OncoGenesis, Inc. is on a mission to eradicate the unnecessary death of more than 4,000 women each year in the US, and 300,000 globally from Cervical Cancer, a largely treatable disease if detected early enough in its progression. Unfortunately, the correlation between those who needlessly die from the disease, and those who are never screened is almost 100%.
Furthermore, survival rates from Cervical Cancer in the US and around the world have been stagnant for a number of years. This suggests that we’ve reached a plateau in terms of our ability to address this disease with current approaches, including testing and vaccinating for human papillomavirus (HPV), which has emerged as the newest way to address this disease. While advancing the cause, even HPV detection and prevention will not fully address the challenge of effectively screening all women at risk.
Given the fact that 80% of women will at one time or another in their lives contract the human papillomavirus in their vaginal tract, and that 90% of these women will naturally clear the virus from their bodies with no lingering effect through their immune response, having HPV at a moment in time does not indicate a patient will get cervical cancer. While having HPV increases the risk of cervical cancer, using HPV DNA screening to screen for cervical cancer is akin to using car ownership alone as an indicator of auto accident risk; there’s a correlation, of course. But one thing doesn’t lead to the other with great concordance.
Therefore, a positive HPV DNA test needs to be complemented with a 2nd, cytologic test to identify those patients with cellular changes that need treatment. If the sample collected was vaginal only (as is the case with most self-collectors) or inadequate for cytology, a second visit to the doctor for collection of a second sample will be required.
This second sampling adds significant cost to the process and is inconvenient for women who must now visit the doctor a second time. In value-based-care (VBC) models, this becomes problematic for physicians as well. Adding to the challenge is the “Great Resignation;” an increasing shortage of trained cytotechnologists available in the laboratory to analyze these second samples that preceded the Covid-19 pandemic.
OncoGenesis is addressing these challenges as follows:
iPap® is the world’s first self-sampler that obtains a cervical cell sample. iPap allows a woman to collect her own sample at home or other convenient place, and then deliver it to any existing laboratory for HPV or cytologic analysis.
In the United States, Canada, Europe, and other markets where cervical cancer screening is currently being done at scale, this can lower costs for screening programs, as well as provide greater convenience for women. In light of the move to virtual and home-based care, iPap can be a strategic way of moving cervical cancer screening forward even where Pap Smears or HPV testing is routine.
iPap has obtained a CE mark in Europe and is currently available for clinical use where such regulatory designation is accepted. FDA and other regulatory designations are currently being sought. However, iPap can be used today in the U.S. for research purposes and under CLIA waiver.
In markets where cervical cancer screening is limited or non-existent because of the cultural or practical challenges of cost-effectively and practically obtaining a sample to enable the complete screening process, iPap similarly is a game-changer.
CerMark® employs a molecular approach, using specific cervical cancer biomarkers to detect cellular changes reflecting cervical pre-cancerous lesions and cancer. CerMark analysis can be performed in a centralized laboratory, or on the company’s forthcoming fully automated, point-of-care device.
Detecting molecular changes within cervical cells that reflect precancerous lesions regardless of the cause – HPV or otherwise – offers a chance to detect all cervical cancers requiring intervention. And by doing it in a single test CerMark will help to lower cost. Further, as an instrument-based test it removes the dependence on the dwindling availability of cytotechnologists.
Available soon for investigational and research use, the biomolecular multiplexed CerMark assay can be used by laboratories equipped to perform PCR testing as an adjunct or alternative to HPV DNA testing as well as cytology.
In the coming months, OncoGenesis anticipates the initial availability of its automated, bench-top, and mobile Point-of-Care instrument (CerMark POC) that can be used where centralized laboratories may not be cost-effective, or practical.
OncoGenesis is first bringing iPap to market to address challenge #1 and to support the evolving role of virtual care (telehealth) as much of the world takes a more patient-centric approach to care. They are doing this directly with laboratories, health insurers, and retailers where patients are currently being screened for cervical cancer.
The company is also beginning to introduce the CerMark assay to laboratories currently able to conduct PCR testing. And finally, the company will introduce the CerMark POC to policymakers, retailers, and others interested in creating more rapid, point-of-care testing programs.