Current cervical cancer screening programs vary by global markets but typically utilize one or more of the following methodologies:
This is the original method developed by Dr George Papanicolaou over 70 years ago. A cervical sample is collected by a clinician then the sample is smeared onto a microscope slide, stained, and read via microscopic examination by a cytologist. A subjective evaluation of stacked cells and other debris may hide abnormal cells.
Liquid-based Cytology (LBC)
This is an improved method of the pap smear in that the clinician collected sample is processed to form a mono-layer of cervical cells on the microscope slide prior to cytological examination. While still a subjective test, LBC provides an enhanced cellular view to identifying abnormal cells more readily.
HPV (Human Papillomavirus) DNA Screening
Virtually all cervical cancer cases are caused by molecular and cellular changes resulting from the genomic integration of certain HPV genomes into cervical cells. As an objective test, HPV DNA screening detects the presence of these specific high-risk HPV genomes but provides no information on the presence or progress of precancerous or cancerous lesions. Thus, patients testing positive for these HPV strains ultimately require reflex or co-testing with one of the methods described above.
These approaches are dependent on several key things that impede the efficient expansion of screening programs in much of the world: Trained Professional collection of cervical cell samples Complex and technical laboratory infrastructure including trained cytologists and/or pathologists, LBC and HPV sample processing equipment Time and follow-up access to the patient for treatment or reflex testing after sample analysis
Oncogenesis is addressing these limitations by addressing two primary barriers to screening:
Improving sample collection: iPap® enables women to self-collect a cellular cervical specimen adequate for HPV and other sexually-transmitted disease testing, cytologic analysis(1), as well as testing in OncoGenesis’ CerMark Point-of-Need solution (below). OncoGenesis’ iPap offers improved comfort and convenience at lower cost than MD-office-based collections, or HPV-only self-collection devices. Furthermore, self-sampling with the iPap overcomes cultural, personal or religious barriers to having a trained professional collect a specimen.
Patented and offered in select markets as a direct-to-consumer (DTC) test with laboratory testing under the brand Cervi✓™, iPap enables both HPV screening and when positive for high-risk HPV, automated reflex to cytology from the same sample. No other self-collection device is capable of doing this today.
Automating Analysis at the Point-of-Need (PON): CerMark® brings objective, biomarker-based screening for hrHPV, cervical cancer and pre-cancer to the point of sample collection, be that in a patient's home, while traveling, the MD's office, or a mobile clinic. CerMark uses the proprietary biomarker-based assay in a single-use. disposable cartridge to enable rapid and convenient screening results. Combined with the iPap®, CerMark offers a complete solution for convenient and comfortable cervical screening at the Point-of-Need, negating the need for central labs and expanding the opportunity for screening worldwide.
(1) Studies have demonstrated iPap collected samples are sufficient for cytologic analysis. Further US FDA studies are underway.