October 31, 2019 | October featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Illumina, QIAGEN, Optibrium, and more.
Illumina and QIAGEN announced a 15-year partnership intended to broaden the availability and use of NGS-based in-vitro diagnostic (IVD) kits, including companion diagnostics, for patient management. The agreement grants QIAGEN non-exclusive rights to develop and globally commercialize IVD kits to be used together with Illumina’s MiSeq Dx and NextSeq 550Dx Systems. The agreement also includes rights for expansion of the partnership on future Illumina diagnostic (Dx) systems. Both partners are also exploring opportunities for QIAGEN to develop and market companion diagnostics based on Illumina’s TruSight Oncology (TSO) assays that enable comprehensive genomic profiling of tumor samples in immunotherapy. Illumina and QIAGEN will cooperate to commercialize a menu of clinically validated workflows that combine QIAGEN’s proprietary content and bioinformatics solutions. The partnership will initially focus on commercializing oncology IVD kits to support patient management and may expand in the future to include additional clinical diagnostic fields, such as cardiology, hereditary diseases, infectious diseases, as well as inflammatory and autoimmune diseases. Press release
Optibrium announced the introduction of its Augmented Chemistry services, which provide collaborators with novel artificial intelligence technologies to supplement their skills and experience, enabling them to make more effective decisions and advance their drug discovery projects. In discovery projects, it is important to base decisions on reliable data to avoid wasted effort pursuing incorrectly selected compounds or missing opportunities by inappropriately discarding potentially valuable compounds. Augmented Chemistry services are built on a unique deep learning capability for data imputation, Alchemite, which has been developed in collaboration with Intellegens Limited. Alchemite has been demonstrated to outperform traditional predictive models, both in benchmarking studies and in partnerships with global pharma and biotech research organisations. Unlike conventional machine learning approaches, Alchemite learns simultaneously across all experimental endpoints in a project or corporate database, even based on limited data. The resulting model can automatically highlight the most confident, and therefore accurate, predictions on which to base experimental decisions, including the identification of new or previously overlooked high-quality compounds. Press release
Optibrium also announced the introduction of StarDrop 6.6, the latest version of this comprehensive software platform for small molecule design, optimization and data analysis. The enhanced software will introduce new in silico modelling approaches, ensuring scientists can easily link two- and three-dimensional structural information, identify potential liabilities and design new compounds with the highest chance of success. The acid dissociation constant (pKa) has an important influence on molecular properties that are crucial to compound synthesis, formulation and optimisation of absorption, distribution, metabolism and excretion properties. StarDrop’s new pKa model, featured in StarDrop’s ADME QSAR module, integrates quantum mechanics and machine learning to make accurate predictions for a wide range of compounds. Rigorously validated, this model shows excellent on external benchmark datasets specifically created to assess pKa prediction methods. StarDrop 6.6 also includes an extended suite of SeeSAR modules that enhance StarDrop’s capabilities for structure-based design. Developed in collaboration with BioSolveIT GmbH, SeeSAR View enables researchers to visualise ligands in their protein environment to identify the key interactions driving binding affinity. SeeSAR Affinity uses the award-winning HYDE scoring method to analyse a ligand’s binding affinity, related to free energies with visual atomic contributions, and view torsion angle heat maps to assess docked poses. SeeSAR Pose generates docked compound poses for virtual screening and interactive 3D design. The combination of these modules within StarDrop will enable researchers to better understand 2D and 3D structure-activity relationships and design compounds with a higher chance of downstream success. Press release
Biofourmis has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its machine-learning and artificial intelligence (AI)-powered Biovitals Analytics Engine as a medical device for ambulatory physiological monitoring. This regulatory approval of the Biovitals Analytics Engine is part of FDA's growing recognition of machine-learning and AI in the Software as a Medical Device category. "This milestone approval is foundational to the Biovitals ecosystem, which includes not only our most advanced solution, BiovitalsHF for heart failure—but also our range of solutions across therapeutic areas, such as pain, oncology, sleep disorders and others in development," said Kuldeep Singh Rajput, CEO and founder of Biofourmis, in a press release. "Receiving this important regulatory approval will only accelerate the development and commercialization of these innovative digital therapeutic solutions." This FDA approval is the second market authorization for Biofourmis, having earned the agency's approval in May 2019 for its Biovitals RhythmAnalytics platform, which is cloud-based software for automated interpretation of more than 15 types of cardiac arrhythmias. The newly cleared Analytics Engine is a much broader approval to process multiple physiology signals, as the technology serves as the foundation for all of Biofourmis' digital therapeutics product pipeline. Press release
Cryopak Canada and Launchworks Manufacturing Lab are announcing a collaboration with the National Research Council of Canada (NRC) to create the Laboratory of Industrial Fluidic Translation (LIFT). By joining their knowledge in nanofabrication and lab-on-a-chip technologies and in manufacturing, LIFT will offer a competitive capacity to accelerate the creation, certification and deployment of microfluidic bio-devices, a one-stop shop expertise and service not available in North America. LIFT will support the diagnostic device industry’s objectives by combining the NRC’s expertise in sciences, materials, and design with Launchworks’ expertise in cGMP and ISO 13485 manufacturing at clinical and industrial scale. Through this partnership, the organizations will work with diagnostic companies to translate microfluidic application ideas into workable devices. “Microfluidic diagnostic companies are driving device development to be faster, easier to use and more cost effective,” Jeff Kelly, VP of Corporate Development for Cryopak, said in a press release. “The NRC’s 20 years of experience in scientific development combined with Launchworks ISO 13485 manufacturing capabilities will provide point-of-care diagnostic companies a complete and cost-effective service solution to rapidly bring their ideas to successful commercialization.” Design and development will be done at the NRC in Montréal, with manufacturing to be done initially at the LaunchWorks facility in Beverly, MA, and plans to develop an additional manufacturing facility with Cryopak Canada in the near future. Cryopak and LaunchWorks are affiliate companies both owned by TCP Reliable. Press release
Almac Diagnostic Services launched the complete version of claraT at the ESMO Congress in Barcelona. The Almac claraT Total mRNA Report content has expanded considerably from the initial version launched the previous year at the ESMO Congress. The complete version now includes 92 gene expression signatures, 100 single gene drug targets and over 7,000 additional biology linked genes, categorized by all 10 Hallmarks of Cancer. The innovative claraT Total mRNA Report benefits both academic and biopharma biomarker discovery and translational researchers by saving them valuable time in analyzing gene expression data and helping to maximize the understanding of their dataset. claraT analyzes multiple published gene expression signatures that represent the Hallmarks of Cancer simultaneously, and presents the results in a comprehensive, easy-to-interpret format. Researchers are provided with an interactive report that facilitates easy visualization of novel molecular subgroups within the sample cohort and the key discriminating biologies within an individual tumor sample. By allowing multiple biologies to be evaluated in parallel, as opposed to the traditional method of focusing on one biology alone, the claraT Total mRNA Report supports the identification of novel insights, highlighting consensus signatures within, and between, the Hallmarks of Cancer. This analysis allows researchers to confirm known findings in the field, but more importantly helps to identify new and unique observations such as novel pathways and biologies predicting response to therapeutic targets that may not yet be proven to do so. Press release
Roche announced the release of its latest app, in collaboration with GE Healthcare, as part of NAVIFY Decision Support portfolio. NAVIFY Guidelines app embeds the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) covering the four most common cancers within NAVIFY Tumor Board. When opening a patient case, the app identifies the appropriate guidelines based on the patient’s cancer type. Clinicians can then select the intended pathway, easily click through the digitized decision tree or flowchart, and personalize steps for a specific patient. The pathway is accessible to all tumor board participants and can be exported to include in the practice’s EMR system, send to patients or submit for reimbursement approval by payers. Guidelines in clinical practice help explain a disease and determine the optimal evidence-based treatment for individual patients based on their diagnosis, disease stage, age and other factors. In addition, clinical guidelines contribute to care management by promoting practice conformity and reducing cost. Due to advances in medicine, NCCN Guidelines are updated continuously. At the same time, with the move to more value-based care and respective payment models, clinicians face an increasing need for adhering to proven guideline recommendations. By digitizing the guidelines process, alerting users real-time about new and updated guidelines, and making the respective pathway available as part of the holistic patient dashboard in NAVIFY Tumor Board, NAVIFY Guidelines app not only ensures that oncology care teams refer to latest information and are aligned regarding what is planned for the patient but also facilitates documentation. Press release
NervGen announced a research initiative to advance its proprietary therapeutic technology platform, currently in development for spinal cord injury and multiple sclerosis, to generate new treatments for Alzheimer's disease (AD). Alzheimer's disease, a progressive neurodegenerative disorder that destroys memory and cognitive functions, is becoming a healthcare crisis with an estimated 30 million people affected globally including 5.8 million in the United States. As AD research and development efforts have failed to produce new effective treatments in the last fifteen years, the medical community and pharmaceutical industry are seeking technologies with novel approaches through new targets and pathways. "We remain dedicated to delivering on our clinical program preparing our NVG-291 compound for a Phase 1a study to begin in Q1 2020 followed by a Phase 1b on subsets of both chronic and sub-acute spinal cord patients and a Phase 2 study on multiple sclerosis in 2021. We are excited to expand our platform to Alzheimer's disease," Dr. Ernest Wong, NervGen's President & CEO, said in a press release. "Chondroitin sulfate proteoglycans (CSPG) are intimately associated with senile plaques and our work with PTPσ knockout mice and other data with chondroitinase all suggest a pivotal role for PTPσ in AD. We will consult with Alzheimer's disease experts to generate a research and development program for AD with our platform and at the same time increase our business development efforts. Given the novelty of our approach and the potential applications to different disease indications, we believe that the technology should be of strong interest to prospective partners." Press release
Fight Colorectal Cancer (Fight CRC) is turning to Komodo Health to help target its efforts to increase screening and close gaps in colorectal cancer care, including access to biomarker testing. Their efforts will focus on targeted outreach and education to healthcare teams through data-driven intelligence that can identify which providers and care networks have the greatest impact on specific populations of patients. Colorectal cancer is the second-leading cause of cancer deaths in the U.S. Despite recent improvements in treatment and prevention, the rate of diagnosis for people under age 50 has been rising steadily due to lack of awareness in patients and their doctors about the signs and symptoms. Additionally, patients and their families continue to struggle with gaps in quality of care – particularly in rural locations. This is despite recent advances in molecular therapies and biomarker testing, which create significant breakthroughs for improved therapeutic options and outcomes. “Despite the fact that colorectal cancer mortality rates have been falling, the incidence of these cancers has actually risen steadily among certain pockets of the population over the last ten years – particularly in younger adults,” said Fight CRC president Anjee Davis in a press release. “We refuse to accept that, which is why we are turning to technology to help our team get smarter about how we target our education and outreach efforts. We hope to expand our reach into local communities providing no-cost, medically-reviewed resources. Our partnership with Komodo Health enables us to better support community-based healthcare providers who serve families in the greatest need.” Komodo Health will leverage Aperture, its AI-driven analytics software, to help Fight CRC analyze patterns of care, detailed physician referral histories and patient data to identify healthcare providers and regions of the country most in need of outreach and education. Built on the largest, most representative healthcare map of the U.S., Komodo Health’s Aperture platform draws on the real-world healthcare experiences of more than 320 million patients and their providers to highlight gaps in care and target locations most in need of intervention. Press release
BD announced that FDA 510(k) clearance was obtained for a molecular screening test for antibiotic-resistant carbapenemase-producing organisms (CPOs) on the fully-automated BD MAX System. The BD MAX Check-Points CPO assay provides detection of the five most common carbapenemase genes directly from the patient specimen in approximately 2.5 hours, as compared to traditional methods that can take up to 24 hours to confirm a negative or longer for a final positive result. Early detection of patients colonized with these organisms can provide the necessary information to implement proper infection control measures. Together with the BD Phoenix CPO Detect Panels, BD provides solutions for screening and infection management to support clinical microbiology laboratories in detecting CPOs, and helping hospitals implement robust programs to address antimicrobial resistance (AMR). “The launch of the BD MAX Check-Points CPO assay in the US is another example of BD’s commitment to helping prevent and reduce the spread of healthcare associated infections (HAIs),” Nikos Pavlidis, vice president and general manager, molecular diagnostics and women’s health for BD, said in a press release. “Our solutions for CPO detection and identification are an important part of our portfolio of products for infection prevention, diagnostics, and surveillance and monitoring that help hospitals combat antimicrobial resistance.” Press release