GEN-PROBE

Gen-Probe Incorporated develops, manufactures, and markets nucleic acid probe-based products used for the clinical diagnosis of human diseases, and for screening donated human blood in North America and internationally. The company markets and sells its clinical diagnostic products in the United States directly and outside the United States primarily through distributors, as well as through its direct sales force, and the company also markets and sells its other products through collaborative pa... rtners. The company's blood screening products are marketed and distributed worldwide by Novartis. In addition, the company has agreements with Siemens (as assignee of Bayer Corporation), bioMérieux, Inc., or bioMérieux, and Fujirebio, Inc., through its subsidiary Rebio Gen, Inc., or Rebio Gen, to market products in various overseas markets. The company is developing NAT assays and instruments for the detection of harmful pathogens in the environment and biopharmaceutical and beverage manufacturing processes. The company has entered into collaboration agreements with GE Infrastructure Water and Process Technologies, or GEI, a unit of General Electric Company, and Millipore Corporation, or Millipore, under which the company would be primarily responsible for developing and manufacturing assays for exclusive use or sale by its collaborative partners in specified fields with in the industrial testing market. Products The company has applied its core technologies to develop multiple product lines, all of which utilize its expertise in NAT probes, sample collection and processing. The company categorizes its products into clinical diagnostic products and blood screening products. Clinical Diagnostic Products Within its clinical diagnostic product group, the company has developed products for the detection of non-viral and viral microorganisms and for the detection of markers for cancer. Clinical Diagnostic Products for the Detection of Non-Viral Microorganisms The company has developed FDA-approved amplified and non-amplified NAT assays that detect non-viral micro-organisms primarily for use in clinical diagnostics. The company's principal products for the detection of non-viral microorganisms include its non-amplified AccuProbe and PACE family of products and its amplified Mycobacterium Tuberculosis Direct Test and amplified APTIMA products. AccuProbe Products: The company's AccuProbe Culture Identification products are tools for the identification of mycobacterial, fungal and bacterial pathogens, with sensitivities and specificities approaching 100% in most cases. These products allow for the detection of target organisms from primary cultures, eliminating the additional labor of purifying secondary cultures. All AccuProbe Culture Identification assays are based on its HPA technology. As part of its AccuProbe Culture Identification product line, the company also has developed a procedure to detect GBS from broth culture. Group A Streptococcus Direct: The Group A Streptococcus Direct Test, or GASDirect assay, is a NAT assay for the direct detection of Streptococcus pyogenes in one hour from a throat swab. PACE Product Family: The company's PACE 2C offers the testing for both chlamydia infections and gonorrhea from a single patient specimen.More