Applications

Head-and-Neck Cancer Detection

DiaCarta QuantiVirus® HPV test detects HPV oncogenes E6 and E7 mRNA from 14 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) directly from oral samples for Head & Neck cancer screening without RNA extraction and RT-PCR.

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Description

Human Papilloma Viruses (HPV) are DNA-based pathogens that infect the epithelial surface of the skin and mucous membranes in humans and other animal species. Oncogenic strains of HPV have been associated with several human cancers including those of the cervix and anus. More recently, it has also been linked to squamous cell carcinoma of the head and neck region, specifically of the oropharynx. HPV induced oropharyngeal carcinoma has an increasing incidence in white males in the United States and Europe, and represents about 40-80% of all oropharyngealcarcinomas in the USA. Two viral oncogenes, E6 and E7, are invariably expressed in HPV-positive cancer cells. Their gene products are known to inactivate two major tumor suppressors, p53 and RB. Overtime, these effects of E6/E7 lead to the oncogenesis of infected epithelial cells in multiple locations, such as the oropharynx. HPV E6 and E7 are necessary for the oncogenic transformation, and therefore are invariably expressed in HPV induced tumors, and serve as biological markers for these tumors. Likewise, E6 and E7 expression may also function as surrogate markers to aid in prognosis assessment and evaluation of cancer response to treatment.

Using branched DNA technology, a highly sensitive and specific nucleic acid hybridization assay is developed to simultaneously detect E6 and E7 mRNAs of all 14 high-risk HPV subtypes(16, 18, 31, 33,35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) directly from saliva samples without RNA purification and reverse transcription or PCR. DiaCarta QuantiVirus® HPV test is capable of detecting as few as 50 RNA transcript molecules and requires a luminometer as reader.

Product

HPV E6/E7 mRNA Completed Kit for Head-and-Neck Cancer (92 test)
Consists of:

  • All the reagents for performing 92 tests in the 96-well plate format and instruction manual.
  • Note: additional equipment required, which are not supplied in the kit.

Benefits

1.Minimal hands-on required minimizing un-necessary errors.

2. Assay directly from saliva without DNA / RNA purification.

3. No cleanroom required and a small laboratory foot-print to operate.

4. Highly sensitive and specific using branched DNA technology.

5. CE and IVD marks

Target customers

Laboratories providing screening for head-and-neck cancer in men.