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Moderna's stock falls 4% as CEO says enrollment in vaccine trial has been slowed to ensure diversity – MarketWatch

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Shares of Moderna Inc.
MRNA,
-3.45%

were down 4.6% in trading on Friday after the company’s CEO told CNBC that it was slowing down enrollment in the Phase 3 clinical trial for its experimental COVID-19 vaccine to ensure diversity of the study’s participants. The late-stage trial is expected to enroll about 30,000 participants and will be a crucial test to understanding whether the vaccine candidate can protect against infections with the virus. “We believe these efforts will improve the quality of the study and confidence in the vaccine by building evidence for benefit in the communities at highest risk of COVID-19,” a company spokesperson said in an email. As of Aug. 24, the company said that 17,458 people had enrolled in the Phase 3 trial. Moderna’s stock is up 215.6% so far this year, while the S&P 500
SPX,
-0.81%

has gained 6.9%. |NEW] that it was slowing down enrollment in the Phase 3 clinical trial for its experimental COVID-19 vaccine to ensure diversity of the study’s participants. The late-stage trial is expected to enroll about 30,000 participants and will be a crucial test to understanding whether the vaccine candidate can protect against infections with the virus. “We believe these efforts will improve the quality of the study and confidence in the vaccine by building evidence for benefit in the communities at highest risk of COVID-19,” a company spokesperson said in an email. As of Aug. 24, the company said that 17,458 people had enrolled in the Phase 3 trial. Moderna’s stock is up 215.6% so far this year, while the S&P 500
SPX,
-0.81%

has gained 6.9%.

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Ottawa in second wave of COVID-19 pandemic: Dr. Etches – Newstalk 1010 (iHeartRadio)

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Ottawa’s medical officer of health says Ottawa is now in the second wave of the COVID-19 pandemic, after people got a little too relaxed with COVID-19 measures in August.

Dr. Vera Etches announced Ottawa was in the second wave shortly after Ottawa Public Health reported 63 new cases of COVID-19 in the capital on Friday.

Dr. Etches says the current rise in COVID-19 cases is unsustainable, but residents can help flatten the second wave if they increase physical distancing practices and limit contacts. 

Speaking with reporters after meeting with Premier Doug Ford, CTV News Ottawa’s Christina Succi asked Dr. Etches if Ottawa is in the second wave of the pandemic.

“Yes, we’re seeing a rise in cases and it’s the speed of the increase that concerns us,” said Dr. Etches Friday morning outside the Fairmont Chateau Laurier.

“We can’t sustain a rapid rise in cases, we need to be able to keep it to a manageable level.”

Ottawa has seen at least 60 new cases of COVID-19 three days this week, including 61 cases on Monday and 63 on Friday.

The medical officer of health says she believes Ottawa residents can help flatten the curve and limit the spread of COVID-19.

“I do believe that people in Ottawa, they’ve done it before. They did it in the first wave, but they did it in July as well. When we started to see an increase in July it came back down when people increased their distance between each other,” said Dr. Etches.

“In August, we got a little too relaxed, we had too many gatherings and we need to do it again.”

New social gathering limits are now in effect for Ottawa. Starting today, gatherings are limited to 10 people indoors and 25 people outdoors at homes and private setting.

MORE: I ask “Are we in a 2nd wave” @VeraEtches “Yes. We are seeing a rise in cases and it’s the speed of the increase that concerns us, we can’t sustain a rapid rise in cases we need to keep it to a manageable level”

“Can we do that?”

“Yes we can…”#COVID19 #ottawa

WATCH: https://t.co/8zoEsqHwph pic.twitter.com/0Dm8FrnxfQ

— Christina Succi (@CTVChristina)
September 18, 2020

Dr. Vera Etches told reporters there will be “multiple waves” of COVID-19 cases in Ottawa.

“In July, we saw a small wave, now we’re seeing another wave. We don’t know how big it will get,” said Dr. Etches.

“When people talk about the second wave, they’re talking about is it going to be crisis again. That’s what we want to change. We want to flatten it, keep it a small bump.”

Speaking with reporters Friday afternoon, Dr. Etches suggested the actions of residents could help stem the second wave of COVID-19.

“The actions we take today could make that wave flatten, that curve flatten again within the next two-to-three weeks,” said Dr. Etches.

“That’s what I hope is that this is another peak that will not last longer than the next two weeks and it is up to each of us to make that happen.”

The medical officer of health urges people to practice COVID-19 measures, including physical distancing, limiting contacts with others and wearing face masks in public spaces.

Ottawa Public Health blamed private gatherings and parties for a rise in cases in mid-July.

This news should not come as a surprise…and neither should this: you already know what to do. Wear a mask, stay home if you’re sick, maintain distancing & wash your hands.

Remember: limiting close contacts = reducing COVID-19 transmission.

This virus is not stronger than us. https://t.co/hCymKt6x53

— Ottawa Public Health (@ottawahealth)
September 18, 2020

This is a developing story. CTV News Ottawa will have the latest as it becomes available

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UK study finds effective new Covid-19 rapid test in a box – Times of India

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LONDON: A new small-boxed Covid-19 rapid test device, which gives results within 90 minutes, has been found to have a high level of accuracy and produced very few false negatives and no false positives in a UK study.
The Lab-in-Cartridge tests can be performed in cartridges smaller than a mobile phone and do not require a laboratory.
The study, led by Imperial College London scientists and published in ‘The Lancet Microbe’ this week, involved high-speed tests on 386 National Health Service (NHS) staff and patients and were found to have over 94 per cent sensitivity and 100 per cent specificity.
“These results suggest the test, which can be performed at a patient’s bedside without the need to handle any sample material, has comparable accuracy to standard laboratory testing,” said Professor Graham Cooke, lead author of the study from the Department of Infectious Disease at Imperial College London.
“Many tests involve a trade-off between speed and accuracy, but this test manages to achieve both. Developing an effective bedside test in under three months has been an incredible collaboration between teams of engineers, clinicians and virologists,” he said.
The test is currently being used successfully across eight London hospitals, and due to be rolled out at a national level in the UK as data continues to be gathered from the testing device for continual assessment.
Imperial College London said the UK government recently placed an order for 5.8 million of the testing kits.
To perform the test, a paediatric-sized nose swab from a patient is inserted into the device, which then looks for traces of genetic material belonging to the SARS-CoV-2 or novel coronavirus, which causes the infection.
A result is available within 90 minutes, compared to conventional Covid-19 testing which delivers a result in 24 hours.
According to the research team, the test is now being developed for assessing simultaneously Flu-A, Flu-B, and RSV as well as Covid-19.
The device, produced by Imperial’s London-based start-up DnaNudge, was used on 280 NHS staff members with suspected Covid-19, 15 patients in Accidents and Emergency (A&E) with suspected Covid-19, and 91 hospital in-patients — some of who were not displaying Covid-19 symptoms.
The percentage of those found to be positive for Covid-19 during the study at the peak of the pandemic was 18 per cent.
The results showed 67 samples tested positive on the CovidNudge test, compared with 71 positive results against a range of NHS standard laboratory machines, which represents the value of 94 per cent sensitivity.
“The DnaNudge test was developed as a lab-free, on-the-spot consumer service that can be delivered at scale, so we clearly believe it offers very significant potential in terms of mass population testing during the Covid-19 pandemic,” said Regius Professor Chris Toumazou, CEO and co-founder of DnaNudge and founder of the Institute of Biomedical Engineering at Imperial College London.
“The platform is well suited to testing in primary care and community settings with potential for use in non-healthcare settings such as care homes, schools, transport hubs, offices, and, to help bring the arts back, in theatres and venues. However, further studies of real-world effectiveness in non-clinical settings would be required prior to widespread deployment,” he said.
The research team, which included scientists and clinicians from Imperial and a number of NHS hospital trusts, assessed sensitivity and specificity.
Sensitivity is a measure of how well a test gives a positive result for people who have disease, and is an indication of how likely a test will produce false negative results.
Specificity, on the other hand, is a measure of a test’s ability to give a negative result for a people who don’t have the disease, and is an indication of the likelihood of false positive results.
“As an organisation we are focused on using research and innovation to continuously drive improvements to care.Getting accurate results back to clinicians and their patients as quickly as possible makes a huge difference to how we safely manage clinical pathways and we are very much looking forward to rolling this out more widely,” said Dr Bob Klaber, director of strategy, research and innovation at Imperial College Healthcare NHS Trust.
The device has been approved by the UK Medicines and Healthcare Regulatory Agency and has also obtained a CE mark, enabling its additional use in non-clinical locations. The team explain each device is wi-fi enabled, allowing the test result to be securely sent to a hospital’s record system.
Testing for the study took place between April 10 and May 12 at three NHS sites: St Mary’s Hospital, Imperial College Healthcare NHS Trust, London; Chelsea & Westminster Hospital NHS Foundation Trust, London and the John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford.
It was supported by the National Institute for Health Research, Imperial Biomedical Research Centre.

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Another Rapid COVID-19 Test Shows Promise – HealthDay News

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FRIDAY, Sept. 18, 2020 (HealthDay News) — Yet another rapid COVID-19 test has proven its mettle in spotting infection with the new coronavirus, this time in a British study.

The lab-in-a-cartridge testing device — which can be performed at bedside, doesn’t require a laboratory, and can be performed in cartridges smaller than a mobile phone — was tested on 386 National Health Service staff and patients in Britain.

The test had 94% sensitivity and 100% specificity, meaning it had a high level of accuracy and produced very few false negatives and no false positives. The results are available within 90 minutes, while conventional COVID-19 tests provide results within 24 hours, the researchers said. The findings were published Sept. 17 in The Lancet Microbe journal.

In the United States, four rapid coronavirus tests have already been developed. These tests detect COVID-19 antigens, proteins found on the surface of the coronavirus, rather than the virus itself, according to the Associated Press. It’s considered a faster, but less precise, screening method.

One of these tests, made by Abbott Laboratories and called BinaxNOW, has already secured a $760 million deal with the White House to produce 150 million rapid nasal swab tests for community testing, according to the AP.

The 15-minute BinaxNOW test will sell for $5, giving it an edge over similar tests that need to be popped into a small machine, the AP reported. No larger than a credit card, the Abbott test is based on the same technology used to test for the flu, strep throat and other infections.

“Those [rapid] screening tests are what we need in schools, workplaces and nursing homes in order to catch asymptomatic spreaders,” Dr. Jonathan Quick, an adjunct professor of global health at Duke University in North Carolina, told the AP.

With the British test, a nose swab from a patient is inserted into the cartridge device, which analyzes the sample for genetic material belonging to SARS-CoV-2 virus.

The new test is being used at eight London hospitals, and is due to be rolled out at a national level. The U.K. government recently placed an order for 5.8 million of the testing kits.

“These results suggest the test, which can be performed at a patient’s bedside without the need to handle any sample material, has comparable accuracy to standard laboratory testing,” said study author Graham Cooke. He is a professor in the department of infectious disease at Imperial College London.

“Many tests involve a trade-off between speed and accuracy, but this test manages to achieve both,” Cooke said in a college news release.

The test — made by DnaNudge, an Imperial College London start-up — is now being developed to simultaneously check for COVID-19, influenza and respiratory syncytial virus, the researchers added.

Chris Toumazou is CEO and co-founder of DnaNudge and founder of the Institute of Biomedical Engineering at Imperial College London. He said, “The DnaNudge test was developed as a lab-free, on-the-spot consumer service that can be delivered at scale, so we clearly believe it offers very significant potential in terms of mass population testing during the COVID-19 pandemic.”

More information

The U.S. Centers for Disease Control and Prevention has more on COVID-19 testing.

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