MOLECULAR DIAGNOSTIC (OTC:MCDG)
Industry: Healthcare
Molecular Diagnostics, Inc. (MDI), incorporated in December 1998, is a biomolecular diagnostics company engaged in the design, development and commercialization of cost-effective screening systems to assist in the early detection of cancer. MDI is focused on the design, development and marketing of its InPath System and related image analysis systems, which are intended to detect cancer and cancer-related diseases, and may be used in a laboratory, clinic or doctor's office. The Company has also designed and manufactured the AcCell computer-aided automated microscopy instrument and the AcCell Savant, an instrument that includes an AcCell instrument and software, which collects quantitative cellular information used in support of a diagnostic process. MDI is also focused on marketing a new, fully integrated workstation called the Automated Image Proteomic System (AIPS). InPath System The Company is developing and testing a family of products for use in cancer screening and diagnosis, called the InPath System. The core of the InPath System is a combination of protein antibodies, the Cocktail-CVX and Cocktail-GCI, which allow the system to detect and highlight abnormal cervical cells in a rapid and objective fashion. The initial application of the InPath System is designed to enhance the current cervical cancer screening process performed in laboratories, commonly referred to as the Pap test. MDI's United States Food and Drug Administration (FDA)-approved sample collection device, referred to as the e(2) Collector, consist of a small disposable balloon and shaped to fit the cervix. The device is intended to replace the spatula and brush used to collect patient cytology samples. The Cocktail-CVX and Cocktail-GCI are fully automated biochemical assays that get applied to a sample to identify abnormal cells. In the laboratory version of the InPath System slide-based test, this biochemical assay is applied to sample cells released from a collection device into a liquid preservative and deposited on a glass slide. InPath System features an instrument that performs an automated analysis of a sample by means of an optical scan that detects the presence of multiple wavelengths of fluorescent light. This light is produced byfluorescent reporter tags, which are attached to certain components used in the Cocktail-CVX and Cocktail-GCI biochemical assays. In the laboratory version of the InPath System, the Company's new, fully integrated workstation, AIPS workstation, uses a camera to read the various wavelengths of light from the sample. InPath System also has a custom-designed image analysis software that controls the automated instruments and analyzes the captured wavelengths of light. Automated Microscopy Instruments In November 2001, Ventana Medical Systems, Inc. (Ventana) agreed to purchase and distribute AcCell instruments with their image analysis software. The AcCell product is a computer-aided automated microscopy instrument designed to help medical specialists examine and diagnose specimens of human cells. During 2002, the Company agreed that Ventana would assume responsibility for manufacturing the AcCell 2500 instruments directly, rather than purchasing them from the Company. MDI subsequently elected not to develop the 2500 model and, in November 2003, MDI and Ventana entered into a settlement agreement providing for a non-exclusive, royalty-free license from MDI to Ventana to the source code for the AcCell 2500 for Ventana's internal use or in the creation of executable code for its customers. In October 2004, MDI agreed to settle an arbitration proceeding instituted by MonoGen, Inc. against the Company through the transfer to MonoGen of certain patents, patent applications and other intellectual property rights relating to the AcCell technology, as well as inventory and a unsecured installment note. MonoGen granted MDI a non-exclusive license agreement for the use of the patent rights and technology as they relate to cervical and ovarian cancer in exchange for a three percent royalty on all gross sales of l
As Of: 10/07 00:00 ET
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