OncoGenesis - Oncology Solutions/Service Company

OncoGenesis: Upgrading the Cervical Cancer Screening Paradigm

Peter Gombrich, Founder, OncoGenesisPeter Gombrich, Founder, OncoGenesis For decades, preventive screenings have undeniably helped the medical community to detect and subdue several critical diseases, including cancer; however, cervical cancer continues unabated with over 342,000 deaths reported in 2020. The reason for this alarming situation is the lack of access to cervical screening and, more importantly, some women’s unwillingness to undergo this life saving screening test.

Cervical cancer is the disease of the unscreened or under-screened. Despite Pap smear, liquid-based cytology (LBC), and HPV screening along with HPV vaccinations, the cervical cancer survival rate in the last three decades has been stagnant. The solutions are expanding screening access using selfsampling, detecting cervical disease, and its progression using biomarkers, and providing affordable point-of-care testing.

OncoGenesis, a California-based company, is taking a phased approach to upgrading the cervical cancer-screening paradigm.

Established in 2008, OncoGenesis is on a mission to provide tools that help expand access to screening and detect cervical disease and its progression. “Our iPap® Personal Cervical Sample Collector and CRISPR-enabled point-ofcare (POC) Biomarker Screening System expands access to increase screening participation and the biomarkers provide greater clinical information to guide treatment decisions,” says Peter Gombrich, the Founder and Executive Chairman of OncoGenesis.

Expanding Screening Access

OncoGenesis’ iPap is the first cervical cell collector that enables women to conveniently self-collect a cervical specimen adequate for co-testing both HPV and cytology testing. The innovative cervical self-sample collector helps expand cervical screening access by empowering women to collect samples without needing a clinical visit, clinician, exam room, and speculum. The iPap serves as a breakthrough option for women who often fail to participate in regular cervical screening due to cultural, religious, or personal objections. The self-collected specimens can then be mailed or returned to physicians’ offices or convenient drop-off locations such as partner wellness centers/pharmacies or labs for processing.

iPap is deemed the most effective and clinically-efficient cervical screening methodology for self-sampling, given its exceptional co-testing capabilities. According to a recent analysis of over 13 million cervical samples processed by Quest Diagnostics labs from 2010 to 2018, co-testing enhances screening for the identification of cervical cancer (Kaufman, et al., AJCP (2020); 154:510). If an iPap-collected cervical specimen is found to be positive for high-risk HPV (hr-HPV) strains, it can be co-tested using cytology in accordance with ACOG guidelines. By doing this, the solution eliminates the need for a second specimen and ensures that test results are available before any in-clinic or telehealth visit to optimize time with the patient and reduce unnecessary invasive procedures.

Objectively Detecting Cervical Disease

While iPap increases cervical cancer screening participation, OncoGenesis’ biomarker screen detects cervical disease, unlike HPV screening that only determines the presence of the virus, which is cleared by 80 percent of women within two years. Pap smear and LBC assess the morphological characteristics of the cervical specimen for cellular abnormalities which can be very subjective depending on an individual’s capabilities and training.

Through extensive R&D, OncoGenesis identified the presence of certain mRNA biomarkers at various stages of cervical cancer progression.

The company then decided to use these biomarkers to objectively understand the clinical status of cervical specimens, opening a new era for cervical cancer screening with its novel CerMark® Multiplex Biomarker Cervical Cancer Screen. The CerMark Multiplex Biomarker Cervical Cancer Screen will be available as both lab-based high throughput and POC formats. “Our solution employs a panel of biomarkers, which serve as objective indicators of human papillomavirus (HPV) infection progressing to cervical disease, and cancer risk, providing greater clinical information in a single test compared with HPV DNA screening or cytology alone,” says Co-Founder, Paul Vichi, PhD.

Decentralizing Screening

OncoGenesis’ CerMark POC format is specifically designed to address the deficiencies in lab infrastructure and the need for highly-trained personnel to support current screening methods. The solution leverages CRISPR-Cas enzyme technology to formulate a CerMark POC assay for rapid, enhanced screening of Cervical Intraepithelial Neoplasia (CIN) and cancer. Initially used as a tool for gene editing, CRISPR has more recently been combined with low-cost, minimally instrumented approaches for rapid testing for SARS-CoV-2 and other infectious diseases, offering innovative technology for disease screening and diagnostics at the POC.

CerMark POC is compatible with both standard cervical collection tools and OncoGenesis’ iPap collector. It offers convenient, rapid, low-cost, biomarker-based POC screening for precancerous lesions and cervical cancer. It improves upon HPV or cytology by objectively detecting primary evidence of hr-HPV infection as well as precancerous cervical intraepithelial neoplasia and cervical cancer in a single test, offering advantages over current screening methods, which require two or more assays to reach the same clinical endpoint.

CerMark biomarkers provide evidence of:

1. Persistent infections with hr-HPV strains that have progressed towards disease. Clinical indications include both the presence of hr-HPV as well as disease progression, providing a highly specific indicator for HPV-related cervical disease risk.

2. Important molecular changes in cervical cells caused by hr-HPV and associated with precancerous lesions, e.g., altered expression of specific growth and apoptotic genes. These biomarkers aid in detecting progressive disease, are increasingly expressed in HPV-positive cervical intraepithelial neoplasia (CIN), and provide a strong positive predictive indicator for disease.

3. Cellular conditions conducive to the progression of HPVrelated cervical disease and reduced survival. Although most infections with HPV are effectively addressed by a patient’s immune system and even many precancerous lesions regress rather than progress towards high-grade lesions or invasive cancer, OncoGenesis’ prognostic cervical disease biomarker aids in cervical cancer risk determination by detecting a cellular environment that supports disease progression and reduced patient survival independent of disease stage.

“We’re creating the path to move cervical cancer screening beyond the lab, reducing infrastructure and personnel requirements, and providing a portable, low-cost platform that improves access to screening worldwide at the POC,” adds Vichi.

It can be used in doctor’s offices, mobile clinics, remote or central labs, reducing requirements for expensive instrumentation and trained professionals.

Unified to Save Lives

“Our business operations are built around the social ethos to provide seamless access to cervical screening for ultimately saving the lives of women,” mentions Gombrich. OncoGenesis and its partners strive to make their products available in the market quickly at a price affordable to all. To do this, the company is joining hands with leading pharmacy and wellness partners as well as laboratories to implement iPap-based collection options throughout the United States. They are also partnering with several retail outlets like Walmart to make iPap readily available to patients and companies that provide screening kits direct to patients. The advantages of providing a self-collected specimen sent to the testing laboratory have been successfully proven through the FDA-cleared Cologuard® system.

Our business operations are built around the social ethos to provide seamless access to cervical screening for ultimately saving the lives of women

In developing countries, where cervical screening is minimal, OncoGenesis is collaborating with medical foundations, NGOs, WHO, and other laboratories to reach out to people and deliver its solution. The company is approaching the final stages of development for CerMark based on the use of proven biomarkers. In addition to the combined experience of its in-house executives, scientists, and medical advisors, the company has collaborated with a leading third-party firm that holds extensive expertise in building POC systems to develop its CerMark platform.
  • We’re creating the path to move cervical cancer screening beyond the lab, reducing infrastructure and personnel requirements, and providing a portable, low-cost platform that improves access to screening worldwide at the POC

Upgrading Cervical Cancer Screening

OncoGenesis is creating the tools needed to increase screening participation and detect disease early, thereby sparing women from unnecessary invasive procedures, improving health outcomes, and saving lives while delivering value to healthcare providers, payers, strategic partners, and investors. Considering the pace at which OncoGenesis has been innovating, several key players in the healthcare industry have approached the company to partner in its mission. In fact, OncoGenesis is in discussions with a leading women’s healthcare company managed by one of its medical advisors for a strategic merger that would result in an IPO.

“Together, the OncoGenesis iPap and CerMark screen offer a less expensive more clinically relevant approach that provides women with expanded access to more convenient cervical cancer screening that can be used in regions with the highest incidence, supporting the elimination of cervical disease and saving lives around the world,” concludes Vichi.

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Salt Lake City, UT

Peter Gombrich, Founder, OncoGenesis

OncoGenesis addresses the tremendous, unmet clinical need for an easy-to-use and accurate screening of women for cervical cancer. The company offers a comprehensive solution ranging from optimal specimen collection to point-of-care diagnostic testing, setting a new standard of care for diagnosing and treating cervical cancer worldwide.