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Summit, Colorado Center for Personalized Medicine to Develop Saliva Tests for COVID, Head & Neck Cancer

AURORA, Colo., Oct. 14, 2020 /PRNewswire/ — Summit Biolabs, Inc., an early-stage molecular diagnostics company specializing in saliva-based testing for COVID-19 and head & neck cancer, and the Colorado Center for Personalized Medicine (CCPM) at the University of Colorado Anschutz Medical Campus announced today a broad strategic collaboration involving research, development and commercialization of saliva liquid-biopsy tests for early cancer detection and diagnosis of COVID-19 and other viral contagions.

The CCPM holds one of the largest research biobanks in the United States with clinical data from more than 8.7 million de-identified patient records and plans to integrate the data with personalized genomic information.

“This partnership brings two innovative programs together to optimize COVID testing at a time when it’s desperately needed,” says Kathleen Barnes, Ph.D., Professor and Director of CCPM at the University of Colorado Anschutz Medical Campus. “Collaborations like this are crucial in moving research forward and advancing and expanding clinical testing to as many members of our community as possible. Working with Summit Biolabs, and leveraging technology developed by our colleagues here at the Anschutz Medical Campus, will help us achieve these goals and establish a non-invasive testing process that will benefit patients in Colorado and beyond.”

Summit Biolabs is developing breakthrough tests to improve the detection of COVID-19 and to advance the early detection of human cancers, including head & neck cancer, using simple, non-invasive saliva liquid-biopsy technology developed by Dr. Shi-Long Lu and colleagues at the University of Colorado Anschutz Medical Campus. Head & neck cancer has been scientifically overlooked, yet is medically important. Summit Biolabs’ research foundation and competency in head & neck cancer diagnosis enabled the company’s pivot to saliva-based testing for coronavirus, COVID-19.

“We are excited to collaborate with CCPM to develop and commercialize Summit Biolabs’ portfolio of developmental saliva or non-blood liquid-biopsy tests.” said Bob Blomquist, Chief Executive Officer at Summit Biolabs. “This collaboration broadens and strengthens Summit Biolabs’ ability to bring to market life-changing saliva liquid-biopsy tests that ultimately enable better treatment and improved outcomes for patients.”

About Summit Biolabs

Summit Biolabs is harnessing the power of saliva-based diagnostics to address critical challenges in COVID-19 and head & neck cancer testing. Founded on the discoveries of Dr. Shi-Long Lu, Associate Professor of Otolaryngology, Summit Biolabs is being spun out from the University of Colorado Anschutz Medical Campus.

Summit Biolabs is pioneering early detection of head & neck cancer recurrence using a first of its kind saliva liquid-biopsy test, HNKlear. HNKlear is a proprietary, non-invasive saliva test that provides more effective, more accurate, and earlier detection of head and neck cancer recurrence than traditional diagnostic methods. Summit Biolabs is leveraging its core competencies in saliva-based molecular diagnostics and viral nucleic acid testing (i.e., oral oncogenic human papillomavirus detection) to diagnose COVID-19. Along with our clinical and laboratory partners, Summit Biolabs is developing the first comprehensive panel of highly-accurate saliva-based tests for COVID-19 infection, quantitation, and immune response. Summit Biolabs is headquartered in Aurora, Colorado.

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Positive Virus Tests, Hospitalizations Surge in Colorado | Colorado News

DENVER (AP) — Colorado is experiencing another surge of coronavirus cases and hospitalizations, prompting Gov. Jared Polis to plead Tuesday with residents to wear masks, stay home as much as possible, and maintain social distancing practices.

As of Tuesday, Colorado’s three-day average positivity rate — the percentage of total tests coming in positive — was 5.4%, and the state recorded 1,000 newly confirmed cases both Saturday and Monday, the highest daily numbers recorded during the pandemic, Polis said.

About 290 people were hospitalized for COVID-19 on Tuesday, the highest total since May 31, The Denver Post reported.

During a briefing on the pandemic, Polis didn’t suggest he was contemplating renewed mandatory restrictions on business or other activities to stem the surge. But he insisted: “If this continues, our hospital capacity will be in jeopardy.”

The World Health Organization recommends trying to keep the positivity rate below 5% of all tests. Higher rates suggest authorities are missing large numbers of infections.

On Monday, the head of the Colorado Department of Public Health and Environment suggested daily coronavirus caseloads may have surpassed 4,000 in March and April. The numbers weren’t recorded because far fewer people were being tested, said Jill Hunsaker Ryan.

She said the state has experienced three surges: In March and April, after July 4, and after Labor Day, Sept. 7. State data suggest Denver and Adams counties are among those recording the highest numbers of newly confirmed cases.

More than 2,000 people have died and more than 80,000 people have been hospitalized for the disease since the pandemic began.

The coronavirus causes mild or moderate symptoms for most people. For some, especially older adults and people with existing health problems, it can cause more severe illness or death.

Copyright 2020 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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China Tests Entire City For Virus As Europe Tightens Controls

China rushed Tuesday to test an entire city of nine million people within days after a minor coronavirus outbreak in the sprawling country, a far cry from the struggle in Europe to tackle surging infections with tough new steps including partial lockdowns.

The virus is still spreading rapidly worldwide, with over one million deaths and 37 million infections, and many nations that suppressed their first outbreaks now face a second wave.

Without a vaccine, governments are wary of allowing the virus to spread unchecked.

More than four million samples had been collected as of Tuesday in the Chinese city of Qingdao More than four million samples had been collected as of Tuesday in the Chinese city of Qingdao Photo: AFP / STR

China — where Covid-19 first emerged late last year — launched a drive to test all residents of Qingdao after a handful of cases were detected on Sunday.

More than four million samples had been collected and 1.9 million results returned as of Tuesday afternoon, Qingdao authorities said, adding that no new cases had been found beyond already confirmed infections.

Chinese officials intend to test the entire city — around 9.4 million people — by Thursday.

Britain's Prime Minister Boris Johnson has ordered pubs to close early to help stem the virus spread Britain’s Prime Minister Boris Johnson has ordered pubs to close early to help stem the virus spread Photo: AFP / JUSTIN TALLIS

In scenes contrasting with the fumbled testing efforts elsewhere, health workers in protective clothing swiftly set up tents and residents queued deep into Monday night to provide samples.

In Europe, governments are battling to curb surges with new controls and increased testing, while trying to avoid the devastating nationwide lockdowns of March and April.

Dutch Prime Minister Mark Rutte announced the Netherlands will go into “partial lockdown” from 2000 GMT on Wednesday, with all bars, caf?s and restaurants to close for two weeks at least.

French President Emmanuel Macron is expected to announce tighter restrictions and faster testing in a prime-time TV interview Wednesday night, with some media speculating Paris and other cities could face evening curfews.

Map with number of Covid-19 deaths by country as of October 13 at 1100 GMT Map with number of Covid-19 deaths by country as of October 13 at 1100 GMT Photo: AFP / Simon MALFATTO

Hospitals in Paris will have most of their intensive care beds packed with Covid-19 patients as soon as next week, the system’s chief warned Tuesday.

“It’s inevitable,” Martin Hirsch, the head of the 39 hospitals in Paris and its suburbs, told the Parisien newspaper, estimating beds would reach 70-90% capacity by October 24.

Russia on Tuesday reported its highest-ever number of daily virus deaths, at 244, and a record number of new cases at almost 14,000.

With the pandemic already claiming more than one million lives worldwide, scientists in different nations are rushing to develop vaccines and effective treatments With the pandemic already claiming more than one million lives worldwide, scientists in different nations are rushing to develop vaccines and effective treatments Photo: AFP / Yasin AKGUL

Italy imposed new, tougher rules to control a resurgence, including an end to parties, amateur football matches and snacking at bars at night.

Polish Prime Minister Mateusz Morawiecki on Tuesday became the latest high-profile figure to go into quarantine after coming into contact with a person with Covid-19.

And Portugal’s football federation said star striker Cristiano

China tests entire city for virus as WHO slams herd immunity idea

China rushed Tuesday to test an entire city of nine million within days after a minor coronavirus outbreak, as the WHO warned that letting the pathogen run free to achieve herd immunity was “scientifically and ethically problematic”.

The virus is still spreading rapidly around the world, with well over 37 million infections, and nations that had suppressed their first outbreaks are now struggling with fresh surges — especially in some parts of Europe.

In the absence of a vaccine, governments are wary of allowing the virus to spread unchecked, with China launching a sweeping drive to test all residents of Qingdao after a handful of cases were detected on Sunday.

“As of 8 am… our city has taken 3.08 million samples for nucleic testing,” the city’s health commission said Tuesday, adding that no new positive samples were found.

Chinese officials intend to test the entire city — around 9.4 million people — by Thursday.

In scenes contrasting with the fumbled testing efforts of other nations, health workers in protective clothing swiftly set up tents and residents queued deep into Monday night to provide samples.

In opposition to economically painful lockdowns and social distancing, there have been proposals in some countries to let the coronavirus circulate in the population to build up “herd immunity” — where so much of the population has been infected there are insufficient new victims for the virus to jump to.

But the World Health Organization said such plans were unworkable, and required mass vaccinations to work.

“Herd immunity is achieved by protecting people from a virus, not by exposing them to it,” WHO chief Tedros Adhanom Ghebreyesus said Monday, describing the idea as “scientifically and ethically problematic”.

“Allowing a dangerous virus that we don’t fully understand to run free is simply unethical. It’s not an option.”

Further illustrating the challenge, a study published in The Lancet Infectious Diseases journal indicated that exposure to the virus may not guarantee future immunity — and the second infection could come with even more severe symptoms.

– Vaccine setback –

The pandemic has claimed more than one million lives worldwide, and spurred breakneck efforts to develop vaccines and effective treatments.

Some have made it to late-stage clinical testing, but the optimism was dented Monday when Johnson & Johnson announced it had temporarily halted its 60,000-patient trial because of an unexplained illness in one participant.

There are ten firms conducting Phase 3 trials of their candidates globally, including Johnson & Johnson.

The pharma giant has been awarded about $1.45 billion in US funding under Operation Warp Speed, championed by President Donald Trump, who is keen for a political boost ahead of the November election with a coronavirus breakthrough.

Critics have excoriated Trump for his handling of the crisis, with more known infections and deaths in the United States than anywhere else in the world.

Trump was sidelined from the campaign trail for 10 days after he got Covid-19, but returned to the stage Monday.

“I went through it and

Trump tests negative for COVID-19, is not infectious

WASHINGTON (Reuters) – U.S. President Donald Trump has tested negative for COVID-19 and he is not infectious to others, the White House physician said on Monday, 10 days after Trump announced he had contracted the coronavirus.

In a memo released by the White House just hours before Trump was due to resume holding campaign rallies, Dr. Sean Conley said the president had tested negative on consecutive days using an Abbott Laboratories <ABT.N> BinaxNOW antigen card.

Conley said the negative tests and other clinical and laboratory data “indicate a lack of detectable viral replication.”

Trump’s medical team had determined that based on the data and guidelines from the U.S. Centers for Disease Control and Prevention “the president is not infectious to others,” Conley said.

Trump returns to the campaign trail on Monday night with a rally in Sanford, Florida, his first since he disclosed on Oct. 2 that he tested positive for COVID-19.

Critics fault Trump for failing to encourage supporters at campaign events, and even White House staff, to wear protective masks and abide by social-distancing guidelines. At least 11 close Trump aides have tested positive for the coronavirus.

(Reporting by Eric Beech; Editing by Chris Reese and Bill Berkrot)

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Trump Holds Florida Rally After White House Physician Reports Negative COVID-19 Tests

On Monday, White House physician Sean Conley said that President Trump had registered consecutive days in which he’s tested negative for COVID-19. The news came on the same date that Trump headed to a packed campaign rally in Sanford, Florida. 

“In response to your inquiry regarding the President’s most recent COVID-19 tests, I can share with you that he has tested NEGATIVE, on consecutive days, using the Abbott BinaxNOW antigen card,” said Conley. He added that those tests occurred “in context with additional clinical and laboratory data.”

Speaking of this data, Conley wrote that it was made up of “viral load, subgenomic RNA and PCR cycle threshold measurements, as well as ongoing assessment of viral culture data.”

The letter concluded that the president is “not infectious to others,” which echoes a similar message that Conley issued on Saturday. He also stated, on Saturday, that the president is cleared for an “active schedule.” 

CNN adds that it’s not clear what consecutive days Trump tested positive, while also noting that the Abbott BinaxNOW test he reportedly took may lack precision, as it’s only proven accurate in people being tested within the first week of their symptoms starting to show. The FDA has also said they’re not certain of how accurate Abbott BinaxNOW results are. 

Trump’s positive test was first announced on Thursday, October 1. The White House has not said when the president last tested negative prior to that announcement. 

As for that aforementioned rally, a large crowd gathered for the event. The campaign was issuing temperature checks and distributed masks/hand sanitizer, but social distancing remained absent. 

Trump also claimed to be “immune” and offered to kiss anyone in the crowd daring enough to chance it:

On a related note, this all comes on the same day that Dr. Anthony Fauci said that holding large rallies “was asking for trouble” due to the virus’s surge in several states. 

“We know that that is asking for trouble when you do that,” Fauci said of Trump’s decision to re-up a full campaign rallying schedule, according to The New York Times. “We’ve seen that when you have situations of congregate settings where there are

UK study tests if BCG vaccine protects against COVID

LONDON (Reuters) – The widely used BCG tuberculosis vaccine will be tested on frontline care workers in Britain for its effectiveness against COVID-19, researchers running the UK arm of a global trial said.

Bacillus Calmette-Guérin (BCG) vaccine, used to protect against tuberculosis, induces a broad innate immune-system response and has been shown to protect against infection or severe illness with other respiratory pathogens.

“BCG has been shown to boost immunity in a generalised way, which may offer some protection against COVID-19,” Professor John Campbell, of the University of Exeter Medical School, said.

“We are seeking to establish whether the BCG vaccine could help protect people who are at risk of COVID-19. If it does, we could save lives by administering or topping up this readily available and cost-effective vaccination.”

The UK study is part of an existing Australian-led trial, which launched in April and also has arms in the Netherlands, Spain and Brazil. The BCG vaccine is also being tested as a protection against COVID-19 in South Africa.

The British trial is recruiting volunteers ahead of winter months that officials have warned may be tough as the country grapples with a second wave of infections.

UK Prime Minister Boris Johnson has indicated that restrictions to curb the pandemic could be in place until spring.

The trial’s UK arm, which is being run from Exeter, southwest England, is seeking to recruit 1,000 people who work in care homes and community healthcare nearby.

Globally, more than 10,000 healthcare staff will be recruited.

(Reporting by Alistair Smout; Editing by Christina Fincher)

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UK Study Tests if BCG Vaccine Protects Against COVID | Top News

LONDON (Reuters) – The widely used BCG tuberculosis vaccine will be tested on frontline care workers in Britain for its effectiveness against COVID-19, researchers running the UK arm of a global trial said.

Bacillus Calmette-Guérin (BCG) vaccine, used to protect against tuberculosis, induces a broad innate immune-system response and has been shown to protect against infection or severe illness with other respiratory pathogens.

“BCG has been shown to boost immunity in a generalised way, which may offer some protection against COVID-19,” Professor John Campbell, of the University of Exeter Medical School, said.

“We are seeking to establish whether the BCG vaccine could help protect people who are at risk of COVID-19. If it does, we could save lives by administering or topping up this readily available and cost-effective vaccination.”

The UK study is part of an existing Australian-led trial, which launched in April and also has arms in the Netherlands, Spain and Brazil. The BCG vaccine is also being tested as a protection against COVID-19 in South Africa.

The British trial is recruiting volunteers ahead of winter months that officials have warned may be tough as the country grapples with a second wave of infections.

UK Prime Minister Boris Johnson has indicated that restrictions to curb the pandemic could be in place until spring.

The trial’s UK arm, which is being run from Exeter, southwest England, is seeking to recruit 1,000 people who work in care homes and community healthcare nearby.

Globally, more than 10,000 healthcare staff will be recruited.

(Reporting by Alistair Smout; Editing by Christina Fincher)

Copyright 2020 Thomson Reuters.

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Rep. Hayes tests negative for virus, 3 weeks after diagnosis

WATERBURY, Conn. (AP) — U.S. Rep. Jahana Hayes said a test Saturday showed no signs of the coronavirus in her body, nearly three weeks after she was diagnosed with COVID-19.

The Democrat, who represents Connecticut’s 5th District, has been documenting her battle against the disease on social media since revealing her positive test results on Sept. 20.

“Tossed and turned most of the night,” she posted on Sept. 21. “Breathing is so labored.”

Hayes said a follow-up COVID-19 test on Saturday came back negative. She said she also received a flu shot and made an appointment with the American Red Cross to donate plasma.


“We can all do our part to keep our community safe,” she tweeted Saturday in a post followed by three mask-wearing emojis and the hashtag “#HealthyATHome.”

In other coronavirus related news:

___

RAPID TESTS

Sacred Heart University and the University of Saint Joseph are the latest in Connecticut to use the rapid saliva-based coronavirus test developed at Yale.

The schools hope adding the testing method to tests already being conducted will help them identify cases earlier and prevent large outbreaks on campus. Both schools also are using the nasal swab form of testing.

“Over the last few weeks as we saw upticks of positive cases on other campuses we decided to increase the percentage of students tested each week and we also wanted more rapid results,” University of Saint Joseph President Rhona Free said in a statement. “SalivaDirect was able to complete the new level of testing that we needed with quick results.”

Sacred Heart spokesperson Deb Noack said the 900 saliva tests they plan to due each week will augment the 1,300 nasal swab tests that had already been conducted.

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Newborn Tests Negative After First-Time Mother Gets COVID-19 Ahead of Due Date

A baby in California tested negative for COVID-19 after her mother contracted the disease ahead of the birth earlier this year.



The child’s mother, Rachel Collette, opened up about the “emotional rollercoaster” she endured after contracting the infectious respiratory illness roughly six months ago -- as coronavirus outbreak was spreading globally.


© Anastasiia Chepinska/Unsplash
The child’s mother, Rachel Collette, opened up about the “emotional rollercoaster” she endured after contracting the infectious respiratory illness roughly six months ago — as coronavirus outbreak was spreading globally.

The child’s first-time mom, Rachel Collette, has now opened up about the “emotional rollercoaster” she endured after contracting the infectious respiratory illness roughly six months ago—as the ongoing coronavirus outbreak was spreading rapidly.

Collette revealed her personal experience after taking part in a University of California San Francisco (UCSF) study that found COVID-19 symptoms for pregnant people can be prolonged, lasting two months or longer for some participants.

In the days before giving birth to her daughter, Collette said her symptoms consisted of a dry cough, a sore throat and a headache. Luckily, she said those eventually subsided and her child had tested negative after being born at hospital.

“Definitely that whole week leading up to giving birth was an emotional rollercoaster. Because it was the end of March, beginning of April, there still wasn’t that much information, there were still so many unknowns,” Collette told KRON4.

According to data compiled by the U.S. Centers for Disease Control and Prevention (CDC) there have been more than 25,300 cases of pregnant patients with COVID-19 in the U.C., logged between January 22 and October 6. Of that number, over 5,899 people were hospitalized. It is estimated at least 44 pregnant patients have died.

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The CDC noted one study suggested pregnant people with COVID-19 are more likely to be hospitalized or need mechanical ventilation than nonpregnant people, but it warned the “risk of death is similar for both groups [and] much remains unknown.”

Speaking to KRON, Collette said her daughter, who is six months old, is healthy. Collette was one of 594 women who shared her insights with the academic study this year, the largest to date analyzing COVID-19 among non-hospitalized pregnant women.

The findings, now published in Obstetrics & Gynecology, suggested the most common early symptoms for pregnant women were cough, sore throat, body aches and fever.

It said half of the participants still reported COVID-19 symptoms after three weeks and approximately 25 percent appeared to still show symptoms after eight weeks.

“We found that pregnant people [who have] COVID-19 can expect a prolonged time with symptoms,” senior author Vanessa Jacoby, UCSF vice chair of research in the Department of Obstetrics, Gynecology and Reproductive Sciences, wrote in the report.

The project—officially known as the Pregnancy Coronavirus Outcomes Registry—is now ongoing in the U.S., where the virus is still circulating. It was launched March 22.

It has found a loss of taste or smell was the first symptom in six percent of the pregnant women, while 60 percent of women had no symptoms after four weeks of illness.

“The majority of participants in