When genome editing goes off-target

Editing DNA in eukaryotic cells with CRISPR-based systems has revolutionized the genome engineering field. Cas (CRISPR-associated) endonucleases are directed to a particular location in the genome by a short guide RNA, providing an easily programmable strategy to target any section of DNA. As of now, two CRISPR-based approaches can introduce targeted, permanent edits. DNA cleavage with the Cas endonuclease facilitates small insertions or deletions of nucleotides that can disable the targeted gene (1). A second modified “base editor” system can generate precise single-base mutations in the targeted DNA (2). For both approaches, it is imperative that DNA modifications are made in the intended region (“on-target”) and not elsewhere in the genome (“off-target”). On pages 286, 289, and 292 of this issue, Wienert et al. (3), Zuo et al. (4), and Jin et al. (5), respectively, describe methods that identify off-target activities, which will be invaluable in therapeutic contexts as well as for stringent evaluation of future iterations of gene-editing tools.

Spotlight

Neogen Europe Ltd.

Neogen Europe Ltd, the European subsidiary of Neogen Corporation, is a high technology business dedicated to the development and marketing of novel diagnostic kits. These kits focus on topical concerns about the quality and safety of food and agricultural products, from the quality of seed that goes into the ground, right through the chain to the safety of fully processed food products.

OTHER ARTICLES
MedTech

Better Purification and Recovery in Bioprocessing

Article | July 11, 2022

In the downstream portion of any bioprocess, one must pick through the dross before one can seize the gold the biotherapeutic that the bioprocess was always meant to generate. Unfortunately, the dross is both voluminous and various. And the biotherapeutic gold, unlike real gold, is corruptible. That is, it can suffer structural damage and activity loss. When discarding the dross and collecting the gold, bioprocessors must be efficient and gentle. They must, to the extent possible, eliminate contaminants and organic debris while ensuring that biotherapeutics avoid aggregation-inducing stresses and retain their integrity during purification and recovery. Anything less compromises purity and reduces yield. To purify and recover biotherapeutics efficiently and gently, bioprocessors must avail themselves of the most appropriate tools and techniques. Here, we talk with several experts about which tools and techniques can help bioprocessors overcome persistent challenges. Some of these experts also touch on new approaches that can help bioprocessors address emerging challenges.

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MedTech

Next-Gen Genetics Cancer Therapies Creating Investment Prospects

Article | July 12, 2022

Genetic therapeutics such as genetic engineering and gene therapy are increasingly emerging as one of the most influential and transformed biotechnological solutions around the globe in recent times. These genetic solutions are being assessed across various medical domains, including cancer treatment, neurology, oncology, and ophthalmology. Citing the trend, the genetics industry is estimated to experience a tsunami of approvals, with over 1,000 cell and gene therapy clinical trials currently underway and over 900 companies worldwide focusing on these cutting-edge therapies. Growing Cancer Encourages Advancements in Genetic Technologies With the surging cases of cancers such as leukemias, carcinomas, lymphomas, and others, patients worldwide are increasing their spending on adopting novel therapeutic solutions for non-recurring treatment of the disease, such as gene therapy, genetic engineering, T-cell therapy, and gene editing. As per a study by the Fight Cancer Organization, spending on the treatment of cancer increased to $200.7 billion, and the amount is anticipated to exceed $245 billion by the end of 2030. Growing revenue prospects are encouraging biotechnology and biopharmaceutical companies to develop novel genetic solutions for cancer treatment. For instance, Bristol-Myers Squibb K.K., a Japanese pharmaceutical company, introduced a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, Abecma, for the treatment of relapsed or refractory (R/R) multiple myeloma in 2022. Amid a New Market: Genetics Will Attract Massive Investments Despite several developments and technological advancements, genetics is still considered to be in a nascent stage, providing significant prospects for growth to the companies that are already operating in the domain. Genetics solutions such as gene therapies, gene editing, and T-cell immunotherapy are emerging as highly active treatments across various medical fields, resulting in increasing research and development activities across the domain, drawing significant attention from investors. Given the potential of genetic treatments and the focus on finding new ways to treat cancer and other related diseases, it's easy to understand why companies are investing in the domain. For instance, Pfizer has recently announced an investment of around $800 million to construct development facilities supporting gene therapy manufacturing from initial preclinical research through final commercial-scale production. Due to these advancements, cell and gene therapies are forecast to grow from $4 billion annually to more than $45 billion, exhibiting growth at a 63% CAGR. The Future of Genetics Though there is a significant rise in advancement in genetic technologies and developments, the number of approved genetic treatments remains extremely small. However, with gene transfer and CRISPR solutions emerging as new modalities for cancer treatment, the start-up companies will attract a growing amount and proportion of private and public investments. This is expected present a tremendous opportunity for biopharma and biotechnology investors to help fund and benefit from the medical industry's shift from traditional treatments to cutting-edge genetic therapeutics in the coming years.

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MedTech

Laboratory Information Management System for Biotech Labs: Significance & Benefits

Article | July 16, 2022

If you have ever visited the testing laboratory of a large biotechnology company, you will be aware that managing the laboratory's operations single-handedly is no easy task. The greater the size of a lab, the more research and testing activities it must accommodate. A variety of diagnostic tests are prescribed for patients in order to detect various diseases. For example, it may include blood glucose testing for diabetics, lipid panel, or liver panel tests for evaluating cardiac risk and liver function, cultures for diagnosing infections, thyroid function tests, and others. Laboratory management solutions such as laboratory information management systems (LIMS) and other software play a significant role in managing various operational data at biotech laboratories. It is one of the important types of software developed to address thedata management and regulatory challenges of laboratories. The software enhances the operational efficiency of biotech labs by streamlining workflows, proper record-keeping, and eradicating the need for manually maintaining data. What Are the Benefits of Laboratory Information Management Software in Biotechnology? As the trends of digitization and technology continue to create deeper inroads into the biotechnology sector, a significant rise in the adoption of innovative medical software solutions, such as LIMS, is being witnessed for managing research data, testing reports, and post-research results globally. Here are a few reasons that are encouraging biotech facilities to adopt LIMS solutions Real-Time Data Collection and Tracking Previously, collecting and transporting samples was a tedious and time-consuming task. However, the adoption of LIMS with innovative tracking modules has made the job easier. The real-time sample tracking feature of LIMS has made it possible for personnel to collect the research data in real-time and manage and control the workflow with a few mouse clicks on the screen. Increase Revenue LIMS makes it possible to test workflows while giving users complete control over the testing process. A laboratory is able to collect data, schedule equipment maintenance or upgrades, enhance operational efficiency, and maintain a lower overhead with the help of the LIMS, thereby increasing revenue. Streamlined Workflow With its completion monitoring, LIMS speeds up laboratory workflows and keeps track of information. It assigns tasks to the specialist along with keeping a real-time track of the status and completion of each task. LIMS is integrated into the laboratory using lab information, which ultimately speeds up internal processes and streamlines the workflow. Automatic Data Exchange LIMS solutions store data in a centralized database. Automated transfer of data between departments and organizations is one of the major features of LIMS. Through its automated information exchange feature, LIMS improves internal operations, decreases the reporting time for data sharing, and assists in faster decision-making. Final Thoughts As the healthcare sector continues to ride the wave of digital transformation, biotech laboratories are emphasizing adopting newer technologies to keep up with the changes. Citing this trend, laboratory information management systems are becoming crucial for biotech and medical organizations for maintaining research data, instant reporting, and managing confidential, inventory, and financial data with centralized data storage.

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Research

2022 U.S. Market Research Report with COVID-19 Forecasts2

Article | July 11, 2022

The global biotechnology market is expected to grow at a compound annual growth rate (CAGR) of 13.9 percent from 2022 to 2030, with a value estimated at USD 1,023.92 billion in 2021. The market is being propelled by strong government support in the form of initiatives aimed at modernizing the regulatory framework, improving approval processes and reimbursement policies, and standardizing clinical studies. The growing presence of personalized medicine and an increasing number of orphan drug formulations are opening up new avenues for biotechnology applications and driving the influx of emerging and innovative biotechnology companies, which is driving market revenue even further. The 2022 Biotech Research and Development Market Research Report is one of the most comprehensive and in-depth assessments of the industry in the United States, containing over 100 data sets spanning the years 2013 to 2026. This Kentley Insights report contains historical and forecasted market size, product lines, profitability, financial ratios, BCG matrix, state statistics, operating expense details, organizational breakdown, consolidation analysis, employee productivity, price inflation, pay bands for the top 20 industry jobs, trend analysis and forecasts on companies, locations, employees, payroll, and much more. Companies in the Biotech Research and Development industry are primarily engaged in biotechnology research and experimental development. Biotechnology research and development entails the investigation of the use of microorganisms and cellular and bimolecular processes to create or modify living or non-living materials. This biotechnology research and development may result in the development of new biotechnology processes or prototypes of new or genetically altered products that can be replicated, used, or implemented by various industries. This report was created using the findings of extensive business surveys and econometrics. The professionals follow reports with accurate and apt information on market sizing, benchmarking, strategic planning, due diligence, cost-cutting, planning, understanding industry dynamics, forecasting, streamlining, gap analysis, and other ana

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Spotlight

Neogen Europe Ltd.

Neogen Europe Ltd, the European subsidiary of Neogen Corporation, is a high technology business dedicated to the development and marketing of novel diagnostic kits. These kits focus on topical concerns about the quality and safety of food and agricultural products, from the quality of seed that goes into the ground, right through the chain to the safety of fully processed food products.

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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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