Profile: Gen Probe Inc (GPRO.O)

Gen-Probe Incorporated (Gen-Probe), incorporated in 1987, is engaged in the development, manufacture and marketing of nucleic acid probe-based products used for the clinical diagnosis of human diseases and for screening donated human blood. It also develops and manufactures nucleic acid probe-based products for the detection of harmful organisms in the environment and in industrial processes. 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. It also markets and sells its other products through collaborative partners. Gen-Probe generates revenues primarily from sales of clinical diagnostic and blood screening assays. Its clinical diagnostic products are marketed to clinical laboratories, public health institutions and hospitals in the United States, Canada and certain countries in Europe. In April 2009, Gen-Probe completed the acquisition of Tepnel Life Sciences PLC. In October 2009, the Company completed its acquisition of Prodesse, Inc. In December 2009, the Company disposed the BioKits food safety business to Neogen Corporation.

Gen-Probe’s blood screening products are marketed and distributed worldwide by Novartis. In addition, it has agreements with Siemens (as assignee of Bayer Corporation), bioMerieux, Inc. (bioMerieux), and Fujirebio, through its subsidiary Rebio Gen, Inc. (Rebio Gen), to market products in various overseas markets. It also generates revenues through collaborations with various companies, and through licensing of its nucleic acid testing (NAT) technologies. The Company categorizes its products into clinical diagnostic products and blood screening products.

In August 2008, the United States Food and Drug Administration (FDA) approved the Procleix Ultrio assay to screen donated blood, plasma, organs and tissues for hepatitis B virus (HBV), in individual blood donations or in pools of up to 16 blood samples on the enhanced semi-automated system (eSAS), and on the TIGRIS instrument. In May 2008, the Company launched its APTIMA HPV assay in Europe. In January 2008, Millipore Corporation launched the Company’s first product in the industrial market.

Clinical Diagnostic Products

Within Gen-Probe’s clinical diagnostic product group, it has developed products for the detection of non-viral and viral microorganisms, and for the detection of markers for cancer. The Company has developed FDA-approved amplified and non-amplified NAT assays that detect non-viral microorganisms primarily for use in clinical diagnostics. Its 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.

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. As part of its AccuProbe Culture Identification product line, the Company also developed a procedure to detect Group B Streptococcus (GBS) from broth culture. The Group A Streptococcus Direct Test (GASDirect assay) is a NAT assay for the direct detection of Streptococcus pyogenes in one hour from a throat swab. Gen-Probe’s PACE 2C is a NAT product that offers testing for both chlamydia infections and gonorrhea from a single patient specimen. Other products in the PACE 2 product line include individual tests to separately detect and confirm both chlamydia infections and gonorrhea. The PACE product family also includes the PACE Specimen Collection kits for endocervical and urethral swab specimens.

The Company’s amplified Mycobacterium Tuberculosis Direct (MTD) test has sensitivity similar to a culture test but can detect the tuberculosis (TB) pathogen within a few hours. The test is performed directly on a patient sample, and can be used to differentiate between TB and other mycobacteria, resulting in reduced isolation time and treatment of an infected patient. Its APTIMA Combo 2 assay utilizes target capture, hybridization protection assay (HPA) and dual kinetic assay (DKA). APTIMA Combo 2 qualitatively detects and differentiates ribosomal ribonucleic acid (rRNA) from Chlamydia trachomatis and Neisseria gonorrhoeae bacteria.

The Company developed an amplified transcription-mediated amplification (TMA) assay for the qualitative detection of hepatitis C virus (HCV) based on the same technology used in its FDA-approved Procleix human immunodeficiency virus (type 1) (HIV-1)/HCV assay for screening donated blood. It has also developed, through its collaboration with Siemens, analyte specific reagents (ASRs) to quantitatively determine the amount of HCV present in a sample. These ASRs and general purpose reagents are provided by Siemens to Quest Diagnostics Incorporated, a national diagnostics company. The Company has developed APTIMA HPV assay that is designed to detect 14 types of high-risk HPV associated with cervical cancer.

Blood Screening Products

The Company’s principal blood screening products that it has developed include Procleix HIV-1/ HCV Assay, Procleix West Nile virus (WNV) Assay and Procleix Ultrio Assay. The Procleix HIV-1/HCV assay is performed on the semi-automated instrument system (eSAS), which provides sufficient throughput for screening pooled samples of donated blood. The Procleix Ultrio assay is designed to detect the presence of all known HIV-1 groups and subtypes, and HCV and hepatitis B virus (HBV) genotypes in human plasma.

The Company competes with Roche, Abbott Laboratories, Becton Dickinson, bioMerieux S.A., Siemens and Johnson & Johnson.