Advancing Cervical Cancer Screening™

iPap is the world's first and only CE marked self-sampler capable of collecting a cervical cell sample adequate for co-testing of samples(1), including:      

• Human Papillomavirus (HPV) testing
• Cytologic Analysis (pap staining, etc.) (1)
• Other sexually-transmitted diseases (STDs)

iPap allows a woman the privacy, comfort, and confidence to collect & preserve a sample on her own at home or other location, improving the likelihood of screening for cervical pre-cancer, cancer, or even the presence of HPV and other STDs.     

After collection, the sample can be mailed or delivered to a central processing laboratory or analyzed in the CerMark system (when available). This enables a multi-faceted screening program model from a lower-cost sample collection process.      

Cervical samples collected with iPap enable both cytologic analysis(1) as well as molecular testing with HPV or OncoGenesis' proprietary CerMark multiplexed assay test.      

iPap is currently:

• Registered with the US-FDA for sale in the United States for self-collection of a gynecologic sample 
• Available where CE certification is required  
• Available for Research use  
• Will soon be available directly to women in the U.S. and other select markets as a complete screening test based on sample self-collection and mail-in for a full HPV test with reflex to cytology (cotesting) where indicated under the brand Cervi✓™.

(1) Studies have demonstrated iPap collected samples are sufficient for cytologic analysis. Further US FDA studies are underway.

With CerMark OncoGenesis is developing a breakthrough approach to screen for molecular changes of the cervix that lead to Cervical Cancer.   

Moving beyond the mere detection of Human Papilloma Virus (HPV) - the viral cause of most cervical cancers - CerMark multiplex biomarker assay uses specific mRNA biomarkers to detect changes in the expression of viral and host genes that reflect the development of precancerous lesions and/or cervical cancer.   

The CerMark multiplex assay is being applied to provide women with the utmost convenience and access to help identify their risk for cervical disease in their home or other place of convenience. Using iPap self-collected specimens and low-cost, lab-on-chip technology, CerMark will screen for high-risk HPV infections and cervical disease risk in minutes similar to other home-based tests like Covid-19 and home pregnancy tests. 

CerMark expands access to screening by enabling rapid, low-cost screening for both HPV (cause) and cellular changes (disease) at the point-of-care or at the point-of-need in minutes. In so doing, CerMark will:

• Negates the need for large, centrally located infrastructure, and,
• Offer greater specificity than HPV testing alone, with no loss of sensitivity
• Provides greater clinical information in a single test compared with routine HPV DNA screening alone
• Lowers the cost of screening by moving from labor-intensive, manual cytologic review to high-volume instrument-based processing. 
• Significantly reduces the time-to-results, 
• Expands access and availability of cervical screening to the millions of women who are currently underserved by existing practice. 

The CerMark application of the multiplexed biomarker assay uses specific and proprietary chemistry and technologies licensed from development partners.   

The technology facilitates amplification and detection of targeted biomarkers for cervical precancerous lesions and/or cancer in real-time with very low background, supporting accurate and ultra-sensitive measurements within isolated biological samples. The approach is compatible with large-scale manufacturing and allows miniaturization of the test module that significantly enhances the POC & PON devices, improves performance, simplifies instrument design, and reduces manufacturing costs.  

The current panel of biomarkers contained in the assay indicates critical molecular changes associated with HPV infection and cervical cancer progression. Analysis of these biomarkers in cervical samples provides a comprehensive assessment of the state of cervical disease within the sample, identifying those patients with high-grade lesions who require additional diagnostic follow-up or treatment.   

Assays are particularly useful for triaging HPV-positive patients who genuinely need follow-up and/or treatment from the vast majority of HPV-positive individuals who do not have abnormal lesions and do not need expensive and stressful follow-up procedures.

The CerMark POC CRISPR-Cas based platform utilizes an integrated test cartridge incorporating quantitative detection of target biomarkers. The patient sample is introduced into the cartridge via an integrated preprocessing component and inserted into the       CerMark POC instrument. The cartridge contains all processing steps associated with target amplification and detection.   

The CerMark PON uses proprietary "Lab-on-a-Chip" technology to apply a collected sample along with the CerMark multiplexed assay into a simple, disposable test cartridge.  

All fluids are maintained internally in the device for safe disposal and to eliminate the potential for cross-contamination between patient samples. Target biomarkers indicating hr-HPV and cervical disease are detected in real-time, supporting rapid results reporting. OncoGenesis’ robust approach supports low resource application while ensuring compatibility with telemedicine practices for remote review or consult if necessary.