RNA, often referred to as the “messenger molecule,” plays a crucial role in regulating gene expression and cellular function. Circular RNAs (circRNAs) are single-stranded, covalently closed RNA molecules found across species ranging from viruses to mammals. They are highly stable, enriched in the brain, and crucial for brain development and function. Notably, circRNAs can cross the blood-brain barrier and remain in the blood long enough for testing via blood draw. By focusing on circRNAs, researchers can identify specific brain-derived biomarkers linked to mental health conditions, enabling the development of highly precise diagnostic tools for earlier and more reliable condition identification
In this dynamic field of biotechnology, where most circRNA-focused companies pursue therapeutic strategies, Circular Genomics stands out as an innovator. Unlike other companies in this space, this company specializes in diagnostic applications. Its unique approach leverages circRNA biomarkers to create advanced diagnostic tools specifically designed to revolutionize mental health care assessment and understanding.
Beyond its scientific achievements, Circular Genomics showcases the transformative potential of circRNA technology in bringing precision insights to mental health treatment and neurology. Its approach to bridging the gap between research and practical application is advancing medical science and inspiring a healthcare future built on precision, empathy, and meaningful impact.
Paul Sargeant, President, CEO, and Member of the Board of Directors, leads the company with a steadfast commitment to integrating precision medicine into mental health and neurology. Emphasizing that precision medicine should address mental health with the same focus and accuracy as physical health. Under his leadership, the organization is dedicated to providing tools for a more personalized and effective approach to these often-underserved fields.
Circular Genomics is the brainchild of Dr Nikolaos Mellios, who founded the organization with a mix of scientific dedication and personal compassion. The core principle was to address critical gaps in mental health care, a field where treatments are often based on educated guessing. Inspired by his upbringing and early experiences as a young physician, Dr. Mellios recognized an urgent need for precise brain-associated diagnostic and prognostic molecular tools that could empower healthcare providers to make targeted decisions.
Alongside Sargeant, the Circular Genomics team continues to push boundaries, paving the way for a future where mental health and neurological diagnostics are precise and impactful, providing patients with clearer and more hopeful paths to recovery.
A Vision Built on Compassion and Science
Circular Genomics wasn’t established solely on scientific aspirations, but also on the grounds of urgency, empathy and firsthand encounters. Dr. Mellios became interested in this field because he experienced how psychiatric and neurological conditions affected his family, especially with his father’s struggles with severe treatment-resistant depression and early-onset Parkinson’s disease
There is a significant unmet need in mental health and neurology for precise, reliable biomarkers that can aid in understanding disease processes, predicting treatment responses, and providing timely diagnoses and risk assessments for brain disorders. Recognizing this gap, Mellios focused on circular RNA, a unique biomarker with transformative potential across various brain conditions.
Unlike traditional linear RNA, circular RNA forms a stable closed-loop structure, making it highly suitable for diagnostic applications. This innovative approach has become central to advancing care and accuracy in diagnosing complex conditions like depression and Alzheimer’s disease, paving the way for improved treatment strategies in fields often marked by uncertainty.
Advancing Precision Medicine in Mental Health
Major depressive disorder (MDD) remains a widespread challenge in mental health, with 29% of US adults affected. However, it is insufficiently addressed, as it is often managed through trial-and-error approaches to find effective treatments. Circular Genomics seeks to transform the standard of care for depression with the “MindLight™” test, a blood-based diagnostic tool designed to predict how individuals will respond to specific antidepressants. By eliminating the guesswork, the company aims to provide quicker, more reliable treatment options, offering patients the possibility of knowing within days whether an antidepressant will work—redefining the future of mental health care.
The MindLight assay is a breakthrough in precision medicine that has the potential to improve care by being faster and more effective. It is a blood-based test that analyzes circRNAs in patients diagnosed with depression and identifies those patients that are most likely to benefit from SSRI treatment. This test offers healthcare providers information that significantly enhances patient outcomes by determining early on if a patient is suitable for SSRIs or if they should explore other medication options. This new method doesn’t just improve the treatment paradigm but also boosts patient morale by offering a more defined route to mental health and wellness.
Circular Genomics is dedicated to improving accessibility to precision medicine in mental health, addressing this critical gap in care. Paul highlights that “mental health disorders impact millions, yet the precision tools that have been developed for cancer and heart disease are lacking in mental health. We’re here to change that.” Through innovative diagnostic tools, the company aims to provide individuals with tailored, effective solutions, bringing the same level of precision seen in other areas of medicine to those affected by mental health conditions.
Shining a Light in the Dark
In addition to its work on depression, the company is breaking new ground in Alzheimer’s disease research, striving for the critical goal of early and accurate diagnosis. Collaborating with Dr. Carlos Cruchaga from Washington University, they have identified a blood circular RNA signature capable of both diagnosing Alzheimer’s and predicting the risk to develop the disease with very high accuracy years before symptoms arise. This innovative approach aims to provide families and caregivers with the tools to prepare for and manage the illness and guide physicians on selecting appropriate preventative interventions and disease-modifying treatments at an early stage.”
The transformative impact of this ability to diagnose and predict disease risk early is significant, benefiting patients, families, and the success of clinical trials. Numerous studies on Alzheimer’s disease have been unsuccessful because patients were not categorized according to the stage of their disease progression. Using the Circular Genomics assay can help researchers classify clinical trial participants more effectively, improving the chance of obtaining significant results. Circular Genomics brings a new outlook to a field with often ineffective traditional methods through its RNA signature-based diagnostic platform.
A Distinctive Approach in a Competitive Market
As RNA technology evolves, Circular Genomics has carved out a unique niche by focusing on natural circular RNA for diagnostics and outcome prediction in mental health and neurology, setting itself apart from biotech firms pursuing synthetic RNA for treatments. However, Paul emphasizes that “We’re not here to replace mRNA or other technologies; instead, we’re showing what’s possible with a different class of RNA.” By leveraging the inherent stability and diagnostic potential of circular RNA, the company provides an accessible, cost-effective approach to disease detection, complementing existing RNA-based technologies rather than competing with them.
Achieving success in this field goes beyond technological innovation; it requires specialized expertise in identifying the precise circular RNA biomarkers linked to each condition. Supported by access to the world’s most rigorously characterized clinical samples, Circular Genomics refines these biomarkers with unmatched accuracy, ensuring their diagnostic tools are both reliable and impactful.
Challenges and Solutions in Disrupting Standard of Care
There are significant challenges in transforming entrenched practices within traditional healthcare, particularly in mental health, where treatment often relies on a prolonged trial-and-error approach. The company aims to disrupt this decades-old standard of care with its innovative diagnostic tools, which have the potential to redefine how mental health conditions are managed.
Scaling these tools, however, requires extensive efforts to educate both clinicians and patients about their benefits. Acknowledging the medical community’s cautious approach to change, the company is focused on demonstrating the proven efficacy of its tests. Through proactive awareness campaigns, Circular Genomics is working to foster acceptance and drive progress in mental health diagnostics, ultimately aiming to deliver more precise and effective care.
Celebrating Milestones
Circular Genomics has made significant progress in a short period, establishing itself as a leader in innovation within the biotech sector. Milestones such as securing Series A funding, launching the MindLight assay, and advancing Alzheimer’s research through the acquisition of key intellectual property underscore the company’s ability to transform concepts into impactful solutions. The launch of the MindLight assay exemplifies their capability to deliver groundbreaking products that address critical needs in mental health and neurology, solidifying their technological foundation and market presence.
Circular Genomics’ achievements are especially impressive considering the current challenges in the biotech funding landscape. Despite a tightening of resources in the industry, the company successfully secured $8.3 million in Series A funding, reflecting strong investor confidence in their vision. This financial support will enable Circular Genomics to refine its platform and further develop innovative, precise diagnostic tools for mental health and neurological disorders, positioning the company for continued growth and impact.
Future Horizons
Looking ahead, Circular Genomics plans to broaden its diagnostic offerings to include additional neurological conditions like Parkinson’s and bipolar disorder. Their goal is to build a comprehensive platform that supports care throughout the entire treatment journey, from standard SSRIs to advanced therapies such as ketamine and psychedelics. This vision aims to ensure that patients at any stage of mental health treatment can benefit from the company’s innovative technology, enhancing care across a wide spectrum of conditions.
Additionally, Circular Genomics is working to make its technology more accessible to consumers, with plans to develop capillary blood-based tests for early detection. By moving beyond specialist labs, the company aims to offer patients everywhere faster, more convenient insights into their mental health. This shift reflects their commitment to empowering individuals through accessible, direct-to-consumer diagnostics.
Lessons for Aspiring Biotech Entrepreneurs
Circular Genomics’ journey provides valuable lessons for other innovators aiming to make a meaningful impact. The company’s success is rooted not just in its technological expertise but also in its deep understanding of the healthcare industry. Key to their approach is a focus on building an agile, committed team while recognizing the importance of balancing visionary goals with practical limitations. A thorough knowledge of their market and the capabilities of their team has been crucial to their progress, enabling them to navigate challenges and drive innovation effectively.
The company’s mission goes beyond scientific advancement to focus on improving quality of life and, in some cases, preserving identity for patients. By combining visionary leadership, scientific rigor, and compassionate goals, Circular Genomics is leading the charge toward a new era in mental health and neurology. Their approach is reshaping diagnostics to be more personalized, effective, and empowering for both patients and clinicians.
In a world where neurological conditions and mental health challenges continue to grow, Circular Genomics’ journey serves as a powerful reminder of the transformative potential of biotech. By pioneering circular RNA diagnostics, the company is shedding light on conditions defined by uncertainty, offering hope and precision to those who need it most.
