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美國(guó)AutoGenomics
AutoGenomics公司開(kāi)發(fā)出Infiniti生物干片芯片微陣列，分子診斷技術(shù)

AutoGenomics, Inc., a privately held company based in Vista, CA has developed one of the first automated microarray based multiplexing molecular diagnostic platforms that can be used to assess disease signatures with novel genetic biomarkers in the areas of women’s health, cancer and personalized medicine. With discovery of genes and their link to various disease states the platform has the versatility to revolutionize the way patients are diagnosed, monitored and managed, leading to a new era of personalized medicine.

Mission

The Company's mission is to empower clinical laboratories by supplying them with a fully integrated system to perform a large menu of automated, cost-effective and easy to use tests with a high degree of accuracy and sensitivity.

Overview

Since the Company's inception in 1999, scientists and engineers at AutoGenomics have endeavored to create automated technologies that simplify the complex test processes inherent in genetic analysis within a format that is user friendly and increases productivity in the clinical laboratory.

The INFINITI? system is designed specifically for processing AutoGenomics' unique proprietary BioFilmChip? microarrays that can be multiplexed and configured with hundreds of biomarkers to assess disease signatures from a single sample specimen.

The INFINITI? system provides clinical laboratories with significant improvements in laboratory productivity, workflow and cost per reportable results.

Regulatory Strategy

AutoGenomics' regulatory strategy is consistent with the company's overall mission and objectives: to develop, manufacture and market a molecular diagnostics solution specifically designed for the clinical laboratory.

The AutoGenomics Regulatory Strategy :

To obtain the necessary FDA clearance/approval to market products in the U.S.

To apply the CE marking that will allow products to be distributed in Europe. This will require compliance with ISO 13485 and to the IVDD (European In Vitro Diagnostic Device Directive).

To pursue regulatory approvals to market products in Canada, Asia and Latin America.
AutoGenomics has developed instrumentation, reagents and applications that are at various stages of development and regulatory process:

US
AutoGenomics has obtained 510(k) clearance for its INFINITI System Assay for Factor II, Factor V Leiden and Factor II/V Leiden Panel.

AutoGenomics has obtained 510(k) clearance for its INFINITI Warfarin Assay.

AutoGenomics has submitted a request for 510(k) clearance for its INFINITI CYP450 2C19+ Assay.

AutoGenomics has submitted a request for 510(k) clearance for its INFINITI UGT1A1 Assay.

AutoGenomics has submitted pre-IDE for its INFINITI HPV Screening Assay.

AutoGenomics has submitted pre-IDE for its INFINITI CFTR-31 Assay.

AutoGenomics has submitted a request of EUA (Emergency Use Authorization) for its
INFINITI Flu A-sH1N1 Assay.

AutoGenomics is in the process of discussing premarket submissions strategies for several of its products with the FDA.

International
AutoGenomics has obtained certification for ISO 13485 and CMDCAS (Canada).

In addition to the INFINITI Analyzer, AutoGenomics has CE-marked:

Factor II
Factor V
MTHFR
FII-V Panel
FII-V-MTHFR
CFTR-31
UGT1A1
Warfarin Assay
CYP450 2C9-VKORC1
CYP450 2C19+
CY450 2D6I
HPV Genotyping
HPV QUAD
HPV-HR QUAD
To ensure product quality, AutoGenomics has established a quality system designed to meet the requirements of the FDA QSR and ISO 13485.

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Management Team

Members of the AutoGenomics' management team have a proven track record in developing new analytical systems and successfully bringing them to market for companies such as Abbott Laboratories, Behring Diagnostics, Baxter International, Hycor Biomedical, and Sequenom. With diverse management backgrounds in sales, marketing, R&D and operations, the management team has developed 16 analytical instruments, set up manufacturing of 6 systems and worked on a number of projects from concept-to-launch, three of which have annual recurring consolidated sales in excess of $1 billion.

Fareed Kureshy, Founder, Chairman, President and CEO
Mr. Kureshy has 30 years of entrepreneurial leadership experience in the healthcare industry beginning in R&D and advancing to general management where he has led three entrepreneurial organizations from start-up through market introduction and financial success. Previously, Mr. Kureshy served as President and CEO of Sequenom, Inc., President of Behring Diagnostics and PB Diagnostics where he has set up the infrastructure to design, develop, manufacture and market platform technologies in the area of chemistry, immunoassays and DNA analysis. Mr. Kureshy holds undergraduate degrees in physics, chemistry, mathematics and engineering and has completed graduate engineering studies. He was awarded a MBA from Southern Methodist University.

Thomas V. Hennessey, Chief Financial Officer and Director
Mr. Hennessey has 30 years of experience in medical and technology industries. Mr. Hennessey was previously the CFO of PB Diagnostics and six start-ups, four of which he took public. Over this period he has served as Chief Operating Officer and as Chief Financial Officer for several public and private start-up companies including Behring Diagnostics, Inc., Autoimmune, Inc., Medical Diagnostics, Inc., Cambridge Heart, Inc., Sonamed Corporation, PHT Corporation and Photovac, Inc. Mr. Hennessey received a B.S. and a M.S. degree in mechanical engineering from MIT and a M.B.A. from Harvard Graduate School of Business.

Nanibhushan Dattagupta, Ph.D., Chief Scientific Officer
Dr. Dattagupta has over 35 years of research and management experience in pharmaceutical R&D clinical diagnostics and ethical products. Dr. Dattagupta has held executive positions at Bayer, Gen-Probe, Chugai Biopharmaceuticals and Applied Gene Technologies. Dr. Dattagupta is an inventor or co-inventor of 59 issued US patents and more than 150 issued and pending patents internationally. He is an author or co-author of 57 scientific publications in peer reviewed journals. He received B.S. M.S. and a Ph.D. in Chemistry from Calcutta University.

Shelley Singh, Ph.D., Co-founder, Vice President, System Development
Dr. Singh has 32 years of experience in software engineering, systems development and integration, the last 27 years having been spent in the healthcare industry and developing eight medical instruments. Dr. Singh was previously Vice President of Systems Development at Sequenom, Inc., PB Diagnostics and Behring Diagnostics. Dr. Singh received a B.S. in electrical engineering, an M.E. in mechanical engineering and a Ph.D. from Southern Methodist University.

Ramanath Vairavan, Co-founder, Sr. Vice President, Sales and Marketing
Mr. Vairavan has over 30 years of experience in the healthcare industry in the areas of research, product development, manufacturing, sales, marketing and business development. He began his career with Hoechst AG / Behring Diagnostics where he held various management positions in research, development, operations, international sales and marketing in the U.S., Singapore and Germany. Mr. Vairavan received a B.S. in chemical engineering, a M.S. in biomedical engineering from Washington University and a M.B.A. from Fairleigh Dickinson University.

Raymond Earl, Vice President, Sales
Mr. Earl has 30 years of experience and has held a number of management positions in the diagnostics industry, including Vice President of Sales and Marketing for Ivax Diagnostics, Vice President and General Manager, Sales, Marketing and Product Support at Behring Diagnostics, Inc. and over 15 years of sales and management experience at Abbott Laboratories in their diagnostics division. He received a B.S. degree in bacteriology from the University of Pittsburgh.

Saeed Kureshy, Vice President, Operations
Mr. Kureshy has 35 years of experience in engineering, manufacturing, plant expansion and facility design, including 18 years with Abbott Labs in the Diagnostics Division where Mr. Kureshy held various management positions in production, industrial engineering, material flow operations, and facilities design and new plant start-up. Mr. Kureshy holds a B.S. in electrical engineering and a B.S. in mathematics.

Evelyn Lopez, Vice President, Regulatory Affairs
Ms. Lopez brings over 20 years of regulatory/clinical affairs/quality assurance experience in medical devices and pharmaceuticals companies. Her experience includes US and international regulations related to clinical trials/premarket submissions (PMA, IDE, 510k, MDD/IVDD) and quality systems (FDA QSR, ISO), as well as activities related to strategic planning, contract manufacturing, and mergers/acquisitions. Ms. Lopez served as Vice President, Regulatory & Quality Assurance for Novatrix Biomedical, Director of Clinical Affairs at Micro Therapeutics, and Director of Regulatory Affairs at Cryogen. Ms. Lopez holds a B.S. in chemical engineering from the Philippines, and a MS in operations research from Stanford University.

Jeffrey L. Irwin, Director of Finance
Mr. Irwin has more than 20 years experience in the finance sector. Mr. Irwin was previously the Director of Finance for Tadpole Computer, Inc., a wholly-owned subsidiary of General Dynamics. Mr. Irwin has held executive and management positions at computer manufacturing firms and mortgage banking companies. He holds a B.A. in history from the University of California, Santa Barbara and a M.B.A. in Financial Management from National University in San Diego, California.

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Board of Directors

Fareed Kureshy
Mr. Kureshy is Chairman, President and Chief Executive Officer of AutoGenomics, Inc and has 30 years of entrepreneurial leadership experience in the healthcare industry beginning in R&D and advancing to general management where he has led three entrepreneurial organizations from start-up through market introduction and financial success. Previously, Mr. Kureshy served as President and CEO of Sequenom, Inc., President of Behring Diagnostics and PB Diagnostics where he has set up the infrastructure to design, develop, manufacture and market platform technologies in the area of Chemistry, Immunoassays and DNA analysis. Mr. Kureshy holds undergraduate degrees in physics, chemistry, mathematics and engineering, and completed graduate engineering studies. He was awarded a MBA from Southern Methodist University.

William H. Davidson, Ph.D.
Dr. Davidson is Chairman of MESA Research Group and a former tenured professor at the Marshall Business School at USC, a director of six public companies, and holds both a M.B.A. and a Ph.D. degree in Management from Harvard Business School. Dr. Davidson was an early participant in the Chinese capitalist revolution. He served as a core faculty member in the early 1980's for the first management institute in China dedicated to training senior state executives. He has remained active in China and is currently involved in several ventures there. Dr. Davidson has also lived and worked in Japan and in Europe. He has worked with a number of major global corporations, typically with specific focus on their global growth strategies.

Thomas V. Hennessey, Jr.
Mr. Hennessey is the Chief Financial Officer and Financial Consultant of AutoGenomics, Inc. He has over 30 years of experience in financial and operations management with medical and technology companies. Over this period Mr. Hennessey has served as Chief Operating Officer and as Chief Financial Officer for several public and private start-up companies including Behring Diagnostics, Autoimmune, Inc., Medical Diagnostics, Inc., Cambridge Heart, Inc., Sonamed Corporation, PHT Corporation and Photovac, Inc. Also during this period, Mr. Hennessey took four of these start-up companies public. Mr. Hennessey received a B.S. and a M.S. degrees in mechanical engineering from MIT and a M.B.A. from the Harvard Graduate School of Business Administration.

Thomas R. Testman
During his 30 years with Ernst & Young, Mr. Testman's responsibilities among others included managing the regional and national healthcare practice, management consulting and tax practices. Mr. Testman has served on several public Boards including MiniMed, Inc., ChromaVision Medical Systems, Inc. and Specialty Laboratories, Inc. He also is on the Boards of several other private healthcare companies. Mr. Testman received a MBA from Trinity University.

Eugene J. Zurlo
Mr. Zurlo has over 40 years experience in the healthcare industry. Currently he is managing director of Zurlo Investment Trust as well as a director of Penny Creek Associates, Plasma Technologies and Radio Properties. Previously he was chairman, CEO and founder of Hemasure, Inc., and before that held senior executive positions at Millipore Corporation, Baxter Healthcare and the New York Blood Center. He holds a B.S. in pharmacy from Fordham University and a M.S. in pharmacy administration from Long Island University.

Laurence M. Demers, Ph.D., DABCC, FACB
Dr. Demers, DABCC, FACB is Distinguished Professor of Pathology and Medicine at the M. S. Hershey Medical Center of The Pennsylvania State University, Director of the Core Endocrine Laboratory in the University Hospital and Director of the Clinical Research Center Core Laboratory. Dr. Demers is a diplomat of the American Board of Clinical Chemistry, a fellow of the National Academy of Clinical Biochemistry. a past president of the AACC as well as past president of the National Academy of Clinical Biochemistry, and the founding director of Clinical Chemistry at the Hershey Medical Center where he has practiced for the past 33 years. His primary research interests have been in the area of biochemical endocrinology, laboratory automation, thyroid disease, metabolic bone disease, and breast cancer. Dr. Demers has had extensive experience as principal investigator of clinical trials for both the pharmaceutical and diagnostic industry.

Eric S. Kentor
Mr. Kentor has over 20 years experience advising and working for organizations in the healthcare sector and is currently an independent business consultant. Previously, Mr. Kentor was Sr. Vice President, General Counsel and Corporate Secretary of MiniMed Inc., where he also served as an original and permanent member of MiniMed?s Executive Management Committee. Prior to MiniMed, he was Vice President of Legal Services for Health Net and also served as Executive Counsel of Health Net's parent corporation. From 1987 until 1994, Mr. Kentor practiced with the national law firm of McDermott, Will & Emery, where he was elected partner in 1992. Mr. Kentor has served on the Board of Directors of both private and public companies, and is currently a member of the Board of Directors of Endocare, Inc.

Randall R. Lunn
Mr. Lunn is currently the General Partner and Founder of Palomar Ventures, L.P. He was previously Managing Partner, U.S. Operations of TVM Techno Venture Management, L.P., General Partner of Fairfield Ventures Partners, L.P., and founded Harrison Capital, Inc., the venture capital subsidiary of Texaco, Inc. Mr. Lunn received a B.A. in Systems Engineering and a B.E. in Engineering Sciences from Dartmouth College and an MBA from Amos Tuck School of Business, Dartmouth College.