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Jun 9, 2010

IncellDx to Start U.S. Clinical Trials of HPV Test with $3M Financing

IncellDx to Start U.S. Clinical Trials of HPV Test with $3M Financing

HPV OncoTect is available in Europe, South America, and South Asia to detect the progression of HPV to cervical cancer. [© Natalia Merzlyakova - Fotolia.com]

  • IncellDx closed a $3 million Series A financing round that will help advance its HPV OncoTect test. The company will use the money to bolster commercialization in regions where it is approved as well as to initiate clinical investigations in the U.S.

    HPV OncoTect is currently CE marked for use in Europe and is also available in South America and Southeast Asia to identify whether an HPV infection is progressing to cervical cancer. It provides quantification of the overexpression of E6/E7 mRNA in each cell as well as the total proportion of cells that are overexpressing.

    One of the limitations of existing screening tests is lack of specificity, IncellDx points out. “Since 92% of women spontaneously clear high-risk HPV infections in two years, many women with positive test results will not proceed to cervical cancer,” explains Bruce Patterson, M.D., founder and CEO.

    Since HPV OncoTect detects and quantifies the cellular oncogenes responsible for triggering progression to cervical cancer, it has the promise of improving specificity, Dr. Patterson adds.

    The technology behind HPV OncoTect has applications for many infectious-disease tests. In May IncellDx entered a supply agreement with Accuri Cytometers that combines this diagnostic with the Accuri C6 Flow Cytometer® technology.

    HPV OncoTect test can be performed directly on routine liquid-based cytology samples and provides results in about 3.5 hours, says IncellDx. An automation upgrade is also available that reportedly allows 96 samples to be performed in two hours.

    The C6 flow cytometer also performs additional tests from IncellDx’ pipeline, including the HIVTROPISM Probe and the HCVVR Viral Reservoirs Probe. These probes are currently available as research use only products.


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