LBC Automation Research

Gen-Probe is developing a small, standalone instrument to automate the de-capping and transfer of liquid-based cytology samples to the TIGRIS and PANTHER systems. This instrument is expected to facilitate the use of the APTIMA HPV, APTIMA COMBO 2 and APTIMA Trichomonas assays.

This product has not been CE marked or cleared for marketing by the FDA.

APTIMA HSV Research

The APTIMA HSV 1/2 is an in vitro nucleic acid amplification test (NAAT) for the qualitative detection and discrimination of both herpes simplex virus 1 and 2. Genital herpes is common in the United States; one in six people 14-49 years of age have genital herpes infection. The APTIMA HSV 1/2 assay will complement our existing women’s health assays while leveraging our best-in-class automation.

This product has not been CE marked or cleared for marketing by the FDA.

APTIMA HCV Quant Assay Research

The APTIMA HCV Quant Assay is an in vitro Real-time Transcription Mediated Amplification (TMA) assay in development for the quantification of hepatitis C viral ribonucleic acid (HCV RNA), in human serum and plasma from HCV-infected individuals, for use on the fully automated PANTHER system.

This product has not been CE marked or cleared for marketing by the FDA.

APTIMA HBV Quant Assay Research

The APTIMA HBV Quant Assay is an in vitro Real-time Transcription Mediated Amplification (TMA) assay for the quantification of hepatitis B DNA (HBV DNA) in human serum and plasma from HBV-infected individuals, for use on the fully automated PANTHER system.

This product has not been CE marked or cleared for marketing by the FDA.

TMPRSS2 Gene Fusions Development

A gene fusion (or translocation) is the physical joining together, or fusion, of two pieces of DNA in an aberrant fashion. TMPRSS2:ERG gene fusions are prostate cancer-specific genomic rearrangements found in approximately 50% of prostate tumors, resulting in androgen-driven expression of oncogenes. Gen-Probe licensed TMPRSS2:ERG from the University of Michigan, and is developing assays to detect this marker. Research studies indicate that TMPRSS2:ERG tests can identify a subset of aggressive prostate cancers with high specificity, and may play a role in monitoring response to hormonal or more targeted therapies.

This product has not been CE marked or cleared for marketing by the FDA.

APTIMA HIV Quant Assay Development

The APTIMA HIV-1 Quant Assay is an in vitro Real-time Transcription Mediated Amplification (TMA) assay in development for the quantification of Human Immunodeficiency Virus type 1 (HIV-1) in human plasma from HIV-1 infected individuals, for use on the fully automated PANTHER system.

This product has not been CE marked or cleared for marketing by the FDA.

APTIMA HPV 16 18/45 Genotype Assay Clinical Trials

The APTIMA HPV 16 18/45 Genotype Assay is an in vitro nucleic acid amplification test (NAAT) for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from human papillomavirus (HPV) high-risk types 16, 18, and 45. The APTIMA HPV 16, 18/45 Genotype Assay can differentiate samples positive for HPV 16 from those positive for HPV 18 and/or 45, but does not differentiate HPV 18 from HPV 45.

This product has not been CE marked or approved for marketing by the FDA. The United States clinical trial on the TIGRIS DTS system is complete.

PANTHER System FDA Regulatory Review

The PANTHER system has been designed to extend the power and simplicity of chemistry and immunoassay instrumentation into the molecular diagnostics world. Created to be a "sample-in-result-out" instrument, the PANTHER system fully automates all aspects of nucleic acid testing on a single, integrated platform. The extensive list of PANTHER system features includes full automation for true walkaway freedom; random access for maximum productivity; and intuitive design for ease of use-working together to help small- to medium-sized laboratories maximize productivity and operator efficiency. Tests being developed for the PANTHER system include the APTIMA COMBO 2 assay, the APTIMA Trichomonas assay, the APTIMA HPV assay, and the HIV, HCV and HBV quant assays, In addition, in early 2012 Gen-Probe announced plans to add real-time PCR capabilities for the next-generation PANTHER system.

This product is CE marked and is available in Europe.
This product has Health Canada clearance and is available in Canada.
This product has not been cleared for marketing by the FDA.
Gen-Probe has filed a 510(k) application with the FDA for the PANTHER system.

PROGENSA PCA3 Assay FDA Regulatory Review

In Europe, the PROGENSA PCA3 assay received marketing clearance in 2006. The assay detects the overexpression of a gene called PCA3 in urine. Studies have shown that PCA3 is highly over-expressed in the vast majority of prostate cancers, indicating that PCA3 may be a useful biomarker for the disease.

Data show that the PCA3 assay is more specific to prostate cancer than the traditional serum prostate specific antigen (PSA) test, thus decreasing the likelihood of false positive results.1 PSA is produced by both cancerous and non-cancerous prostate cells. Non-cancerous conditions can therefore cause elevated serum PSA levels that must be investigated, resulting in unnecessary medical procedures and patient anxiety. For more information, go to: http://www.pca3.org/.

1. Hessels, D., Klein Gunnewiek, J.M., van Oort, I., Karthaus, H.F., van Leenders, G.J., van Balken, B., et al. DD3(PCA3)-based molecular urine analysis for the diagnosis of prostate cancer. Eur Urol (2003); 44: 8-15; discussion 15-16.

This product is CE marked and is available in Europe.
This product has Health Canada clearance and is available in Canada.
This product has not been cleared for marketing by the FDA.
Gen-Probe has filed a PMA application with the FDA for the PROGENSA PCA3 Assay.