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Point-of-Care Diagnostics For COVID-19 and Other News

May 22, 2020 | A proposed point-of-care diagnostics platform would use either nanoparticles or magnetic levitation to diagnose COVID-19 infection and assess future risk. An online COVID Digital Pathology Repository. These and other news are included as we round up the week’s research and industry news for COVID-19.

Literature Updates

Researchers from Michigan State University have proposed a point-of-care diagnostic platform that uses either nanoparticles or magnetic levitation to diagnose COVID-19 infection and assess future risk. (Read more about magnetic levitation in disease diagnosis.) The concept is based on the varying levels of infection and stages of disease which alter the composition of biological fluids such as tears, saliva, urine and plasma. Different infections and diseases create different patterns specific to the viral load and disease stage, somewhat akin to a fingerprint. The work was published in Molecular Pharmacies. DOI: 10.1021/acs.molpharmaceut.0c00371

Industry Updates

Indica Labs and Octo have launched the online COVID Digital Pathology Repository (COVID-DPR), a virtual collection of high resolution microscopic COVID-related human tissue images hosted at the National Institutes of Health. COVID-DPR was created to enable international collaboration by providing a centralized, cloud-based repository for sharing and annotating digital whole slide images of lung, liver, kidney and heart tissues from patients infected with COVID19, as well as the closely related coronaviruses associated with SARs and MERs. The whole slide images, annotations and metadata in the repository will be used as a reference data set for education, research and future clinical trials aimed at limiting further infection, disease, and death. COVID-DPR is underpinned by Indica Labs’ HALO Link software, a collaborative image management platform designed specifically for secure sharing of digital whole slide images and data. The HALO Link instance associated with COVID-DPR will be deployed in a web portal developed and managed by Octo and Axle Informatics to provide a secure, globally accessible central repository. COVID-DPR.

Mount Sinai Health System and Renalytix AI have formed Kantaro Biosciences, LLC, a Mount Sinai venture, to develop and scale production and distribution of a test kit based on the Mount Sinai-developed high-performance serologic assay for SARS-CoV-2 antibodies. Kantaro has partnered with Minneapolis-based Bio-Techne Corporation to develop and launch the new kit, with the goal of producing more than ten million patient tests per month by July. The two companies have formed a joint commercialization and distribution team to support the rapid distribution of kits to clinical laboratories in the US and around the world. Press release.

Johns Hopkins researchers recently received a $195,000 Rapid Response Research grant from the National Science Foundation to use machine learning to identify which COVID-19 patients are at risk of adverse cardiac events such as heart failure, sustained abnormal heartbeats, heart attacks, cardiogenic shock and death. The first phase of the one-year project, which just received IRB approval for Suburban Hospital and Sibley Memorial Hospital within the Johns Hopkins Health System (JHHS), will collect the following data from more than 300 COVID-19 patients admitted to JHHS: ECG, cardiac-specific laboratory tests, continuously-obtained vital signs like heart rate and oxygen saturation, and imaging data such as CT scans and echocardiography. This data will be used to train the algorithm. The researchers will then test the algorithm with data from COVID-19 patients with heart injury at JHHS, other nearby hospitals and perhaps some in New York City. The hope is to create a predictive risk score that can determine up to 24 hours ahead of time which patients are at risk of developing adverse cardiac events. Press release.

A sleep apnea home diagnostic and monitoring system based on the Internet of Things can be used for the remote monitoring of individuals with suspected COVID-19 or mild symptoms of the disease. Developed by Biologix, a startup headquartered in São Paulo, Brazil, the system can also be used to recommend transfer to a hospital if the patient’s clinical signs worsen. The physical part of the system is a cordless portable sensor, which, when placed on the patient’s index finger, captures oxygen saturation and heart rate data. Data are collected in real time by a free smartphone app available for the Android and iOS platforms. The program automatically sends the data to the cloud and to a control panel operated by the medical team responsible for monitoring each patient. If the system shows a drop in oxygen saturation, the medical team contacts the patient or on-site caregiver. Two private hospitals in São Paulo will test the technology. Press release.

Avacta Group has entered into an exclusive distribution agreement with Medusa19 Limited for direct-to-consumer sales of a saliva-based rapid test for the COVID-19 antigen. Avacta recently announced a partnership with Cytiva (formerly GE Healthcare Life Sciences) to develop a saliva-based rapid antigen test to indicate whether a person has the COVID-19 infection which will be in the form of a simple test strip. The test is intended to give a result within minutes and for use by both healthcare professionals and consumers. The Group has agreed an exclusive distribution agreement with Medusa19 for the supply of the COVID-19 rapid test direct to consumers globally, subject to the necessary regulatory approvals. Press release.

Researchers in the UK have launched the DISCOVER (DIagnostic and Severity markers of COVID-19 to Enable Rapid triage) study to identify blood-based biomarkers and their ability to predict a patient's disease course alongside demographic factors such as age, sex, frailty and other medical conditions. This early triage of patients is crucial to manage the pressure on hospital beds safely. When patients with suspected or confirmed COVID-19 are admitted to hospital, they will be approached by the research team and consented for blood sampling and access to their medical history. These patients will then be followed up for 28 days, remotely, and their clinical progress recorded. Blood samples from the study will be stored anonymously for future research. The team will test suPAR (soluble urokinase plasminogen activating receptor), which has already had encouraging results from Greek data, alongside other more conventional tests, such as troponin, NT-proBNP and ferritin. The team will also test a variety of cytokines. Press release.

An interdisciplinary team from Northern Arizona University is working to develop a new test for SARS-CoV-2 using Single Molecule Surface Enhanced Raman Spectroscopy. The project was recently awarded a $200,000 grant from the National Science Foundation's Rapid Response Research (RAPID) funding program supporting virus-related research. The method, Single Molecule Surface Enhanced Raman Spectroscopy (SM-SERS), will detect the S proteins of the SARs-Cov-2 virus, which participate in infection at the cellular level. Press release.

Advanced Biological Laboratories (ABL) has announced the CE-IVD registration of its UltraGene Combo2Screen SARS-CoV-2 assay, now available for in-vitro diagnostics use. This test is intended to be used for the qualitative detection of nucleic acids from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen. The real-time RT-PCR test aids the diagnosis of coronavirus disease (Covid-19) infection. Targeting the N gene + E gene regions of the SARS-CoV-2 genome (in full compliance with the WHO Guidelines) in a multiplex format with internal control for the reverse transcription and PCR steps, the UltraGene® Combo2Screen CE-IVD assay is a fast and easy-to-use diagnostic solution with the highest TCID50 sensitivity (1*10-6 TCID50/mL). The specimen is intended to be collected from nasopharyngeal swab. It is compatible with most automatic or manual RNA extraction methods, as well as with most qPCR instruments equipped with at least three channels. Press release.