Samsung Biologics and Vir Biotechnology, Inc announced April 9th a manufacturing agreement under which Samsung Biologics will perform large scale manufacturing services for Vir’s SARS-CoV-2 monoclonal antibody (mAb) program. “Vir’s candidate molecules supported by Samsung Biologics’ production scale have the potential to bring hope to countless lives across nations suffering from COVID-19.” said Dr. Tae Han Kim, CEO of Samsung Biologics. Vir’s lead SARS-CoV-2 mAb development candidates, VIR-7831 and VIR-7832, have demonstrated high affinity for the SARS-CoV-2 spike protein and are highly potent in neutralizing SARS-CoV-2 in live-virus cellular assays. Vir plans to proceed directly into a phase 2 clinical trial…
Author: Brett Johnson
Long-term protection to this virus comes from antibodies, small proteins produced by your immune system that attack the virus and neutralise it so it cannot be spread and cannot do any more damage to the person infected. These antibodies emerge during an infection and peak 28 days after the infection. They then remain for months afterwards continuing to provide protection, and the cells that produce them also are available to fight off the infection if it returns. These antibodies see anything foreign (like a virus) and bind to many different parts of the virus. Some antibodies are better than others…
Cepheid has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its rapid molecular diagnostic test, Xpert Xpress SARS-CoV-2. The test is designed for the qualitative detection of SARS-CoV-2 virus, which causes coronavirus (Covid-19) disease. Designed to operate on the company’s automated GeneXpert Systems, it has a detection time of approximately 45 minutes. Cepheid chief medical and technology officer Dr David Persing said: “By leveraging the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted to provide rapid detection of current and potential future…
Co-Diagnostics offers a range of products and services to suit the needs of diagnostics laboratories, research institutions, and enterprises across the globe that rely on PCR technology. Co-Diagnostics was founded with a simple but ambitious goal: to bring high-quality molecular diagnostics for infectious diseases to areas and populations of the world that need them most. Since that time, Co-Diagnostics researchers have developed additional applications far beyond the detection of infectious diseases.
Discussion of Trump’s comments regarding withholding funds from the WHO (World Health Organization) because of its failure to manage China. USA contributes about 118 million each year to WHO. China about 40 million.
The Food and Drug Administration on Thursday authorized its first emergency use coronavirus serology test. The test was developed by Cellex Inc. and involves a blood draw done at a certified lab. It can provide results in 15 minutes. FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19,” FDA chief scientist Denise M. Hinton said, adding “The known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product.” The test will determine whether an individual has developed antibodies to the virus, which would be…
A Canadian company is pushing forward to developed to indicate a positive result only when the Covid-19 virus is present, allowing for direct and clear interpretation. When completed, this test Covid-19 test is expected to produce results in 5-15 minutes and is anticipated to cost less than $50. It will not require any additional laboratory-based equipment and can be administered by a layperson at the point of care. Until now the majority of testing completed for Covid-19 uses molecular-based technology (PCR), a testing platform that typically costs more than $200 per test, frequently takes 2-4 hours to produce results, and…
For diagnosing SARS-CoV-2, a PCR test starts with a nasopharyngeal swab, which looks like a long Q-tip that draws mucus from the back of a patient’s nasal cavity where it meets the throat. This swab goes in a vial and is shipped to an FDA-approved central lab facility. There, technicians use reagents to extract any viral RNA. An enzyme called reverse transcriptase converts the RNA to a complementary sequence of DNA, which can be replicated many times over to make it easy to detect. To accomplish this replication and detection, technicians—or automated machines, in most cases—add additional reagents that include…