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 cleared 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

Based on our expertise in hardware and software engineering, we have developed instrument platforms that offer superior automation and workflow for our customers. For example, we have commercialized the TIGRIS instrument, the world's first and only fully automated, integrated, high-throughput, molecular diagnostics instrument system. Launched in 2004, the TIGRIS instrument significantly reduces labor costs and contamination risks in high-volume diagnostic testing environments, and enables large blood screening centers to individually test donors' blood. The TIGRIS system is used by customers to perform our APTIMA women's health products, as well as the PROCLEIX ULTRIO and West Nile virus assays for blood screening.

We have built on the success of the TIGRIS system and developed a new automated instrument platform, called the PANTHER system. We believe the PANTHER system, which is designed for low- to mid-volume customers, will be a pillar in our future instrumentation platform strategy. We believe that the use of automated instrumentation, such as our TIGRIS system and our PANTHER System, 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 cleared 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.