‘We expect careHPV test to be one of our key growth drivers in this market in the foreseeable future’
How has cervical cancer screening evolved?
The pap smear was invented by Dr George Papanicolaou in 1943. Gradually, developed countries began to use the pap opportunistically – only testing women who went to the doctors for other things. In the 1960s, some of the European countries wanted to reduce the incidence of cervical cancer, so they made the pap smear free of charge and ran public awareness campaigns. This had limited success as the same small group of women got screened repeatedly, but the majority of women still didn’t take up screening, despite not having to pay for it. In the 1990s, a new type of pap test called liquid-based cytology (LBC) was developed. This uses a slightly different technique for preserving the sample, but still requires a highly trained cytoscreener to examine every slide. It is still vulnerable to the same failure rate and false negative rate as conventional pap smears. In the meantime, a test called visual inspection with acetic acid (VIA) was developed. The only real development has been in the organisation and operational side of screening, until the invention of HPV testing by Digene (part of QIAGEN) in the 1990s. Over the past few years, we have seen organised screening programmes in developed countries replace the pap smear with HPV testing and an acceptance that VIA is not the best option for developing countries. The careHPV Test should make HPV testing possible for India too.
What are the challenges in the current cervical screening process?
The limitation of pap testing is that it requires constant repeat training as well as costly and burdensome quality assurance (QA) programmes to deliver good quality cytology. At best, cytology only detects around 70 per cent of cervical cancers. At worst, this can be as low as 30 per cent. So the pap test (conventional and LBC) is a very old technology with obvious disadvantages.
The most recent and reliable data shows that VIA test is extremely inaccurate (lots of false positive and false negative results). Also, experience from screening projects around the world has shown that when it comes to scaling up to screen large numbers of women, VIA is not practical because it requires lots of highly trained healthcare workers. In addition, cost effectiveness data suggests that because VIA has to be performed every year, whereas HPV testing can be performed every 5-10 years, or even once in a lifetime in very low resource settings, HPV testing is a more cost effective method than VIA. The result of these recent developments is that the World Health Organization (WHO) has issued its most recent set of guidelines for cervical screening, which recommend HPV testing as the test of choice for cervical screening. Only where HPV testing is not possible (for operational reasons) should VIA be used.
QIAGEN has recently developed a cervical cancer screening product. Could you tell us more about it?
The randomised controlled trial run in India, by Dr Rengaswamy Sankaranarayanan of International Agency for Research on Cancer (IARC) and published in 2009, was the first trial to demonstrate that HPV testing could reduce the incidence and mortality of cervical cancer. HPV testing detects over 96 per cent of cervical cancers and in the eight-year period of the Indian trial, resulted in over 50 per cent reduction in mortality from cervical cancer. However, the Digene HPV Test which was used in this trial requires a good quality laboratory and so QIAGEN, in partnership with PATH and the Bill and Melinda Gates Foundation adapted the Digene HPV Test for use in low-infrastructure settings – this became the careHPV test which was launched in India recently.
The careHPV Test is a nucleic acid hybridisation assay with signal amplification that uses microplate chemiluminescence for the qualitative detection of 14 high-risk types of HPV DNA in cervical specimens. The HPV types detected by the assay are the high-risk HPV DNA types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. Individual HPV types cannot be determined using this test. The careHPV Test is CE-marked for use as a diagnostic test.
What are the main benefits of the product?
The careHPV test is designed to screen women in settings with limited healthcare infrastructure, such as areas lacking electricity, water or laboratories. It is for primary, standalone screening in women 30 years and older, to determine high-risk HPV infection, which is a risk factor for developing cervical intraepithelial neoplasia (CIN) 2 or higher. The test may be run by a healthcare worker with basic training — no formal laboratory skills are required. Cervical cells are collected by a healthcare worker using the careBrush and careHPV Collection Medium. The assay may be run on mains electricity or using a battery with an inverter, making it portable and adaptable. The assay can be run in a flexible temperature range, from 15 to 40°C.
What are your expectations of this product in terms of units sold/ revenue?
Globally speaking, HPV testing is one of the largest segments in molecular diagnostics, with a potential of more than $1 billion.
The potential of HPV testing to prevent cervical cancer through routine screening programmes, in developing and developed countries, has been demonstrated in numerous scientific studies involving more than one million women that were screened using QIAGEN technology. As a result, the degree and scope of HPV awareness has increased significantly in recent years, with HPV testing becoming a more routine part of cervical cancer screening. India is the fastest-growing country within QIAGEN’s Asia Pacific region, especially in the molecular diagnostics area. There are about 72,000 women who die of cervical cancer each year in this country, more than one-fourth of the world’s 270,000 annual deaths. The disease accounts for about 20 per cent of all cancer-related deaths in women and is the number one cause of death in middle-aged Indian women. Therefore, QIAGEN considers careHPV, the world’s first molecular diagnostic designed to screen women in low-resource settings, a perfect match with the local market and we expect it to be one of our key growth drivers in this market in the foreseeable future.
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