**Thomas E. Worthy, Ph.D.**

**SUMMARY**

Twenty-five years of Research and Development experience in *In Vitro*
Diagnostics and Commercial Reference Laboratory businesses in positions
of increasing management responsibility. Managed groups of scientific
personnel from junior chemists to Ph.D's. Directed multiple groups
within a departmental structure. Managed multi-million dollar budgets. R
& D project management experience for both reagents and photometric
chemistry analyzers. Experienced in managing contract personnel to
achieve objectives without adding permanent headcount. Experienced in
the design and management of clinical trials to support both PMA and
510(k) submissions to the FDA. Experienced in working with the FDA to
obtain regulatory approval of new diagnostic tests and audits of Class 1
manufacturing Company.

**PROFESSIONAL EXPERIENCE**

**Cholestech Corporation**, Hayward, CA 1998 -- Present

Vice President, Development and Regulatory Affairs 1999-Present

-   Responsible for:

    -   Research and Development Department including development of new
        products for Point of Care, product improvements, definition of
        new product portfolio

    -   Regulatory Affairs and Quality Assurance.

    -   Management of Intellectual Property Portfolio for Cholestech.

Director, Technical Affairs

-   Responsible for:

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-   Regulatory Affairs including preparation and submission of 510(k)'s.

-   Reimbursement issues affecting the ability of Cholestech to expand
    their sales.

-   Evaluations/Clinical trials of new and existing products.

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-   Defining the market opportunities for new products for Cholestech
    Corporation in the coronary heart disease and diabetes markets.

-   Responsible for managing Intellectual Property for Cholestech.

+----------------------------------------------------+-----------------+
| **Boehringer Mannheim Corporation**, Pleasanton,   | 1994 - 1998     |
| CA                                                 |                 |
|                                                    |                 |
| (Formerly Microgenics Corporation)                 |                 |
+----------------------------------------------------+-----------------+
| Director, Research and Development, Clinical       |                 |
| Applications                                       |                 |
+----------------------------------------------------+-----------------+

-   Directed the Clinical Applications Department, composed of five
    groups, that was responsible for :

-   Evaluations of new clinical chemistry analyzers.

-   Application Development and Evaluation of CEDIA and TinaQuant
    immunoassays

-   Technical Product support.

-   Responsible for planning, design and management of the PMA clinical
    studies for Tumor Markers and Infectious Disease assays.

-   Project Leader and R & D Manager for the CEDIA Therapeutic Drug
    Monitoring Product

Improvement Team

  ---------------------------------------------------- ------------------
  **Microgenics Corporation,** Concord, CA             1990 - 1994

  Director, Research and Development, Clinical         
  Applications                                         
  ---------------------------------------------------- ------------------

-   Directed the Clinical Applications Department that was responsible
    for the development of applications of CEDIA technology to multiple
    clinical chemistry analyzers; assessment of shelf-life and
    reconstituted stability of CEDIA products; external evaluations of
    CEDIA products.

-   Managed the Technical Services Department (1993-1994)

  ---------------------------------------------------- ------------------
  **Microgenics Corporation,** Concord, CA             1988 - 1990

  Senior Manager, R & D                                
  ---------------------------------------------------- ------------------

-   Managed the CEDIA Applications Group. Created and managed several
    groups to :

-   Determine reconstituted reagent stability and shelf life claims.

-   Acquire and provide appropriate patient samples.

-   Managed clinical trials.

+----------------------------------------------------+-----------------+
| **MetPath, Incorporated,** Teterboro, NJ           | 1977 - 1988     |
|                                                    |                 |
| Director, Research and Development                 |                 |
+----------------------------------------------------+-----------------+

-   Established and managed a corporate research and development
    function that was

    responsible for the development and evaluation of new tests and
    instrumentation.

+----------------------------------------------------+-----------------+
| **Columbia University College of Physicians and    | 1974 - 1977     |
| Surgeons**                                         |                 |
|                                                    |                 |
| New York, NY                                       |                 |
+----------------------------------------------------+-----------------+
| Research Associate, Dept. of Human Genetics and    |                 |
| Development                                        |                 |
+----------------------------------------------------+-----------------+

-   Directed the daily activities of a research laboratory in human
    biochemical genetics and supervised several research projects.

-   Taught in Cellular Biology course for second year medical students.

-   Taught General Biochemistry course in Genetic Counseling Program at
    Sarah Lawrence College, Bronxville, NY.

+----------------------------------------------------+---+--------------+
| **Duke University Medical Center Department of     | 1 |              |
| Medicine**                                         | 9 |              |
|                                                    | 7 |              |
| Durham, NC                                         | 2 |              |
|                                                    |   |              |
|                                                    | - |              |
|                                                    | 1 |              |
|                                                    | 9 |              |
|                                                    | 7 |              |
|                                                    | 4 |              |
+----------------------------------------------------+---+--------------+
| -   Conducted research in the biochemistry of      |   |              |
|     pyrimidines and genetic diseases of pyrimidine |   |              |
|     biosynthesis in humans.                        |   |              |
+----------------------------------------------------+---+--------------+

**EDUCATION**

+----------------------------------------------------+-----------------+
| University of Tennessee, Knoxville, TN             | Ph.D. Radiation |
|                                                    | Biology         |
+----------------------------------------------------+-----------------+
| Northern Illinois University, Dekalb, IL           | M.S. Biology    |
+----------------------------------------------------+-----------------+
| Albion College, Albion, MI                         | B.A.            |
|                                                    |                 |
|                                                    | Biology         |
+----------------------------------------------------+-----------------+

**PROFESSIONAL AFFILIATIONS**

American Association for Clinical Chemistry