Digene Corporation develop, manufacture and market proprietary DNA and RNA tests for the detection, screening and monitoring of human diseases. The lead product, the Hybrid Capture ® 2 HPV Test, is the only FDA- approved tests for the detection of the human papillomavirus (HPV), the cause of essentially all cervical cancer. In addition, Digene have developed and launched tests internationally for the detection and viral load monitoring of major blood viruses, including cytomegalovirus (CMV) and hepatitis B virus (HBV), as well as tests for two of the most common sexually transmitted diseases (STDs) Chlamydia trachomatis ("chlamydia") and Neisseria gonorrhoeae ("gonorrhea"). The products are designed to improve clinical outcomes and reduce the overall cost of disease management.

The Hybrid Capture Technology ® used, the basis for the DNA and RNA tests, represents a significant improvement over existing technologies because of its sensitivity, speed, ease-of-use, accuracy and ability to measure viral load. The technology combines the sophistication of nucleic acid technology with the simplicity of an immunoassay.

Hybrid Capture (HC) technology detects nucleic acid targets directly and uses signal amplification to provide sensitivity that is comparable to target amplification methods. It is significant to note that reliable detection is achieved without the need for dedicated and isolated lab space, sophisticated laboratory expertise or concern regarding inhibition and contamination. HC technology achieves clinically relevant levels of detection with a user-friendly, inexpensive method ideally suited for use in a routine laboratory.

Digene's Hybrid Capture ® System offers:

• Same-day, objective results in a chemiluminescent tube or microplate format.
• Sensitivities equivalent to many target amplification technologies without the complexity.
• User-friendly technique that promotes consistent results run-to-run and lot-to-lot.
• Minimal specimen preparation which facilitates processing samples quickly and efficiently.
• Not susceptible to cross-contamination often found in target amplification assays. Hybrid Capture ® Tests are available to detect Human Papillomavirus (HPV), Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and blood viruses such as Hepatitis B virus (HBV) and Cytomegalovirus (CMV). An assay for Herpes Simplex Virus (HSV) is in development.

The basic steps of the Hybrid Capture assay are as follows:

	1. Release Nucleic Acids Clinical specimens are combined with a base solution which disrupts the virus or bacteria and releases target DNA. No special specimen preparation is necessary.
	2. Hybridise RNA Probe with Target DNA Target DNA combines with specific RNA probes creating RNA:DNA hybrids.
	3. Capture Hybrids Multiple RNA:DNA hybrids are captured onto a solid phase coated with universal capture antibodies specific for RNA:DNA hybrids.
	4. Label for Detection Captured RNA:DNA hybrids are detected with multiple antibodies conjugated to alkaline phosphatase. Resulting signal can be amplified at least 3000-fold.
	5. Detect, Read and Interpret Results The bound alkaline phosphatase is detected with a chemiluminescent dioxetane substrate. Upon cleavage by alkaline phosphatase, the substrate produces light that is measured on a luminometer in Relative Light Units (RLUs).

DIGENE SHARP SIGNAL SYSTEM

Digene Diagnostics' SHARP Signal ™ System provides rapid nonisotopic detection of PCR products in a convenient microplate format. Cost-effective and sensitive, this ready to use detection system is recommended for its unsurpassed advantages:

• Universal detection capability
• Nonisotopic
• Sensitive
• Quantitative results
• Specific
• Standardised detection
• Batch size flexibility.

1. PCR with biotinylated primers 2: Denature & hybridise 3: Bind to plate 4: Detect and read absorbance

Digene has initially focused on two major women's health issues, cervical cancer and STDs.
For more information on these issues go to cervical cancer.

For detailed information on Digene products select a Molecular Diagnostic Test.
HPV | CT/GC | HBV | CMV

For detailed information on Digene go to www.digene.com.