Uniting humans and data: the role of AI in genomics

VICTORIA REES | August 27, 2019 | 78 views

AI has applications in many areas of research, including genomics. Slavé Petrovski of AstraZeneca reveals how AI is used in the study of the human genome and how it may evolve in the future. The field of genomics generates large datasets that are utilised in the discovery and development of potential new therapeutics. Artificial intelligence (AI) is highly valuable in this area of study as it accelerates the time it takes to get from information to insight.

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IDEXX

IDEXX Laboratories, Inc. (NASDAQ: IDXX) is a leader in pet healthcare innovation, serving practicing veterinarians around the world with a broad range of diagnostic and information technology-based products and services. Headquartered in southern Maine, IDEXX conducts operations through more than 70 locations around the world, serves customers in over 175 countries, and employs more than 7,000 people.

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How to Choose a Reliable Biotech Clinical Trial Management System?

Article | July 20, 2022

Introduction The medical and life-science industries are experiencing a robust transformation with the increasing prevalence of various types of diseases, including infectious diseases, chronic disorders, and acute conditions around the world. As a result, a significant rise in demand for more effective therapeutic drugs and bionics is being witnessed, leading to a swift increase in the number of clinical trials. For a successful trial, it is important for biotech companies to ensure the data submitted to regulatory bodies regarding clinical trials is accurate, reliable, and definitive from an ethical point of view. A reliable clinical trial management system plays a vital role in collecting, monitoring, and managing clinical data. The availability of high-quality clinical data also helps clinical research institutions make efficient treatment decisions and provide proper patient care. Hence, a number of biotech companies and research organizations are focusing on leveraging innovative clinical trial management solutions to handle a large amount of data, particularly in multi-center trials, and generate reliable, high-quality, and statistically sound data from clinical trials. However, selecting the most appropriate and reliable clinical trial management system is vital for the clinical trial's success. Let's see some of the steps that will assist these firms in choosing the right CTMS. Key Steps for Selecting Right Biotech Clinical Trial Management System Prioritize Study Needs Considering and prioritizing study needs is a crucial step in choosing the most reliable clinical trial management system for biotech companies. Prioritizing helps them to identify a solution that improves the study's quality and removes uncertainty for researchers when faced with difficult choices. Hence, biotech and life-science organizations should choose a clinical trial system that is simple to use, well-organized, and suitably designed to minimize the number of clicks required to complete a task. Select CTMS with Multiple Integrations Integrated clinical trial management systems provide the best value for the companies’ funds as they guarantee the smooth functioning of research protocols. In addition, integrations are necessary to fully understand the importance and advantages of clinical trial management software for ensuring smooth transitions between site management and data collection. Biotech and clinical research should look for CTMS platforms that can integrate with electronic medical record (EMR) platforms and clinical research process content (CRPC) billing grids. This will allow them to use the same billing designations and ensure compliance while minimizing the need for duplicate processes. Ensure System Compliance and Security Clinical research organizations need to adhere to a plethora of complex regulations in order to ensure compliance with one of the most challenging environments of principles, which is information security and privacy. Security and system compliance are vital aspects of choosing the right CTMS solutions for biotech firms as they assist in building trust and form a part of the system’s duties. While selecting CTMS systems, it is essential for companies engaged in clinical research to ensure that these platforms are able to configure both, group and individual permissions, along with having a data backup and recovery plan for hosted systems. This will allow companies to assess the privacy and security implications of research and anticipate complications that may arise in each phase of the project. Assess the Scalability Choosing a scalable CTMS that can accommodate various types of fluctuations and expansions enables biotech and clinical firms to quickly adapt to fast-changing trends and demand spikes while reducing maintenance costs and enhancing user agility. As scalability also means secure and expanded data storage, these businesses should instead use SaaS solutions than manually manage an ever-growing collection of hard drives. The right CTMS ensures accommodating the firm’s availability requirements without incurring the capital costs associated with expanding a physical infrastructure. The Closing Thought A well-executed and successful clinical trial involves multiple stages and processes. Several quality controls and stringent adherence to regulations are essential for the steps, along with efficient cross-departmental processes and procedures. Incorporating the right CTMS paves the way for paperless data collection, regulatory filing, and fiscal management tools for biotech researchers and administrative personnel.

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Top 3 Biotech Clinical Data Management Trends to Watch in 2022

Article | July 11, 2022

Introduction The administration of medical records and data has advanced significantly during the past few decades. Clinical data management, which was once only a small subset of biotech research organizations, has now developed into a mission-critical, specialized unit. In the late 1990s, electronic data capture (EDC) began to alter the traditional function of clinical data management. After that, the data configuration and management of data queries for the EDC system fell under the purview of clinical data management services. Today, clinical data management is not only responsible for managing the clinical data configuration and data queries but also developing and implementing data administration plans, ensuring data accuracy and completeness, and maintaining optimum data security. In recent years, as digital technologies have gained acceptance around the globe, data has become a vital aspect in decision-making across numerous industries, and the life sciences and biotechnology sectors are no exception. Using data has provided granular insights to biotech organizations, assisting them in creating breakthroughs in drug development and medical research and signifying the importance of clinical trial management systems in these medical verticals. The Biggest Biotech Clinical Data Management Trends to Know About Today The future of clinical data management is contingent upon the implementation of systems and regulations. It is imperative for all organizations participating in a medical or life science trial to have transparent rules in place for sharing and retaining patient data. Also, there is a need to have a standardized format for maintaining these records and documents related to trials. This assists biotech organizations in reducing the chances of ambiguity regarding who owns what kind of data or paperwork at any given time. Over the past couple of years, the focus of the life science and biotechnology industries has shifted towards developing more effective medications and therapies, implementing personalized treatment, and finding cures for diseases such as cancer and AIDS. In response to this, a substantial rise in the number of clinical trials is being witnessed globally. As the number of clinical trials continues to accelerate, the spending on these trials rises as well. In response to this, the worldwide cost of conducting clinical trials is anticipated to reach US$ 49.80 billion in 2022. With the transition of the world from traditional to digital, medical professionals and biotech businesses are increasingly shifting towards adopting high-tech and reliable clinical trial management systems for various applications, starting from diagnosis and clinical trials to patient data documentation. But, what are the future trends in biotechnology clinical data management? Let’s discuss. Cloud-Based Clinical Metadata Repositories Automation is emerging as a new frontier in the biotech clinical data management domain, along with other innovative technologies such as artificial intelligence and machine learning. Because of this, life science establishments are witnessing a huge shift from paper-based documentation toward data-based documentation, which is creating mountains of research, compliance, and clinical data. The growing demand for new and more effective medications and drugs is augmenting the need to expedite clinical trials. This is resulting in an increased number of initiatives aimed at optimizing clinical trial processes to prepare and launch successful trials. However, pharmaceutical and biotechnology laboratories are encountering several challenges in collecting, managing, and analyzing metadata due to its complexities. So, what is the best solution to this problem? The answer to this is cloud-based clinical metadata repositories. Clinical research facilities are leveraging advanced, all-in-one, cloud-based clinical metadata repositories to assist them in centralizing and managing metadata; increasing metadata quality, consistency, and accuracy; and speeding up clinical trial management, documentation, and compliance processes. Shift Towards Digital Solutions Electronic Case Report Form Adequate research and accurate data are crucial for a clinical trial to succeed. Whether developing new drugs, medication, or therapies; conducting life science research; or studying the latest clinical trial systems, it is best to use electronic solutions as it reduces the room for mistakes during the transition of clinical data from paper-based format. Realizing this, biotech organizations are shifting towards using electronic case report forms to speed up record retrieval, improve record security, and cut down on operational costs associated with running clinical trials. The electronic case report form assists in lowering the failure rate of the clinical trial, enhancing efficiency, and optimizing security along with improving clinical trial documentation and productivity, further driving its adoption in the medical space. Electronic Clinical Outcome Assessment Electronic clinical outcome assessment is surfacing as one of the fast-growing future trends in biotechnology. It allows clinical trial facilities to automate data entry and improve the reliability of the collected information. The technology enables clinical trial institutions to automatically record patient-provided information about side effects, symptoms, drug timing, and other aspects during the clinical trial for increased precision. It also helps these institutions analyze the results of medication or therapy in clinical trials and lets clinical researchers use medical technologies like biosensor-enabled devices, self-service applications, and medical wearables for evaluation. Hence, biotech clinical facilities are increasingly deploying advanced electronic clinical outcome assessment systems to ensure adherence to protocols and regulations. Clinical Trial Customization The success of a new drug is determined by numerous factors other than its effectiveness, safety, and creativity of its developers, such as a successful clinical trial. Each clinical trial involves a number of decision-making points, and one wrong choice in any of these aspects can jeopardize the success of the entire endeavor. A crucial component of making well-informed decisions is data management, which is a part of clinical study as a whole. Clinical trial customization is emerging as one of the most prominent biotech clinical trial management trends. Every clinical trial is unique and needs a tailored approach to be successful. With the emergence of the trend of personalized treatment around the globe, biotech and pharmaceutical organizations are adopting innovative customized clinical trial management solutions to accelerate the pace of clinical trials and approvals. This is giving clinical researchers innovative ways to come up with new medicines for patients and streamline the clinical data as per the requirements for faster approvals. What Are the Key Clinical Data Management Challenges Faced by Biotech Companies? Groundbreaking medical interventions are of no use without reliable, accurate, and extensive clinical trial data. Without the data, biotech and pharmaceutical companies will not be able to provide the assurance of safety and efficacy required to bring the medication to market. Regulatory bodies such as the Food and Drug Administration (FDA), the Medicines and Healthcare Products Regulatory Agency (MHRA), and others are putting stricter rules in place to ensure the quality of clinical data. In addition, the fast-changing clinical development environment is creating more obstacles for biotech and medical spaces to ensure the accuracy, standard, and completeness of the clinical trial data. Hence, clinical teams are spending valuable time cleaning up data instead of analyzing it. Time spent trying to figure out issues with clinical trial data is detrimental and expensive but also mission-critical. This is because a small issue in the data can lead to numerous consequences, from small delays to calamitous setbacks, making it necessary to rerun clinical trials. This problem will only get more challenging to address as the volume of data and the types of data sources continue to grow. Here are some of the major clinical data management challenges that biotech firms encounter Standardization of Clinical Metadata Stringent Regulatory Compliance Increased Clinical Trial Complexity Mid-Study Changes Why Are Clinical Data Management Systems Garnering Popularity in the Biotech Industry? With the changing regulatory and clinical landscape, biotech and pharmaceutical companies are facing several obstacles in the management of clinical data and clinical trials. In addition, regulatory agencies are moving toward integrated electronic systems, which is making it more and more important for clinical laboratories to change the format of their submissions. Because of this, several biotech clinical labs are focusing on adopting innovative laboratory solutions, such as biotech clinical data management systems, to meet the need for standardized data inputs and replace all manual ways of working with electronic systems. A clinical data management system establishes the framework for error-free data collection and high-quality data submission, resulting in speedier drug discovery and shorter time-to-market. These solutions are gaining huge traction among biotech and pharmaceutical companies, owing to their ability to effectively manage clinical data, accelerate clinical trials, and ensure compliance. Let’s see some of the features of biotech clinical data management software that are most sought after by life-science companies Controlled, standardized data repository. Centralized data analysis and administration. Reduced operational expenditures for clinical data processes. Enhanced process effectiveness. Superior submission quality Compliance with predefined standards. Clinical Data Management Systems: The Future The role of clinical data management systems is evolving at a rapid pace as the life science and medical industries continue to incorporate digital solutions for diverse operations. These systems are being used in a variety of biotech clinical settings, ranging from clinical data compliance to data science and analytics, to help them analyze large and growing volumes of clinical data. Hence, a number of high-tech medical companies are aiming at integrating innovative technologies, such as artificial intelligence and machine learning, into clinical data management software to automate clinical data management tasks, improve clinical data submission, and enhance data quality. These new biotech clinical management technologies are anticipated to help life science laboratories gain a better understanding of diseases and speed up clinical trials in the coming years. FAQ What is a clinical data management system? A clinical data management system (CDMS) is a tool used in clinical research to track, record, and manage clinical trial data across medical establishments such as biotech laboratories. What are the key functions of the biotech clinical data management system? Some of the key functions of biotech clinical data management system are Documentation of Protocols and Regulations Patient Recruitment Real-time Clinical Study Analytics Reporting Investigator Relationship Management Electronic Visit Report Why is a clinical data management system needed for clinical trials today? A clinical data management system helps shorten the time from drug development to marketing by assisting in the collection of high-quality, statistically sound, and accurate data from clinical trials.

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MEDTECH

Top 10 biotech IPOs in 2019

Article | October 7, 2022

The big question at the start of 2019 was whether the IPO window would stay open for biotech companies, particularly those seeking to pull off ever-larger IPOs at increasingly earlier stages of development. The short answer is yes—kind of. Here’s the long answer: In the words of Renaissance Capital, the IPO market had “a mostly good year.” The total number of deals fell to 159 from 192 the year before, but technology and healthcare companies were standout performers. The latter—which include biotech, medtech and diagnostics companies—led the pack, making up 43% of all IPOs in 2019. By Renaissance’s count, seven companies went public at valuations exceeding $1 billion, up from five the year before

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Cell Out? Lysate-Based Expression an Option for Personalized Meds

Article | February 18, 2020

Cell-free expression (CFE) is the practice of making a protein without using a living cell. In contrast with cell line-based methods, production is achieved using a fluid containing biological components extracted from a cell, i.e., a lysate. CFE offers potential advantages for biopharma according to Philip Probert, PhD, a senior scientist at the Centre for Process Innovation in the U.K.

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IDEXX

IDEXX Laboratories, Inc. (NASDAQ: IDXX) is a leader in pet healthcare innovation, serving practicing veterinarians around the world with a broad range of diagnostic and information technology-based products and services. Headquartered in southern Maine, IDEXX conducts operations through more than 70 locations around the world, serves customers in over 175 countries, and employs more than 7,000 people.

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AXIM Biotech Develops Rapid Quantitative Tear Test for MMP-9, An Inflammatory Biomarker of Dry Eye Disease

AXIM Biotech | March 10, 2022

AXIM Biotechnologies, Inc (OTCQB: AXIM) (“AXIM Biotech,” “AXIM” or “the Company”), an international healthcare solutions company targeting dry eye disease (DED), today announced that it has successfully developed a rapid quantitative tear test for MMP-9, an inflammatory biomarker for Dry Eye Disease. Dry Eye Disease, though widespread, is under-diagnosed, in part because symptoms do not always correlate with objective signs. It has a highly variable symptom profile at different stages of the disease, and there is often a discordance between signs and symptoms. A patient can have severe symptoms yet show no sign of ocular surface damage, while others have advanced ocular surface damage, yet report no symptoms. This lack of correlation between clinical signs and symptoms of Dry Eye Disease makes diagnosing and treating patients a challenge. Often times, inflammation is present before the clinical signs of Dry Eye Disease. The challenge has been in early detection of inflammation. Matrix metalloproteinase-9 (MMP-9), an inflammatory biomarker consistently elevated in the tears of dry eye patients, may accelerate early diagnosis when detected. The central role of inflammation in ocular surface disease is widely recognized, but our ability to measure this in the clinic has been limited to the InflammaDry test that measures tear matrix metalloproteinase (MMP) levels and provides a positive/negative result around a threshold of 40ng/ml of MMP-9. This 'yes or no' report has clinical value, but it is limited. Currently available MMP-9 testing does not detect a reduction in tear MMP-9 levels until the concentration drops below 40ng/ml and thus may miss clinically significant improvement that did not reach that threshold.” Dr. Joseph Tauber, AXIM’s Chief Medical Officer. The clinical benefits of the quantitative test for MMP-9 as a tool for accurate diagnosis of Dry Eye Disease and subsequent treatment include more accurate pre-surgical and post-surgical outcomes. Post-surgical complications, such as corneal wound healing, is facilitated by identifying dry eye prior to surgery. The availability of quantitative tear MMP-9 testing would be a significant advance in our ability to measure the degree of inflammation affecting our dry eye patients, allowing for more objective classification of their disease, Equally important would be the ability to measure improvement in control of inflammation that is the goal of many of our therapies for ocular surface disease, including pharmaceuticals, thermal pulsation treatments and even light based therapies.” Dr. Joseph Tauber. Some reports indicate that nearly half of all U.S. adults experience dry eye symptoms and 33% of patients in eye care clinics present with complaints about dry eye. Given the size of the market, AXIM made the strategic decision to develop a test for MMP-9 to assist in early detection of Dry Eye Disease. Together with our Lactoferrin and IgE Tests and now with the addition of our MMP-9 Test, AXIM will be positioned to corner the market for Dry Eye Disease diagnostic testing.” John Huemoeller, AXIM’s CEO. About AXIM® Biotechnologies Founded in 2014, AXIM® Biotechnologies, Inc. (AXIM) is a vertically integrated research and development company focused on improving the landscape for diagnosis of ophthalmological conditions such as Dry Eye Disease (DED) through rapid diagnostic tests. Additionally, it owns IP and has conducted research on SARS-CoV-2 (COVID-19) rapid neutralizing antibody tests to detect levels of functional neutralizing antibodies that are believed to prevent SARS-CoV-2 from entering the host cells, as well as for oncological indications.

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CELL AND GENE THERAPY

Childhood Trauma and Genetics Linked to Increased Obesity Risk

DRI | March 10, 2022

New research from the Healthy Nevada Project® found associations between genetics, obesity, and childhood trauma, linking social health determinants, genetics, and disease. The study, which was published this week in Frontiers in Genetics, found that participants with specific genetic traits and who experience childhood traumas are more likely to suffer from adult obesity. In 2016, DRI and Renown Health launched the Healthy Nevada Project®, the nation’s first community-based, population health study, which now has more than 60,000 participants. The project is a collaboration with personal genomics company, Helix, and combines genetic, environmental, social, and clinical data to address individual and community health needs with the goal of improving health across the state and the nation. The new study focuses on Adverse Childhood Experiences (ACEs), which are traumatic and unsafe events that children endure by the age of 18. Over 16,000 participants in the Healthy Nevada Project® answered a mental health survey, and more than 65 percent of these individuals self-reported at least one ACE occurrence. These 16,000 participants were cross-referenced with their genetic makeup, and clinical Body Mass Index (BMI) measures. According to the research team’s findings, study participants who had experienced one or more types of ACE were 1.5 times more likely to become obese adults. Participants who experienced four or more ACEs were more than twice as likely to become severely obese. Our analysis showed a steady increase in BMI for each ACE a person experienced, which indicates a very strong and significant association between the number of adverse childhood experiences and adult obesity, More importantly, participants’ BMI reacted even more strongly to the occurrence of ACEs when paired with certain mutations in several genes, one of which is strongly associated with schizophrenia.” lead author Karen Schlauch, Ph.D., of DRI. We know that genetics affect disease in the Healthy Nevada Project®, and now we are recognizing that ACEs also affect disease, Our new study shows that the combination of genes and environmental factors like ACEs, as well as many social determinants of health, can lead to more serious health outcomes than either variable alone. More broadly, this new work emphasizes how important it is for population genetic studies to consider the impact of social determinants on health outcomes.” Healthy Nevada Project® Principal Investigator Joseph Grzymski, Ph.D., of DRI and Renown Health. The study team believes that it is important for clinical caregivers to understand the strong impact that negative childhood experiences such as ACEs can have on both child and adult health. The researchers hope the information from this study will encourage doctors and nurses to conduct simple screenings for ACEs and consider a patient’s social environment and history in combination with genetics when developing treatment plans for better patient health. According to the 2019 Youth Behavior Risk Survey (YRBS), 25.6 percent of Washoe County teenagers are overweight or obese. Obesity is a serious health concern for children and adolescents. According to the Centers for Disease Control and Prevention, obese children and adolescents are more likely to become obese as adults. Obese and overweight children and adolescents are at risk for multiple health problems during their youth, which are likely to be more severe as adults, Obese and overweight youth are more likely to have risk factors associated with cardiovascular diseases, such as high blood pressure, high cholesterol, and type 2 diabetes. Losing weight, in addition to a healthy diet, helps to prevent and control multiple chronic diseases and improves quality of life for a lifetime.” Max J. Coppes, MD, PhD, MBA, FAAP, Nell J Redfield Chair of Pediatrics at the University of Nevada Reno School of Medicine, Physician in Chief of Renown Children's Hospital. We’d like to thank all of the Healthy Nevada Project® participants who provided information to make our work possible, Our research illustrates that it’s not just genetics that cause disease, but that our environment and life experiences interact with our genes to impact our health in ways that we are only beginning to understand.” Robert Read, M.S., of DRI. About DRI The Desert Research Institute (DRI) is a recognized world leader in basic and applied environmental research. Committed to scientific excellence and integrity, DRI faculty, students who work alongside them, and staff have developed scientific knowledge and innovative technologies in research projects around the globe. Since 1959, DRI’s research has advanced scientific knowledge on topics ranging from humans’ impact on the environment to the environment’s impact on humans. DRI’s impactful science and inspiring solutions support Nevada’s diverse economy, provide science-based educational opportunities, and inform policymakers, business leaders, and community members. With campuses in Las Vegas and Reno, DRI serves as the non-profit research arm of the Nevada System of Higher Education.

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MEDICAL

HealthPartners, Helix partner to create DNA testing program that helps families better understand their genetic health

Helix | March 09, 2022

HealthPartners and leading genomics company, Helix, are launching myGenetics, a population genomics program that will provide important health information to families across Minnesota and surrounding states. The myGenetics program hopes to enroll more than 100,000 participants over four years. Genomic data generated will be integrated with patient health records and shared during their personal clinical care. Through the partnership, HealthPartners will be able to identify risk earlier and potentially mitigate serious disease. In similar programs, as many as 1 in 75 participants were found to be at risk for a serious health issue, of which 90 percent would not have been discovered through traditional practice. We see population genomics as a critical step in our efforts to improve the health of the communities we serve across Minnesota and surrounding states, By understanding the role genetics play in an individual's health, we can deliver more personalized care and improve the lives of our patients." Steve Connelly, MD, co-executive medical director at HealthPartners. The program aligns with HealthPartners ongoing drive to deliver simple, personalized, affordable care. The program will be strictly voluntary and will come at no cost to the patient. It's a partnership both HealthPartners and Helix say will help advance precision medicine and greater health equity. We are thrilled to partner deeply with one of the leading integrated delivery networks in the nation. We are excited to enable population access to preventable and actionable genetic insights and to empower providers and patients to make more informed medical decisions, The partnership will also generate cutting edge insights on the best ways to improve quality outcomes, close care gaps and lower the cost of care." James Lu, MD, PhD, CEO and co-founder of Helix. HealthPartners will leverage Helix's end-to-end genomic platform and unique Sequence Once, Query OftenTM model. It allows patient access to genetic data in a cost-efficient manner while also advancing ongoing genomics research. Helix has helped to launch similar programs at the Mayo Clinic, Renown Health and most recently, the Medical University of South Carolina. About Helix Helix is the leading population genomics and viral surveillance company operating at the intersection of clinical care, research, and data analytics. Through its CLIA / CAP laboratory, its end-to-end workflow, and data analytics platforms, Helix enables health systems, life sciences companies, payers, and government partners to accelerate the integration of genomic data into patient care and public health decision making. About HealthPartners HealthPartners is dedicated to improving health and well-being in partnership with members, patients and the community. As an integrated health system, it provides care to more than one million patients and coverage to more than 1.8 million medical and dental health plan members nationwide. HealthPartners also provides medical education and conducts research through HealthPartners Institute.

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MEDICAL

AXIM Biotech Develops Rapid Quantitative Tear Test for MMP-9, An Inflammatory Biomarker of Dry Eye Disease

AXIM Biotech | March 10, 2022

AXIM Biotechnologies, Inc (OTCQB: AXIM) (“AXIM Biotech,” “AXIM” or “the Company”), an international healthcare solutions company targeting dry eye disease (DED), today announced that it has successfully developed a rapid quantitative tear test for MMP-9, an inflammatory biomarker for Dry Eye Disease. Dry Eye Disease, though widespread, is under-diagnosed, in part because symptoms do not always correlate with objective signs. It has a highly variable symptom profile at different stages of the disease, and there is often a discordance between signs and symptoms. A patient can have severe symptoms yet show no sign of ocular surface damage, while others have advanced ocular surface damage, yet report no symptoms. This lack of correlation between clinical signs and symptoms of Dry Eye Disease makes diagnosing and treating patients a challenge. Often times, inflammation is present before the clinical signs of Dry Eye Disease. The challenge has been in early detection of inflammation. Matrix metalloproteinase-9 (MMP-9), an inflammatory biomarker consistently elevated in the tears of dry eye patients, may accelerate early diagnosis when detected. The central role of inflammation in ocular surface disease is widely recognized, but our ability to measure this in the clinic has been limited to the InflammaDry test that measures tear matrix metalloproteinase (MMP) levels and provides a positive/negative result around a threshold of 40ng/ml of MMP-9. This 'yes or no' report has clinical value, but it is limited. Currently available MMP-9 testing does not detect a reduction in tear MMP-9 levels until the concentration drops below 40ng/ml and thus may miss clinically significant improvement that did not reach that threshold.” Dr. Joseph Tauber, AXIM’s Chief Medical Officer. The clinical benefits of the quantitative test for MMP-9 as a tool for accurate diagnosis of Dry Eye Disease and subsequent treatment include more accurate pre-surgical and post-surgical outcomes. Post-surgical complications, such as corneal wound healing, is facilitated by identifying dry eye prior to surgery. The availability of quantitative tear MMP-9 testing would be a significant advance in our ability to measure the degree of inflammation affecting our dry eye patients, allowing for more objective classification of their disease, Equally important would be the ability to measure improvement in control of inflammation that is the goal of many of our therapies for ocular surface disease, including pharmaceuticals, thermal pulsation treatments and even light based therapies.” Dr. Joseph Tauber. Some reports indicate that nearly half of all U.S. adults experience dry eye symptoms and 33% of patients in eye care clinics present with complaints about dry eye. Given the size of the market, AXIM made the strategic decision to develop a test for MMP-9 to assist in early detection of Dry Eye Disease. Together with our Lactoferrin and IgE Tests and now with the addition of our MMP-9 Test, AXIM will be positioned to corner the market for Dry Eye Disease diagnostic testing.” John Huemoeller, AXIM’s CEO. About AXIM® Biotechnologies Founded in 2014, AXIM® Biotechnologies, Inc. (AXIM) is a vertically integrated research and development company focused on improving the landscape for diagnosis of ophthalmological conditions such as Dry Eye Disease (DED) through rapid diagnostic tests. Additionally, it owns IP and has conducted research on SARS-CoV-2 (COVID-19) rapid neutralizing antibody tests to detect levels of functional neutralizing antibodies that are believed to prevent SARS-CoV-2 from entering the host cells, as well as for oncological indications.

Read More

CELL AND GENE THERAPY

Childhood Trauma and Genetics Linked to Increased Obesity Risk

DRI | March 10, 2022

New research from the Healthy Nevada Project® found associations between genetics, obesity, and childhood trauma, linking social health determinants, genetics, and disease. The study, which was published this week in Frontiers in Genetics, found that participants with specific genetic traits and who experience childhood traumas are more likely to suffer from adult obesity. In 2016, DRI and Renown Health launched the Healthy Nevada Project®, the nation’s first community-based, population health study, which now has more than 60,000 participants. The project is a collaboration with personal genomics company, Helix, and combines genetic, environmental, social, and clinical data to address individual and community health needs with the goal of improving health across the state and the nation. The new study focuses on Adverse Childhood Experiences (ACEs), which are traumatic and unsafe events that children endure by the age of 18. Over 16,000 participants in the Healthy Nevada Project® answered a mental health survey, and more than 65 percent of these individuals self-reported at least one ACE occurrence. These 16,000 participants were cross-referenced with their genetic makeup, and clinical Body Mass Index (BMI) measures. According to the research team’s findings, study participants who had experienced one or more types of ACE were 1.5 times more likely to become obese adults. Participants who experienced four or more ACEs were more than twice as likely to become severely obese. Our analysis showed a steady increase in BMI for each ACE a person experienced, which indicates a very strong and significant association between the number of adverse childhood experiences and adult obesity, More importantly, participants’ BMI reacted even more strongly to the occurrence of ACEs when paired with certain mutations in several genes, one of which is strongly associated with schizophrenia.” lead author Karen Schlauch, Ph.D., of DRI. We know that genetics affect disease in the Healthy Nevada Project®, and now we are recognizing that ACEs also affect disease, Our new study shows that the combination of genes and environmental factors like ACEs, as well as many social determinants of health, can lead to more serious health outcomes than either variable alone. More broadly, this new work emphasizes how important it is for population genetic studies to consider the impact of social determinants on health outcomes.” Healthy Nevada Project® Principal Investigator Joseph Grzymski, Ph.D., of DRI and Renown Health. The study team believes that it is important for clinical caregivers to understand the strong impact that negative childhood experiences such as ACEs can have on both child and adult health. The researchers hope the information from this study will encourage doctors and nurses to conduct simple screenings for ACEs and consider a patient’s social environment and history in combination with genetics when developing treatment plans for better patient health. According to the 2019 Youth Behavior Risk Survey (YRBS), 25.6 percent of Washoe County teenagers are overweight or obese. Obesity is a serious health concern for children and adolescents. According to the Centers for Disease Control and Prevention, obese children and adolescents are more likely to become obese as adults. Obese and overweight children and adolescents are at risk for multiple health problems during their youth, which are likely to be more severe as adults, Obese and overweight youth are more likely to have risk factors associated with cardiovascular diseases, such as high blood pressure, high cholesterol, and type 2 diabetes. Losing weight, in addition to a healthy diet, helps to prevent and control multiple chronic diseases and improves quality of life for a lifetime.” Max J. Coppes, MD, PhD, MBA, FAAP, Nell J Redfield Chair of Pediatrics at the University of Nevada Reno School of Medicine, Physician in Chief of Renown Children's Hospital. We’d like to thank all of the Healthy Nevada Project® participants who provided information to make our work possible, Our research illustrates that it’s not just genetics that cause disease, but that our environment and life experiences interact with our genes to impact our health in ways that we are only beginning to understand.” Robert Read, M.S., of DRI. About DRI The Desert Research Institute (DRI) is a recognized world leader in basic and applied environmental research. Committed to scientific excellence and integrity, DRI faculty, students who work alongside them, and staff have developed scientific knowledge and innovative technologies in research projects around the globe. Since 1959, DRI’s research has advanced scientific knowledge on topics ranging from humans’ impact on the environment to the environment’s impact on humans. DRI’s impactful science and inspiring solutions support Nevada’s diverse economy, provide science-based educational opportunities, and inform policymakers, business leaders, and community members. With campuses in Las Vegas and Reno, DRI serves as the non-profit research arm of the Nevada System of Higher Education.

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MEDICAL

HealthPartners, Helix partner to create DNA testing program that helps families better understand their genetic health

Helix | March 09, 2022

HealthPartners and leading genomics company, Helix, are launching myGenetics, a population genomics program that will provide important health information to families across Minnesota and surrounding states. The myGenetics program hopes to enroll more than 100,000 participants over four years. Genomic data generated will be integrated with patient health records and shared during their personal clinical care. Through the partnership, HealthPartners will be able to identify risk earlier and potentially mitigate serious disease. In similar programs, as many as 1 in 75 participants were found to be at risk for a serious health issue, of which 90 percent would not have been discovered through traditional practice. We see population genomics as a critical step in our efforts to improve the health of the communities we serve across Minnesota and surrounding states, By understanding the role genetics play in an individual's health, we can deliver more personalized care and improve the lives of our patients." Steve Connelly, MD, co-executive medical director at HealthPartners. The program aligns with HealthPartners ongoing drive to deliver simple, personalized, affordable care. The program will be strictly voluntary and will come at no cost to the patient. It's a partnership both HealthPartners and Helix say will help advance precision medicine and greater health equity. We are thrilled to partner deeply with one of the leading integrated delivery networks in the nation. We are excited to enable population access to preventable and actionable genetic insights and to empower providers and patients to make more informed medical decisions, The partnership will also generate cutting edge insights on the best ways to improve quality outcomes, close care gaps and lower the cost of care." James Lu, MD, PhD, CEO and co-founder of Helix. HealthPartners will leverage Helix's end-to-end genomic platform and unique Sequence Once, Query OftenTM model. It allows patient access to genetic data in a cost-efficient manner while also advancing ongoing genomics research. Helix has helped to launch similar programs at the Mayo Clinic, Renown Health and most recently, the Medical University of South Carolina. About Helix Helix is the leading population genomics and viral surveillance company operating at the intersection of clinical care, research, and data analytics. Through its CLIA / CAP laboratory, its end-to-end workflow, and data analytics platforms, Helix enables health systems, life sciences companies, payers, and government partners to accelerate the integration of genomic data into patient care and public health decision making. About HealthPartners HealthPartners is dedicated to improving health and well-being in partnership with members, patients and the community. As an integrated health system, it provides care to more than one million patients and coverage to more than 1.8 million medical and dental health plan members nationwide. HealthPartners also provides medical education and conducts research through HealthPartners Institute.

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