Geneoscopy Signs Multi-Year Agreement with Labcorp to Distribute Noninvasive Multi-Target Stool RNA (mt-sRNA) Colorectal Cancer Screening Test
Collaboration expected to increase provider and patient access to potentially life-saving colorectal cancer screening that enables earlier disease detection
ST LOUIS, MO – November 14, 2023 – Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced a strategic collaboration with Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services. This multi-year agreement will increase access to Geneoscopy’s next-generation colorectal cancer screening test, which offers at-home collection and high sensitivity for early cancer detection. Geneoscopy’s test is under FDA review. Once approved by the FDA, Labcorp will offer the test, which will be performed by Geneoscopy, enabling health care customers to conveniently order it through Labcorp as part of their comprehensive screening programs.
“Colorectal cancer is one of the most preventable cancers, yet millions of eligible Americans do not get screened as directed by guidelines,” said Vince Wong, Chief Commercial Officer at Geneoscopy. “Working with Labcorp, an organization trusted daily by thousands of clinicians and millions of patients, is an incredible opportunity to expand patient and clinician access to our noninvasive screening test. Given Labcorp’s extensive access to communities across the country, we believe this collaboration will help reduce the barriers to screening and address health inequities.”
Although colorectal cancer ranks second in U.S. cancer-related deaths overall and is the leading cause of cancer death in men younger than 50, research indicates a large proportion of colorectal cancer incidence and mortality is preventable through regular screening, surveillance and high-quality treatment. Adding to this challenge, colorectal cancer incidence trends are rapidly shifting the patient population to younger individuals; 20% (1 in 5) of colorectal cancers in 2019 were in people 54 years or younger, up from 11% (1 in 10) in 1995, and over the past decade, incidence has increased for advanced disease, especially in people younger than 65 years of age. Geneoscopy’s technology offers this age group convenient at-home test collection with the highest sensitivity currently available for non-invasive CRC screening.
“This agreement builds on Labcorp’s commitment to bring the latest advancements in cancer screening and diagnostic testing to healthcare providers and patients,” said Dr. Brian Caveney, Chief Medical and Scientific Officer at Labcorp. “Geneoscopy’s highly sensitive colorectal cancer screening test, once approved, will be another innovative, accessible and reliable option available to providers and patients nationwide for the detection of colorectal cancer.”
Geneoscopy’s multi-target stool RNA (mt-sRNA) biomarker panel is designed to detect precancerous lesions and colorectal cancer. The company has submitted a Premarket Approval Application (PMA) to the FDA based on the favorable results from the pivotal CRC-PREVENT trial, in which Geneoscopy’s test demonstrated high sensitivity for CRC and advanced adenomas. Notably, for younger participants (ages 45 to 49), sensitivity for CRC was 100%. These results are the highest reported for any noninvasive CRC screening test in any prospective registrational clinical study completed to date.
About Geneoscopy, Inc.
Geneoscopy Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy’s mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. Beyond colorectal cancer screening, Geneoscopy is developing tests for diagnosis, treatment selection, and therapy monitoring in other disease areas in partnership with leading universities and biopharmaceutical companies. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.
Geneoscopy Inc. Forward-Looking Statements
This release includes information about Geneoscopy’s future plans concerning its noninvasive molecular test that can detect colorectal cancer and precancerous adenomas, which 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, many of which are outside the Company’s control. Geneoscopy’s actual results and financial condition may differ materially from those in the forward-looking statements. Although the Company believes its business plans and objectives reflected in or suggested by these forward-looking statements are reasonable, such plans or objectives may not be achieved. The actual results may differ substantially from the projected result.
Geneoscopy Contact
Judy Pretto, Director-Communications
judy.pretto@geneoscopy.com
Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com
Investor Contact
Carrie Mendivil / Ji-Yon Yi
Gilmartin Group
investors@geneoscopy.com
GI Oncology Today: Multitarget Stool RNA Test Proves Sensitive for Colorectal Cancer, Advanced Adenomas
Erica Barnell, MD, PhD, of Washington University School of Medicine, and founder of Geneoscopy Inc, describes the multitarget stool RNA “ColoSense” test and the CRC-PREVENT study that demonstrated its superior sensitivity and specificity in comparison to traditional colonoscopy.
Originally published in GI Oncology Now | November 7, 2023
Why did you found Geneoscopy and develop the multitarget stool RNA “ColoSense” test?
Dr. Barnell: In 2014, when I entered the MD-PhD program, I was deeply involved in developing technology in the microbiome labs at Wash University. During my clinical rotations, I had a pivotal encounter with an individual who was diagnosed with stage 4 colorectal cancer. This encounter made me realize that in a time when we can sequence the human genome in just 24 hours, we should be able to offer alternative solutions for individuals who either cannot undergo a colonoscopy or for whom it does not align with their lifestyle. This realization inspired me to establish Geneoscopy with the goal of leveraging the microbiome research I had been involved in to improve healthcare solutions for individuals, providing them with options that align with their lifestyles and preferences.
Please detail the CRC-PREVENT study. What kind of patients did you enroll, from where were they sampled, and what were ColoSense test samples compared against?
Dr. Barnell: The ColoSense pivotal study, known as CRC-PREVENT, was a cross-sectional prospective pivotal trial designed to support a pre-market approval application to the FDA. This study was unique in how we recruited patients. We utilized social media advertising to reach patients where they are. Once a patient expressed interest and enrolled in the clinical trial, we would send them a stool sample collection kit, which they would use to provide a stool sample. They would then send the sample back to our laboratory. Afterward, we would facilitate their access to a follow-up colonoscopy. We compared the results of the ColoSense test, whether it was positive or negative, with the results of the colonoscopy to assess the test’s sensitivity for colorectal cancer, sensitivity for advanced adenomas, and specificity for detecting no findings on a colonoscopy.
How did you go about identifying your target participants for the ColoSense test on social media?
Dr. Barnell: Our approach to identifying target participants for the ColoSense test on social media was to target a representative cohort of the approximately 150 million average-risk Americans recommended for colorectal cancer screening. We aimed to include typical individuals over the age of 45 in our study. By employing a decentralized recruitment model, we aimed to obtain a more accurate representation of the population in need of colorectal cancer screening. Instead of relying on site-based recruitment, we were able to reach individuals who had no colonoscopy scheduled at the time of enrollment and who had never previously undergone a colonoscopy or noninvasive screening. Our study targeted individuals who may not have been aware of colorectal cancer screening options or who could not undergo invasive procedures like colonoscopies. These are the individuals for whom ColoSense testing is designed, those who may not be familiar with or cannot tolerate traditional screening methods.
What was the success rate among patients enrolled for undergoing the ColoSense test and getting the colonoscopy?
Dr. Barnell: Through our online enrollment process, we engaged with over 275,000 individuals. Out of that large pool, we identified approximately 14,000 individuals who met our criteria as average-risk, asymptomatic individuals over the age of 45. Among these, around 85% successfully provided a viable ColoSense test to our laboratory. Afterward, about 85% of these patients were successfully guided to undergo a colonoscopy.
What did you find in terms of the sensitivity and specificity of ColoSense testing versus colonoscopy?
Dr. Barnell: In terms of sensitivity and specificity, the ColoSense test showed impressive results when compared to colonoscopy. We achieved the highest sensitivity for colorectal cancer at 94.4%, which is a remarkable outcome. Our test also demonstrated the highest reported sensitivity for advanced adenomas, standing at 46%. Furthermore, the specificity of the ColoSense test for identifying no findings during a colonoscopy was 88%. These results indicate that ColoSense is a highly effective noninvasive screening option for colorectal cancer.
How scalable is the ColoSense test to be commonly used as a noninvasive colorectal cancer screening option?
Dr. Barnell: The ColoSense test has been developed with scalability in mind. We have submitted the data from the pivotal study to the FDA as part of a pre-market approval application. Currently, the FDA is reviewing the data, and we anticipate receiving their decision within the next 3 months. Once we receive FDA approval, we plan to launch the ColoSense test commercially, making it available to healthcare providers and patients. We have established a partnership with a large decentralized laboratory, which will allow us to successfully commercialize this test and reach the 150 million Americans who require colorectal cancer screening. The scalability of the ColoSense test makes it feasible to become a widely used noninvasive colorectal cancer screening option.
Do you believe other “decentralized recruitment efforts” based on regulatory guidance should be used for future trials involving population health screening?
Dr. Barnell: I believe that our decentralized recruitment model has the potential to be a game-changer for future population health screening trials. Our approach offers significant advantages in terms of reaching a diverse and representative cohort, addressing disparities, and ensuring that individuals who traditionally have been underrepresented in clinical trials have the opportunity to participate. The success of our model has even prompted the FDA to produce guidance on the use of decentralized recruitment for clinical trials, which highlights its significance. I hope that our experience will serve as an example for other companies and clinical trials to conduct studies with inclusivity and diversity in mind.
Are there any other takeaways from the ColoSense test or CRC-PREVENT that you would like to add?
Dr. Barnell: Another noteworthy takeaway from the ColoSense test and the CRC-PREVENT study is the high sensitivity and specificity observed in the younger age population (ages 45 to 50). This is particularly significant because colorectal cancer screening recommendations now include individuals aged 45 and above. In our study, approximately 22% of the cohort fell within this age group. We observed 100% sensitivity for colorectal cancer and 45% sensitivity for advanced adenomas in this age bracket. This provides robust evidence that ColoSense testing can effectively screen patients in the 45 to 50 age range noninvasively, offering a valuable option for early detection in this population.
JAMA Publishes Geneoscopy’s Pivotal CRC-PREVENT Trial Results, Reporting Highest Sensitivity for Detecting Colorectal Cancer and Advanced Adenomas Among Available Noninvasive Screening Tests
- Geneoscopy’s noninvasive, multi-target, stool RNA (mt-sRNA) colorectal cancer screening test showed extraordinary sensitivity for detecting early-stage (Stage 1) colorectal cancer at 100% and advanced adenomas at 46%
- Sensitivity for CRC was 100% among individuals ages 45 to 49, an age group now recommended for screening given the rapid rise of early onset CRC
- Study will be presented at the American College of Gastroenterology 2023 Annual Meeting
ST LOUIS, MO. – Oct. 23, 2023 – Geneoscopy Inc., a life sciences company focused on developing diagnostic tests for gastrointestinal health, announced a publication in The Journal of the American Medical Association (JAMA), highlighting the company’s pivotal CRC-PREVENT trial results. The novel study will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Vancouver, Canada, October 20-25, showcasing its highly sensitive screening test for colorectal cancer (CRC) and advanced adenomas (AA). The company will also present findings from its inflammatory bowel disease research at the meeting.
“Although colorectal cancer is the second deadliest cancer in the U.S., millions of eligible Americans do not get screened due to a lack of access or avoidance of invasive options like colonoscopies,” said Erica Barnell, MD, PhD, Chief Science and Medical Officer at Geneoscopy. “Geneoscopy is dedicated to addressing this challenge and improving access to a reliable, noninvasive CRC screening test, especially as incidence is rising among younger populations. Providing reliable tools for early detection allows providers to intervene and start treatment earlier, potentially saving patients’ lives.”
The CRC-PREVENT trial evaluated 8,920 participants (ages 45 and older) using Geneoscopy’s novel mt-sRNA test. CRC was detected with 94% sensitivity, including 100% sensitivity for early-stage (Stage I) CRC. The test also detected AAs with a 46% sensitivity, rising to 50% for AAs over two centimeters in size. Notably, for younger participants (ages 45 to 49), CRC sensitivity was 100% and AA sensitivity was 45%. The study published in JAMA, “CRC-PREVENT: Multi-target Stool RNA Test for Colorectal Cancer Screening,” will be presented at ACG by study co-author David Lieberman, MD, Oregon Health & Science University.
“CRC rates are climbing among younger populations less than 50 years old, prompting a recent shift in screening guidelines from the USPSTF to initiate screening at age 45 years. There is a notable gap in data regarding the efficacy of noninvasive screening tests for this age group, including the sensitivity for colorectal cancer (CRC) and advanced adenomas,” said Dr. Lieberman. “This prospective pivotal study of a new stool-derived RNA test demonstrates excellent sensitivity for CRC and advanced adenomas across the entire age spectrum of adults eligible for CRC screening, including ages 45 to 49. Geneoscopy’s technology can potentially provide millions of people with a convenient and reliable option for detecting and preventing CRC.”
Geneoscopy will also present results at ACG from a recent study predicting therapeutic response and monitoring for mucosal healing for patients with Inflammatory Bowel Disease (IBD) using the company’s RNA technology.
“Geneoscopy’s research and development efforts come at a critical time when 60-70 million Americans suffer from GI diseases, including CRC and IBD,” said Vince Wong, JD, MBA, Chief Commercial Officer at Geneoscopy. “These studies are an example of our commitment to drive research and product development leveraging our proprietary RNA technology to help prevent, detect, monitor, and improve treatment for gastrointestinal diseases.”
Geneoscopy has submitted a Premarket Approval Application (PMA) to the FDA for its noninvasive, multi-target, stool RNA (mt-sRNA) colorectal cancer screening test.
Geneoscopy’s Presentations at ACG 2023
Oral Presentation: CRC-PREVENT: Multi-target Stool RNA Test for Colorectal Cancer Screening
Session: Plenary Session 3B – General Endoscopy / Practice Management / Colorectal Cancer Prevention
Date & Time: Tuesday, October 24, 2023, from 2:25–2:35 p.m. PT (UTC -7)
Location: Ballroom B
Scientific Poster Presentation: Stool-derived Eukaryotic RNA Biomarkers for Predicting Therapeutic Response and Monitoring Mucosal Healing for Patients with Inflammatory Bowel Disease
Session: Scientific Poster Session – Open & Authors Present
Date & Time: Sunday, October 22, 2023, from 3:30–7 p.m. PT (UTC -7)
Location: Exhibit Hall
About CRC-PREVENT Trial
CRC-PREVENT was a pivotal prospective, single-arm study designed to evaluate the efficacy of Geneoscopy’s noninvasive, at-home diagnostic screening test to detect colorectal cancer and advanced adenomas in average-risk individuals aged 45 years and older. Using a collection kit, participants submitted self-collected stool samples via express delivery and underwent an optical colonoscopy examination. All significant lesions discovered during the colonoscopy were biopsied or removed and sent for histopathology. A comparative analysis was conducted to determine sensitivities and specificities for colorectal cancer, advanced adenomas, non-advanced adenomas, benign hyperplastic polyps, and colonoscopies with no findings.
About Geneoscopy, Inc.
Geneoscopy Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy’s mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. Beyond colorectal cancer screening, Geneoscopy is developing tests for diagnosis, treatment selection, and therapy monitoring in other disease areas in partnership with leading universities and biopharmaceutical companies. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.
Geneoscopy Inc. Forward-Looking Statements
This release includes information about Geneoscopy’s future plans concerning its noninvasive molecular test that can detect colorectal cancer and precancerous adenomas, which 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, many of which are outside the Company’s control. Geneoscopy’s actual results and financial condition may differ materially from those in the forward-looking statements. Although the Company believes its business plans and objectives reflected in or suggested by these forward-looking statements are reasonable, such plans or objectives may not be achieved. The actual results may differ substantially from the projected result.
Media Contact
Judy Pretto
Director, Marketing Communications
815.534.0521
media@geneoscopy.com
Geneoscopy to Present and Exhibit at American College of Gastroenterology 2023 Annual Meeting
Company to Showcase Its Noninvasive RNA-based Technology Platform Designed to Improve Diagnostic Tools for Gastrointestinal Health
ST LOUIS, MO – Oct. 5, 2023 – Geneoscopy Inc., a life sciences company focused on developing diagnostic tests for gastrointestinal health, will present at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting in Vancouver, Canada, Oct. 20-25, highlighting how its novel platform technology is being used to develop noninvasive diagnostic and precision medicine tools for gastrointestinal (GI) diseases, such as colorectal cancer (CRC) and inflammatory bowel disease (IBD). The company will also feature its technology at booth #908.
Oral Presentation | Session Details
Session: Plenary Session 3B – General Endoscopy / Practice Management / Colorectal Cancer Prevention
Date & Time: Tuesday, October 24, 2023 from 2:25–2:35 p.m. PT (UTC -7)
Location: Ballroom B
Click here for full details
Scientific Poster Presentation | Session Details
Session: Scientific Poster Session – Open & Authors Present
Date & Time: Sunday, October 22, 2023 from 3:30–6:30 p.m. PT (UTC -7)
Location: Exhibit Hall
Click here for full details
“We are excited about this year’s ACG Scientific Meeting and look forward to sharing the results of our studies with the gastrointestinal (GI) community,” said Erica Barnell, Geneoscopy’s Chief Science and Medical Officer. “We firmly believe that our technology addresses the pressing need for expanded access to more convenient and accurate screening options for CRC and will enable a precision medicine approach to GI disease management and treatment.”
Geneoscopy’s research and development efforts come at a critical time when 60-70 million Americans suffer from GI diseases, including CRC and IBD. Despite declining incidence in the overall population, CRC is increasing amongst individuals under 55 and shifting to a more advanced disease. This trend should motivate everyone 45 and older to get screened. Additionally, despite a significant focus on improving care for the estimated 2.9M people diagnosed with IBD, clinicians and patients lack effective noninvasive tools for therapy selection and disease monitoring.
Geneoscopy is leveraging its novel RNA-based technology platform to address these challenges to develop noninvasive diagnostic and precision medicine tools for GI diseases. The company’s at-home colorectal cancer screening test is designed to detect high-risk precancerous lesions (advanced adenomas) and CRC in average-risk individuals. It received the U.S. Food and Drug Administration’s Breakthrough Device designation in 2020 and has been submitted to the FDA for Premarket Approval.
“Geneoscopy is focused on providing innovative screening and diagnostic tests to help empower patients and providers to transform gastrointestinal health,” said Andrew Barnell, CEO of Geneoscopy. “Given the promise of our technology, we are confident that our pipeline of tests can address gaps in care for patients who critically need noninvasive diagnostics solutions. We want to meet patients where they are with accessible, convenient, and highly accurate tools that fit into their busy lives.”
About Geneoscopy, Inc.
Geneoscopy Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy’s mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. Beyond colorectal cancer screening, Geneoscopy is developing diagnostic tests, treatment selection, and therapy monitoring in other disease areas in partnership with leading universities and biopharmaceutical companies. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.
Geneoscopy Inc. Forward-Looking Statements
This release includes information about Geneoscopy’s future plans concerning its noninvasive molecular test that can detect colorectal cancer and precancerous adenomas, which 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, many of which are outside the Company’s control. Geneoscopy’s actual results and financial condition may differ materially from those in the forward-looking statements. Although the Company believes its business plans and objectives reflected in or suggested by these forward-looking statements are reasonable, such plans or objectives may not be achieved. The actual results may differ substantially from the projected result.
Media Contact
Judy Pretto
Director, Marketing Communications
815.534.0521
media@geneoscopy.com
Geneoscopy CEO Andrew Barnell to Present at the Morgan Stanley 21st Annual Global Healthcare Conference
“…We believe that our pipeline of tests will enable a precision medicine approach to GI disease management and treatment, bringing value to healthcare stakeholders, most importantly, patients.”
Andrew Barnell, Geneoscopy CEO and co-founder
ST LOUIS – Sept. 6, 2023 – Geneoscopy Inc., a life sciences company focused on developing diagnostic tests for gastrointestinal health, today announced that Chief Executive Officer and Co-founder Andrew Barnell, MBA, will be presenting at the Morgan Stanley Global Healthcare Conference in New York, NY, on Monday, Sept. 11, at 2:15 p.m. Eastern Time.
Geneoscopy’s research and development efforts come at a critical time when 60-70 million Americans suffer from gastrointestinal (GI) diseases, including colorectal cancer (CRC) and inflammatory bowel disease (IBD). Many Americans do not get screened for CRC—often due to a lack of access or avoidance of invasive options like colonoscopies, resulting in increased incidence and mortality rates.
In addition, a recent study found that nearly 1 in 100 Americans suffer from IBD, with an estimated 2.39 million diagnosed. Although many IBD therapies are available and in development, clinicians and patients lack effective tools for therapy selection and monitoring to help ensure patients benefit from prescribed therapies.
To address these challenges, Geneoscopy is leveraging its novel platform technology to develop noninvasive diagnostic and precision medicine tools for GI diseases.
“We are pleased to be presenting at Morgan Stanley’s Annual Global Healthcare Conference to share the promising market opportunities for our proprietary RNA biomarker platform and high-value diagnostic tests,” said Andrew Barnell, CEO and Co-founder of Geneoscopy. “Our mission to transform gastrointestinal health begins by addressing the pressing need to expand access to more convenient and accurate screening options for CRC. And we believe that our pipeline of tests will enable a precision medicine approach to GI disease management and treatment, bringing value to healthcare stakeholders, most importantly, patients.”
Geneoscopy’s noninvasive, multi-target, stool RNA (mt-sRNA) colorectal cancer screening test received U.S. Food and Drug Administration’s (FDA) Breakthrough Device designation in 2020 and has been submitted to the FDA for Premarket Approval (PMA). This at-home screening test is designed to detect high-risk precancerous lesions (advanced adenomas) and CRC in average-risk individuals. In its pivotal CRC-PREVENT clinical trial, the test demonstrated 94% sensitivity for CRC and 46% sensitivity for advanced adenomas. These results are the highest reported for any noninvasive CRC screening test in any prospective registrational clinical study completed to date.
About Geneoscopy, Inc.
Geneoscopy Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy’s mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. Beyond colorectal cancer screening, Geneoscopy is developing tests for diagnosis, treatment selection, and therapy monitoring in other disease areas in partnership with leading universities and biopharmaceutical companies. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.
Geneoscopy Inc. Forward-Looking Statements
This release includes information about Geneoscopy’s future plans concerning its noninvasive molecular test that can detect colorectal cancer and precancerous adenomas, which 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, many of which are outside the Company’s control. Geneoscopy’s actual results and financial condition may differ materially from those in the forward-looking statements. Although the Company believes its business plans and objectives reflected in or suggested by these forward-looking statements are reasonable, such plans or objectives may not be achieved. The actual results may differ substantially from the projected result.
Media Contact
Judy Pretto
Director, Marketing Communications
815.534.0521
media@geneoscopy.com
Closing the Gap: Why Healthcare Needs More Gender Diversity in Leadership
"Embrace your flaws: Everyone has flaws. I feel that I have been successful because I am able to recognize these flaws, understand where I need help, and fill in the gaps with resources and other people who are better than me in those areas. If you always assume you know everything or are always making the right decision you will be opening yourself up to failure in so many ways."
Dr. Erica Barnell, Chief Science Officer and co-founder of Geneoscopy Tweet
Original interview - published in Health Care IT Today | July 26, 2023
Women comprise 70% of the healthcare workforce and 59% of medical, biomedical, and health sciences graduates, yet are the minority at leadership levels — holding only 25% of senior executive roles. As a result, the lack of women in significant decision-making positions is evident.
According to U.S. Census estimates, no single ethnic or racial group will represent a majority of the U.S. population by 2055. The potential for more positive patient care experiences, greater innovation, and improved organizational performance exists by creating more balance in healthcare leadership.
Existing Disparities and Challenges
Over a century ago, women founded, led, and operated hospitals. Today, they comprise most of the healthcare workforce — but not in leadership positions.
Women represent only 25% of top leadership roles in healthcare while holding an even lower percentage of corporate board seats (~14%) for publicly held life sciences companies. Within privately held companies, these numbers are even more underwhelming.
Despite significant advancements, we have a long way to go to address existing gender disparities in education and careers within STEM. As few as ten years ago, I was one of only a handful of women scientists in research labs and often the only woman in the boardroom. During presentations, I was asked more questions about my personal life than my business ideas — questions I have never heard asked of my male peers. Additionally, when defending research results, questions were often directed to my male peers even though I was the subject matter expert.
Gender Bias in Medical Research
Women’s health is often considered a niche area. But how can half the world’s population be considered niche? Of the nearly $42 billion the National Institute of Health (NIH) funds annually on health research, only $5 billion is spent studying women’s health issues in research labs led by men.
These numbers are consistent with female representation in clinical trials. On average, 41.2% of study participants are female. This number is often lower than the number of females typically diagnosed with the disease being studied. Unconscious biases can also significantly impact gender and racial equity in research studies. For example, a recent study showed that 80% of black women with breast cancer expressed willingness to participate in clinical trials; however, only 40% were included.
In colorectal cancer research, clinical studies have traditionally been held at large academic or endoscopy centers where patients typically have a colonoscopy scheduled, are health literate, and have insurance. This sample does not accurately reflect the population most at risk for developing colorectal cancer due to a lack of screening.
Researchers must adopt alternatives to traditional research methods to impact health equity positively. One approach is using decentralized recruitment efforts for clinical trials to support engaging diverse populations at greater risk for disease. For example, using social media to recruit study participants can help reach underserved communities and requires a low marketing dollar commitment. Decentralizing clinical trials can improve prevention and treatment for all populations, particularly racially and ethnically diverse communities.
The Importance of Women Leaders in Healthcare
Decades of research have shown that when women leaders are empowered to lead, everyone benefits. Fiscally, studies indicate that companies with women in top leadership positions are valued at $42 million higher than other companies. They generate a 10.1% return on equity annually versus 7.4% for those without female leadership.
When looking beyond the bottom line, including women in a leadership team increases a company’s global human capital wealth by 22%, with substantial health, social, and economic gains. The presence of women leaders helps achieve better results, including increased productivity, improved collaboration, greater commitment, and a fair work experience. Women are considered encouraging in a collaborative environment and are more honest, compassionate, outgoing, and creative.
What Does the Future Hold?
We are already seeing glimpses into the future with advances in digital technologies, including artificial intelligence, virtual and augmented reality, 3D printing, robotics, gene sequencing, and nanotechnology. As this unfolds, healthcare leaders must hire, train, and lead increasingly diverse teams of healthcare professionals along with teams from product development, training, tech, engineering, and manufacturing/construction to ensure inclusivity. But most importantly, leadership must align all decisions and directions to ensure the patient always comes first.
Witt/Kieffer discovered that 84% of survey respondents agreed that one of the best ways to support these endeavors is to establish mentorship programs that track to leadership roles. They offered these tips to create a successful mentorship program:
- Provide role models that help with advancement
- Develop a robust mentorship program
- Create internship opportunities
Advice For Future Women Healthcare Leaders
Trying to live up to someone else’s ideals will only cause you to sacrifice your own and block your path to the top. To be the best version of yourself, which includes being a fantastic leader, set your expectations and live up to those.
Here are three pieces of advice to guide you both personally and professionally:
- Be resilient and have humility: Adversity is a given. Keeping a positive attitude, being optimistic, controlling emotions, and seeing obstacles and failures as opportunities are keys to learning, improving, and growing.
- Look for opportunities, take risks, push yourself, and go for it: Successful leaders are proactive. Don’t wait for others to reach out to you – build and develop the relationships you need to make your goals happen.
- Success means finding YOUR balance: Life and work are often not in harmony in the real world. Living a successful and balanced life is more about knowing what motivates you and having tough conversations with people who matter most in your life.
While things are improving, there’s work ahead to close the gender gap in healthcare leadership. Prioritizing an inclusive and safe environment where people acknowledge the experience and expertise of women at all levels is essential to creating the culture shift necessary to make change happen throughout our industry.
About Erica Barnell
Erica Barnell graduated from Cornell University with a dual degree in Biological Sciences and Applied Economics & Management. Dr. Barnell completed her MD PhD at the Washington University School of Medicine with a PhD focus in Molecular Genetics and Genomics. Her thesis work surrounded the development of bioinformatics tools to alleviate the analysis bottleneck within precision oncology. Dr. Barnell has published 24 peer-reviewed manuscripts, four patents, and two book chapters within the oncology space. Dr. Barnell conducted the original research to validate Geneoscopy’s stool extraction method and managed all clinical studies for Geneoscopy’s colorectal cancer screening test. Dr. Barnell has contributed to the existing engagement with the FDA, which includes submitting a pre-market approval application, holding three presubmission meetings, completing BIMO/PAI audits, and obtaining Breakthrough Device Designation for the lead colorectal cancer (CRC) screening test. Dr. Barnell was named to the Forbes 30 Under 30 list in 2020 for her contribution to the Healthcare space.
Geneoscopy receives Z-Code from Palmetto GBA for its Noninvasive Multi-Target Stool RNA Colorectal Cancer Screening Test
ST. LOUIS, April 12, 2023 / Geneoscopy, Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced the assignment of a unique DEX Z-code from Palmetto GBA’s MolDX program for the company’s noninvasive multi-target stool RNA (mt-sRNA) colorectal cancer screening test.
“Obtaining this Z-code is vital for market access and aligns with our plans for commercial launch,” said Andrew Barnell, Chief Executive Officer of Geneoscopy. “Once approved and launched, we anticipate Geneoscopy’s noninvasive mt-sRNA colorectal cancer screening test will offer patients and healthcare providers a convenient and reliable CRC screening option for earlier detection and treatment.”
The assignment of the DEX Z-code as a test identifier is a significant step as Geneoscopy awaits the US Food and Drug Administration’s decision regarding the PMA submitted in January 2023. Geneoscopy’s test is not FDA approved and not available for sale.
About Geneoscopy Inc.
Geneoscopy Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy’s mission is to empower patients and healthcare providers with the confidence to detect, prevent and monitor disease with our innovative tests developed to transform gastrointestinal health. Beyond colorectal cancer screening, Geneoscopy is developing tests for diagnosis, treatment selection, and therapy monitoring in other disease areas in partnership with leading universities and biopharmaceutical companies. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.
Geneoscopy Inc. Forward-Looking Statements
This release includes information about Geneoscopy’s future plans concerning its noninvasive molecular test that can detect colorectal cancer and precancerous adenomas, which 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, many of which are outside the Company’s control. Geneoscopy’s actual results and financial condition may differ materially from those in the forward-looking statements. Although the Company believes its business plans and objectives reflected in or suggested by these forward-looking statements are reasonable, such plans or objectives may not be achieved. The actual results may differ substantially from the projected result.
MEDIA CONTACT
Judy Pretto
Director, Marketing Communications
815.534.0521
Oncology Tube Interview with Dr. David Lieberman, OHSU
Dr. David Lieberman discusses the Geneoscopy: Efficacy of Non-Invasive Colorectal Cancer Screening Test Evaluated in the CRC-PREVENT Phase 3 Trial
Geneoscopy Joins White House for Cancer Moonshot Colorectal Cancer Forum
“As leaders, we have a responsibility to come together to impact cancer. Colorectal cancer is one of the most preventable and treatable cancers when diagnosed early. Geneoscopy is honored to contribute to the efforts to address disparities and increase access to screening alternatives by developing highly effective noninvasive screening tests and personalized patient journeys that can save more lives.”
Andrew Barnell, Geneoscopy CEO and co-founder
March 10, 2023 (St. Louis, MO) | Geneoscopy Chief Executive Officer and co-founder Andrew Barnell is joining colorectal cancer (CRC) advocacy and industry leaders from across the country to attend the Cancer Moonshot Colorectal Cancer Forum, hosted by the White House on March 10. Together a national coalition of insurers, industry, federal agencies, health care providers, retail businesses, and CRC patients, will highlight existing successes in CRC screening and prevention access, identify opportunities to improve CRC screening for all communities and discuss advances in targeted treatment options.
In February 2022, President Biden reignited the Cancer Moonshot with renewed leadership and ambitious goals to “end cancer as we know it.” To address colorectal cancer and assist with increasing screening efforts, Mr. Barnell has joined national advocacy organization Fight Colorectal Cancer (Fight CRC) along with leading patient advocacy organizations and industry leaders in the CRC community.
In addition to the forum, Mr. Barnell will join Fight CRC’s coalition dedicated to developing a report that will outline a blueprint to address the serious equity gaps facing communities and affecting colorectal cancer prevention in America, highlighting the patient screening journey and setting bold metrics to increase colorectal cancer screening and improve patient care.
“As leaders, we have a responsibility to come together to impact cancer.” said Mr. Barnell. “Colorectal cancer is one of the most preventable and treatable cancers when diagnosed early. Geneoscopy is honored to contribute to the efforts to address disparities and increase access to screening alternatives by developing highly effective noninvasive screening tests and personalized patient journeys that can save more lives.”
Colorectal cancer is currently the second leading cause of cancer-related deaths in the U.S. For people younger than 55, colorectal cancer diagnosis has doubled from 11% (1 in 10) in 1995 to 20% (1 in 5) in 2019, according to a recent report published by the American Cancer Society CA: Cancer Journal for Clinicians.
“Our focus at the Cancer Moonshot Colorectal Cancer Forum is to advocate for taking action, not just talk about it but operationalize change,” said Anjee Davis, Fight CRC President. “We need to dig deeper into the systemic and behavioral patterns that accompany colorectal cancer from screening to treatment and identify the best opportunities to intervene, educate and – ultimately – drive large-scale advancements. We have the momentum to do this, and it will ultimately save lives.”
The forum will be closed to media; however, it will be live-streamed by the White House at wh.gov/live, and for photos, b-roll, or official comments before or after the forum, 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 developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy’s mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. Beyond colorectal cancer screening, Geneoscopy is developing tests for diagnosis, treatment selection, and therapy monitoring in other disease areas in partnership with leading universities and biopharmaceutical companies. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.
Geneoscopy Inc. Forward-Looking Statements
This release includes information about Geneoscopy’s future plans concerning its noninvasive molecular test that can detect colorectal cancer and precancerous adenomas, which 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, many of which are outside the Company’s control. Geneoscopy’s actual results and financial condition may differ materially from those in the forward-looking statements. Although the Company believes its business plans and objectives reflected in or suggested by these forward-looking statements are reasonable, such plans or objectives may not be achieved. The actual results may differ substantially from the projected result.
Media Contact
Judy Pretto
Director, Marketing Communications
815.534.0521
media@geneoscopy.com
