November 10, 2020 | New products, collaborations and deployments from the past two months from Qiagen, Perkin Elmer, Scopio Labs, Caris Life Sciences, Dotmatics, Thirona, New England Biolabs, and more.
Mammoth Biosciences has signed agreements with MilliporeSigma and Hamilton Company targeting commercialization of a high-throughput CRISPR-based SARS CoV-2 test. The test leverages Mammoth’s DETECTR BOOST platform and will provide a sample-to-answer turnkey solution for commercial laboratories to enable a multi-fold increase in testing capacity. The high-throughput systems will be compatible with both nasal swab and saliva samples and are targeting 1500 tests per 8-hour shift with minimal user interaction. Mammoth Biosciences plans to submit the assay for FDA Emergency Use Authorization later this year. Press release.
Scopio Labs was granted FDA clearance to market and sell its X100 with Full Field Peripheral Blood Smear (Full Field PBS) Application, unlocking the potential of in vitro hematology diagnosis. Full Field PBS is also available in Europe with CE mark certification granted earlier this year. Using advanced computational photography imaging and tailored AI tools, Full Field PBS gives clinical laboratories an unprecedented ability to capture digital scans with full field view of the monolayer and feathered edge at 100X oil immersion resolution level. The Full Field PBS utilizes adaptive monolayer identification in support of long and short smears and automates the analysis process by pre-classifying 200 white blood cells (WBC), providing platelet pre-estimate, and enabling RBC morphology evaluation. Press release.
Caris Life Sciences has launched CODEai (Comprehensive Oncology Data Explorer), using an advanced Artificial Intelligence (AI) backbone. CODEai is a real-world clinico-genomic data platform that integrates Caris’ extensive catalog of molecular data with cancer treatment information and clinical outcomes data for over 215,000 patients covering over 1,000,000 data points per patient. Integrating Caris’ database of profiled patient cases with associated treatments and outcomes, CODEai allows for customized cohort analysis based on a variety of search queries that include Caris’ industry-leading molecular profiling results, demographic data, diagnostic data, and treatment and survival data. CODEai provides accurate data visualization and advanced predictive analytics to deliver clinicians, researchers and scientists with personalized and precise cancer insights that can lead to better understanding of how different cancers respond to treatments. Press release.
The Rady Children’s Institute for Genomic Medicine and Genomenon have announced a strategic collaboration to accelerate the diagnosis of critically-ill newborns with rare genetic disorders. The collaboration combines the Institute’s genomic research expertise with Genomenon’s Mastermind Genomic Search Engine to advance precision medicine for infants in an intensive care setting. Under the collaboration, the use of Mastermind has become part of RCIGM’s standard analysis and interpretation workflow. The use of Mastermind has enhanced RCIGM’s rapid Whole Genome Sequencing (rWGS) workflow by helping to identify and curate diagnostic variants to help deliver precision medicine genomic results in a matter of days. Press release.
Genomenon also announced the latest release of the Mastermind Genomic Search Engine including Copy Number Variation (CNV) search. The new feature allows users to identify CNV citations from full-text articles no matter how authors have described them, and to discover how they are associated with clinical diseases and phenotypes. Press release.
Thirona has obtained an exclusive license on a patent in relation to Cystic Fibrosis (CF) that will allow Thirona to develop an AI algorithm to analyze CT scans to identify even the smallest abnormalities in the lungs, especially early on, ensuring that the right treatment can follow. PRAGMA-CF is a quantitative method for the analysis of chest CT scans of children with CF. The current PRAGMA-CF method allows clinicians to manually assess the extent of lung disease in children with CF. However, Thirona plans to integrate the method into its certified LungQ software, as well as co-exclusive rights to use the underlying datasets of PRAGMA-CF. By leveraging artificial intelligence, clinicians will have an automated method to detect and quantify the extent of CF lung disease. Press release.
New England Biolabs has launched its Luna Probe One-Step RT-qPCR 4X Mix with UDG, which is optimized for the sensitive detection of target RNA sequences for probe-based applications and allows for increased throughput by multiplexing up to five targets. The new master mix consolidates all essential components into a single tube for one-step RT-qPCR. The master mix contains UDG and dUTP to reduce the risk of carryover contamination between reactions. Paired together, Luna WarmStart Reverse Transcriptase and Hot Start Taq DNA Polymerase enhance performance robustness and stability, while also allowing reactions to be set up at room temperature. Also included in the mix are dNTPs, a universal passive reference dye, and Murine RNase Inhibitor in an optimized buffer. Press release.
PerkinElmer has announced that its EONIS screening assay for newborns that simultaneously tests for SMA (spinal muscular atrophy), SCID (severe combined immunodeficiency) and XLA (X-linked agammaglobulinemia) has received CE-IVD approval. This IVD RT-PCR assay integrates into PerkinElmer’s entire newborn screening workflow to provide labs with a complete, single source solution encompassing everything from sample to solution. The design of the EONIS assay enables automation with JANUS Liquid Handlers to further streamline the workflow of high-throughput laboratories without compromising the sample traceability from punch to result. The traceable dried blood spot workflow consists of five main elements to detect SMA, SCID and XLA: sample collection, punching, DNA extraction, amplification and data analysis utilizing dedicated analysis software. Press release.
QIAGEN has acquired the remaining 80.1% of diagnostics instruments company NeuMoDx Molecular, Inc. for $248 million in cash. The move rounds out QIAGEN’s portfolio of automated molecular testing solutions based on the proven PCR technology. The transaction was completed after QIAGEN received U.S. regulatory clearance for the full acquisition. In 2018, QIAGEN had purchased a 19.9% stake in NeuMoDx along with the right to acquire the remaining NeuMoDx stake at a price of $234 million. The final payment price for this remaining stake includes customary purchase price adjustments for cash, indebtedness and transaction costs. Also as part of the 2018 agreement, QIAGEN has distributed the high-throughput NeuMoDx 288 and the medium-throughput NeuMoDx 96 platforms in Europe and other markets outside the U.S. Press release.
The University of California, San Francisco (UCSF) will be utilizing VivaLNK’s continuous wearable ECG sensor for a 3,000 subject multi-year study on atrial fibrillation (AF). Spanning up to 10 years, the study aims to detect biomarkers of early atrial transformation in AF. Subjects in the study will be monitored using the VivaLNK wearable ECG sensor, which can capture ECG and heart rate on a continuous basis 24 hours a day. Each subject will wear the ECG sensor for about one week every month, even while ambulatory or at home. Data from the sensor will then be captured through a mobile app and sent to the cloud for analysis. In addition to capturing ECG rhythm and heart rate, the VivaLNK sensor can also derive respiratory rate and offer accelerometer data. The same sensor is used in other applications and studies, such as in-hospital patient monitoring, remote patient monitoring, heart failure event detection, and chemo treatment event detection. Press release.
Samsung Medison and Intel are collaborating on new smart workflow solutions to improve obstetric measurements that contribute to maternal and fetal safety and can help save lives. Using an Intel Core i3 processor, the Intel Distribution of OpenVINO toolkit and OpenCV library, Samsung Medison’s BiometryAssist automates and simplifies fetal measurements, while LaborAssist automatically estimates the fetal angle of progression (AoP) during labor for a complete understanding of a patient’s birthing progress, without the need for invasive digital vaginal exams. Press release.
The Society to Improve Diagnosis in Medicine (SIDM) is issuing the first of three grant rounds, totaling $3 million, as part of the organization’s DxQI Seed Grant Program. The initial awards are up to $50,000 for 17 organizations testing interventions to improve the quality, accuracy, and timeliness of diagnoses. Most of the grantees selected in this first round will focus on developing interventions to reduce diagnostic errors in three specific disease categories—cancers, vascular events, and infections. Several grantees are developing improvement projects that address racial and gender disparities in diagnosis. Ultimately, the program will help clinicians, hospitals and health systems take specific steps to reduce diagnostic errors by building an evidence base of effective interventions. Once tested, SIDM will create a clearinghouse of the interventions and be a catalyst for the adoption of effective practices by other organizations across the country. Press release.
Dotmatics has announced eln.online, a quick start version of its Electronic Laboratory Notebook (ELN). Designed specifically to meet the needs of research organizations at an early stage in their development, eln.online is a new implementation of the company’s existing ELN Studies Notebook and adds to Dotmatics’ established portfolio of cloud-based scientific software solutions. eln.online enables the search and capture of a wide variety of experimental data in a secure, cloud-based notebook, thereby facilitating effective collaboration between multiple scientists within or between organizations. It also ensures that organizations secure and protect their IP from an early stage, which is essential for future licensing, partnering and M&A plans. As an efficient alternative to spreadsheets, eln.online provides a standard template to capture an unlimited amount of diverse discovery experiments, as well as an additional template designed specifically for medicinal and synthetic chemistry projects. Press release.
Median Technologies announced the promising results of a first retrospective study on the implementation of the iBiopsy platform for the analysis of patients with solid tumor cancer who are likely to be responsive to immuno-oncology treatments such as those based on immune checkpoint inhibitors (ICIs). These results relate to one of three clinical development plans for the iBiopsy imaging biomarker discovery platform, which integrates cutting-edge artificial intelligence technologies. Press release.
Biocartis Group has expanded its collaboration with LifeArc, a UK-based independent medical research charity, with a new agreement aimed at the development of highly innovative prototype assays in the field of infectious and immune related diseases on Biocartis’ fully automated molecular diagnostics platform Idylla. The new license and development agreement is an extension of the existing partnership1 between LifeArc and Biocartis, which is today focused on the development and the commercialization of the Idylla ABC (Advanced Breast Cancer) assay2. This assay is positioned to target a multi-gene panel of predictive and resistance-inducing mutations based on an FFPE3 sample type. Under the new agreement, LifeArc obtains a non-exclusive license to use the Idylla platform for the development of Idylla assays in the area of infectious and immune related diseases, aimed at supporting patient stratification and treatment monitoring of patients with, amongst others, bacterial, fungal and viral infections. Press release.