November 30, 2021 | French AI startup Owkin announces big funding and Memorial Sloan Kettering Cancer Center partnership, Roche and Genentech choose Flywheel cloud informatics, and Talis Biomedical gets FDA EUA for COVID-19 test. Plus new products from VIDA Diagnostics, Oncocyte, Metabolon and more.
Roche and Genentech have integrated the Flywheel cloud informatics platform for ingestion, classification, standardization, curation and analysis of medical imaging data. The secure, scalable Flywheel platform enables aggregation and management of medical imaging and associated data to accelerate drug discovery. The data is organized and processed with automated pipelines—saving significant time and minimizing the potential for human error in the drug development process. Cost and timeline efficiencies allow researchers to focus on what matters most—bringing life-changing therapies to patients faster. Moreover, Flywheel’s unique approach has enabled multi-site collaboration and development of a customized solution for Roche and Genentech’s needs. Press release.
VIDA Diagnostics has introduced a new AI-powered portal. The cloud-based VIDA Intelligence Portal (VIP) streamlines challenges often associated with imaging in trials such as site onboarding, staff training, image data management, and data quality. Leveraging a powerful AI engine, the portal automates cumbersome and time sensitive tasks such as subject anonymization and quality control workflow processes. VIP automatically applies AI prior to human interaction, allowing for immediate intervention in the event of poor data quality, for example. The result is smoother trials that produce high quality data, leading to more efficient and successful outcomes. With VIP, available broadly as part of VIDA Discovery, trial sponsors and sites can effortlessly manage scans and related information, eliminating manual steps that often slow trials and can affect data integrity. The highly secure portal serves as a centralized information hub, replacing a patchwork of existing online and offline third-party solutions. Press release.
Caption Health and Ultromics, leaders in using AI to improve heart ultrasound diagnostics, have announced a strategic partnership to accelerate cardiovascular disease detection and treatment for more patients in more accessible care settings. Together, the companies will jointly offer the Caption AI software platform alongside Ultromics’ EchoGo deep ultrasound analytics allowing a broader set of providers the ability to perform ultrasounds and automatically calculate key indicators of heart function, which drive earlier and more accurate disease diagnosis. By linking these platforms, images acquired using Caption AI can be analyzed through Ultromics’ EchoGo platform, making advanced diagnostic capabilities that had been limited to experts in specialty care settings and expanding their access to more doctors and patients in more places. In the new year, these integrated capabilities are expected to be available on the Butterfly iQ+ platform, as part of Butterfly Network and Caption Health’s strategic partnership. Press release.
The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Talis Biomedical Corporation’s Talis One COVID-19 Test System, a nucleic acid amplification test (NAAT). The Talis One COVID-19 test runs on an integrated system that includes a compact instrument, self-contained, single-use test cartridges and software for reporting results. Designed for use in a variety of healthcare and congregate settings, the Talis One system enables sample-to-answer molecular testing in less than 30 minutes. The Talis One COVID-19 Test System targets two genes, ORF1ab and N, to optimize sensitivity and the inclusion of variants. The ORF1ab and N gene were selected for their conserved nature and their unique sequence specific for SARS-CoV-2. Designed for cloud connectivity, the instrument is being further developed to enable easy results sharing and simplified patient data management in the future. Press release.
Bluestar Genomics presented new analytical performance data on its proprietary non-invasive pancreatic cancer test at the American Pancreatic Association (APA) annual meeting. Data from the study showed that the company’s test detected a pancreatic cancer signal in people across various age groups, including patients with new-onset diabetes, occurring in 25% of new pancreatic cancer cases. Bluestar Genomics’ pancreatic cancer test uses a standard blood draw to assess whether an individual has an abnormal DNA signal associated with pancreatic cancer. This one-of-its-kind test would allow for early diagnosis of pancreatic cancer, one of the deadliest cancers in part because there are no existing screening methods to enable early detection. When found early, accurate detection of pancreatic cancer enables more timely, potentially curative surgical and therapeutic options for patients. People with new-onset diabetes are at high-risk of pancreatic cancer. Out of an estimated 60,000 patients diagnosed each year with pancreatic cancer in the U.S. alone, nearly 25% are found to have new-onset diabetes before a pancreatic cancer diagnosis. Press release.
French-American AI startup Owkin has announced a new research collaboration with the Memorial Sloan Kettering Cancer Center Innovation Hub to improve the treatment of some of the most aggressive forms of bile duct cancer. Cancer that develops in the bile ducts within the liver, known as intrahepatic cholangiocarcinoma, is often only diagnosed at an advanced stage. As a result, median survival is approximately 7 months following diagnosis. To help improve these statistics, Owkin and MSK are collaborating to use machine learning to detect candidates for this treatment at a much earlier stage. Owkin will train deep learning models using de-identified data from MSK patients in order to predict the prognosis of cholangiocarcinoma and discover biomarkers of treatment response. Press release.
Genomenon and Inozyme Pharma plan to make critical information readily accessible to genetic testing labs and clinicians. This information will help inform diagnosis and thus treatment decisions in patients with ENPP1 Deficiency, a rare disease also known as generalized arterial calcification of infancy (GACI) or autosomal recessive hypophosphatemic rickets Type 2 (ARHR2). Inozyme Pharma focuses on the development of therapeutics that treat diseases of abnormal mineralization—one of these is ENPP1 Deficiency. To help inform and accelerate the diagnosis for patients of all ages with this disease, Genomenon produced the world’s most comprehensive variant landscape for ENPP1 Deficiency. This AI-driven and expertly curated genetic dataset, along with information on available clinical trials and therapies, has been made available to doctors, researchers, and clinicians through Genomenon’s Mastermind Genomic Search Engine. Press release.
Oncocyte Corporation has announced the clinical launch of its DetermaIO test. DetermaIO is a proprietary gene expression test that assesses the tumor immune microenvironment (TIME) to predict response to immunotherapy. In multiple clinical studies evaluating hundreds of patients across multiple tumor types, including lung, breast, bladder and renal cancers, the test has demonstrated the ability to predict response to immune checkpoint inhibitors (ICI) which has the potential to help inform the optimal use of immunotherapy treatment for more than one million eligible patients annually in the United States alone. DetermaIO has demonstrated superior utility in identifying patients who may respond to immunotherapy compared to alternative biomarkers in development and in identifying patients who are unlikely to benefit from these immune therapies which can cause serious, long-lasting side effects. Press release.
Illumina has announced that its world-class sequencing and bioinformatics solutions are being used by HostSeq, part of the Canadian COVID-19 Genomics Network (CanCOGeN), to identify biomarkers that can help predict potential risk of serious disease and support the development of novel therapeutics to combat COVID-19. By sequencing the genomes of up to 10,000 patients diagnosed or affected by COVID-19 throughout Canada, the findings from this program will help researchers and the medical community better understand the role of human genetics in COVID-19 susceptibility. Illumina Connected Analytics (ICA), the company's signature bioinformatics solution, will enable researchers to safely and securely move petabyte-sized datasets generated by CGEn, the country's platform for sequencing and informatics, from state-of-art sequencers in Toronto (The Centre for Applied Genomics (TCAG) at The Hospital for Sick Children (SickKids), Montreal (McGill Genome Centre), and Vancouver (Canada's Michael Smith Genome Sciences Centre) into a common "cloud" accessible to approved researchers at some of the country's leading research facilities and hospitals. Illumina has worked closely with CGEn since early 2020 to help provide comprehensive, end-to-end solutions for reagent supply, sequencing and informatics to HostSeq. Press release.
Biofortuna, a specialist contract development and manufacturing partner to the IVD and point of care testing sectors, has more than doubled its manufacturing capacity following its relocation to new state-of-the-art facilities in Deeside, North Wales. The purpose-built facilities have been designed to provide the most efficient and modern manufacturing laboratories from which to meet the evolving needs of the world’s leading IVD and point of care businesses. The new premises provide 450m³ of class-leading, humidity controlled clean room environment for formulation, dispensing, manufacturing and analysis of more than 10 million reactions per week. Press release.
Roche announced that results from the IMPACT (IMproving Primary screening And Colposcopy Triage) trial demonstrate clear patient benefit in using Roche’s CINtec PLUS Cytology dual-stain biomarker technology as a triage test for women who test positive for high-risk human papillomavirus (HPV). The data from the trial, established from a study cohort of more than 35,000 women aged 25-65 years, was published recently in the International Journal of Cancer. In the IMPACT trial, women who were positive for high-risk HPV received a follow-up triage test to help determine if their cervical cells were transforming to cervical pre-cancer. The biomarker-based CINtec PLUS Cytology test showed a significantly higher sensitivity in detecting cervical pre-cancers, compared to Pap cytology. The Roche test aids clinicians in more confidently determining which women are at increased risk for high-grade cervical pre-cancer and require immediate further diagnostic procedures, and which women may need repeat testing or routine screening. Press release.
Foundation Medicine has signed agreements for in-network provider status with Humana Military and Health Net Federal Services, which administer the TRICARE health program for military members, retirees and their families. TRICARE is one of the largest health plans in the United States with 9.6 million beneficiaries. Under the new agreements, TRICARE beneficiaries now have improved access to Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) tests, FoundationOneCDx and FoundationOneLiquid CDx, in accordance with their approved indications for all solid tumors. Press release.
Microbiome DX company Genetic Analysis AS has received an important patent (US20200400666) by the United States Patent and Trademark Office (USPTO) entitled “A Companion Diagnostic Method For Use In The Treatment Of Irritable Bowel Syndrome With Dietary Interventions Or Faecal Microbiota Transplant”. The invention covered provides a diagnostic method to be used to determine the likelihood that a patient with Irritable Bowel Syndrome (IBS) will respond to treatment with a low-FODMAP diet or Fecal Microbiota Transplant (FMT). The patent family claims priority from 15th October 2016 and hence will be in force until 2037 and is part of the company’s active patent strategy covering all major geographical markets. It confirms the company’s strategic commitment to developing innovative non-invasive diagnostic tools useful for patients, doctors and healthcare providers. Press release.
Metabolon has launched the first offering from its new SmartPanel portfolio. SmartPanel solutions provide drug discovery and precision medicine researchers with a novel, dynamic process to explore biologically relevant views of metabolomic data in the context of specific metabolic pathways, biological themes, and disease associations. Metabolon’s Microbiome SmartPanel demystifies the gut microbiome by zeroing in on biologically relevant microbial and host-derived metabolites, along with xenobiotic molecules, to reveal deep insight into microbiome function and its impact on host health. The proprietary Heliogram visualization tool allows users to explore 13 microbiome pathways for rapid connectivity to the impact of therapeutic interventions on the host microbiome. In addition, the on-demand access to Metabolon’s comprehensive pathway knowledge base gives seamless access to expertly curated, microbiome-relevant disease associations and biological themes. Press release.