Colorectal Cancer: Screening Options and Potential Emerging Role for Pharmacists
Haytham Gareer, MD, PhD, MBA, FACS for Pharmacy Times
Nearly 63% of newly diagnosed patients have advanced colorectal cancer, which requires more aggressive treatment and reduces the associated 5-year survival rate.
Colorectal cancer (CRC) is the second leading cause of cancer-related death in the United States. This year alone, more than 150,000 new cases of CRC will be diagnosed, and more than 53,000 people will die from a disease that is not only treatable when discovered early but also preventable.
Yet, 1 in 3 people are not up-to-date with CRC screening. The COVID-19 pandemic impacted screening by causing canceled or delayed colonoscopies and postponed physician visits, which should have included recommendations for CRC screenings. Additional screening barriers include disparities in care for underserved populations, lack of awareness, fear or concerns about the colonoscopy procedure or required prep for it, lack of recommendations by health care providers, or insurance issues.
Delaying regular screenings or follow-up on abnormal results for these reasons or barriers could mean CRC is not detected until later stages. Unfortunately, nearly 63% of newly diagnosed patients have advanced CRC, which requires more aggressive treatment and reduces the associated 5-year survival rate to as low as 14%. In contrast, if detected early, patients with CRC have a 5-year survival rate of 92%.
The Pharmacist’s Role: Earlier Screening is the Key to Prevention
Access, convenience, and options
Pharmacists hold a trusted position in their communities and patients see their pharmacists more than twice as often as their primary care providers. In addition, patients visit the pharmacy 35 times a year compared to just 4 visits to see medical providers.
The pharmacists’ role in providing direct patient care and impacting health outcomes holds great potential. Today, pharmacists are perceived as a partner in care and can influence adherence to provider-prescribed treatment plans, such as prescription fulfillment and screenings.
One example is the Kentucky Board of Pharmacy’s 2021 approval of the pharmacy protocol that specifies the criteria and procedures for a pharmacist to provide education and information specific to CRC. As part of the protocol, when appropriate, a pharmacist may initiate noninvasive, stool-based CRC screening with a customer by distributing a take-home fecal immunochemical test (FIT) or stool DNA test (e.g., sDNA-FIT)—making it even easier for patients to follow their health care providers’ recommended screening guidelines.
These patients can now take care of their CRC screening at their local pharmacy—the same place they go for a flu shot, COVID-19 vaccination, or regular prescriptions. The protocol was approved following advocacy efforts to remove barriers to screening in Kentucky by the Colon Cancer Prevention Project and Fight Colorectal Cancer (Fight CRC).
CRC is treatable and preventable when caught early. Providing people with additional options to get screened saves more lives, a position that resonates with the American Association of Colleges of Pharmacy’s Oath of the Pharmacist vow. Removing barriers to access and opening paths to prevention and detection align with the pharmacists’ promise to advance health equity and embrace and advocate for changes that improve patient care.
Most CRC develops from precursor polyps, the most common neoplastic finding in colonoscopy. Colonoscopy has a 3.5% false-negative rate for detecting CRC, but its significant advantage is the ability to remove premalignant lesions discovered during the screening or surveillance procedure.
The potential for these polyps to become malignant correlates with the polyp's type, size, and degree of dysplasia. Advanced adenomas (AA) are considered the most concerning and high-risk type of polyp. Secondary prevention of CRC involves screening at-risk populations to detect and remove early-stage cancers and adenomatous polyps.
The American Cancer Society and the United States Preventative Task Force (USPSTF) recommend secondary prevention in average-risk individuals, including beginning screening at age 45. While the USPSTF does not specify the advantages of any screening strategy, colonoscopy remains the gold standard for CRC screening and detecting colorectal lesions. Despite this, compliance with colonoscopy is not optimal due to discomfort and unpleasant preparation procedures.
Limitations include the risk of complications, cost, and access. By contrast, the ideal CRC screening method would be low-cost and noninvasive, with good patient acceptance and high sensitivity and specificity values.
FIT, which detects hemoglobin in the stool, has been used with some success. FIT has a low sensitivity for colon adenomas (66–80% sensitivity for CRC) and poor precursor lesion detection rates (only 10–28% for AA). But even with an excellent specificity (93–95%), the aggregate metrics limit its effectiveness.
It is well known that not all colorectal adenomas will progress to CRC. Increasing the sensitivity for high‐risk adenomas can raise the detection rates for these lesions. Therefore, it is imperative to explore alternative or complementary strategies with the potential to improve CRC screening performance, especially for the detection of cancers at their early stages and AA.
Identifying novel protein biomarker panels with higher sensitivities for high‐risk adenomas and CRC than FIT will improve current screening strategies. These additional biomarkers could aid in enhancing the sensitivity for early detection of CRC. The development of tests performed on stool samples that see indirect signs of CRC, such as occult blood or genetic and epigenetic alterations related to the presence of CRC, has been achieved with good results.
One attractive category of molecules considered for stool-based CRC screening is RNA. RNA-based biomarkers can be measured in small sample volumes with simple economic assays. Combining specific stool‐based RNA biomarkers outperform hemoglobin and DNA in detecting molecularly defined high‐risk adenomas.
Host mRNA has also been investigated in stool as a potential biomarker. In one study, a multitargeted stool RNA (mt-sRNA) assay combined 8 stool-derived eukaryotic RNA (seRNA) biomarkers, patient demographic information (smoking status), and a FIT to detect colorectal neoplasia.1
In stool samples using a robust predictive model, the test attained a 95% sensitivity for CRC, 62% sensitivity for AA, 25% sensitivity for other non-AA, 80% specificity for hyperplastic polyps, and 85% specificity for no findings on a colonoscopy. This study demonstrated that specific RNA expression alterations in colon tissue prove valuable in early CRC diagnosis and potentially prognosis prediction and targeted therapy. More recently, a multitarget mRNA assay demonstrated a significant strengthening of both sensitivity and specificity for CRC detection.
In summary, the cost-benefit of such new methods for the health care system may encourage changes to current screening recommendations. The high cost of CRC treatment, particularly for more advanced diseases, is considered to improve the cost-effectiveness of CRC screening. Furthermore, higher threshold costs for a biomarker test that could significantly increase the sensitivity of AA detection while maintaining reasonable specificity would likely be cost-effective relative to currently available noninvasive tests.
Reference
1. Barnell EK, Kang Y, Barnell AR, et al. Multitarget stool RNA test for noninvasive detection of colorectal neoplasias in a multicenter, prospective, and retrospective cohort. Clin Transl Gastroenterol. 2021;12(5):e0036.
Works Cited:
Joseph Moose, P., & Ashley Branham, P. (2014). Pharmacists as Influencers of Patient Adherence. Pharmacy Times Oncology Edition, 1(5). https://www.pharmacytimes.com/view/pharmacists-as-influencers-of-patient-adherence-[Accessed 16 June 2022].
Bushak, L., 2022. "Pharmacists' role in primary care set to grow.” [online] MM+M - Medical Marketing and Media. https://www.mmm-online.com/home/channel/pharmacists-[Accessed 16 June 2022].
“Pharmacists Want More Time with Patients.” (n.d.). Drug Topics. https://www.drugtopics.com/view/pharmacists-want-more-time-patients
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Siegel RL, Miller KD, Fedewa SA, et al. Colorectal cancer statistics, 2017. CA Cancer J Clin. 2017;67(3):177-193.
Welch HG, Robertson DJ. Colorectal cancer on the decline--why screening can’t explain it all. N Engl J Med. 2016;374(17):1605-1607.
Lieberman DA, Rex DK, Winawer SJ, Giardiello FM, Johnson DA, Levin TR. Guidelines for colonoscopy surveillance after screening and polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2012;143(3):844-857.
Westwood C, Lee T, McSherry R, Bettany-Saltikov J, Catlow J. Decision making in the management of adults with malignant colorectal polyps: An exploration of the experiences of patients and clinicians. Colorectal Dis. 2021;23(8):2052-2061.
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Almeida-Lousada H, Mestre A, Ramalhete S, et al. Screening for colorectal cancer leading into a new decade: The “roaring '20s” for epigenetic biomarkers? Curr Oncol. 2021;28(6):4874-4893.
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Barnell EK, Kang Y, Barnell AR, et al. Multitarget stool RNA test for noninvasive detection of colorectal neoplasias in a multicenter, prospective, and retrospective cohort. Clin Transl Gastroenterol. 2021;12(5):e0036.
Geneoscopy announces rebranding
New look matches focus on transforming GI health
ST. LOUIS, MISSOURI (October 3, 2022) | Geneoscopy today announced a corporate rebrand and launch. The rebranding comes at a transformational time for the company.
“We’ve come far since first founding the company,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “With our recent milestones, we felt it was time to refresh our brand to reflect where we are today. Geneoscopy is a dynamic and agile company with an exciting future focused on innovative diagnostics for gastrointestinal health. Our new identity captures this and conveys our organization’s personality and purpose.”
Within the past year, the company has grown to a team of 50 professionals, established headquarters at an 11,000 sq. ft. laboratory and office space in St. Louis, Missouri, and received CLIA-certification for its laboratory. Geneoscopy also recently concluded its pivotal 10,000-patient CRC-PREVENT clinical trial and is preparing to file its Premarket Approval application (PMA) with the Food and Drug Administration (FDA) in anticipation of a commercial launch for its noninvasive, stool-based seRNA colorectal cancer screening test.
The new branding pays tribute to Geneoscopy’s founders and the company’s roots – depicting a stylized strand of RNA (ribonucleic acid) within the letter “g” of the logomark. RNA is the foundation of Geneoscopy’s patented technology – unique to Geneoscopy’s innovative stool-based diagnostics platforms.
By using contrasting colors for the words “Gene” and “oscopy,” the brand and logo design emphasizes critical aspects of Geneoscopy’s diagnostic capabilities while visually highlighting the pronunciation of the company name – “Gene” and “oscopy”. According to color psychology, the bold palette of blue, teal and gray conveys confidence, trust, inspiration, openness and clarity. The use of design principles – including negative and positive space and incisive line work connect to communicate collaboration, reliability, precision, agility, innovation and breakthroughs.
The corporate branding will appear across Geneoscopy’s print and digital communications beginning in October 2022.
Visit geneoscopy.com to learn more.
###
About Geneoscopy Inc.
Geneoscopy Inc. is a life sciences company focused on the development of diagnostic tests for astrointestinal health. Geneoscopy’s lead diagnostic uses stool-derived eukaryotic RNA (seRNA) to detect olorectal cancer and precancerous adenomas. This device was awarded Breakthrough Device Designation from the U.S. FDA for its ability to reduce morbidity associated with colorectal cancer through advanced adenoma detection. Indicative of its breakthrough status, preliminary trials suggest that the diagnostic can detect these lesions at a higher rate than all existing noninvasive screening tests. Visit geneoscopy.com to learn more.
Geneoscopy Inc. Forward-Looking Statements.
The information contained in this release includes information about Geneoscopy’s future plans concerning its noninvasive molecular test that can detect colorectal cancer and precancerous adenomas, and as such constitute forward-looking statements. These forward-looking statements are based on the Company’s reasonable estimates of future results or trends. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company’s control. Geneoscopy’s actual results and financial condition may differ materially from those indicated in the forward-looking statements. Although the Company believes that its business plans and objectives reflected in or suggested by these forward-looking statements are reasonable, such plans or objectives may not be achieved, and the actual results may differ substantially from the projected results.
Geneoscopy Completes Pivotal Colorectal Cancer Trial Enrollment with Diverse Participant Population
Trial Enrollment Over Indexes in Traditionally Under-Represented Black Community
ST. LOUIS, Aug. 23, 2022 /PRNewswire/ -- Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced completed enrollment of the CRC-PREVENT pivotal trial for its noninvasive, at-home diagnostic screening test to detect colorectal cancer (CRC) and advanced adenomas in average-risk individuals. Through a decentralized recruitment strategy, Geneoscopy enrolled more than 14,000 individuals across all 48 continental United States, many from traditionally under-represented communities in clinical trials, in terms of gender, race, ethnicity, socioeconomic status, and geography.
Of the participants:
- More than a quarter were racial or ethnic minorities
- 16% were Black or African American – an over-index proportionally based on:
- Just 5% of U.S. clinical trial participants are Black1
- 12% of the U.S. population is Black or African American2
- 3% were Asian
- 7% were Hispanic or Latino
- 16% were Black or African American – an over-index proportionally based on:
According to the American Cancer Society, CRC disproportionately affects the Black community, where the incidence and mortality rates are the highest of any racial/ethnic group in the U.S. In fact, Black people are about 20 percent more likely to be diagnosed with CRC and about 40 percent more likely to die from CRC than most other groups.
"Too often, underserved communities face barriers that exclude them from participating in important clinical trials. Our decentralized recruitment strategy helped mitigate these challenges, resulting in a diverse group of participants that are representative of the individuals that may use our noninvasive CRC screening tool," said Dr. Erica Barnell, Chief Science Officer and co-founder of Geneoscopy. "We were particularly encouraged to see a substantial number of Black participants in our trial. Unfortunately, these individuals have a greater chance of having and dying from CRC compared with other racial groups, and yet too often, are underrepresented in clinical research. We believe that basing advances in cancer screening and prevention on data from all Americans will build greater confidence in new screening tests and, ultimately, save more lives."
Complete efficacy and enrollment findings from the trial will be presented later this year. These findings will support a Pre-market Approval application to the U.S. Food and Drug Administration by the end of 2022.
About Colorectal Cancer & Screening
Responsible for over 50,000 deaths annually, colorectal cancer (CRC) is the second leading cause of cancer death in the United States. CRC usually begins as a growth (or polyp) that may or may not develop into cancer over time. Early detection and treatment are crucial to improve survival; however, many newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold standard for CRC screening in the U.S., yet this method is frequently met with patient aversion due to its required bowel preparation, sedation, and associated discomfort, resulting in low patient compliance. Currently available noninvasive screening methods lack sufficient sensitivity to reliably detect both early-stage CRC and high-risk precancerous lesions, including advanced adenomas which are a precursor in up to 70 percent of CRC cases.
About Geneoscopy Inc.
Geneoscopy Inc. is a life sciences company focused on the development of diagnostic tests for gastrointestinal health. Geneoscopy's lead diagnostic uses stool-derived eukaryotic RNA (seRNA) to detect colorectal cancer and precancerous adenomas. This device was awarded Breakthrough Device Designation from the U.S. FDA for its ability to reduce morbidity associated with colorectal cancer through advanced adenoma detection. Indicative of its breakthrough status, initial trials suggest that the diagnostic can detect these lesions at a higher rate than that demonstrated by all existing noninvasive screening tests in their respective studies. Visit geneoscopy.com to learn more.
Geneoscopy Inc. Forward-Looking Statements
The information contained in this release includes information about Geneoscopy's future plans concerning its noninvasive molecular test that can detect colorectal cancer and precancerous adenomas, and as such constitute forward-looking statements. These forward-looking statements are based on the Company's reasonable estimates of future results or trends. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. Geneoscopy's actual results and financial condition may differ materially from those indicated in the forward-looking statements. Although the Company believes that its business plans and objectives reflected in or suggested by these forward-looking statements are reasonable, such plans or objectives may not be achieved, and the actual results may differ substantially from the projected results.
Media Contact
Judy Pretto, MBA, Director, Marketing Communications
815.534.0521
media@geneoscopy.com
Geneoscopy to Join Fight CRC at the White House to Address Colorectal Cancer Screening Needs
ST. LOUIS, MISSOURI (JULY 19, 2022) | Earlier this year, President Joe Biden announced plans to reignite the Cancer Moonshot with renewed leadership and new ambitious goals to ‘end cancer as we know it.’ As part of this effort, the President and First Lady Jill Biden have issued a call to action to prioritize progress on cancer screening and to ensure that all Americans benefit from advances in cancer prevention. In response, the national advocacy organization Fight Colorectal Cancer (Fight CRC) convened a group of colorectal cancer (CRC) advocacy and industry leaders to answer that call.
On July 25, 2022, Andrew Barnell, CEO and Co-founder of Geneoscopy, and 18 others will join Fight CRC at the White House to discuss their shared response to the President’s call to action to improve and increase access to CRC screening, with a particular emphasis on reaching the underserved and the 44 million people who need to be screened.
These advocacy and industry leaders are coming together and supporting efforts that speak to their shared commitment to helping increase access to colorectal cancer screening for all Americans. The group will explore both policy solutions and ideas for public-private partnerships that will help meet the President’s Cancer Moonshot goals.
“We have a moral responsibility to work together on issues critical to population health such as colorectal cancer early diagnosis and prevention,” said Andrew Barnell, CEO and Co-founder of Geneoscopy. “By coming together, we can develop more universal solutions, more effectively address screening inequities, provide broader access to screening, and better meet the needs of patients and health care professionals. Coming together around these common ideals will allow us to save more lives.”
Although colorectal cancer is preventable with timely screening and highly treatable if caught early, one in three people are not up to date with colorectal cancer screening. The COVID-19 pandemic exacerbated this, and in a recent analysis by Komodo Health, new CRC diagnoses were down more than 32%. Despite the availability of several safe and effective CRC screening options, CRC remains the No. 2 overall cancer killer for men and women combined, with communities of color seeing even higher incidence and mortality rates.
“We commend the bold vision to fight cancer by President Biden and the Moonshot program,” said Anjee Davis, President of Fight CRC. “It is our hope as catalysts for the colorectal cancer community that with this meeting, we can address inequities within colorectal cancer screening and make progress toward our Path to a Cure. Prevention plays a huge role in ending colorectal cancer. The White House asked for a plan to get more people screened, and we are here to deliver—leading with the power of the patient voice.”
Participants who will be attending the White House Meeting:
Carolyn Aldigé – Prevent Cancer Foundation, Founder
Alexey Aleshin, MD – Natera, General Manager, Early Cancer Detection
Andrew Barnell, MBA – Geneoscopy Inc., CEO & Co-Founder
Danielle Carnival, PhD – White House Cancer Moonshot, Coordinator
Austin Chiang, MD, MPH – Medtronic, CMO
Kevin Conroy – Exact Sciences, CEO
Anjee Davis, MPPA – Fight Colorectal Cancer, President
AmirAli Talasaz, PhD – Guardant Health, Co-CEO
Greg Hamilton, MBA – Epigenomics, CEO
Lisa Lacasse – American Cancer Society Cancer Action Network (ACS CAN), President David Lieberman, MD, AGAF – American Gastroenterological Association, Former President
Molly McDonnell – Fight Colorectal Cancer, Director of Advocacy
Arif Nathoo, MD, MPA – Komodo Health, Co-Founder & CEO Angela Nicholas, MD – Fight Colorectal Cancer, Board Member Mike Nolan, MBA – Freenome, CEO
AmirAli Talasaz, PhD – Guardant Health, Co-CEO
Catharine Young, MPA – Office of Science & Technology Policy (OSTP), Senior Director The meeting will be closed; however, for photos, b-roll or official comments before or after
the roundtable, please contact media@fightcrc.org or media@geneoscopy.com.
About Fight Colorectal Cancer
Fight Colorectal Cancer (Fight CRC) is a leading patient-empowerment and advocacy organization in the United States, providing balanced and objective information on colon and rectal cancer research, treatment, and policy. We are relentless champions of hope, focused on funding promising, high-impact research endeavors while equipping advocates to influence legislation and policy for the collective good. Learn more at FightCRC.org.
About Geneoscopy Inc.
Geneoscopy Inc. is a life sciences company focused on the development of diagnostic tests for gastrointestinal health. Geneoscopy’s lead diagnostic uses stool-derived eukaryotic RNA (seRNA) to detect colorectal cancer and precancerous adenomas. This device was awarded Breakthrough Device Designation from the U.S. FDA for its ability to reduce morbidity associated with colorectal cancer through advanced adenoma detection. Indicative of its breakthrough status, preliminary trials suggest that the diagnostic can detect these lesions at a higher rate than all existing noninvasive screening tests. Visit geneoscopy.com to learn more.
Geneoscopy Inc. Forward-Looking Statements
The information contained in this release includes information about Geneoscopy’s future plans concerning its noninvasive molecular test that can detect colorectal cancer and precancerous adenomas, and as such constitute forward-looking statements. These forward-looking statements are based on the Company’s reasonable estimates of future results or trends. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company’s control. Geneoscopy’s actual results and financial condition may differ materially from those indicated in the forward-looking statements. Although the Company believes that its business plans and objectives reflected in or suggested by these forward-looking statements are reasonable, such plans or objectives may not be achieved, and the actual results may differ substantially from the projected results.
Geneoscopy Announces Formation of Scientific Advisory Board to Inform Strategy for the Advancement of Gastrointestinal Health
ST. LOUIS, June 21, 2022 /PRNewswire/ -- Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal (GI) health, today announced the formation of its Scientific Advisory Board (SAB) comprised of leading experts in gastroenterology, oncology, and internal medicine. The SAB will provide strategic input based on their scientific knowledge and clinical expertise to help guide Geneoscopy through the development, regulatory and commercial phases for their RNA-based technology to improve GI health, starting with colorectal cancer.
The seven-member SAB includes:
- John Carethers, M.D., MACP – Professor and Chair, Department of Internal Medicine and Professor, Department of Human Genetics at University of Michigan
- President of the American Gastroenterological Association
- Past President of the American Association of Physicians - Samir Gupta, M.D. – Professor of Medicine at University of California San Diego
- John Inadomi, M.D. – Chair, Department of Internal Medicine at University of Utah School of Medicine
- Immediate Past President of the American Gastroenterological Association - Uri Ladabaum, M.D. – Director, Gastrointestinal Cancer Prevention Program and Head, Clinical Service of the Division of Gastroenterology and Hepatology at Stanford University School of Medicine
- David Lieberman, M.D. – Professor of Medicine, Division of Gastroenterology and Hepatology in the School of Medicine at Oregon Health & Science University
- Past President of the American Gastroenterological Association - Folasade May, M.D., Ph.D., MPhil – Assistant Professor at University of California Los Angeles (UCLA) School of Medicine and Associate Director of UCLA Kaiser Permanente Center for Health Equity
- Director of Quality Improvement in Gastroenterology at UCLA Health
- Member of the U.S. Multi-Society Task Force on Colorectal Cancer - Aasma Shaukat, M.D., MPH – Professor of Medicine and Gastroenterology, Department of Medicine and Professor, Department of Population Health at New York University School of Medicine
- Member of the U.S. Multi-Society Task Force on Colorectal Cancer
"Gastrointestinal diseases affect 70 million Americans,1 and for some such as colorectal cancer, survival is highly dependent upon the stage of disease at diagnosis. The advancement of new technologies is critical for the early detection, diagnosis – and potentially even prevention – of these illnesses," noted Board member David Lieberman, M.D. "I am pleased to serve as the Chair of this esteemed group of thought leaders as we work together to shape the future of GI health and help guide Geneoscopy's efforts to maximize the potential of their promising technology to improve the standard of care for patients and providers."
"The establishment of our Scientific Advisory Board is a significant step forward in our mission to transform GI health. We are pleased to assemble such a distinguished panel of advisors and look forward to their deep insights as leading experts in their fields. Our SAB members' valuable guidance will inform the clinical and commercial advancement of our innovative RNA technology for other potential and future applications currently under investigation," stated Haytham Gareer, M.D., Ph.D., MBA, FACS, Chief Medical Officer.
About Geneoscopy Inc.
Geneoscopy Inc. is a life sciences company focused on the development of diagnostic tests for gastrointestinal health. Geneoscopy's lead diagnostic uses stool-derived eukaryotic RNA (seRNA) to detect colorectal cancer and precancerous adenomas. This device was awarded Breakthrough Device Designation from the U.S. FDA for its ability to reduce morbidity associated with colorectal cancer through advanced adenoma detection. Indicative of its breakthrough status, preliminary trials suggest that the diagnostic can detect these lesions at a higher rate than all existing noninvasive screening tests. Visit geneoscopy.com to learn more.
Geneoscopy Inc. Forward-Looking Statements
The information contained in this release includes information about Geneoscopy's future plans concerning its noninvasive molecular test that can detect colorectal cancer and precancerous adenomas, and as such constitute forward-looking statements. These forward-looking statements are based upon the Company's reasonable estimates of future results or trends. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. Geneoscopy's actual results and financial condition may differ materially from those indicated in the forward-looking statements. Although the Company believes that its business plans and objectives reflected in or suggested by these forward-looking statements are reasonable, such plans or objectives may not be achieved, and the actual results may differ substantially from the projected results.
1 NIH – National Institute of Diabetes and Digestive and Kidney Diseases. Digestive Diseases Statistics for the United States. Available at https://www.niddk.nih.gov/health-information/health-statistics/digestive-diseases#specific. Accessed May 11, 2022.
Geneoscopy Cost-Effectiveness Modeling Data Demonstrates Potential to Reduce Colorectal Cancer Cases and Deaths in the United States with RNA-FIT Screening Test
Data at 2022 Digestive Disease Week Meeting Also Shows RNA-FIT Test to Be Cost-Effective
ST. LOUIS, May 23, 2022 /PRNewswire/ -- Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced findings from an early cost-effectiveness modeling study that aimed to assess the total costs and health outcomes associated with the use of an investigational RNA-FIT biomarker panel versus multi-target stool DNA (mt-sDNA), fecal immunochemical test (FIT), and colonoscopy alone for the screening of colorectal cancer (CRC). Geneoscopy's RNA-FIT test is being evaluated as a potential noninvasive, at-home diagnostic screening test to detect colorectal neoplasms, including advanced adenomas, in average-risk individuals. The data was highlighted in a poster at the 2022 Digestive Disease Week meeting being held in San Diegofrom May 21-24. The poster can be viewed here.
The study demonstrated that use of the RNA-FIT test could result in:
- A reduction in CRC cases of 17.6%, 59.5%, and 43.2% versus mt-sDNA, FIT, and colonoscopy, respectively.
- A reduction in CRC-related deaths of 18.1%, 60.6%, and 45.3% versus mt-sDNA, FIT, and colonoscopy, respectively.
- Fewer colonoscopies (compared to a colonoscopy-only screening program), with colonoscopies that detect advanced adenomas or CRC increasing from 14% to 35%.
- An increase in the number of screening colonoscopies following a positive test result by 362 and 919, per 1,000 patients over a 30-year time horizon, versus mt-sDNA and FIT, respectively, due to the higher number of pre-cancerous adenomas detected.
- A comparable cost to mt-sDNA, with an additional $207 per patient over a 30-year time horizon due to higher colonoscopy and surveillance costs. This is offset by lower costs associated with CRC diagnosis.
"Screening for CRC is critical for early detection and intervention, and it saves lives. Unfortunately, approximately 40% of people eligible for CRC screenings fail to get screened, in part due to the invasive and time-consuming nature of the gold-standard option – a colonoscopy. Noninvasive screening may serve as an alternative; however, available options have lower detection rates for pre-cancerous polyps," stated Haytham Gareer, MD, PhD, MBA, FACS, Chief Medical Officer for Geneoscopy and lead author on the poster. "The findings from this health outcomes analysis reinforce the potential for our RNA-FIT test to be a significant advancement in CRC screening by helping to reduce overall CRC cases and deaths while being affordable for patients."
To conduct the analysis, the model combined data on sensitivity, specificity, and compliance for each screening method with incidence and prevalence rates to assess each method's detection rates. Data on distribution across disease stages and five-year survival rates were used to determine long-term outcomes. The model also accounted for the cost of screening, complications associated with colonoscopy, surveillance programs, and the cost of CRC treatment.
About Colorectal Cancer & Screening
Responsible for over 50,000 deaths annually, colorectal cancer (CRC) is the second leading cause of cancer death in the United States. CRC usually begins as a growth (or polyp) that develops into cancer over time. Early detection and treatment are crucial to improve survival; however, many newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold-standard for CRC screening in the U.S., yet this method is frequently met with patient aversion due to its required bowel preparation, sedation, and associated discomfort, resulting in low patient compliance. Currently available noninvasive screening methods lack sufficient levels of sensitivity to reliably detect both early-stage CRC and high-risk precancerous lesions, including advanced adenomas which are a precursor in up to 70 percent of CRC cases.
About Geneoscopy Inc.
Geneoscopy Inc. is a life sciences company focused on the development of diagnostic tests for gastrointestinal health. Geneoscopy's lead diagnostic uses stool-derived eukaryotic RNA (seRNA) to detect colorectal cancer and precancerous adenomas. This device was awarded Breakthrough Device Designation from the U.S. FDA for its ability to reduce morbidity associated with colorectal cancer through advanced adenoma detection. Indicative of its breakthrough status, preliminary trials suggest that the diagnostic can detect these lesions at a higher rate than all existing noninvasive screening tests. Visit geneoscopy.com to learn more.
Geneoscopy Inc. Forward-Looking Statements
The information contained in this release includes information about Geneoscopy's future plans concerning its noninvasive molecular test that can detect colorectal cancer and precancerous adenomas, and as such constitute forward-looking statements. These forward-looking statements are based upon the Company's reasonable estimates of future results or trends. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. Geneoscopy's actual results and financial condition may differ materially from those indicated in the forward-looking statements. Although the Company believes that its business plans and objectives reflected in or suggested by these forward-looking statements are reasonable, such plans or objectives may not be achieved and the actual results may differ substantially from the projected results.
Geneoscopy Tackles Healthcare Disparities in Pivotal Colorectal Cancer Clinical Trial Utilizing a Digital Recruitment Strategy
Trial Enrollment Data Presented at 2022 ASCO Gastrointestinal Cancers Symposium
ST. LOUIS, Jan. 20, 2022 /PRNewswire/ -- Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced clinical trial recruitment findings from the CRC-PREVENT pivotal trial evaluating the safety and efficacy of its noninvasive, at-home diagnostic screening test to detect colorectal neoplasms, including advanced adenomas, in average-risk individuals. The data was highlighted in a poster at the 2022 ASCO Gastrointestinal Cancers Symposium being held in San Francisco from January 20-22. The poster can be viewed here.
The data demonstrated that use of a decentralized recruitment strategy – launched through a digital campaign – allowed for an efficient and more diverse participant enrollment in terms of race, ethnicity, socioeconomic status, and geography as compared with traditional clinical studies. Specifically, after three months of active enrollment, 32,934 eligible (as determined via a pre-screener survey) individuals – coming from all 48 continental United States – had expressed interest in participating in the CRC-PREVENT trial. Of these eligible individuals:
- 21% were Black or African American; 3% were Asian; and 1.6% were Native Hawaiian, Pacific Islander, American Indian, or Alaskan Native
- 9.4% identified as Hispanic or Latinx
- 33% had income under $29,999, and 18% were on Medicaid
- 3% were from rural areas
- 49% were female
- 15% were over the age of 65 years old
"Underrepresentation of women, minorities, and individuals with health disparities in clinical trials has been an ongoing challenge. For Americans, colorectal cancer represents the second leading cause of cancer death, despite being considered the most preventable type of cancer when screening is done effectively. Colorectal cancer disproportionately affects the Black community, where the rates are the highest of any racial/ethnic group in the U.S., with African Americans being 20 percent more likely to be diagnosed with colorectal cancer. The COVID-19 pandemic has highlighted the devastating impact of healthcare disparities, making it more critical than ever that data pertaining to the detection, prevention, or treatment of this cancer be representative of all individuals who could be impacted by it," stated Dr. Erica Barnell, Geneoscopy's co-founder and Chief Scientific Officer, and lead author on the poster. "We are proud that our patient-centric, digital recruitment strategy effectively led to the successful enrollment of a diverse participant population, which ultimately will provide data that is reflective of the intended use population for our noninvasive colorectal cancer screening tool."
About Colorectal Cancer & Screening
Responsible for over 50,000 deaths annually, colorectal cancer (CRC) is the second leading cause of cancer death in the United States. CRC usually begins as a growth (or polyp) that may or may not develop into cancer over time. Early detection and treatment are crucial to improve survival; however, many newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold-standard for CRC screening in the U.S., yet this method is frequently met with patient aversion due to its required bowel preparation, sedation, and associated discomfort, resulting in low patient compliance. Currently available noninvasive screening methods lack sufficient levels of sensitivity to reliably detect both early-stage CRC and high-risk precancerous lesions, including advanced adenomas which are a precursor in up to 70 percent of CRC cases.
About Geneoscopy Inc.
Geneoscopy Inc. is a life sciences company focused on the development of diagnostic tests for gastrointestinal health. Geneoscopy's lead diagnostic uses stool-derived eukaryotic RNA (seRNA) to detect colorectal cancer and precancerous adenomas. This device was awarded Breakthrough Device Designation from the U.S. FDA for its ability to reduce morbidity associated with colorectal cancer through advanced adenoma detection. Indicative of its breakthrough status, preliminary trials suggest that the diagnostic can detect these lesions at a higher rate than all existing noninvasive screening tests. Visit geneoscopy.com to learn more.
Geneoscopy Inc. Forward-Looking Statements
The information contained in this release includes information about Geneoscopy's future plans concerning its noninvasive molecular test that can detect colorectal cancer and precancerous adenomas, and as such constitute forward-looking statements. These forward-looking statements are based upon the Company's reasonable estimates of future results or trends. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. Geneoscopy's actual results and financial condition may differ materially from those indicated in the forward-looking statements. Although the Company believes that its business plans and objectives reflected in or suggested by these forward-looking statements are reasonable, such plans or objectives may not be achieved and the actual results may differ substantially from the projected results.
Geneoscopy Announces Positive Results of Colorectal Cancer Screening Test in Prospective, Multicenter Clinical Study
Study Results Show Diagnostic Accurately Detects Colorectal Cancer and Precancerous Adenomas With High Sensitivity
ST. LOUIS--(BUSINESS WIRE)--Geneoscopy Inc., a life sciences company that develops diagnostic tests for gastrointestinal health, today announced positive results of their diagnostic in detecting both colorectal cancer and precancerous adenomas in a large, multicenter prospective study. In particular, the observed detection rate of advanced adenomas offers novel capabilities for preventing the development of colorectal cancer, the second deadliest cancer in the United States.
“While preliminary, these results highlight that Geneoscopy’s RNA-FIT test can both detect and prevent cancer through sensitive identification of all colorectal neoplasias, which includes precancerous adenomas and early-stage cancers,” said Dr. Erica Barnell, Chief Scientific Officer at Geneoscopy. “This test will provide patients with an easy, safe, at-home screening tool that will facilitate compliance with screening guidelines and result in better health outcomes through high sensitivity for all clinically relevant colorectal lesions.”
Geneoscopy’s platform presentation at the Association for Molecular Pathology (AMP) 2020 Annual Meeting highlighted the robustness of the clinical trial that supported the RNA-FIT test’s preliminary accuracy. The prospective, multicenter clinical study used digital platforms to virtually recruit and enroll 1,305 participants who provided a stool sample to Geneoscopy prior to receiving a screening colonoscopy. The cohort matched the intended use population, and participants were recruited from 48 states with high representation of women, ethnic minorities, and rural populations. To supplement the prospective cohort, Geneoscopy also assessed a retrospective cohort of patients previously diagnosed with colorectal cancer. The aggregate results across all 1,322 patients are presented in the table below.
Sensitivity | Specificity | ||
Colorectal Cancer | Advanced Adenomas | Other Adenomas | No Findings |
95% | 60% | 25% | 85% |
The full presentation can be accessed via the portal for the AMP 2020 Annual Meeting which is being held virtually from November 16-20, 2020. A summary of the full presentation can be accessed through the Geneoscopy website.
About Colorectal Cancer
Colorectal cancer (CRC) is the second-deadliest cancer worldwide, accounting for over 50,000 deaths annually in the U.S. If detected early, CRC has a five-year survival rate of 92%. However, 63% of newly diagnosed patients have advanced disease, with an associated five-year survival rate as low as 14%. Disease onset may start as a small polyp that in several years may develop into an invasive carcinoma. Early detection of these polyps, as well as resection of precancerous adenomas via colonoscopy, significantly reduces morbidity and mortality associated with CRC. It is critically important to detect advanced adenomas, the most severe category of precancerous adenomas, during screening because of the high rate of transformation to malignant cancer.
About Geneoscopy Inc.
Geneoscopy Inc. is a life sciences company focused on the development of diagnostic tests for gastrointestinal health. Geneoscopy’s lead diagnostic uses stool-derived eukaryotic RNA (seRNA) to detect colorectal cancer and precancerous adenomas. This device was awarded a Breakthrough Device Designated from the FDA for its ability to reduce morbidity associated with colorectal cancer through advanced adenoma detection. Preliminary trials suggest that the diagnostic can detect these lesions at a higher rate than all existing noninvasive screening tests.
Web | www.geneoscopy.com
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Geneoscopy Inc. Forward-Looking Statements
The information contained in this release includes information about Geneoscopy’s future plans concerning its noninvasive molecular test that can detect colorectal cancer and precancerous adenomas, and as such constitute forward-looking statements. These forward-looking statements are based upon the Company’s reasonable estimates of future results or trends. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company’s control. Geneoscopy’s actual results and financial condition may differ materially from those indicated in the forward-looking statements. Although the Company believes that its business plans and objectives reflected in or suggested by these forward-looking statements are reasonable, such plans or objectives may not be achieved and the actual results may differ substantially from the projected results.
Geneoscopy Closes $105M in Financing to Advance its Noninvasive Multifactor RNA Screening Test for Colorectal Cancer Prevention
Funding to support U.S. CRC-PREVENT pivotal trial, scale commercial infrastructure, and expand diagnostic product pipeline
ST. LOUIS, Nov. 16, 2021 /PRNewswire/ -- Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced the closing of a Series B financing, raising a total of $105 million through a combination of debt and equity. The round is led by previous investors Lightchain Capital and NT Investments. Other investors in the round include Morningside Ventures, Labcorp, Cultivation Capital, BioGenerator Ventures, and Innovatus Capital Partners.
"We are extremely pleased to secure this financing with strong support from our previous and new investors. It reflects their confidence in our ability to address the significant unmet need within the colorectal cancer (CRC) screening market for a noninvasive means to not only accurately detect cancer at an early stage, but also advanced adenomas—pre-cancerous polyps that are most likely to become cancerous," said Andrew Barnell, Geneoscopy's co-founder and CEO. "As positive momentum continues to build for our pivotal and ongoing 10,000-patient trial, the team remains focused on ensuring a successful launch of our noninvasive multifactor RNA colorectal cancer screening test as a meaningful advancement in the fight to prevent colorectal cancer. Moreover, we have already made exciting progress towards broadening our diagnostic portfolio to address additional unmet needs within gastrointestinal health."
Unlike other noninvasive screening options that use DNA or blood-based biomarkers, Geneoscopy's proprietary method analyzes RNA extracted from patient stool samples to provide the phenotypic and quantitative information necessary to accurately detect precancerous lesions. Early detection is critical as it allows these lesions to be removed and prevents progression to cancer. The U.S. Food and Drug Administration (FDA) granted Geneoscopy's test its Breakthrough Device Designation in January 2020.
"Geneoscopy's multifactor RNA screening test shows great potential to provide increased sensitivity over current noninvasive screening methods to effectively and reliably detect both early-stage CRC and high-risk precancerous lesions, including advanced adenomas, which are a precursor in up to 70% of CRC cases," said Jason Dinges of Morningside. "We are pleased to join the other investors in this round and believe Geneoscopy's novel diagnostic approach is poised to shift the standard of care for CRC screening, lower cancer incidence in average-risk patients, and holds great promise to improve the management of additional gastrointestinal diseases."
Responsible for over 50,000 deaths annually, colorectal cancer is the second leading cause of cancer-related death in the United States.1 Disease progression begins with polyps that may develop into cancer over time. Early detection and treatment are crucial to improve survival. Unfortunately, most newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold standard for CRC screening in the U.S. However, this screening method is challenged with low patient compliance. This has only been exacerbated by the COVID-19 pandemic, which led to a more than 37% decline in CRC screenings. Noninvasive, at-home collection testing options, such as Geneoscopy's future test, have become increasingly important options to ensure patients receive the CRC screening they need.
To learn more about the CRC-PREVENT clinical trial and join the fight to help prevent colorectal cancer, visit https://cv.colonscreeningstudy.com/.
About Geneoscopy Inc.
Geneoscopy Inc. is a life sciences company focused on the development of diagnostic tests for gastrointestinal health. Geneoscopy's lead diagnostic uses stool-derived eukaryotic RNA (seRNA) to detect colorectal cancer and precancerous adenomas. This device was awarded Breakthrough Device Designation from the US FDA for its ability to reduce morbidity associated with colorectal cancer through advanced adenoma detection. Indicative of its breakthrough status, preliminary trials suggest that the diagnostic can detect these lesions at a higher rate than all existing noninvasive screening tests. Visit geneoscopy.com to learn more.
Geneoscopy Inc. Forward-Looking Statements
The information contained in this release includes information about Geneoscopy's future plans concerning its noninvasive molecular test that can detect colorectal cancer and precancerous adenomas, and as such constitute forward-looking statements. These forward-looking statements are based upon the Company's reasonable estimates of future results or trends. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. Geneoscopy's actual results and financial condition may differ materially from those indicated in the forward-looking statements. Although the Company believes that its business plans and objectives reflected in or suggested by these forward-looking statements are reasonable, such plans or objectives may not be achieved and the actual results may differ substantially from the projected results.
1Colorectal Cancer Fact Sheet, American Cancer Society, 2021.