Cervical cancer screening (PAP) today involves the collection of cells (cytology) from the cervix. A slide is prepared and the cells are analyzed under a microscope by a trained professional or physician. In some countries, to increase the accuracy of the PAP, a HPV test may be undertaken to identify false positives reported with the PAP.
The cytological processing is done in a laboratory and involves the analysis of the Pap smear under a microscope. The analysis is very subjective and results in 10% to 30% false positives and 10% to 30% false negatives.
With 160 million pap smears conducted per year this means at least 16 million false positives and at least 16 million false negatives
The false positives result in additional costs for further testing in addition to unnecessary emotional trauma to the patient. The false negatives have potentially clinically critical consequences to the patient. The process is also long and very labor intensive. Patients exhibiting positive results from Pap smears are followed with tissue biopsies to confirm a histological diagnosis of cervical cancer.
Advances in understanding the development of cervical cancer and its close relationship with HPV infection have led to additional approaches for cervical cancer screening that primarily depend on detecting the presence of HPV virus DNA in cervical samples.
CerMed’s Cervical Cancer Screening System consists of two distinct products: