A Covid-19 test that processes saliva samples and does not require special swabs or collection devices received emergency-use authorization by the U.S. Food and Drug Administration on Saturday. SalivaDirect test is expected to be priced at $10 per sample. Cheap, fast saliva-based test could boost testing frequency. Research for the test was done by Yale University’s School of Public Health and was partly funded by the National Basketball Association and the union representing NBA players. The rapid detection test, known as SalivaDirect, “is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” FDA Commissioner Stephen…
Author: Brett Johnson
SUMMARY: NPR reports more than 8 in 10 supported aggressive new measures by the federal government, including expanded testing are needed. The author suggests we have relied on poorly coordinated efforts among 50 states and thousands of local jurisdictions to solve a national problem. “The United States is not currently on course to get control of this epidemic,” said a Johns Hopkins University report. “It is time to reset.”. The writer suggests testing every American once a week for four weeks. There’s a model for this idea. In March, the Broad Institute of Harvard and MIT converted its lab into a…
Opinion in the Wall Street Journal describes a Covid-19 therapy using “medicinal signaling cells,” or MSCs, which are found on blood vessels throughout the body. These cells eliminate the virus, calm the immune overreaction known as a cytokine storm, and repair damaged lung tissue. According to the author who is a co-founder of a company in this space, this combination is offered by no other drug, making this a regenerative medicine that could be as revolutionary as Jonas Salk’s polio vaccine. NOTE: Share price of Osiris (the company developing this technology) rose dramatically after this article appeared, moving from .03…
Current tests for active infection of COVID-19 are given long after the infected person has stopped transmitting making results virtually useless for public-health efforts to contain the pandemic. Harvard professor makes the case that our current approach is all wrong. The vast majority of PCR positive tests we currently collect are finding people for whom we can’t even act because they are done transmitting and that rapid and inexpensive tests even with low sensitivity can better address the challenge. FDA policy is slowing these tests to market. AT THE MOMENT, THE UNITED STATES has no semblance of public-health testing” for…
SUMMARY: The first injection for Moderna’s vaccine trail in partnership with the National Institutes of Health aims to enroll about 30,000 people from 89 widely dispersed sites across the U.S. It is the first possible coronavirus vaccine to enter a phase three trial in the U.S. If the vaccine remains on track, Moderna previously said it will be able to deliver “approximately 500 million doses per year, and possibly up to 1 billion doses per year” starting in 2021.The company announced earlier this month that healthy adults whowere given the vaccine in the phase one trial tolerated it generally well and all…
A COVID-19 vaccine called AZD1222 being developed by AstraZeneca and the University of Oxford showed “robust immune responses” in early-stage clinical trials neutralizing antibody responses in 91 percent of the participants who received a single dose of AZD1222 and 100 percent of the participants who received the booster dose. The United States announced it secured 300 million doses of the experimental vaccine—nearly one-third of the first one billion doses the drug maker plans to produce. The U.S. Department of Health and Human Services pledged up to $1.2 billion to accelerate the program. Though these early trial results show that the vaccine induced a…
Mologic has announced that, following successful independent validation by the Liverpool School of Tropical Medicine (LSTM) and St George’s, University of London, its professional-use rapid diagnostic test for COVID-19 has received a CE mark (meeting European Economic Area standards) and is ready for manufacture and global distribution. Rigorous independent assessment has shown the tests to have a sensitivity of up to 96% (21-28 days post-symptom onset), and specificity of 98.8% (95% CI 96.6-99.8). The test has been validated to date on 108 positive samples, 255 negative samples, and 223 cross-reacting samples in line with the WHO pre-qualification requirements. As with…
A common drug, already approved by the FDA, may also be a powerful tool in fighting COVID-19, according to research published this week. Heparin could be used as a decoy to prevent SARS-CoV-2 from infecting human cells. SARS-CoV-2, the virus that causes COVID-19, uses a surface spike protein to latch onto human cells and initiate infection. But heparin, a blood thinner also available in non-anticoagulant varieties, binds tightly with the surface spike protein, potentially blocking the infection from happening. This makes it a decoy, which might be introduced into the body using a nasal spray or nebulizer and run interference…