USDA Proposes Allowing Genetic Engineering Editing in Certified Organic Food

Advocates of organic agriculture, including Beyond Pesticides, are sounding a yellow alert on the heels of recent comments, by the U.S. Department of Agriculture USDA Under Secretary for Marketing and Regulatory Programs, Greg Ibach, before the U.S. House Agriculture Subcommittee on Biotechnology, Horticulture, and Research.

Spotlight

Provention Bio

Provention Bio, Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics aimed at intercepting and preventing immune-mediated diseases. -We seek technologies or targets designed to predict, preempt or intervene before immune disease begins, re-appears or progresses. -We are creating a new biopharmaceutical category for autoimmunity.

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MedTech

How to Choose a Reliable Biotech Clinical Trial Management System?

Article | September 22, 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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MedTech

Advancement in Genomics Accelerating its Penetration into Precision Health

Article | October 7, 2022

Genomics is an interdisciplinary field of biology emphasizing the structure, editing, evolution, function, and mapping of genomes. It is creating deeper inroads across the precision health domain with the increasing introduction of advanced technologies such as quantum simulation, next-generation sequencing (NGS), and precise genome manipulation. As precision health focuses on providing the proper intervention to the right patient at the right time, genomics increasingly finds applications in human and pathogen genome sequencing in clinical and research spaces. Rising Hereditary Diseases Burden Paving the Way for Genomics in Precision Health In the last few years, a significant surge in the prevalence of diseases and ailments such as diabetes, obesity, baldness, and others has been witnessed across the globe. A history of family members with chronic diseases, such as cancer, diabetes, high blood pressure, hearing issues, and heart disease, can sometimes continue into the next generation. Hence, the study of genes is extensively being conducted for predicting health risks and early treatment of these diseases. It also finds use in CRISPR-based diagnostics and the preparation of precision medication for the individual. In addition, ongoing advancements in genomics are making it possible to identify different genetic traits that persuade people to more widespread diseases and health problems. The Emergence of Genomics Improves Disease Understanding Genomics refers to the study of the complete genetic makeup of a cell or organism. Increasing scientific research in the area substantially contributes to increasing knowledge about the human genome and assists in improving the ability to understand disease etiology, risk, diagnosis, treatment, and prevention. On account of these improvements, innovative genomic technologies and tools are being developed to enable better precision health not only for the individual but for various regional populations as well. The Way Forward With growing preference for personalized medicine and an increasing need for more accurate pathogen detection and diagnostics, genomics is gaining huge popularity across the precision health domain. Also, increasing research activities for developing novel high-precision therapeutics and rising importance of gene study in the prevention, diagnosis, and management of infectious and genetic diseases will further pave the way for genomics in the forthcoming years.

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Medical

Making Predictions by Digitizing Bioprocessing

Article | July 14, 2022

With advances in data analytics and machine learning, the move from descriptive and diagnostic analytics to predictive and prescriptive analytics and controls—allowing us to better forecast and understand what will happen and thus optimize process outcomes—is not only feasible but inevitable, according to Bonnie Shum, principal engineer, pharma technical innovation, technology & manufacturing sciences and technology at Genentech. “Well-trained artificial intelligence systems can help drive better decision making and how data is analyzed from drug discovery to process development and to manufacturing processes,” she says. Those advances, though, only really matter when they improve the lives of patients. That’s exactly what Shum expects. “The convergence of digital transformation and operational/processing changes will be critical for the facilities of the future and meeting the needs of our patients,” she continues. “Digital solutions may one day provide fully automated bioprocessing, eliminating manual intervention and enabling us to anticipate potential process deviations to prevent process failures, leading to real-time release and thus faster access for patients.” To turn Bioprocessing 4.0 into a production line for precision healthcare, real-time release and quickly manufacturing personalized medicines will be critical. Adding digitization and advanced analytics wherever possible will drive those improvements. In fact, many of these improvements, especially moving from descriptive to predictive bioprocessing, depend on more digitization.

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MedTech

Biotech in 2022

Article | July 11, 2022

The robust global channel of more than, 800 gene and cell curatives presently in trials will produce clinical readouts in 2022, revealing what lies ahead for advanced curatives. The impact will be felt in 2022, no matter how you slice it. Eventually, how well industry and non-supervisory bodies unite to produce new frameworks for advanced therapies will shape the year 2022 and further. Pacific Northwest talent will continue to contribute to the advancement of gene and cell curatives in both the short and long term, thanks to its deep pool of ground-breaking scientific developers, entrepreneurial directorial leadership, largely skilled translational scientists, and endured bio manufacturing technicians. We may see continued on-life science fund withdrawal from biotech in 2021, but this can be anticipated as a strong comeback in 2022 by biotech industry, backed by deep-pocketed life science investors who are committed to this sector. A similar investment, combined with pharma's cash-heavy coffers, can result in increased junction and acquisition activity, which will be a challenge for some but an occasion for others. Over the last five years, investment interest in Seattle and the Pacific Northwest has grown exponentially, from Vancouver, British Columbia, to Oregon. The region's explosive portfolio of new biotech companies, innovated out of academic centres, demonstrates the region's growing recognition of scientific invention. This created a belief that continued, especially because Seattle's start-ups and biotech enterprises are delivering on their pledge of clinical and patient impact. Talent and staffing will continue to be difficult to find. It's a CEO's market, but many of these funds' return, and are not rising in proportion to the exorbitant prices they're paying to enter deals. This schism has become particularly pronounced in 2021. Hence, everyone in biotech is concerned about reclamation and retention.

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Spotlight

Provention Bio

Provention Bio, Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics aimed at intercepting and preventing immune-mediated diseases. -We seek technologies or targets designed to predict, preempt or intervene before immune disease begins, re-appears or progresses. -We are creating a new biopharmaceutical category for autoimmunity.

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Industrial Impact

Verantos Named "BioInformatics Company of the Year" by BioTech Breakthrough

BioTech Breakthrough, Verantos | October 28, 2021

Verantos, the market leader in high-validity real-world evidence (RWE) generation, today announced it has been named "BioInformatics Company of the Year" in the inaugural BioTech Breakthrough Awards program conducted by BioTech Breakthrough. This independent market intelligence organization evaluates and recognizes standout life sciences and biotechnology companies, products, and services around the globe. The Verantos real-world evidence (RWE) platform leverages data science, artificial intelligence, and advanced data sources to generate evidence that enables precision medicine. It also provides a more inclusive approach to a learning healthcare system, in which underrepresented populations are better represented than in other evidence generation approaches. The platform is able to de-identify, enrich, and integrate data from electronic health records, medical claims, and registries to produce exacting and exceptionally valid RWE. Bryan Vaughn, Managing Director of BioTech Breakthrough Awards said, "Verantos continues to develop high-validity RWE in collaboration with pharmaceutical, regulatory and scientific institutions, enabling personalized medicine, and improved, more efficient care. Congratulations on being our choice for 'BioInformatics Company of the Year." Verantos has generated advanced RWE for top-tier biotechnology and pharmaceutical firms in addition to leading academic medical centers and health systems. It has also developed advanced science funded by the Food and Drug Administration, the National Institutes of Health, and the National Science Foundation. Additionally, Verantos CEO Dan Riskin testified before Congress on the 21st Century Cures Initiative and has helped shape policy in the use of advanced clinical data and technologies. These partnerships and initiatives have allowed Verantos to trailblaze in their industry and benefit patients living with common conditions across the globe. "We are thrilled to receive this award from BioTech Breakthrough. It supports our mission to advance real-world evidence to improve the standard of care, and furthers our vision to pioneer personalized medicine by setting the quality standard for real-world evidence. said Dan Riskin, CEO of Verantos. The annual BioTech Breakthrough Awards program conducts the industry's most comprehensive analysis and evaluation of the top technology companies, solutions and products in the life sciences and biotechnology industry today. This year's program attracted more than 1,200 nominations from over 12 different countries throughout the world. About Verantos Verantos is the market leader in high-accuracy, real-world evidence generation. The Verantos RWE platform integrates heterogeneous real-world data sources and generates evidence with the accuracy necessary for regulatory and reimbursement use. The Verantos RWE platform leverages data science and artificial intelligence along with advanced data sources such as electronic health records to generate RWE capable of supporting clinical assertions. About BioTech Breakthrough Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the BioTech Breakthrough Awards program is devoted to honoring excellence in life science and biotechnology solutions, services and companies. The BioTech Breakthrough Awards provide public recognition for the achievements of biotechnology companies and products in categories including BioPharma, Genomics, Therapeutics, Food Science and BioAgriculture, and more.

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Industrial Impact

Omega Therapeutics Announces Strategic Research Collaboration with Stanford University School of Medicine

Omega Therapeutics, Inc | October 14, 2021

Omega Therapeutics, Inc. ("Omega"), a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programing™ platform, today announced a strategic research collaboration with researchers at the Stanford University School of Medicine to explore the therapeutic potential of Omega Epigenomic Controllers (OECs) to control ocular disease genes associated with inflammation or regeneration of ocular tissues. Under the terms of the collaboration, Omega and members of the Ophthalmology Department of Stanford University School of Medicine will use the OMEGA Epigenomic Programming platform to discover and research novel ocular targets for potential future OEC development candidates. Albert Wu, M.D., Ph.D., FACS, Associate Professor of Ophthalmology, will serve as principal investigator. Other contributors will include Jeffrey Goldberg, M.D., Ph.D., Professor and Chair of Ophthalmology, and Michael Kapiloff, M.D., Ph.D., Associate Professor (Research) of Ophthalmology. "Through this research collaboration, we aim to expand the reach of our OMEGA platform within regenerative medicine, immunology, and inflammation with ocular disease targets. We will continue exploration of the broad potential of our disruptive platform and OECs, our new class of mRNA therapeutics as programmable epigenetic medicines." Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics About Omega Therapeutics Omega Therapeutics is a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming™ platform. The OMEGA platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth and differentiation to cell death. The OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega's engineered, modular, and programmable mRNA-encoded epigenetic medicines, Omega Epigenomic Controllers™, target specific intervention points amongst the thousands of mapped and validated novel DNA-sequence-based epigenomic loci to durably tune single or multiple genes to treat and cure disease through Precision Genomic Control™. Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases.

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MedTech

Outcomes4Me Partners with Invitae to Offer Genetic Testing to Breast Cancer Patients

Outcomes4Me | October 12, 2021

Outcomes4Me Inc., developer of a leading free mobile app and platform to navigate cancer treatment and care, today announced that it has partnered with Invitae Corporation (NYSE: NVTA), a leading medical genetics company, to expand education and access to genetic testing to breast cancer patients and survivors. The collaboration leverages the strengths of Invitae, which supplies clinical grade genetic testing, and Outcomes4Me’s 360-degree, validated and evidence-based cancer support and treatment options via its free and easy-to-use app. Initially and currently available in the United States, patients can now receive genetic counseling through Invitae’s partnership with Genome Medical, get testing, and upload their results within the Outcomes4Me app.There is a misconception that genetic testing is only useful as a preventative tool prior to a cancer diagnosis. According to Outcomes4Me patient data, almost half of users (46 percent) who qualified for testing (based on NCCN Guidelines®) did not receive testing or did not know if they had received testing. However, genetic testing can provide insights that can help inform and refine precision therapy use and clinical treatment trial enrollment. In addition, genetic testing results can be used to help prevent recurrence and reduce incidence of other inherited cancers. A cancer diagnosis is often overwhelming for patients and their families. Outcomes4Me demystifies cancer by providing the most up-to-date and validated research, support, and treatment options, all grounded in science and data and curated according to the patient’s specific diagnosis. Outcomes4Me partners with the researchers, doctors, and academics that set the rigorous standards of cancer care for all treatment providers, including the National Comprehensive Care Network® (NCCN®), Vanderbilt-Ingram Cancer Center (VICC) and Massachusetts General Hospital (MGH). The collaboration with Invitae expands access to genetic testing, a vitally important tool in the patient’s cancer care arsenal. “Outcomes4Me is an indispensable platform for patients with breast cancer, giving them the personalized knowledge and access to timely new trials and targeted therapies that could lead to better health outcomes. By providing access to our comprehensive genetic testing and counseling services, Outcomes4Me is adding a valuable resource that will empower patients to advance their knowledge, understanding, and therefore, self-advocacy during treatment and survivorship.” Ed Esplin, M.D., Ph.D., FACMG, FACP, Clinical Geneticist at Invitae Unlike popular direct-to-consumer genetic testing services, which test for a few specific genetic variants for certain genes, Invitae provides state-of-the-art clinical grade next-generation sequencing-based (NGS) genetic testing that comprehensively analyses more than 80 genes, including all known mutations of the important BRCA1/BRCA2 genes. This comprehensive approach, combined with associated genetic counseling, not only provides insights for cancer patients, but also for family members who may be at risk. “Our collaboration with Invitae reinforces Outcomes4Me’s mission to give patients back control. Because of this work with Invitae, our valued community now has rare direct access to a much-needed testing service. Outcomes4Me will proudly continue to democratize the best in cancer treatment, research, and support by removing barriers and bias in information flow.” Maya R. Said, Sc. D., Founder and CEO of Outcomes4Me About Invitae Invitae Corporation (NYSE: NVTA) is a leading medical genetics company whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. About Outcomes4Me Outcomes4Me is on a mission to improve health outcomes by empowering patients with understandable, relevant and evidence-based information. Outcomes4Me has developed a platform for shared decision-making between patients and providers. The platform harnesses regulatory-grade, real-world data and patient experiences generating deeper insights and better outcomes to improve care and accelerate research. The Outcomes4Me mobile app enables cancer patients to make decisions and take control of their care based on information that is personalized to their specific condition, including finding treatment options, matching to clinical trials, and tracking and managing symptoms. Based in Boston, Massachusetts, Outcomes4Me, a woman-led company, comprises seasoned healthcare, oncology, pharmaceutical, consumer and technology veterans.

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Industrial Impact

Verantos Named "BioInformatics Company of the Year" by BioTech Breakthrough

BioTech Breakthrough, Verantos | October 28, 2021

Verantos, the market leader in high-validity real-world evidence (RWE) generation, today announced it has been named "BioInformatics Company of the Year" in the inaugural BioTech Breakthrough Awards program conducted by BioTech Breakthrough. This independent market intelligence organization evaluates and recognizes standout life sciences and biotechnology companies, products, and services around the globe. The Verantos real-world evidence (RWE) platform leverages data science, artificial intelligence, and advanced data sources to generate evidence that enables precision medicine. It also provides a more inclusive approach to a learning healthcare system, in which underrepresented populations are better represented than in other evidence generation approaches. The platform is able to de-identify, enrich, and integrate data from electronic health records, medical claims, and registries to produce exacting and exceptionally valid RWE. Bryan Vaughn, Managing Director of BioTech Breakthrough Awards said, "Verantos continues to develop high-validity RWE in collaboration with pharmaceutical, regulatory and scientific institutions, enabling personalized medicine, and improved, more efficient care. Congratulations on being our choice for 'BioInformatics Company of the Year." Verantos has generated advanced RWE for top-tier biotechnology and pharmaceutical firms in addition to leading academic medical centers and health systems. It has also developed advanced science funded by the Food and Drug Administration, the National Institutes of Health, and the National Science Foundation. Additionally, Verantos CEO Dan Riskin testified before Congress on the 21st Century Cures Initiative and has helped shape policy in the use of advanced clinical data and technologies. These partnerships and initiatives have allowed Verantos to trailblaze in their industry and benefit patients living with common conditions across the globe. "We are thrilled to receive this award from BioTech Breakthrough. It supports our mission to advance real-world evidence to improve the standard of care, and furthers our vision to pioneer personalized medicine by setting the quality standard for real-world evidence. said Dan Riskin, CEO of Verantos. The annual BioTech Breakthrough Awards program conducts the industry's most comprehensive analysis and evaluation of the top technology companies, solutions and products in the life sciences and biotechnology industry today. This year's program attracted more than 1,200 nominations from over 12 different countries throughout the world. About Verantos Verantos is the market leader in high-accuracy, real-world evidence generation. The Verantos RWE platform integrates heterogeneous real-world data sources and generates evidence with the accuracy necessary for regulatory and reimbursement use. The Verantos RWE platform leverages data science and artificial intelligence along with advanced data sources such as electronic health records to generate RWE capable of supporting clinical assertions. About BioTech Breakthrough Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the BioTech Breakthrough Awards program is devoted to honoring excellence in life science and biotechnology solutions, services and companies. The BioTech Breakthrough Awards provide public recognition for the achievements of biotechnology companies and products in categories including BioPharma, Genomics, Therapeutics, Food Science and BioAgriculture, and more.

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Industrial Impact

Omega Therapeutics Announces Strategic Research Collaboration with Stanford University School of Medicine

Omega Therapeutics, Inc | October 14, 2021

Omega Therapeutics, Inc. ("Omega"), a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programing™ platform, today announced a strategic research collaboration with researchers at the Stanford University School of Medicine to explore the therapeutic potential of Omega Epigenomic Controllers (OECs) to control ocular disease genes associated with inflammation or regeneration of ocular tissues. Under the terms of the collaboration, Omega and members of the Ophthalmology Department of Stanford University School of Medicine will use the OMEGA Epigenomic Programming platform to discover and research novel ocular targets for potential future OEC development candidates. Albert Wu, M.D., Ph.D., FACS, Associate Professor of Ophthalmology, will serve as principal investigator. Other contributors will include Jeffrey Goldberg, M.D., Ph.D., Professor and Chair of Ophthalmology, and Michael Kapiloff, M.D., Ph.D., Associate Professor (Research) of Ophthalmology. "Through this research collaboration, we aim to expand the reach of our OMEGA platform within regenerative medicine, immunology, and inflammation with ocular disease targets. We will continue exploration of the broad potential of our disruptive platform and OECs, our new class of mRNA therapeutics as programmable epigenetic medicines." Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics About Omega Therapeutics Omega Therapeutics is a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming™ platform. The OMEGA platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth and differentiation to cell death. The OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega's engineered, modular, and programmable mRNA-encoded epigenetic medicines, Omega Epigenomic Controllers™, target specific intervention points amongst the thousands of mapped and validated novel DNA-sequence-based epigenomic loci to durably tune single or multiple genes to treat and cure disease through Precision Genomic Control™. Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases.

Read More

MedTech

Outcomes4Me Partners with Invitae to Offer Genetic Testing to Breast Cancer Patients

Outcomes4Me | October 12, 2021

Outcomes4Me Inc., developer of a leading free mobile app and platform to navigate cancer treatment and care, today announced that it has partnered with Invitae Corporation (NYSE: NVTA), a leading medical genetics company, to expand education and access to genetic testing to breast cancer patients and survivors. The collaboration leverages the strengths of Invitae, which supplies clinical grade genetic testing, and Outcomes4Me’s 360-degree, validated and evidence-based cancer support and treatment options via its free and easy-to-use app. Initially and currently available in the United States, patients can now receive genetic counseling through Invitae’s partnership with Genome Medical, get testing, and upload their results within the Outcomes4Me app.There is a misconception that genetic testing is only useful as a preventative tool prior to a cancer diagnosis. According to Outcomes4Me patient data, almost half of users (46 percent) who qualified for testing (based on NCCN Guidelines®) did not receive testing or did not know if they had received testing. However, genetic testing can provide insights that can help inform and refine precision therapy use and clinical treatment trial enrollment. In addition, genetic testing results can be used to help prevent recurrence and reduce incidence of other inherited cancers. A cancer diagnosis is often overwhelming for patients and their families. Outcomes4Me demystifies cancer by providing the most up-to-date and validated research, support, and treatment options, all grounded in science and data and curated according to the patient’s specific diagnosis. Outcomes4Me partners with the researchers, doctors, and academics that set the rigorous standards of cancer care for all treatment providers, including the National Comprehensive Care Network® (NCCN®), Vanderbilt-Ingram Cancer Center (VICC) and Massachusetts General Hospital (MGH). The collaboration with Invitae expands access to genetic testing, a vitally important tool in the patient’s cancer care arsenal. “Outcomes4Me is an indispensable platform for patients with breast cancer, giving them the personalized knowledge and access to timely new trials and targeted therapies that could lead to better health outcomes. By providing access to our comprehensive genetic testing and counseling services, Outcomes4Me is adding a valuable resource that will empower patients to advance their knowledge, understanding, and therefore, self-advocacy during treatment and survivorship.” Ed Esplin, M.D., Ph.D., FACMG, FACP, Clinical Geneticist at Invitae Unlike popular direct-to-consumer genetic testing services, which test for a few specific genetic variants for certain genes, Invitae provides state-of-the-art clinical grade next-generation sequencing-based (NGS) genetic testing that comprehensively analyses more than 80 genes, including all known mutations of the important BRCA1/BRCA2 genes. This comprehensive approach, combined with associated genetic counseling, not only provides insights for cancer patients, but also for family members who may be at risk. “Our collaboration with Invitae reinforces Outcomes4Me’s mission to give patients back control. Because of this work with Invitae, our valued community now has rare direct access to a much-needed testing service. Outcomes4Me will proudly continue to democratize the best in cancer treatment, research, and support by removing barriers and bias in information flow.” Maya R. Said, Sc. D., Founder and CEO of Outcomes4Me About Invitae Invitae Corporation (NYSE: NVTA) is a leading medical genetics company whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. About Outcomes4Me Outcomes4Me is on a mission to improve health outcomes by empowering patients with understandable, relevant and evidence-based information. Outcomes4Me has developed a platform for shared decision-making between patients and providers. The platform harnesses regulatory-grade, real-world data and patient experiences generating deeper insights and better outcomes to improve care and accelerate research. The Outcomes4Me mobile app enables cancer patients to make decisions and take control of their care based on information that is personalized to their specific condition, including finding treatment options, matching to clinical trials, and tracking and managing symptoms. Based in Boston, Massachusetts, Outcomes4Me, a woman-led company, comprises seasoned healthcare, oncology, pharmaceutical, consumer and technology veterans.

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