Second most common cancer in women worldwide

Cervix cancer is the second most common cancer in women worldwide. Approximately 400,000 new cases are diagnosed each year, 3,400 in France with a mortality of 1,000 women.

In years 1940, Dr G.Papanicolaou invents the Pap-test, diagnosis method based on visual inspection of morphological changes to detect precancerous and cancerous cells in Pap smear under microscope.
Called conventional Pap smear to differentiate it from new alternate solutions, this technique consists of spreading directly onto a slide the sample collected with a brush, a spatula or even a needle, then to stain it to display abnormalities.

Since then, this method has widely developed worldwide and has allowed implementing systematic screening of women. Approximately 140 millions of Pap-tests are realized each year worldwide, 6 millions in France.
Thanks to large prevention programs for early detection of abnormalities, it has been made possible to reduce by 70% cervix cancer prevalence.
However, despite this success, the incidence does not reduce any more since many years. Conventional Pap smear screening is not a perfect tool. It demonstrates important limitations mainly associated with a high rate of false negatives originating from cells layers overlay that can occult malignant cells presence and alter diagnosis.

Considered a true innovative technology, thin layer cytology differs from conventional Pap smear by the cells spreading method. In conventional method, sample is deposited onto slide by rubbing the sampling device whereas cells are deposited on slide after filtration or centrifugation of sampling device thoroughly rinse or agitated into a conservative medium for fixation and cleaning.
Appeared in late 80's, thin layer cytology improves significantly sampling and cell smear quality and representativeness. It improves cell smear reading and demonstrates a superior diagnosis performance that corrects most of conventional Pap smear defaults. Thin layer cytology represents today almost half of cytology Pap smears worldwide.

Resulting from a close collaboration with pathologists, SEROA introduces in the 90s, CYTO-screen system®, a complete solution for thin layer cervix cytology guaranteeing a relevant sampling technique and a fully interpretable cell smear.

CYTOPREP® guarantees the collection of all types of requested cells for a representative cell Pap smear. All types of cells are collected to allow for an early diagnosis for an optimal protection of female patients. Finally, with a high quality sample, clinician avoids patient recall and reduces legitimate anxiety.

It has been recently demonstrated that a cytological screening combined with an HPV test increases conventional Pap smear screening sensitivity by 30 % giving a final detection sensitivity of up to 100 %. The combined thin layer cytology test and HPV test would give a maximal protection against cervix cancer to the vast majority of screened women.
The French commission for accreditation and Evaluation in Health HAS acknowledges the medical and economical benefits of such a combination.
In the USA, the FDA has approved use of HPV test in primary screening of women of age above 30.
HPV test has been accredited in France for its use in ASC-US or ambiguous cytologies. In post-treatment, HPV test is an option of choice to confirm healing and is the most sensitive to detect recurrence or persistence.
HPV test combined with thin layer cytology could prevent 1,000 cervix cancers each year in France.
Thanks to CYTO-screen system®, the sample is stored and stabilized in liquid suspension. It allows achieving additional tests on the residual cells after cytology examination.

CYTO-screen system® compatibility has been tested with success for HPV Digene® (Hybrid capture) (www.digene.com) and for P16ink4a detection by immunohistochemistry with MTMLabs kit (www.mtmlabs.com).