March 2, 2022 | Glycosaminoglycan profiling may enable all-cancer detection, maternal RNA expression profiling can predict preterm birth, Element Biosciences enters several new collaborations, and new COVID diagnostics are available.
Benchling, pioneer of the R&D Cloud powering the biotechnology industry, has acquired Overwatch Research, a Belfast-based startup creating software to accelerate in vivo research. Overwatch’s configurable, end-to-end study management and execution system broadens the capabilities of Benchling’s R&D Cloud, which serves as a single source of truth for biotech R&D. Through this acquisition, Benchling will create the industry’s first comprehensive, cloud-native in vivo solution, completing its Early Development offering and helping customers accelerate the time to bring products to the clinic. Benchling and Overwatch share a vision of digitally transforming R&D. Scientists relying on paper notebooks, spreadsheets, and other manual processes for capturing and analyzing complex experimental data often find it difficult to reproduce results, a fundamental part of the scientific method. In the U.S. alone, the annual economic cost of biomedical research—including in vivo studies—that cannot be replicated was estimated at $10 to $50 billion. Press release.
Lunaphore, a Swiss life sciences company developing technology to enable spatial biology in every laboratory, announced it has entered a collaboration with the Pathology Department at Massachusetts General Hospital to develop an in vitro diagnostic (IVD) that evaluates sensitivity of solid tumors to poly-ADP ribose polymerase (PARP) inhibitors, with an initial focus on ovarian, breast and prostate cancers. The project will be led by Markus D. Herrmann, M.D., Ph.D., Director of Computational Pathology at Massachusetts General Hospital, who is also Assistant Professor of Pathology at Harvard Medical School. Lunaphore and Dr. Herrmann will collaborate to develop a multiplexed immunofluorescence assay that can measure the expression of multiple proteins using the COMET platform currently installed at Massachusetts General Hospital. Press release.
Arima Genomics has launched new solutions for structural variant detection and gene regulation analysis. These solutions enhance the company’s market-leading portfolio of 3D genomics tools that help researchers unlock new insights for disease research. The new Arima-HiC+ FFPE sample preparation kit expands the utility of the Arima-HiC+ workflow to formalin fixed paraffin embedded (FFPE) tissues—a critical archival and clinically relevant sample type. In addition, the new Arima-SV bioinformatics pipeline enables researchers to identify structural variants from their 3D genomic data from a broad range of sample types. By leveraging the Arima-HiC+ FFPE kit and the Arima-SV pipeline, researchers using FFPE tissue samples and short-read sequencing now have a robust workflow to identify structural variants to elucidate connections among the 3D genome, gene function, and disease processes. These tools are relevant across a wide range translational research areas including cancer, blood and neurological disorders, and immune diseases, where FFPE tissues are a critical archival and clinical sample type. Press release.
SQI Diagnostics, a leader in the science of lung health that develops and manufactures respiratory health and precision medicine tests, is pleased to announce that it has completed its previously announced asset acquisition of Precision Biomonitoring Inc.’s human diagnostic COVID-19 PCR testing business and its TripleLock molecular diagnostic testing technology. Press release.
Researchers from the Antimicrobial Resistance (AMR) Interdisciplinary Research Group (IRG) at Singapore-MIT Alliance for Research and Technology (SMART), MIT’s research enterprise in Singapore, alongside collaborators at Nanyang Technological University, have identified a novel phage lysin—Abp013—that could be used as an alternative antimicrobial agent against two of the most deadly bacteria: Acinetobacter baumannii and Klebsiella pneumoniae. The study is supported by the National Research Foundation (NRF) Singapore under its Intra-CREATE Collaborative Seed Grant. In a paper titled “Novel Phage Lysin Abp013 against Acinetobacter baumannii” published in the medical journal Antibiotics, the SMART AMR team reveals Abp013’s ability to effectively access and kill various bacterial strains. The study showed that Abp013 displayed good permeability and killing activity against multiple Acinetobacter baumannii and Klebsiella pneumoniae strains, even when they are in a more complex environment in which typical lysins are ineffective. Press release.
Cleveland Clinic announced their Top 10 Medical Innovations for 2022. The list of breakthrough technologies was selected by a committee of Cleveland Clinic subject matter experts, led by D. Geoffrey Vince, Ph.D., executive director of Innovations and chair of Biomedical Engineering at Cleveland Clinic. In order of anticipated importance, the Top 10 Medical Innovations for 2022 are as follows: next generation mRNA vaccinology, PSMA-targeted therapy in prostate cancer, new treatment for the reduction of LDL (Inclisiran), novel drug for treatment of type 2 diabetes (combo glucose-dependent insulinotropic polypeptide and glucagon-like peptide receptor agonist), breakthrough treatment for postpartum depression (intravenous neurosteroid), new targeted medication for hypertrophic cardiomyopathy (cardiac myosin inhibitor), non-hormonal alternatives for menopause (NK3R antagonists), implantables for severe paralysis, AI for early detection of sepsis, and predictive analytics for hypertension.
Thermo Fisher Scientific is investing $40 million to expand its single-use technology manufacturing facility in Millersburg, Pa. The expansion is part of the company’s $650 million multi-year investment, announced last year, to help ensure flexible, scalable, and reliable bioprocessing production capacity exists for critical materials used in developing new and existing biologics and vaccines, including for COVID-19. Single-use technologies enable development of a growing number of biological drugs and vaccines, creating unprecedented demand for these products. The Millersburg site expansion will add significant capacity to continue providing the biopharma industry with the technology and materials needed to assist in developing new vaccines, cancer treatments, and breakthrough therapies for other conditions. Press release.
Swedish molecular diagnostic company Elypta announced the launch of clinical study LEVANTIS-0087A (LEV87A), intended to validate the diagnostic performance of GAGomes—the complete profile of human glycosaminoglycans—as metabolic biomarkers for Multi-Cancer Early Detection (MCED). The study aims to detect any-type cancer in adults who show no symptoms and have no recent history of cancer. The study builds upon proof-of-concept data shared at the American Society of Clinical Oncology (ASCO) conference in June 2021, which indicated that GAGomes could detect one third of all stage I cancers across 14 types. Elypta’s liquid biopsy exceeds the performance of other proposed approaches that use biomarkers based on circulating tumor DNA, which have been shown to capture less than one in five stage I cancers in asymptomatic adults. LEV87A is a retrospective population cohort-based case-control study enabled in part by the low sample volumes required by Elypta’s liquid biopsy. Press release.
The Canadian Biomarker Integration Network in Depression (CAN-BIND), one of the Ontario Brain Institute’s six Integrated Discovery Programs, announced the public release of a detailed and multi-modal dataset dealing with mental health. CAN-BIND's foundational study features a deeply phenotyped cohort of 211 people with Major Depressive Disorder (MDD) and 112 healthy individuals across six Canadian clinical sites. Data have been standardized, cleaned, and curated to allow maximum utility for analysis across disease and across platform, and are now available on Brain-CODE, the neuroinformatics platform of the Ontario Brain Institute (OBI). During the CAN-BIND foundational study, participants with MDD received escitalopram, an antidepressant, for eight weeks. After eight weeks, if depressive symptoms did not improve, participants then received escitalopram in combination with aripiprazole, an augmentation treatment often used to treat MDD, for a further eight weeks. Throughout the study, participants were assessed with 29 clinical instruments and questionnaires, structural and functional MRI, resting state and task-based EEG, and genomic and molecular measures. Press release.
Avellino Lab USA, Inc., a leader in genetic molecular diagnostics, has launched AvellinoCoV2 - Respiratory Test, a multi-panel RT-PCR-based virus assay that accurately detects four viral infections in one patient sample: COVID-19, respiratory syncytial virus (RSV), influenza A, and influenza B. The expanded panel has 100 percent sensitivity for RSV and influenza A and B, 100 percent accuracy for influenza A and B, and more than 99 percent accuracy for RSV. For the COVID-19 panel, by analyzing the N gene that is minimally affected by viral mutation, the test accurately detects the presence of the Omicron variant (including BA.2), as well as all other known COVID-19 variants. The laboratory developed test (LDT) meets all applicable CLIA requirements for high complexity testing. Test samples are collected via a mid-turbinate nasal swab and sent to Avellino’s high-complexity CLIA-certified laboratory for analysis. Located in Menlo Park, the laboratory operates 24/7, has processed nearly 3 million of its COVID-19 tests to date, and can process up to 30,000 tests a day. Press release.
Foundation Medicine, Inc. announced a collaboration with Eli Lilly and Company (Lilly) for the development of Foundation Medicine’s tissue- and blood-based assays as companion diagnostics for RETEVMO and other therapies in Loxo Oncology at Lilly’s pipeline. The partnership will initially explore the use of FoundationOne CDx for adult patients with metastatic rearranged transfection (RET) fusion across tumor types who may be eligible for Lilly’s RET inhibitor, RETEVMO, in the United States and European Union. Press release. The company also announced approval from the U.S. Food and Drug Administration (FDA) for FoundationOne CDx to be used as a companion diagnostic to identify patients with Microsatellite Instability High (MSI-H) status solid tumors who may be appropriate for treatment with Merck’s KEYTRUDA (pembrolizumab). Press release. And FDA has granted the company a Breakthrough Device designation for its circulating tumor DNA (ctDNA) detection and molecular monitoring assay, FoundationOne Tracker. The assay uses optimized algorithms for identifying patient-specific variants and a personalized assay design that allows for the detection of ctDNA in plasma for detecting minimal residual disease. Press release.
Cleerly, dedicated to creating a new standard of care for heart disease, announced its latest product release, Cleerly 2.2.0, which includes user experience (UX) refinements and three new high-value tools. These updates come in the midst of American Heart Month and allow Cleerly technology to enter into the clinical workflows of health systems and providers across the U.S., drive new efficiencies, and deliver new insights to customers. With Cleerly 2.2.0, customers can now track disease progression, better understand disease burden with a new plaque metric, and automate study workflows. Press release.
AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced an expanded partnership to supply more plasmid DNA (pDNA) starting material for the Pfizer-BioNTech COVID-19 vaccine at the company’s Heidelberg facility. Pfizer and BioNTech have announced the development of an Omicron-based COVID-19 vaccine with first batches expected to be ready for delivery by end of March 2022. The AGC Biologics Heidelberg facility has more than 20 years of experience delivering a wide range of programs for customers. The site is the company’s Center of Excellence for pDNA production, and a central part of the AGC Biologics global network of cell and gene therapy-focused facilities, with additional locations in Milan, Italy and Longmont, Colorado, USA. Press release.
Element Biosciences, developer of a new and disruptive DNA sequencing platform, announced the completed acquisition of Loop Genomics, a long-read solutions company that enables short-read sequencers to obtain long range information. Loop Genomics’ Chief Executive Officer and Founder, Tuval Ben-Yehezkel, PhD, will join Element Biosciences’ leadership team as Senior Director, Applications. Press release.
Element Biosciences also announced several partnerships this month. A key technical milestone was reached using the Roche KAPA HyperPlus and KAPA EvoPlus library preparation and target enrichment kits in microbial whole genome, human whole genome, and human whole exome sequencing applications (Press release). Parternships were announced with Agilent Technologies to use their SureSelect target enrichment panels and providing customers greater access to these genomic tools (Press release), with New England Biolabs (NEB) to commercially develop and launch products to enable compatibility of the NEBNext Ultra II portfolio with the Element AVITI System (Press release), with QIAGEN to validate its leading NGS library prep and target enrichment offerings on the AVITI System (Press release), with Watchmaker Genomics to use Watchmaker’s DNA and RNA Library Prep Kits on Element’s AVITI System (Press release), with Dovetail Genomics to use their proximity ligation-based next-generation sequencing (NGS) library prep solutions on Element’s AVITI System (Press release), and with Jumpcode Genomics to use their CRISPRclean technology on Element’s AVITI System (Press release).
Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, announced that it has entered into a data sharing agreement with Pfizer, a leader in innovative IBD research. The agreement aims to accelerate successful, efficient development of potential new treatments for patients suffering from IBD worldwide by standardizing endoscopic interpretation. As part of the agreement, Pfizer will grant access to one of its IBD clinical trial databases, allowing Iterative Scopes to enrich its disease severity scoring algorithms. Currently, disease severity scoring systems, such as the Mayo Endoscopic Score (MES), are used to meet inclusion criteria in IBD clinical trials and to measure primary and secondary endpoints. These metrics are highly subjective and dependent on physician experience and intuition. Moreover, they present patient recruitment and workflow challenges. Iterative Scopes’ computational algorithms resolve these challenges when integrated with existing colonoscopy imagery to determine clinical trial eligibility. The company’s computational software automates interpretation of colonoscopy videos, enabling clinical trial investigators to arrive at standardized MES scores for individual patients. Press release.
Siemens Healthineers announced the CLINITEST Rapid COVID-19 Antigen Self-Test is now available in the U.S. to self-test for the SARS-CoV-2 virus. The CLINITEST Rapid COVID-19 Antigen Self-Test uses a simple nasal swab to provide accurate COVID-19 test results (including for both the Omicron and Delta variants) in 15 minutes and comes in a five-test-per-box configuration—convenient for families, group, and/or serial testing needs. The test is approved for unsupervised self-testing by individuals ages 14 and older and for adult-collected samples from individuals ages 2-13, with or without symptoms. The CLINITEST Rapid COVID-19 Antigen Self-Test will be available through national retailers and online. Press release.
Mirvie, a pioneer in predicting unexpected pregnancy complications, announced at the Society for Maternal-Fetal Medicine 42nd Annual Pregnancy Meeting (SMFM 2022) that the Mirvie RNA platform is the first to predict preterm birth by revealing the underlying biology of each pregnancy. The breakthrough research shows the platform can predict the condition months before symptoms occur and identify distinct biological pathways driving its development. Research presented at SMFM 2022 analyzed tens of thousands of RNA messages from 229 diverse pregnancies using the Mirvie RNA platform. In addition to predicting preterm birth months before symptoms occur, the platform identified 24 RNA messages related to dramatic and premature changes to the mom’s cervix and 11 separate RNA messages involved with amino acid metabolism and growth factor pathways in cases of extremely premature birth. The results build on landmark research recently published in Nature demonstrating the Mirvie RNA platform can predict preeclampsia months before symptoms occur. Press release.
SomaLogic, a leader in data-driven proteomics technology, announced that the company will begin assaying samples from the Multi-Ethnic Study of Atherosclerosis (MESA) study beginning in the first quarter of 2022. SomaLogic will use its industry-leading assay to analyze 105 million protein measurements from 15,000 samples spanning 15 years of clinical interactions. The MESA study is focused on subclinical cardiovascular disease and the risk factors that predict progression to clinical signs and symptoms. Because the data is shared with outside investigators, this study has also been used by hundreds of investigators to understand other diseases, including COVID-19, eye disease, and non-alcoholic steatohepatitis (NASH). SomaLogic will use the SomaScan assay data from the MESA study, as well as information from clinical visits and health histories, to further validate its SomaSignal tests, specifically for cardiovascular disease, diabetes risk and NASH. Press release.
Science 37 and physIQ announced a collaboration to help research sponsors use remote biosensors and machine learning to build more robust data sets. This will help increase the number of digital biomarkers and generate insights from continuous data streams to more quickly and objectively demonstrate the safety and efficacy of treatments. physIQ’s robust platform scalability, near real-time capabilities, established FDA clearance, and proven ability to support large global clinical trials strengthen Science 37’s ability to support additional novel digital biomarkers, advance clinical events detection, and provide more proactive safety monitoring. physIQ enables Sponsors to efficiently identify valuable digital measures from large amount of noise inherent in biosensors. Press release.
Proscia, a leader in digital and computational pathology solutions, and Uppsala University Hospital, Sweden’s oldest university hospital, announced a multi-year agreement to fully digitize the region’s pathology workflows. The division of Laboratory Medicine at Uppsala University Hospital has selected Proscia’s Concentriq Dx digital pathology solution for full-scale digitization and future deployment of AI applications in routine operations at scale, empowering the region’s pathologists to drive increased quality and productivity gains and unlock hidden insights to better inform patient care. Proscia’s Concentriq digital pathology platform is a robust, end-to-end solution for connecting distributed teams, data, and applications across the global enterprise. The flagship software is used by leading laboratories and health systems, as well as 10 of the top 20 pharmaceutical companies. Press release.