Corporate Overview

Gen-Probe Incorporated is now part of Hologic Incorporated. Hologic and Gen-Probe have joined forces to create Hologic's diagnostics business. This business is dedicated to saving lives through early detection, improved diagnosis and less invasive treatment.

Hologic Gen-Probe is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective molecular diagnostic products and services that are used primarily to diagnose human diseases, screen donated human blood, and ensure transplant compatibility.

Hologic Gen-Probe has nearly three decades of molecular diagnostics expertise, and received the 2004 National Medal of Technology, America's highest honor for technological innovation, for developing molecular assays and systems that help safeguard the blood supply.

Hologic Gen-Probe is headquartered in San Diego.


Women's Health

Hologic Gen-Probe is a world leader in the development, manufacture and commercialization of molecular diagnostics tests for sexually transmitted diseases and microbial infectious diseases that affect women's health. Key products include APTIMA assays to detect Chlamydia and gonorrhea, the two most common bacterial STDs; human papillomavirus, which causes cervical cancer; and trichomonas, a parasitic STD.

Infectious Diseases

As a global leader in molecular diagnostics for infectious disease, Hologic Gen-Probe offers a broad range of products that use patented technologies to detect infectious microorganisms, including those causing sexually transmitted diseases (STDs), respiratory infectious diseases, tuberculosis, strep throat, pneumonia and fungal infections. Key products include the APTIMA assays to detect Chlamydia and gonorrhea, human papillomavirus, and Trichomonas vaginalis; and Prodesse assays that provide a wide range of molecular testing options for various types of respiratory disease and hospital-acquired infections.

Blood Screening

Hologic Gen-Probe's PROCLEIX assays and systems, which are commercialized globally by Novartis, enable blood banks to screen donated human blood for potentially deadly viruses such as HIV-1, hepatitis C and B, and West Nile virus (WNV), thereby preventing them from being passed along to transfusion recipients.

Virology

Hologic | Gen-Probe provides qualitative assays for the detection of the human immunodeficiency virus (HIV-1) and the hepatitis C (HCV) virus in human plasma or serum. The APTIMA HIV qualitative assay is the only FDA-approved assay for diagnosis of HIV-1. It is intended for use as an aid in the diagnosis of HIV-1 infection, including acute or primary infection or to confirm HIV-1 infection in individuals who repeatedly test positive for HIV-1 antibodies. The APTIMA HCV qualitative assay is intended for supplemental testing in individuals with antibody evidence of HCV.

The APTIMA HIV-1 RNA qualitative assay and the APTIMA HCV qualitative assay are approved by the FDA for sale in the US. For additional availability in other countries please contact your local sales rep or distributor.

Prostate Oncology

PCA3 is a gene that is highly over-expressed in more than 95% of prostate cancers, and the PROGENSA PCA3 Assay is a urine-based molecular diagnostic test for the gene. Studies have shown that because PCA3 is highly specific for prostate cancer, the information provided by the test - the PCA3 Score - can be used in conjunction with other patient history to decide whether a repeat biopsy is necessary in men with one or more previous negative biopsies.

PROGENSA PCA3 is approved by the FDA for sale in the US, CE marked for sale in the European Union and licensed by Health Canada for usage in Canada.

Research Products

Tepnel Pharmaceutical Services offers an established and comprehensive range of DNA extraction and purification kits to the pharmaceutical, biotechnology, clinical and academic research markets.

Pharma Services

With over 25 years of experience in pre-clinical, clinical and cGMP drug development services, Tepnel Pharmaceutical Services provides outsourced analytical solutions for large and small molecules from MHRA approved and FDA inspected facilities.

Instrumentation

Leveraging our expertise in hardware and software engineering, we have developed instrument platforms that offer unique, integrated automation and unprecedented workflow flexibility for our customers. We have commercialized the TIGRIS system, the world's first fully automated, fully integrated, high-throughput molecular diagnostics system. Launched in 2004, the TIGRIS system has proven to significantly reduce labor costs and contamination risks in high-volume clinical laboratory molecular testing environments and enables large blood screening centers to individually test donors' blood. The TIGRIS system is used by customers to perform testing with our APTIMA women's health products, as well as the PROCLEIX ULTRIO, PROCLEIX ULTRIO PLUS and West Nile virus assays for blood screening.

Building upon the success of the TIGRIS system, we have developed the PANTHER system, the next generation of absolute automation for a wide range of molecular testing volumes. We believe the PANTHER system, which offers new levels of flexibility to adapt to the laboratory's testing demands, will be a pillar in our future instrumentation platform strategy. For the first time, laboratories are now able to consolidate testing for sexually transmitted infections with our APTIMA products onto a random, continuous access system with true walkaway automation that enables improved productivity and reduced labor utilization. We believe that the use of automated instrumentation, such as our TIGRIS and PANTHER systems, will facilitate growth in both clinical diagnostics and blood screening.

We have been issued more than 100 patents around the world in recognition of our pioneering work in molecular diagnostics automation.

The PANTHER System is cleared by the FDA for sale in the US, CE marked for sale in the European Union and licensed by Health Canada for usage in Canada.

Genetic Disease Testing

Elucigene products, include gel and fluorescent-based kits for the simple and rapid analysis of human genetic disorders and for rapid aneuploidy testing. CE-marked for sale in the European Union; not approved or for sale in the US.