Product Pipeline

Hologic Gen-Probe has a robust development pipeline of innovative products. We are currently cultivating a promising group of product candidates through both licensing efforts and our own research and development programs. Listed below are key clinical products in our development pipeline.

Product Pipeline


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 approved for marketing by the FDA.

Automated Sample Handling Research Research

Hologic Gen-Probe is developing a small, standalone general purpose instrument to automate the de-capping of clinical sample vials, transfer clinical samples into testing vials, and recap the clinical sample vial. This instrument is expected to facilitate the handling of samples (e.g. liquid-based cytology samples) processed by clinical labs.

This product is not currently available in the U.S. or rest of world.

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 approved 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 approved 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.

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. Hologic 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 HPV 16 18/45 Genotype Assay on PANTHER System 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 is CE-marked.

APTIMA HPV and APTIMA HPV 16 18/45 genotype assay on the TIGRIS system are licensed by Health Canada and available in Canada.

APTIMA HPV 16 18/45 on PANTHER has completed clinical trial and has been submitted to the FDA.

APTIMA HPV on the PANTHER System FDA Regulatory Review

The APTIMA HPV assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of HPV in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The APTIMA HPV Assay provides clear positive, negative, or invalid results for the cumulative 14 high-risk genotypes.

APTIMA HPV is CE-marked..

APTIMA HPV on the PANTHER system is approved by the FDA and available in the US.

APTIMA HPV 16 18/45 Genotype Assay on TIGRIS System FDA Regulatory Review

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.

APTIMA HPV 16 18/45 is CE-marked.

APTIMA HPV 16 18/45 on TIGRIS System is approved by the FDA and available in the US..

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 been licensed by Health Canada and is available in Canada.
This product is approved by the FDA and is available in the US.