Geneoscopy

Modeling Study Published in Clinical Gastroenterology and Hepatology Validates Geneoscopy’s ColoSense® Real-World Screening Impact

ST. LOUIS, Mo.—June 24, 2025 — Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced the publication of a new study in Clinical Gastroenterology and Hepatology showing that its FDA-approved multitarget stool RNA (mt-sRNA) test, ColoSense®, achieved notable clinical benefits among colorectal cancer (CRC) screening tests when modeled at real-world adherence levels.

In the absence of a head-to-head study comparing CRC screening options, this peer-reviewed modeling study, titled “Cost-effectiveness of novel noninvasive screening tests for colorectal neoplasia,” provides valuable insights by evaluating five CRC screening strategies for patients aged 45 and older. Using a 10-year Markov model, researchers simulated disease progression, comparing mt-sRNA, two mt-sDNA tests, a blood-based test, and a fecal immunochemical test (FIT), and reported findings similar to previously published modeling studies.^1-3 When test performance was normalized to better reflect the age of the intended use population, the clinical and economic benefits of ColoSense were amplified.

At real-world adherence of 60% (the typical rate observed in practice), the modeling study results showed that ColoSense reduced CRC deaths by 14% compared to FIT, by 19% and 23% compared to the mt-sDNA tests, and by 86% compared to a blood-based test.¹ While FIT remained the most cost-effective strategy overall, ColoSense was the most cost-effective among molecular tests across all levels of screening adherence.

“Study cohorts often don’t reflect the target patient population, which can skew results and limit clinical relevance,” said Dr. Erica Barnell, co-author and Chief Science and Medical Officer at Geneoscopy. “These data reinforce the need to design studies around real-world populations. ColoSense was developed with that in mind, delivering strong performance across diverse groups, including younger adults who are often under-represented in clinical trials.”

This study builds on prior research by using a model that normalizes the age of the populations in independent, peer-reviewed studies to better reflect the general screening population. Given that many assays rely on methylation-based biomarkers, whose sensitivity is lower in younger individuals,^4,5 adjusting sensitivity estimates for colorectal cancer and advanced adenomas is essential for accurate clinical and economic assessment.

ColoSense is included in the 2025 National Comprehensive Cancer Network (NCCN) guideline update, highlighting the strength of its clinical evidence and the robust science behind Geneoscopy’s RNA-based approach. As the only FDA-approved stool RNA test for CRC screening, ColoSense represents a significant step forward in noninvasive screening methods, underscoring the need for accessible alternatives that can increase compliance, especially among groups less likely to pursue colonoscopy.

*All data used in the study were derived from independent, non-head-to-head clinical trial results.

About ColoSense
ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc.

A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults aged 45 years or older who are at the typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

Results from Geneoscopy’s pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA) in October 2023. For more information, visit www.colosense.com.

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. The company’s FDA-approved ColoSense test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other areas of gastrointestinal health. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.

Geneoscopy Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com

References

Shaukat A, Levin TR, Liang PS, Weiss JM, Smare C, Boller E, Venkatachalam M, Barnell EK. Cost-effectiveness of novel noninvasive screening tests for colorectal neoplasia. Clinical Gastroenterology and Hepatology. 2025. doi: https://doi.org/10.1016/j.cgh.2025.06.006.
Ladabaum U, Mannalithara A, Schoen RE, Dominitz JA, Lieberman D. Projected impact and cost-effectiveness of novel molecular blood-based or stool-based screening tests for colorectal cancer. Ann Intern Med. 2024;177(12):1610-1620. doi: 10.7326/ANNALS-24-00910. Epub 2024 Oct 29. PMID: 39467291.
Rui M, Wang Y, You JH. Novel non-invasive tests for colorectal cancer screening – a cost-effectiveness analysis. Cancer Epidemiol Biomarkers Prev. 2025;OF1–OF11. doi:10.1158/1055-9965.EPI-24-1549.
Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, Boardman LA, Thibodeau SN, et al. Abstract 3572: Methylated gene marker levels in stool: Effects of demographic, drug, and body mass and other patient characteristics. Cancer Research. 2012;72(8_Supplement):3572–3572. https://doi.org/10.1158/1538-7445.am2012-3572.
Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, et al. Aberrantly methylated gene marker levels in stool: effects of demographic, exposure, body mass, and other patient characteristics. J Mol Biomark Diagn. 2012;3:133. doi:10.4172/2155-9929.1000133

by Geneoscopy

Geneoscopy’s RNA-based ColoSense® Test Included in Latest National Comprehensive Cancer Network® (NCCN) Guidelines

ColoSense recommended as a first-line test for colorectal cancer screening, with a three-year screening interval

ST. LOUIS, Mo.—June 3, 2025 — Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that its ColoSense® test has been included in the National Comprehensive Cancer Network® (NCCN) Guidelines for Colorectal Cancer (CRC) Screening as a first-line test for average-risk patients, supporting its role as a screening alternative for individuals aged 45 years and older. ColoSense is a noninvasive stool-based test for detecting CRC and advanced adenomas, and is the only FDA-approved screening test utilizing stool RNA biomarkers, which are not subject to age-related methylation.¹,²

The NCCN Guidelines are comprehensive, evidence-based recommendations to support the prevention, diagnosis, and treatment of more than 97% of cancers affecting patients in the United States. They are regularly updated to reflect the latest scientific evidence and improve the quality and consistency of cancer care.

“The NCCN Guidelines are among the most trusted clinical resources in oncology, and the addition of ColoSense is a powerful validation of its clinical performance,” said Erica Barnell, M.D., Ph.D., Chief Science and Medical Officer of Geneoscopy. “As the first and only FDA-approved stool RNA screening test for colorectal cancer, this affirms the scientific rigor behind our technology and reinforces the importance of noninvasive modalities in expanding access and improving screening compliance, especially among populations less likely to undergo colonoscopy.”

ColoSense’s inclusion in the NCCN Guidelines is based on data from Geneoscopy’s CRC-PREVENT pivotal study, which was published in the Journal of the American Medical Association (JAMA).³ Unlike traditional centralized trials, in which patients are typically already engaged in healthcare screening programs, nearly two-thirds of CRC-PREVENT participants had never undergone CRC screening or scheduled a colonoscopy at the time of enrollment. The study demonstrated ColoSense’s ability to detect CRC with 94% sensitivity, identifying 100% of CRC in Stage I. Additionally, ColoSense detected 46% of advanced adenomas, when the disease is most preventable.

“The NCCN Guidelines heavily impact both the clinical adoption and insurance coverage of screening tests,” said Matt Sargent, Chief Commercial Officer of Geneoscopy. “Achieving this milestone as a first-line test marks a pivotal step forward in our mission to bring ColoSense to market as an accurate, accessible screening solution for millions of Americans. NCCN guideline inclusion also positions ColoSense for future inclusion in other major guidelines.”

Results from Geneoscopy’s pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA) in October 2023. For more information, visit www.colosense.com.

Geneoscopy Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com

References

Ahlquist, D. A., Taylor, W. R., Yab, T. C., Devens, M. E., Mahoney, D. W., Boardman, L. A., Thibodeau, S. N., Zou, H., Michael, D., Berger, B. M., & Lidgard, G. P. (2012). Abstract 3572: Methylated gene marker levels in stool: Effects of demographic, drug, and body mass and other patient characteristics. Cancer Research, 72(8_Supplement), 3572–3572. https://doi.org/10.1158/1538-7445.am2012-3572
Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, et al. (2012) Aberrantly Methylated Gene Marker Levels in Stool: Effects of Demographic, Exposure, Body Mass, and Other Patient Characteristics. J Mol Biomark Diagn 3:133. doi:10.4172/2155-9929.1000133
Barnell EK, Wurtzler EM, La Rocca J, et al. Multitarget Stool RNA Test for Colorectal Cancer Screening. JAMA. 2023;330(18):1760–1768. doi:10.1001/jama.2023.22231

by Geneoscopy

Geneoscopy Sibling Co-founders Named Finalists for EY Entrepreneur Of The Year® 2025 Heartland Award

Entrepreneur Of The Year celebrates ambitious entrepreneurs who are shaping the future

ST. LOUIS, Mo. – April 29, 2025 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that co-founders Andrew Barnell, MBA, and Erica Barnell, M.D., Ph.D., have been named finalists for the Ernst & Young (EY) Entrepreneur Of The Year® 2025 Heartland Award.

Entrepreneur Of The Year is one of the preeminent competitive business awards recognizing leaders of high-growth companies that are creating a better future through innovation, purpose, and transformative impact. This recognition places Geneoscopy’s co-founders alongside entrepreneurs and leaders in the Heartland region, which includes Minnesota, Kansas, Missouri, Iowa, Nebraska, North Dakota, and South Dakota.

“Being named a finalist is a testament to the hard work of Geneoscopy’s entire team,” said Andrew Barnell, CEO of Geneoscopy. “Erica and I have always focused on building a strong business foundation—scaling our operations, hiring the right people to advance our mission and technology, establishing key partnerships, and setting the stage for long-term growth. We’re honored to be recognized by EY among such an inspiring group of entrepreneurs.”

Erica and Andrew’s leadership and vision have been instrumental in Geneoscopy’s growth and advancement of non-invasive diagnostics for gastrointestinal health. Through the development of its novel platform for isolating human RNA from stool samples, Geneoscopy has developed FDA-approved ColoSense®, a highly effective screening solution for colorectal cancer. The company is also expanding its diagnostic pipeline to address critical unmet needs in inflammatory bowel disease.

“Building Geneoscopy with my brother has been an incredible journey,” said Erica Barnell, M.D., Ph.D., Chief Science and Medical Officer of Geneoscopy. “From early research efforts to developing a clinically validated technology, it has been deeply rewarding to see our vision translate into real-world impact for patients.”

Regional award winners will be announced on Thursday, June 19, during a special celebration in Minneapolis. Finalists become lifetime members of an esteemed community of Entrepreneur Of The Year alumni from around the world. The winners will then be considered by the National judges for the Entrepreneur Of The Year National Awards, which will be presented in November at the annual Strategic Growth Forum®, one of the nation’s most prestigious gatherings of high-growth, market-leading companies.

Sponsors
Founded and produced by Ernst & Young LLP, the Entrepreneur Of The Year Awards include presenting sponsors PNC Bank, Cresa, LLC, Marsh USA and SAP. In the Heartland, sponsors also include Twin Cities Business, Padilla and Brillect.

About Entrepreneur Of The Year
Founded in 1986, Entrepreneur Of The Year has celebrated more than 11,000 ambitious visionaries who are leading successful, dynamic businesses in the US, and it has since expanded to nearly 60 countries globally.

The US program consists of 17 regional programs whose panels of independent judges select the regional award winners every June. Those winners compete for national recognition at the Strategic Growth Forum® in November where National finalists and award winners are announced. The overall National winner represents the US at the EY World Entrepreneur Of The Year™ competition. Visit ey.com/us/eoy.

About EY
EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets.

Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow.

EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories.

All in to shape the future with confidence.

EY refers to the global organization, and may refer to one or more, of the member firms of Ernst & Young Global Limited, each of which is a separate legal entity. Ernst & Young Global Limited, a UK company limited by guarantee, does not provide services to clients. Information about how EY collects and uses personal data and a description of the rights individuals have under data protection legislation are available via ey.com/privacy. EY member firms do not practice law where prohibited by local laws. For more information about our organization, please visit ey.com.

Geneoscopy Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com

by Geneoscopy

Geneoscopy Appoints Amit Bhalla as Chief Financial Officer to Advance Strategic Growth and Support Commercialization Efforts

ST. LOUIS, Mo. – April 2, 2025 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced the appointment of Amit Bhalla as Chief Financial Officer (CFO). Bhalla brings more than 25 years of experience in healthcare finance, strategy, and investment to support Geneoscopy’s continued expansion, including the commercial launch of ColoSense®, the company’s RNA-based, non-invasive colorectal cancer screening test.

“Amit’s extensive financial leadership and deep understanding of the healthcare landscape will be invaluable as we scale our operations and advance our mission of improving patient outcomes through innovative diagnostic solutions,” said Andrew Barnell, Chief Executive Officer of Geneoscopy. “Following our recent $105 million Series C financing, Amit’s expertise will be instrumental in optimizing our financial strategy as we continue our work to bring ColoSense to market and progress our pipeline of products for inflammatory bowel disease (IBD).”

Bhalla most recently served as Executive Vice President and CFO at Sampled, a global biorepository and laboratory, where he led the financial, supply chain, and facilities operations. Before that, Bhalla served as Vice President of Global Strategy & Development and was a member of the Executive Management Committee at Becton Dickinson. His career also includes almost two decades on Wall Street as a lead healthcare analyst for Lord Abbett’s Value Funds, Director of Equity Research at Citi, and Vice President at Morgan Stanley, where he covered the life science tools, diagnostics, and medical device industries.

“This is an exciting time to join Geneoscopy’s leadership team, and I look forward to leveraging my background and experience to support its growth trajectory,” said Bhalla. “With a strong financial foundation, a differentiated solution for colorectal cancer screening, and the resources to drive meaningful innovation, the company is well-positioned to transform gastrointestinal diagnostics, bringing life-changing solutions to more patients.”

Geneoscopy recently secured $105 million in Series C financing to support the commercial launch of ColoSense, which received FDA approval in May 2024 as a noninvasive colorectal cancer screening test for eligible adults. The funding will also accelerate Geneoscopy’s precision medicine approach for IBD and further advance its proprietary RNA technology platform.

.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. The company’s FDA-approved ColoSense test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other GI disease areas. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.

Geneoscopy Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com

by Geneoscopy

Geneoscopy’s Dr. Erica Barnell to Speak at ACG’s ‘Leading With Guts’ Course on Expanding Career Opportunities in Gastroenterology

ST. LOUIS, Mo. – March 4, 2025 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced its Chief Medical & Science Officer, Erica Barnell, MD, PhD, will present at the American College of Gastroenterology’s (ACG) inaugural, ‘Leading with Guts: Women Shaping the Future of Gastroenterology,’ on Friday, March 14, 2025, in New Orleans. The one-day course is in conjunction with the ACG/LGS Regional Postgraduate Course.

Dr. Barnell’s lecture, “Consider Opportunities for Administrative Roles Inside and Outside Gastroenterology,” will be part of Session 4: Embracing Opportunities from 3:40 to 4:40 p.m. CST. She will draw upon personal experiences to explore how careers beyond the clinic can provide new avenues for professional growth. Options such as laboratory benchwork, clinical trial design and execution, or regulatory engagement provide paths that mitigate challenges gastroenterologists face in practice, especially in a changing healthcare environment.

“I am honored to speak at Leading with Guts and help advance the role of women in the field of gastrointestinal health,” Dr. Barnell said. “Balancing life, family, and career can be challenging, but it is also deeply rewarding. As a scientist, entrepreneur, wife, and mother, I look forward to sharing my journey so that others can find inspiration and forge their own paths to personal and professional fulfillment.”

ACG’s Leading with Guts is designed to empower women in the gastrointestinal field with career and life strategies to help guide professional growth and increase leadership opportunities. Attendees will learn, interact, and network with industry thought leaders, including Dr. Barnell; course directors Dr. Kara M. De Felice, MD, FACG, and Dr. Aasma Shaukat, MD, MPH, FACG; and a distinguished panel of nationally recognized gastroenterologists and researchers.

About Geneoscopy, Inc.

Geneoscopy Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com

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U.S. Patent Trial and Appeal Board Institutes Inter Partes Review Based on Geneoscopy’s Petition Challenging Validity of a Second Patent Owned by Exact Sciences

ST. LOUIS, Mo. – February 18, 2025 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the U.S. Patent Trial and Appeal Board (PTAB) has instituted inter partes review (IPR) of U.S. Patent No. 11,970,746 (“the ‘746 patent”) owned by Exact Sciences.

After reviewing Geneoscopy’s petition, the supporting evidence, and Exact Sciences’ arguments in response, the PTAB determined that Geneoscopy has shown a reasonable likelihood of prevailing on its assertion that the challenged claims of Exact Sciences’ ‘746 patent are unpatentable as obvious over the prior art. Previously, the PTAB instituted an IPR to review the claims of another patent (‘781 Patent) owned by Exact Sciences based on Geneoscopy’s petition challenging the validity of the ‘781 Patent. Both decisions are publicly available on the PTAB website.

“The PTAB’s decision to institute an IPR against the ‘746 patent, following its July 2024 institution of an IPR against the ‘781 patent, means the PTAB has found it likely that both patents Exact Sciences has asserted in court against Geneoscopy are invalid,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “We are confident that the asserted claims of these patents are unpatentable. These decisions reinforce our position and pave the way for Geneoscopy’s launch of ColoSense^®, which will bring a new colorectal cancer screening option to the market to increase access to effective and convenient testing that has the potential to save lives.”

Geneoscopy filed its second IPR petition after Exact Sciences alleged infringement of the ‘746 patent in a lawsuit filed in the U.S. District Court for the District of Delaware. As with the first petition of the ‘781 patent, Geneoscopy explained that nothing in the ‘746 patent is inventive, the method is obvious, and the challenged claims are invalid. The PTAB’s decision further strengthens Geneoscopy’s defenses to Exact Sciences’ allegations in the lawsuit. Geneoscopy has also filed a countersuit against Exact Sciences, alleging breach of contract, misappropriation of trade secrets, and various violations of state and federal law.

About Geneoscopy, Inc.

Geneoscopy Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com

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Geneoscopy Closes $105M in Series C Funding Round to Power Next-Generation of Gastrointestinal Diagnostic Tests

Bio-Rad leads investment to support the launch of ColoSense®, a non-invasive colorectal cancer screening test, and advance diagnostic innovations for inflammatory bowel disease

ST. LOUIS & HERCULES, Calif. – Jan. 8, 2025 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced the closing of a Series C funding round raising $105 million. Bio-Rad Laboratories (NYSE: BIO and BIO.B) led the financing and was joined by Petrichor, Labcorp (NYSE: LH), Morningside Ventures, Lightchain Capital, NT Investments, Granger Management and Mercy Health, Tri Locum Partners, and others.

The capital raise positions the company to achieve key milestones, including the launch and commercialization of Geneoscopy’s at-home, stool-based colorectal cancer screening test, ColoSense. The funding also enables the company to continue investing in its innovative pipeline of diagnostic tests for inflammatory bowel disease, addressing a critical unmet medical need.

Geneoscopy’s novel platform for isolating human RNA from stool samples, combined with the high sensitivity and specificity of Bio-Rad’s Droplet Digital™ PCR (ddPCR™) technology, allows for highly effective screening and detection of colorectal cancer. Further, Geneoscopy and Labcorp will work together to provide broad availability of ColoSense, enabling healthcare providers to conveniently order the test as part of their comprehensive screening programs.

“This past year, we achieved many significant milestones, most notably FDA approval of ColoSense,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “We are extremely pleased to secure this financing, which reflects investor confidence in the potential of our RNA technology to address unmet needs in colorectal cancer and inflammatory bowel disease. This continued support will enable us to deliver innovative solutions that prioritize patient well-being and shape the future of gastrointestinal health.”

Norman Schwartz, CEO of Bio-Rad Laboratories, stated, “As a leader in clinical diagnostics and digital biology, Bio-Rad’s mission is to advance science and save lives by improving healthcare outcomes. Geneoscopy’s ColoSense screening test is designed for use with Bio-Rad’s QXDx ddPCR platform and demonstrates remarkable sensitivity in detecting colorectal cancer and advanced adenomas. With this investment, we look forward to supporting Geneoscopy’s development and commercialization efforts while advancing our Droplet Digital PCR platform as a foundational technology for oncology applications across the clinical diagnostics and translational research markets.”

Colorectal cancer is the second deadliest cancer in the U.S., with incidence rates rising among populations under 50 years old. This alarming trend prompted the United States Preventive Services Task Force to lower the recommended age for initial screening to 45. Despite this change, millions of eligible people do not get screened due to a combination of factors such as limited access or avoidance of invasive procedures like colonoscopies. Following the successful Series C funding round, Geneoscopy is poised to address these challenges with ColoSense, a promising new tool that detects colorectal cancer early and accurately.

Geneoscopy’s CEO, Andrew Barnell, will present a company update and expand on plans for this funding round at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. The presentation will take place on Thursday, Jan. 16, 2025, at 11:30 AM PST / 2:30 PM EST.

About Geneoscopy, Inc.

About Bio-Rad Laboratories, Inc.
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIO.B) is a leader in developing, manufacturing, and marketing a broad range of products for the life science research and clinical diagnostics markets. Based in Hercules, California, Bio-Rad operates a global network of research, development, manufacturing, and sales operations with approximately 7,700 employees and $2.7 billion in revenues in 2023. Our customers include universities, research institutions, hospitals, and biopharmaceutical companies, as well as clinical, food safety and environmental quality laboratories. Together, we develop innovative, high-quality products that advance science and save lives. To learn more, visit www.bio-rad.com.

Bio-Rad Forward Looking Statements

This release may be deemed to contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements we make regarding our expectations about our products, Geneoscopy’s ColoSense screening test, and supporting Geneoscopy’s development and commercialization efforts while advancing our droplet digital PCR platform as a foundational technology for oncology applications across the clinical diagnostics and translational research markets. Forward-looking statements generally can be identified by the use of forward-looking terminology such as “plan”, “believe,” “expect,” “anticipate,” “may,” “will,” “intend,” “estimate,” “continue,” or similar expressions or the negative of those terms or expressions, although not all forward-looking statements contain these words. Such statements involve risks and uncertainties, which could cause actual results to vary materially from those expressed in or indicated by the forward-looking statements. These risks and uncertainties include global economic and geopolitical conditions, our ability to develop and market new or improved products, our ability to compete effectively, international legal and regulatory risks, supply chain risks, and product quality and liability issues. For further information regarding our risks and uncertainties, please refer to the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” in Bio-Rad’s public reports filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. Bio-Rad cautions you not to place undue reliance on forward-looking statements, which reflect an analysis only and speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

Geneoscopy Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com

Geneoscopy Investor Contact
Carrie Mendivil / Ji-Yon Yi
Gilmartin Group
investors@geneoscopy.com

Bio-Rad Media Contact
Anna Gralinska
Corporate Communications
510-741-6643
cc@bio-rad.com

Bio-Rad Investor Contact
Edward Chung
Investor Relations
510-741-6104
ir@bio-rad.com

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Geneoscopy’s Dr. Erica Barnell to Present at Women @ Work Summit and American Gastroenterological Association (AGA) Workshop

Presentations to inspire the next generation of woman scientists and highlight recent advancements in colorectal cancer screening

ST. LOUIS, Mo. – November 7, 2024 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, announced that Erica Barnell, MD, PhD, Geneoscopy’s Chief Medical & Science Officer, will present two important topics in November, showcasing her work as a woman leader in the sciences, as well as an update on advancements in colorectal cancer (CRC) screening and early detection.

2nd Annual Women @ Work Summit at Washington University at St. Louis

Topic: Influencing Across Generations
Date & Time: Nov. 8, 2024, from 3:13-4:35 p.m. CT
Location: Emerson Auditorium
About: The panel discussion, hosted by the McKelvey Women & Engineering Center and the Olin Undergraduate Programs Office, will help prepare students for the workforce and unpack how spheres of influence affect women in a particular way. Dr. Barnell will focus on her experience as a woman leader in the sciences and co-founder of a successful biotech company.

American Gastroenterological Association (AGA) Workshop

Topic: Optimizing Colorectal Cancer Screening
Date & Time: 16, 2024, from 9 a.m.-3 p.m. ET
Location: AGA Headquarters, Bethesda, MD
About: In this discussion, Barnell joins Dr. David A. Lieberman, Oregon Health and Science University; Dr. Chyke Doubeni, The Ohio State University Wexner Medical Center; and Dr. Dominique E. Howard, Capital Digestive Care, to discuss the current landscape of CRC screening, the state of screening adherence, lessons learned from real-world screening models, and how to develop a clinical pathway for CRC screening.

“These events offer an incredible platform to highlight the impact of leadership as a female physician and scientist, emphasizing the essential role of innovative screening methods in healthcare,” Dr. Barnell said. “At the leadership summit, I look forward to sharing my journey in biotech, where diverse voices and perspectives have been instrumental in building Geneoscopy. At the AGA Workshop, I will have the opportunity to collaborate with esteemed colleagues to explore advancements in colorectal cancer screening, providing a unique opportunity to strengthen clinical pathways that can drive early detection and save lives.”

More than 44 million Americans at average risk for CRC remain unscreened despite screening’s vital role in early detection and prevention. Access to reliable options for screening enhances the ability to detect disease early and provides valuable information to guide personalized treatment options. Geneoscopy’s FDA-approved noninvasive CRC screening test, ColoSense™, is the first to use an RNA-based assay, offering a dynamic view of disease activity.

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. The company’s FDA-approved ColoSense™ test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other GI disease areas. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.

Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com

Investor Contact
Carrie Mendivil / Ji-Yon Yi
Gilmartin Group
investors@geneoscopy.com

by Geneoscopy

Geneoscopy Receives New York State Department of Health Permit, Expanding Ability to Provide Laboratory Services Nationwide

ST. LOUIS, Mo. – October 1, 2024 – Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, received its laboratory permit from the New York State Department of Health. Geneoscopy is now able to provide laboratory services in all 50 states and the District of Columbia. The company’s first commercially available laboratory test will be ColoSense™, an FDA-approved, noninvasive multi-target stool RNA (mt-sRNA) screening test for colorectal cancer (CRC) and advanced adenomas..

The New York State Department of Health’s Clinical Laboratory Evaluation Program (CLEP) regulates and oversees laboratories that accept clinical specimens originating in New York State. The CLEP seeks to ensure the accuracy and reliability of test results in clinical laboratories located in or accepting specimens from New York State.

“New York’s CLEP is known to have the most rigorous review process and standards for clinical laboratories, and we believe that this permit reflects the high standard of quality and precision of our laboratory,” said Julie LaRocca, Senior Vice President of Quality Assurance and Regulatory Affairs at Geneoscopy. “Our goal at Geneoscopy is to provide patients with a reliable, accessible, noninvasive option for early detection of CRC. Receiving this permit marks a key milestone in our efforts to offer ColoSense to patients nationwide.”

Colorectal cancer is the second deadliest cancer in the US; however, millions of eligible patients avoid screening due to unpleasant procedures or the perceived low risk of developing CRC. Expanding access to new screening tools will enhance the ability to detect disease early and provide valuable information to guide personalized treatment options. Geneoscopy’s CRC screening test, ColoSense, is the first noninvasive option to use an RNA-based assay, offering a dynamic view of disease activity without dependence on age-related methylation patterns.

Geneoscopy is a Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) accredited laboratory. In total, CLIA oversees approximately 320,000 laboratory entities, and the CAP Laboratory Accreditation Program is considered a benchmark for excellence in clinical laboratory accreditations, ensuring that laboratories adhere to strict guidelines for quality, safety, and accuracy. Additionally, Geneoscopy’s CLIA/CAP laboratory is the only facility approved by the US FDA to process ColoSense.

About ColoSense

ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults 45 years of age or older who are at typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

Geneoscopy’s pivotal CRC-PREVENT trial results were published in The Journal of the American Medical Association (JAMA) in October 2023. For more information, visit www.colosense.com.

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. The company’s FDA-approved ColoSense™ test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other GI disease areas. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.

Media Contact
Andrea Sampson
Sampson Public Relations Group
asampson@sampsonprgroup.com

Investor Contact
Carrie Mendivil / Ji-Yon Yi
Gilmartin Group
investors@geneoscopy.com

by Geneoscopy