iPap is the world's first and only CE marked self-sampler capable of collecting a cellular cervical sample adequate for co-testing of samples(1), including:
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 POC 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 platform, CerMark POC.
iPap is currently:
(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 two (2) distinct applications:
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:
OncoGenesis' product portfolio is enabling a reduction in the number of steps and number of trained and licensed participants in the complex cervical cancer screening process, making screening simpler.
In reducing the barriers of access, cost, and, complexity of the cervical cancer screening process, OncoGenesis is making screening available to more women, and helping the world take a significant step forward in eliminating the suffering from this preventable and treatable disease.
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.
Status: In Process
Patent #: 63251221 provisional
Status: In Process
Patent #: 63249479 provisional
Status: In Process
Patent #: 63056983
Patent #: US 11,246,577
Patent #: US 6,352,513
Patent #: US 10,670,595 B2
Patent #: WO2016191603A1
Patent #: WO2011060184
Patent #: WO2011071555