A French woman scientist has developed a new test, described as both cheap and reliable, for the early detection of lesions that could lead to cancer of the cervix in women. In India, cervical cancer is the leading cause of death among women between the ages of 25 and 55 inflicting huge human, psychological and economic costs on society.
“Each minute, a woman living in the emerging BRIC nations (Brazil, Russia, India, China) dies of cervical cancer. Half these deaths occur before the woman has reached the age of 35. Unfortunately less than three per cent of the women in these countries are systematically screened for a disease that is totally curable if caught in the early stages. In comparison, mass screening in the West is as high as 60 per cent,” said Dr. Francoise Soussaline, the scientist who developed the new low cost method of mass screening for the disease in an exclusive interview.
Dr. Soussaline is no stranger to medical imaging. Her company IMSTAR, which she started in 1985, develops, produces and commercialises automated imaging systems for research in life sciences as well as pre-clinical research both in the public and private domain, working principally on genetic illnesses and cancers. IMSTAR is now the leader in France for automated imaging techniques.
Main concern
For her pioneering work, Dr. Francoise Soussaline was awarded the 2010 Irene Joliot Curie Prize for Scientific Innovation, one of France's top awards for women scientists, on June 21, 2010. “I have always been attracted by cross-cutting, interdisciplinary work. I wanted to see how physics and mathematics, for example, could be applied to medicine and my work has involved several fields. But my main concern has also been the application and utility of this research for human benefit and development,” said Dr. Soussaline, a shy, neat woman in her early sixties, who holds a double doctorate: in instrumental physics and bio- medicine.
It was with this in mind that she and her colleagues at IMSTAR in cooperation with leading French cytopathologists began working on a new test, to detect high-grade epithelial cells in cervical smears that could lead to cancer of the cervix. Caused by the human papilloma virus (HPV), it spreads through sexual contact, which can give rise to an infection leading to cellular changes in the cervix. The infection doesn't last very long because the body is usually able to fight it; but if HPV doesn't go away, the virus may cause cervix cells to change and become pre-cancer cells.
Pre-cancer cells are not cancer. Most cells with early pre-cancer changes return to normal on their own. But sometimes, the pre-cancer cells may turn into cancer if they are not discovered on time and treated. Because HPV is so common, any woman who has ever had sex can get cervix cancer. However, most women who get HPV do not get cervix cancer.
“The concept of this new test is based on proven data that only cervical lesions with high grade cells will evolve into invasive or cancer cells after a space of about two years. These two years are crucial because, during that period, if there is a screening method that allows the detection of these cells then the woman can be easily and inexpensively treated and cured,” Dr Soussaline said.
It is all a question of the economies of scale. The greater the volume of the women screened, the cheaper the test becomes and for several million tests per year the end user price could be reduced to as little as €3.00 per patient or about Rs 180. Since the test is completely automated the need for trained cyto-technicians is dramatically reduced. One of the problems with the pap smear currently used is that it requires the intervention of a large number of highly trained cytotechnicians leading to a significant percentage of “false positives” and “false negatives”.
“In many cases women who are not at risk but are erroneously diagnosed as positive have to undergo additional invasive tests. But that is not as dangerous or damaging as the “false negatives” where inadequately trained or inexperienced cyto-technicians give a negative diagnosis when the test is, in fact, positive. The test developed by IMSTAR limits human intervention and allows high throughput at low cost. The test is made up of a sampling kit for liquid cytology (much like the one used for a pap smear), specific staining agents as well as, and this is crucial, an apparatus for slide preparation and the Pathfinder Cellscan slide reader and analyser that scans all slides for a possible presence of high grade cells,” Dr Soussaline explained.
How it works
The new test, whose specificity (1/False Positive) is over 85 per cent and sensitivity (1/False Negative) is over 90 per cent, is now poised to go into commercial use in China. The specific software programme able to detect suspicious cells was tested on a representative sampling of 25,000 women. The complete technology needed to perform this new test will be licensed by IMSTAR to a Chinese partner for the production of sampling kits and buffer as well as for the automated slide reader/analyser apparatus. The partner comes from the IVD field, not from the pharmaceutical industry.
Asked what such a test could mean for India, Dr Soussaline said: “In India cervical cancer is the number one cause of death by cancer in women. Ironically, it is the only cancer that can be eradicated if an appropriate mass screening programme is put in place.
For India, the HPV vaccine is not a viable solution because of the cost involved and because of the long probation period needed to evaluate its benefit. In India, this test could prove highly cost effective since the volume of patients to be screened is over 20 million per year.
It could lead to a 30-40 per cent decrease in mortality due to cervical cancer five years after the test is introduced and a decrease of over 60 per cent 10 years after the introduction of the test.”
Irene Joliot Curie Prize
The prize is named after the daughter of Pierre and Marie Curie, the world's most famous scientific couple, who discovered Radium and Polonium and jointly won the Nobel Prize for Physics in 1903 (later Marie Curie won it a second time for Chemistry). Repeating the example of her parents Irene Joliot Curie too worked shoulder to shoulder with her husband, Frederic Joliot, and the two won the Nobel Prize for Chemistry in 1927. This year, the president of the Irene Joliot Curie Prize jury was Francoise Barre-Sinoussi, the French woman doctor and researcher who won the Nobel for Medicine in 2008 for her work on HIV Aids.
