries.
Gregg Linn | President/CEO
Gregg Linn joined Avant Diagnostics as president and CEO in February December 2015. Prior to these roles, Linn served as the company's COO and CFO since December 2012. Since 2008, Linn served as the president and managing member of Issuers Capital Advisors, LLC, and since 2001 served as CEO and managing member of Red Rock Advisors, LLC. Both firms specialize in providing strategic financial and business development advisory services to public and non-public companies, with emphasis on capital formation, mergers and acquisition and management of the public side of small cap publicly traded companies. From 2004 to 2007, he was COO and CFO of Vital Living, Inc., a Phoenix, Arizona-based publicly traded nutritional supplements company. Prior to 2004, Linn served as CFO of several other public and privately held companies, senior financial management positions at Fortune 500 companies, as well as worked as a senior analyst at Shearson Lehman. Linn received an undergraduate degree in accounting and business from Michigan State University in 1984 and a Master Degree in Business Administration, summa cum laude, from Pace University-NYC in 1992. Linn is a certified public accountant.
Joseph Roth has spent more than three decades as a corporate sales, marketing and management executive with Fortune 50 companies as well as entrepreneur opportunities. For the past five years he has been self employed as a consultant to small and medium sized companies and C-level executives. From 2008-2010, he was COO of ShopBox, LLC, a business process outsourcing company specialized in the execution of web-based kiosk marketing strategies. He was responsible for securing partnership deals with NASCAR, NFL, NHL and NBA leagues, teams and franchises. From 2003 to 2008, Roth was president of CMB Franchising, Inc., a licensed Area Developer of Extreme Pita Restaurants of Canada for Arizona and Nevada. During this time he oversaw the construction, development and operations of 10 stores generating a 25% increase over the second highest volume franchise in the U.S. From 1996-2003, Roth was managing partner of Cypress Staffing Services, LLC, a company he founded in 1999 that provides private duty home care throughout Central Arizona. Cypress grew from scratch to become the largest company in Arizona within its industry category in less than four years.
Randall Letcavage brings in excess of 25 years of business experience specializing in the financial markets, investment banking and business consulting. Currently, Letcavage is chairman, CEO, and president of Premier Holding Corp., which is publicly traded on the OTCQB exchange. For the past 20 years Letcavage has been an investment banker widely recognized for numerous achievements as well as his role of founder, officer and director of the iCapital Group, which includes iCapital Finance Inc, iCapital Advisory LLC and iCap Development LLC (A National "CDE" Community Development Entity – Certified by the U.S. Treasury Department). Letcavage has advised numerous clients on various transactions and financings in a wide range of industries, including technology, healthcare, financial services, entertainment, energy and green initiatives.
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