A HPV test developed by Qiagen for use in areas of the world with scarce resources is more accurate in identifying women with cervical disease than the current methods used in these regions.
The Care test for HPV (human papillomavirus), the primary cause of cervical cancer, is being developed by Qiagen in partnership with Path and receives funding from the Bill and Melinda Gates Foundation.
This Care HPV test is designed to allow women in areas with limited healthcare resources to benefit from the advanced technology of HPV testing.
It produces rapid, accurate results, is simple to run, requires minimal infrastructure and will be affordable for public-health programmes in under-developed regions.
The product is expected to available for pilot programs early in 2009.
Peer Schatz, chief executive officer of Qiagen, said: 'Qiagen has adapted the most advanced technologies to develop a new molecular HPV DNA test that achieves high performance targets, yet can be made available to under-served regions at an affordable price.' The first published study of patient outcomes with Care HPV involved more than 2,500 women, aged 30-54, in mostly rural areas of China.
In developed regions with established public health budgets and programs, Pap testing (cytology) is the standard screen for cervical disease, supplemented by HPV testing in women over the age of 30 (who are most at risk).
However, both the Pap and the current HPV test require a level of infrastructure unattainable in most areas of the developing world.
Thus, the most common cervical cancer screening tool in low-resource regions of China and similar countries has been visual inspection with acetic acid (VIA) - a procedure in which a woman's cervix is painted with vinegar to highlight any abnormal areas present, then visually examined by a doctor or nurse.
However, VIA misses a significant number of women with cervical disease who need treatment.
In the study published, the 'sensitivity' of VIA (its ability to identify women who have moderate or severe cervical disease, also called CIN2+) was 41 per cent.
In contrast, the sensitivity of Care HPV was 90 per cent when samples of cervical cells collected by healthcare workers were used, and 81 per cent when women used a vaginal 'self-sampling' device.
In this study, Care HPV was more sensitive even than the newer, liquid-based Pap testing, for which the sensitivity was 85 per cent when the sample was collected in the in doctor's office.
Pap testing, which requires trained technicians to interpret, is the primary screening tool in many countries.
The Care HPV test can be conducted by workers with minimal healthcare training and education.
Once collected, samples of vaginal or cervical cells are prepared for analysis using a kit of reagents that contains its own water supply.
The testing itself is conducted on easily portable equipment and will run on batteries.
'In countries with scarce resources, women often live in environments with few amenities or healthcare staff.
'In this study, the Care HPV test was effectively run by inexperienced, newly-trained, minimally-educated technicians under difficult conditions of temperature, humidity, lighting and space,' said Attila Lorincz, PhD, senior author of the study and a professor of molecular epidemiology at Barts and the London School of Medicine, as well as London's Queen Mary College.
'Another advantage of Care HPV is that it can produce results within two and a half hours, allowing treatment to be administered during the same visit - a critical requirement when women would likely not be able to return for follow-up care if sent home after their exam.' Cervical cancer affects nearly 500,000 women around the world every year and kills more than 250,000 - of which 80 per cent are in developing countries.
'The Care HPV test represents a significant advance in our effort to prevent cervical cancer in developing countries, where the burden is greatest and the most women die,' said Chris Elias, president of Path.
The first published study of patient outcomes with Qiagen's Care HPV test, developed with support from Path, appears in the October issue of Lancet Oncology.