August 28, 2020 | Census data shows COVID-19 follows HIV patterns of racial segregation, how virtual imaging studies can help, inflammation markers that predict severe disease, and models of early transmission. Plus, two EUAs for saliva tests and back-to-work testing.
DXX Research Updates
Using publicly available Census data, a research team from amfAR, Foundation for AIDS Research, looks at the role of racial segregation on the risk of acquiring COVID-19. They find that COVID-19 diagnoses follow a similar pattern to HIV diagnoses. Counties with the highest proportion of white residents have the fewest cases of COVID-19 irrespective of geographic region or state political party inclination (i.e., red or blue states). And comparatively fewer COVID-19 diagnoses have occurred in primarily white counties throughout the duration of the US COVID-19 pandemic. Their findings were published in AIDS Patient Care and STDs. DOI:10.1089/apc.2020.0155
Duke University researchers demonstrated how virtual imaging trials can be adapted for imaging studies of COVID-19, enabling effective assessment and optimization of CT and radiography acquisitions and analysis tools for reliable imaging and management of COVID-19 in an open-access article in ARRS' American Journal of Roentgenology (AJR). They developed the first computational models of patients with COVID-19 and as a proof of principle showed how they can be combined with imaging simulators for COVID-19 imaging studies. The developed toolsets in this study provide the foundation for use of virtual imaging trials in effective assessment and optimization of CT and radiography acquisitions and analysis tools to help manage the COVID-19 pandemic. DOI: 10.2214/AJR.20.23429
Mount Sinai scientists have identified two markers of inflammation—IL-6 and TNF-α—that reliably predict the severity of COVID-19 cases and likelihood of survival, providing a foundation for a diagnostic platform and therapeutic targets. Their findings were published in Nature Medicine. The scientists established that the levels of IL-6 and TNF-α in serum, when measured at admission to the hospital, were elevated in patients who fared the worst, a finding that was independent of the patients’ other underlying medical conditions, of demographics such as age and sex, and of other standard clinical biomarkers of disease severity such as low blood oxygen saturation and common markers related to inflammation, iron levels, and blood clotting issues. This study suggests that these cytokines should be monitored in the treatment of COVID-19 patients to help select those who should enter clinical trials and receive specific drugs that can target them, the researchers say. DOI: 10.1038/s41591-020-1051-9
Programmable DNA nanoswitches that bind to viral RNA in human body fluids may provide an inexpensive platform to rapidly detect a wide variety of emerging viruses, including SARS-CoV-2, according to paper published in Science Advances by a team from the State University of New York, Albany. This approach may make testing more manageable in resource-limited areas, since it does not require enzymes or significant laboratory infrastructure, only costs about 1 penny per reaction, and can be performed within hours. DNA nanoswitches that bind to both ends of target viral RNAs, forming loop-shaped compounds. These negatively-charged, RNA-containing nanoswitch loops are then placed in a gel and stimulated with an electrical current, pulling them towards a positive electrode on the other end of the gel. Since the nanoswitches move more slowly when they are bound to viral RNA, this gel electrophoresis technique reveals the virus' presence. DOI: 10.1126/sciadv.abc6246
Recent reports suggest that 10-30% of SARS-CoV-2 infected patients are asymptomatic, and that significant viral shedding may occur prior to symptom onset. Therefore, there is an urgent need to increase diagnostic testing capabilities to prevent disease spread. Researchers in Israel developed P-BEST, a method for Pooling-Based Efficient SARS-CoV-2 Testing which identifies all positive subjects within a large set of samples using a single round of testing. Each sample is assigned into multiple pools using a combinatorial pooling strategy based on compressed sensing designed for maximizing carrier detection. In the current study published in Science Advances, they pooled sets of 384 samples into 48 pools providing both an 8-fold increase in testing efficiency, as well as an 8-fold reduction in test costs. We successfully identified up to 5 positive carriers within sets of 384 samples. We then used P-BEST to screen 1115 healthcare workers using 144 tests. P-BEST provides an efficient and easy-to-implement solution for increasing testing capacity that can be easily integrated into diagnostic laboratories. DOI: 10.1126/sciadv.abc5961
In early 2020, delays in availability of diagnostic testing for COVID-19 prompted questions about the extent of unobserved community transmission in the United States. Research from the University of Notre Dame now estimates that more than 100,000 people were already infected with COVID-19 by early March—when only 1,514 cases and 39 deaths had been officially reported and before a national emergency was declared. The study provides insight into how limited testing and gaps in surveillance during the initial phase of the epidemic resulted in so many cases going undetected. The study was published in the Proceedings of the National Academy of Sciences. DOI: 10.1073/pnas.2005476117
DXX Industry Updates
Fluidigm has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Advanta Dx SARS-CoV-2 RT-PCR Assay, an extraction-free saliva-based test to detect nucleic acid from the SARS‑CoV‑2 virus, designed to be run on the Fluidigm Biomark HD microfluidics platform. Because it is saliva-based, the Advanta Dx SARS-CoV-2 RT-PCR Assay does not require collection via invasive nasopharyngeal swab. The clinical study associated with the EUA submission demonstrated 100% agreement between the saliva results from the Advanta Dx SARS-CoV-2 RT-PCR Assay and the results from paired nasopharyngeal samples tested with authorized assays. Press release.
Boston-based online platform Meenta has launched its comprehensive COVID-19 workplace testing solution. Using the nation’s largest proprietary, digitized network of FDA/EUA-certified labs and testing, Meenta surveillance testing model allows employers to proactively monitor and test a fraction of their staff, resulting in an 80-90% savings in testing costs. This preventative tool helps make testing more affordable and efficient for companies of all sizes—saving businesses potentially hundreds of thousands of dollars in unanticipated costs. In addition, the MeentaSafe app and employer dashboard allow companies to safely control work-site entry and re-entry. Meenta’s end-to-end solution helps companies mitigate risks and get employees back to work safely, featuring three critical pillars: a symptom assessment and tracking app; a scientific, data-driven testing model; and a distributed testing platform. More information.
Avero Diagnostics, a physician-owned laboratory, is pleased to announce the expansion of its COVID-19 testing portfolio with the addition of the Roche Elecsys Anti-SARS-CoV-2 antibody test. Serological testing supports the Centers for Disease Control and Prevention (CDC) efforts to more accurately understand how many people have been infected with SARS-CoV-2, the virus that causes COVID-19, and how it is spreading. This offering, available now, will complement Avero’s existing COVID-19 molecular testing program, which Avero launched in May 2020 to support the diagnostic needs of area hospitals, health systems, multi-specialty family practices, urgent care centers, and county health departments. Press release.
Phosphorus, a leading genomics firm headquartered in New York City with a laboratory in New Jersey that has an FDA Emergency Use Authorization for in-home saliva-based COVID-19 testing, announced today that its tests are available on the Citizen App, an app that allows individuals to track symptoms, find testing sites and learn when they have been potentially exposed to the virus. Citizen’s App, which includes SafePass, is available on iOS and Android. When turned on and with Bluetooth activated, SafePass can monitor potential positive exposure, including exactly when and where someone was exposed. SafePass can also monitor if an individual has had significant contact with somebody who later tests positive for COVID-19. Over the next three months, individuals who are notified of possible exposures will be offered complimentary testing with Phosphorus. Press release.
AnteoTech (Brisbane, Australia) has successfully developed proof-of-concept COVID-19 antigen and Flu A&B point-of-care lateral flow tests that can detect the presence of SARS-Cov-2 and influenza in less than 15 minutes. The tests utilize AnteoTech’s patented AnteoBind activated europium technology and provide significantly higher sensitivity than that offered by currently available COVID-19 tests. AnteoTech intends for the tests to be combined into a single multiplex test platform and be available in as little as 6–9 months following clinical trials and regulatory approvals. AnteoTech is currently looking to build strategic partnerships with medical device manufacturers to expedite commercialization. Press release.