When the COVID-19 pandemic began, Cuba decided not to wait on the rest of the world to develop vaccines. The United States’ 60-year-old economic embargo against the country, which prevents US-made products from being exported there, would make it difficult for Cuba to acquire vaccines and therapies, researchers and officials knew. [...]

Listening to recent discussions in the media on point of care testing (POCT) as a tool to help manage the COVID-19 pandemic one would think that POCT is new to the diagnostic scene. However, nothing could be further from the truth [...]

The coronavirus SARS-CoV-2, which causes Coronavirus disease 2019 (COVID-19), has infected more than 100 million people globally and caused over 2.5 million deaths in just over one year since its discovery in Wuhan, China in December 2019. The pandemic has evoked widespread collateral damage to societies and economies, and has destabilized mental health and well-being. Early in 2020, unprecedented efforts went into the development of vaccines that generate effective antibodies to the SARS-CoV-2 virus. Teams developing twelve candidate vaccines, based on four platforms (messenger RNA, non-replicating viral vector, protein/virus-like particle, and inactivated virus) had initiated or announced the Phase III clinical trial stage by early November 2020, with several having received emergency use authorization in less than a year. [...]

Twenty years ago, our province had several multibillion-dollar biotechnology companies that had developed some of the most innovative life-saving products globally, including the Taxus stent by Angiotech, Visudyne by QLT and Mozobil by Anormed [...]

COVID-19 pandemic will continue to pose a major public health threat until vaccination-mediated herd immunity is achieved. Most projections predict vaccine will reach a large subset of the population late in 2021 or early 2022. In the meantime, countries are exploring options to remove strict lockdown measures and allow for society and the economy to return to normal function. One possibility is to expand on existing COVID-19 testing strategies by including large-scale rapid point of care diagnostic tests (POCTs). [...]

SARS-CoV-2 causing coronavirus disease 2019 (COVID-19) has wreaked havoc during the global pandemic of 2020 infecting millions and leaving over a half million dead. As a new virus, not previously in the human population, but with similarities to other coronaviruses causing severe acute respiratory distress syndrome (SARS/ARDS), and no known treatments, the race to re-purpose existing drugs and to enlist novel therapeutics is underway. In the half-year since the first cases, we have acquired substantial knowledge of this virus and the clinical course of COVID-19 progression. Results from early clinical trials have revealed two treatments (remdesivir, dexamethasone) that mitigate disease progression but clearly, there is much room for improvement.

In only a few months after initial discovery in Wuhan, China, SARS-CoV-2 and the associated coronavirus disease 2019 (COVID-19) have become a global pandemic causing significant mortality and morbidity and implementation of strict isolation measures. In the absence of vaccines and effective therapeutics, reliable serological testing must be a key element of public health policy to control further spread of the disease [...]

A novel coronavirus SARS-CoV-2 causing Coronavirus disease 2019 (COVID-19) has entered the human population and has spread rapidly around the world in the first half of 2020 causing a global pandemic. The virus uses its spike glycoprotein receptor-binding domain to interact with host cell angiotensin-converting enzyme 2 (ACE2) sites to initiate a cascade of events that culminate in severe acute respiratory syndrome in some individuals. In efforts to curtail viral spread [...]

The ongoing coronavirus disease 2019 (COVID-19) outbreak caused by a novel coronavirus (SARS-CoV-2) is posing a great threat to global public health and economies. Accurate and rapid detection of the SARS-CoV-2 virus and diagnosis of infection status will play a critical role in understanding the disease, selecting appropriate treatments, controlling the spread, and developing informed back-to-work policies.

As a country, Canada is doing an admirable job to slow the spread of the new coronavirus based on our existing health care system and available resources at home and abroad. Our frontline healthcare workers are risking their lives daily to help the sick, while policymakers are making tough but necessary calls to close parts of the economy to keep Canadians healthy and safe.

From March 16th, 2020 to May 4th, 2020 FDA allowed antibody-based tests access to market under two pathways during the emergency declaration: Notification (Policy D) and EUA. FDA indicated that EUA application was appropriate for tests seeking a sole diagnosis claim, while notification was appropriate for tests with a qualitative IgG or IgM claim. However, FDA announced a major policy reversal regarding serological tests.

National Health Authorities regulating in vitro diagnostic tests have responded to the COVID-19 pandemic by lowering barriers to market entry in order to increase access to testing. In the United States, the Food and Drug Administration (FDA) has employed the Emergency Use Authorization (EUA) pathway to expedite the review of SARS-COV-2 in vitro diagnostic tests.