Geneoscopy

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.

by Geneoscopy

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.

by Geneoscopy

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.

by Geneoscopy

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
Twitter | http://www.twitter.com/geneoscopyco
Facebook | https://www.facebook.com/GeneoscopyCo
LinkedIn | https://www.linkedin.com/company/geneoscopy

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.

by Geneoscopy

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.

¹Colorectal Cancer Fact Sheet, American Cancer Society, 2021.

by Geneoscopy

Geneoscopy Appoints Dr. Haytham Gareer as Chief Medical Officer

Seasoned medical affairs executive to advance company's diagnostics product pipeline

ST. LOUIS, Mo., Oct. 18, 2021 /PRNewswire/ -- Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced it has named Haytham Gareer, MD, Ph.D. to serve as the company's Chief Medical Officer. A trained surgical oncologist, Dr. Gareer brings two decades of medical and clinical affairs experience and will serve a critical role in Geneoscopy's efforts to launch its non-invasive, RNA-FIT colorectal cancer screening test. Additionally, he will focus on expanding Geneoscopy's portfolio of gastrointestinal diagnostics, leveraging its proprietary and innovative RNA biomarker technology platform.

"The COVID-19 pandemic has highlighted the importance of test sensitivity, as well as providing a means for convenient, at-home screening options, especially for cancer," commented Dr. Gareer. "Geneoscopy's novel approach utilizes RNA extracted from patient stool samples and provides the sensitivity necessary to detect pre-cancerous polyps and early-stage disease. Although the initial focus is on colorectal cancer detection and prevention, the company's robust platform has the potential to address a broad range of unmet needs in managing gastrointestinal conditions. I am excited to join this talented team and drive its mission forward."

Most recently, Dr. Gareer served as Vice President, Global Head of Medical and Clinical Affairs for Olympus Corporation, responsible for leading clinical research efforts, collaborations with key medical advisors, and providing critical insights to support commercialization and technology development across the company's broad portfolio of medical products. Before joining Olympus, he was a practicing surgeon and endoscopist with international experience in Egypt, Italy, and Japan. Dr. Gareer received his MD in surgical oncology from Cairo University, National Cancer Institute, Egypt, and a Ph.D. in Surgical Sciences and Hepatobiliary and Pancreatic Illnesses from the University of Verona, Italy. He holds a Masters in Minimal Invasive Surgical Technology from Italy, an MBA from Hult International Business School, and is currently completing a Masters in Applied Healthcare Economics and Outcomes Research from Jefferson University.

"We are pleased to welcome Haytham to the Geneoscopy team. He is a proven medical affairs leader with an impressive track record developing and executing successful clinical strategies, with key gastrointestinal clinical expertise," commented Andrew Barnell, Geneoscopy's co-founder and Chief Executive Officer. "It is a very exciting time for the company, and Haytham's expertise will be critical as we accelerate towards several key clinical and development milestones."

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.

by Geneoscopy

Geneoscopy Honored by Goldman Sachs for Entrepreneurship

Andrew Barnell, CEO, Among 100 Most Intriguing Entrepreneurs at 2021 Builders + Innovators Summit

ST. LOUIS, Oct. 13, 2021 /PRNewswire/ – Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced that Goldman Sachs (NYSE: GS) is recognizing the company's co-founder and CEO, Andrew Barnell, as one of the 100 Most Intriguing Entrepreneurs of 2021 at its Builders + Innovators Summit in Healdsburg, California.

Goldman Sachs selected Barnell as one of 100 entrepreneurs from multiple industries to be honored at the two-day event. Barnell began his career with J.P. Morgan's healthcare investment banking group, working primarily on M&A and capital markets transactions. Prior to co-founding Geneoscopy, he was an associate at Lindsay Goldberg, a middle-market private equity firm focused on partnering with family-owned businesses. Barnell holds a BA in Applied Economics and Management, with a specialization in Finance, from Cornell University and earned an MBA in Health Care Management and Entrepreneurial Management from The Wharton School.

"We are honored to have Andrew recognized as part of this distinguished group of entrepreneurs," commented Vince Wong, Geneoscopy's Chief Commercial Officer. "With an initial focus on colorectal cancer prevention, Geneoscopy's technology is poised to transform gastrointestinal health by enabling earlier detection, more accurate diagnosis, and more effective therapeutic management. It is exciting to have Andrew's vision for the company recognized, validating the significant impact it will have on shaping the future of gastrointestinal health."

"Innovation doesn't happen just anywhere; it thrives where there's a wide range of thoughts and perspectives," said David M. Solomon, Chairman & CEO of Goldman Sachs. "One of our great strengths is our ability to bring together people from different walks of life and to spark conversations today that will lead to breakthroughs tomorrow. The leaders we've chosen to highlight at our Builders + Innovators Summit are truly remarkable, and we are pleased to recognize Andrew as one of this year's most intriguing entrepreneurs."

In addition to honoring 100 entrepreneurs, the summit consists of general sessions and clinics led by seasoned entrepreneurs, academics, and business leaders as well as resident scholars.

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.

by Geneoscopy

Geneoscopy Enrolls First Patients in CRC-PREVENT U.S. Pivotal Trial

Clinical Trial Investigates Company's Noninvasive Multifactor RNA Screening Test for Colorectal Cancer Prevention

ST. LOUIS, July 12, 2021 /PRNewswire/ -- Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced the enrollment of its first patients in the CRC-PREVENT pivotal trial. The clinical study seeks to evaluate the safety and efficacy of Geneoscopy's noninvasive, at-home diagnostic screening test to successfully detect colorectal neoplasms, including advanced adenomas, in average-risk individuals, a group with no known co-morbidities associated with cancer risk and therefore more challenging to diagnose. The company's innovative diagnostic was granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) in January of 2020.

**Geneoscopy Multi-Factor RNA-Fit Test**

"We are pleased to initiate this important study and validate the use of Geneoscopy's RNA-FIT assay as a valuable noninvasive tool to help prevent cancer through routine colorectal cancer screening," commented Dr. Erica Barnell, Geneoscopy's co-founder and Chief Scientific Officer. "The ultimate goal of colorectal screening is cancer prevention, but this requires diagnostic screening options with the sensitivity to identify clinically relevant pre-cancerous lesions, including advanced adenomas. The RNA-FIT assay aims to deliver the necessary sensitivity and specificity in a simple, at-home collection kit."

The prospective, single-arm study will enroll more than 12,000 patients across all 48 contiguous United States. Patients will submit samples via the mail and subsequently undergo optical colonoscopy examination. All significant lesions discovered during colonoscopy will be biopsied or removed and sent for histopathology. A comparative analysis will be conducted to determine sensitivities and specificities, 00as applicable, for colorectal cancer, advanced adenomas, non-advanced adenomas, benign hyperplastic polyps, and colonoscopies without findings.

"When it comes to detecting advanced adenomas, noninvasive tests are not currently hitting a 50% threshold. Until now, only colonoscopy can detect advanced adenomas reliably," commented Dr. David Lieberman, Professor of Medicine, Division of Gastroenterology and Hepatology at the Oregon Health Sciences University School of Medicine. "A noninvasive, at-home option that successfully detects these pre-cancerous lesions would represent an important, positive step in early detection for colorectal cancer prevention."

Geneoscopy's initial clinical study demonstrated high sensitivity of its multifactor RNA-FIT assay compared with colonoscopy findings, demonstrating 95% sensitivity for colorectal cancer, 62% sensitivity for advanced adenomas, and 25% sensitivity for other non-advanced adenomas with an 85% specificity for no findings on a colonoscopy. The promising data was previously presented by Dr. Barnell, at the Association for Molecular Pathology (AMP) 2020 Annual Meeting and the peer-reviewed article recently published in Clinical and Translational Gastroenterology.

Responsible for over 50,000 deaths annually, colorectal cancer (CRC) is the second leading cause of cancer related death in the United States.¹Disease progression begins with polyps that may or may not develop into cancer over time. Early detection and treatment are crucial to improve survival; however, most newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold-standard for CRC screening in the US, 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 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.

To learn more about the CRC-PREVENT clinical trial and join in the fight to help prevent colorectal cancer, visit https://cv.colonscreeningstudy.com/.

¹Colorectal Cancer Fact Sheet, American Cancer Society, 2021.

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.

by Geneoscopy

Geneoscopy Announces Publication of Peer-Reviewed Article Highlighting Effective Noninvasive Screening Test for Colorectal Cancer Prevention

ST. LOUIS--(BUSINESS WIRE)--Geneoscopy Inc. today announced publication of the peer-reviewed article, “Multitarget Stool RNA Test for Noninvasive Detection of Colorectal Neoplasias in a Multicenter, Prospective, and Retrospective Cohort”, which presents the results of its multifactor RNA-FIT test in Clinical and Translational Gastroenterology. The article reports high sensitivity of the company’s noninvasive, at-home diagnostic screening test to successfully detect colorectal neoplasms, including advanced adenomas, in average-risk individuals within the intended use population for colorectal cancer screening. The promising data was previously presented by Dr. Erica Barnell, Geneoscopy’s co-founder and Chief Scientific Officer, at the Association for Molecular Pathology (AMP) 2020 Annual Meeting.

In comparative analysis versus colonoscopy findings, the RNA-FIT assay demonstrated 95% sensitivity for colorectal cancer, 62% sensitivity for advanced adenomas, and 25% sensitivity for other non-advanced adenomas with an 85% specificity for no findings on a colonoscopy. The prospective study included 1,305 average risk patients and was supplemented with a 22-patient retrospective cohort of patients who were diagnosed with advanced adenomas or colorectal cancer but were sampled prior to treatment or surgical resection. All patients were evaluated with the RNA-FIT assay and an optical colonoscopy.

The RNA-FIT assay was evaluated under a robust study design. Samples were collected from individuals across all 48 contiguous United States and individuals were evaluated at over 600 different endoscopy sites. The study design will be replicated in Geneoscopy’s CRC-PREVENT Clinical Trial, which is currently underway.

“Colorectal cancer can be prevented with early detection of advanced adenomas. Screening compliance is key, and simple, at-home collection kits are emerging as an attractive option. However, it is critical that a diagnostic test has the necessary sensitivity to identify clinically relevant lesions early,” commented Dr. Barnell. “We are pleased to share results of this study and look forward to building upon this body of evidence to support the use of Geneoscopy’s RNA-FIT assay as a valuable noninvasive tool to help prevent cancer through routine colorectal cancer screening.”

Responsible for over 50,000 deaths annually, colorectal cancer (CRC) is the second leading cause of cancer related death in the United States.¹ Disease progression begins with polyps that may or may not develop into cancer over time. Early detection and treatment are crucial to improve survival; however, the majority of newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold-standard for CRC screening in the US, yet this method is frequently met with patient aversion due to its required bowel preparation, sedation, and associated discomfort, which results in low patient compliance. Currently available noninvasive screening methods lack sufficient levels of sensitivity 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.

The article is currently available online and is scheduled to be published in the May 2021 issue.

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

¹Colorectal Cancer Fact Sheet, American Cancer Society, 2021.

by Geneoscopy