Updated on 24 December 2012
The careHPV Test detects 14 high-risk types of HPV DNA (16/ 18/ 31/ 33/ 35/ 39/ 45/ 51/ 52/ 56/ 58/ 59/ 66/ 68). It is designed to be used in low-resource facilities with a running time that is less than three hours. It is a manual assay, specially designed for low-throughput, low-resource settings, and it is designed to be performed by any healthcare worker. It is approved by the regulatory authorities in China (SFDA).
The digene HC2 HPV DNA Test remains the gold standard for HPV DNA testing. It detects 13 high-risk types HPV DNA (16/18/31/33/35/39/45/51/52/56/58/59/68), is fully automated, and has the capability to accommodate any volume of HPV testing, from lowest to highest throughput settings. The digene HC2 HPV DNA Test requires a skilled laboratory technician to perform the test. The sensitivity of the digene HC2 HPV DNA Test is higher than the careHPV Test. It is approved by the regulatory authorities for the US FDA and the European Union (CE mark) and China (SFDA).
When do you plan to launch the test in China and are you planning to launch the product in other geographies in Asia Pacific?
The product will be available by January 2013 in China. This 'country-of-origin' approval is key for dissemination. We can use it as a basis for registration in other countries. In India the marketing launch for the careHPV Test is planned for Q2 2013. QIAGEN is also evaluating product registration in other regions such as Latin America, Asia Pacific and Eastern Europe to assess making the careHPV Test commercially available in these regions as well.
What is the cost of the test?
QIAGEN will offer the careHPV Test following a differential or tiered-pricing model. Low-income countries are charged a reduced price as compared to the open market rate. This is often managed through bulk procurement systems, including IPPF, UNFPA, IARC, JHPIEGO, UNICEF and PAHO.
The pricing for public health systems will be a function of: economic power of the respective countries, requested volume of tests, duration of commitment and the value addition expectations, including education and training. The pricing for private health systems will be market driven and a function of committed test volumes.