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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China tests entire city for virus as Europe tightens controls

China rushed to test an entire city of nine million people within days on Tuesday after a minor coronavirus outbreak, underlining the country’s capacities at a time when European countries in particular are struggling to contain surging new infections. 

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

In the absence of a vaccine, governments are wary of allowing the virus to spread unchecked, with China — where Covid-19 first emerged late last year — launching a drive to test all residents of Qingdao city after a handful of cases were detected on Sunday.

More than four million samples had been collected as of Tuesday afternoon, Qingdao authorities said, adding that 1.9 million results had been obtained. Except for confirmed infections announced earlier, no new cases had been found.

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

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.

Cases have climbed rapidly in Britain, France, Germany, Poland, and the Czech Republic in recent weeks, raising fears that the still-low death rate could rise.

Hospitals in Paris could 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 will be at 70-90% capacity by October 24.

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

Italy also imposed new hardened 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.

Britain’s Prime Minister Boris Johnson, whose country has the highest death toll in Europe, on Monday had already ordered pubs in Liverpool to shut as part of a new strategy.

He said businesses forced to close would get support from the government, but his focus on shutting hospitality venues sparked anger as similar measures have elsewhere.

“Catastrophic, catastrophic,” said Simon Ashdown, owner of the Chepstow Castle pub in Liverpool. “I don’t think there’ll be many businesses after this lockdown.”

– ‘Ethically problematic’ –

In opposition to lockdowns and social distancing, some politicians have proposed letting the coronavirus circulate in the population to build up “herd immunity” — where so much of the population has been infected there are insufficient new

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.

China is rushing to test the entire population of Qingdao -- nine million people -- for the coronavirus China is rushing to test the entire population of Qingdao — nine million people — for the coronavirus Photo: AFP / STR

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.

Graphic looking at countries with the highest coronavirus death tolls, and their respective death rates. Graphic looking at countries with the highest coronavirus death tolls, and their respective death rates. Photo: AFP / John SAEKI

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.

Letting Covid-19 "run free" with eye to herd immunity is "simply unethical", says WHO Director General Tedros Adhanom Ghebreyesus in Geneva. Letting Covid-19 “run free” with eye to herd immunity is “simply unethical”, says WHO Director General Tedros Adhanom Ghebreyesus in Geneva. Photo: WHO

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.”

China is rushing to test the entire population of Qingdao -- nine million people -- for the coronavirus China is rushing to test the entire population of Qingdao — nine million people — for the coronavirus Photo: AFP / STR

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.

A television shows Britain's Prime Minister Boris Johnson addressing the country on new virus restrictions, as customers sit at the bar inside the William Gladstone pub in Liverpool A television shows Britain’s Prime Minister Boris Johnson addressing the country on new virus restrictions, as customers sit at the bar inside the William Gladstone pub in Liverpool Photo: AFP / Paul ELLIS

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

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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The Latest: California Governor Tests Negative for Virus | World News

SACRAMENTO, Calif. — California Gov. Gavin Newsom has tested negative for the coronavirus.

The governor’s office said Newsom was tested on Wednesday after someone in the governor’s office tested positive. The staff member who tested positive had not interacted with Newsom or anyone else who often sees the governor.

The governor’s office said Newsom took the test out of “an abundance of caution.”

Newsom said Wednesday that he has been tested many times and has always been negative. California has reported more than 834,000 coronavirus cases and more than 16,300 deaths.

HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK:

— Washington DC health department asks Rose Garden attendees to get tested

— Paris hospitals on emergency footing as ICUs fill with coronavirus patients

— Am I immune to the coronavirus if I’ve already had it?

— President Trump says he’s ready to hold campaign rallies, credits an experimental drug treatment with helping recovery from COVID-19.

— Coronavirus infections in Ukraine began surging in late summer, hospitals are ‘catastrophically short of doctors.’

— The NFL’s Tennessee Titans had another positive test, bringing the team’s outbreak of COVID-19 to 23.

— Follow AP’s pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

HERE’S WHAT ELSE IS HAPPENING:

BEIJING __ China, which has four coronavirus vaccine candidates in the last stage of clinical trials, announced Friday that it is joining the COVID-19 vaccine alliance known as COVAX.

The country signed an agreement with GAVI, the co-leader of the alliance, on Thursday, China’s Foreign Ministry said in a statement. Initially, China did not agree to join the alliance, missing the global deadline to join in September.

Foreign Ministry spokeswoman Hua Chunying said in a statement that “we are taking this concrete step to ensure equitable distribution of vaccines, especially to developing countries and hope more capable countries will also join and support COVAX.”

The alliance is designed so that richer countries agree to buy into potential vaccines and help finance access for poorer ones. The Trump administration in the U.S. had declined to join the alliance.

The exact terms of the agreement and how China will contribute are not yet clear. .

HARTFORD, Conn. — Dr. Deborah Birx of the White House coronavirus task force says she is concerned about the uptick in coronavirus cases in the Northeast.

She said Thursday at the University of Connecticut’s Hartford campus that a “very different” kind of spread is happening now.

She says it’s not happening in the workplace so much because people are taking precautions. She says more people are becoming infected because of indoor family gatherings and social events as the weather cools.

She says that was a lesson learned in the South during the summer when people went indoors for air conditioning.

BOISE, Idaho — The number of Idaho residents collecting unemployment dropped for the 22nd consecutive week as the state’s reopened economy continues recovering, while at the same time coronavirus pandemic deaths hit 500.

The Idaho Department of Labor said Thursday that the number

Stephen Miller Tests Positive as White House Outbreak Grows

Here’s what you need to know:

Credit…Anna Moneymaker for The New York Times

On Tuesday evening, senior administration officials confirmed that Stephen Miller, Mr. Trump’s top speechwriter and a policy adviser, had tested positive for the coronavirus, joining a growing list of Mr. Trump’s close aides who have the virus.

“Over the last five days I have been working remotely and self-isolating, testing negative every day through yesterday,” Mr. Miller said in a statement. “Today, I tested positive for Covid-19 and am in quarantine.”

Mr. Miller is married to Katie Miller, Vice President Mike Pence’s communications director. A senior administration official said Ms. Miller, who contracted the virus this spring and returned to work in May, was tested Tuesday morning and was negative for any new infection.

On Tuesday, many White House offices were empty as officials stayed home to wait out the infectious period from an outbreak of the coronavirus within the building and among people who had been there.

President Trump was in the White House residence, convalescing, as a number of advisers and other officials stayed home, either because they had contracted the coronavirus or had been near people who did.

The White House communications and press shops were bereft of people. The White House press secretary, Kayleigh McEnany, announced on Monday that she had tested positive. Two other press office aides have also contracted the virus, and two more aides on Tuesday were said to have tested positive, people familiar with the results said.

The outbreak in the White House, which has extended to some lawmakers on Capitol Hill, has raised concerns in the city that surrounds it. Washington, D.C., which has managed to bring infection rates down in recent weeks through preventive laws and high rates of compliance, has almost no control over the federal government.

The city reported 105 new coronavirus cases on Tuesday, the highest number since June 3.

The gathering at the Rose Garden would have violated the city’s mandates limiting the size of gatherings and requiring masks. But because the White House is on federal property, it is exempt from such rules.

City officials said they would be closely monitoring infection trends for several days to see if the Capitol and White House cases affected the city’s overall infection rate.

Credit…Doug Mills/The New York Times

The White House physician, Dr. Sean P. Conley, said on Tuesday that President Trump was experiencing no symptoms of Covid-19 and doing “extremely well” on his first full day at home since a three-night stay in the hospital.

But outside doctors and medical experts in Covid-19 and lung disease said they were struggling to piece together an accurate picture of Mr. Trump’s health. Far from having vanquished Covid-19, the outside experts said, Mr. Trump is most

Nevada Halts Use of Rapid Coronavirus Tests in Nursing Homes, Citing Inaccuracies

Kristen Cardillo, BD’s vice president of global communication, said the company was aware of the situation in Nevada and was “conducting thorough investigations.” She added that “based on the information in the directive and the total tests performed, we believe the rate of reported false positives is well within what we would expect for the BD Veritor System.”

Representatives for the Department of Health and Human Services did not respond to requests for comment.

Concerns have also been raised about the ability of antigen tests to accurately pinpoint infections, especially if administered during a period when a person harbors low levels of the coronavirus. BD’s test is advertised as having a false negative rate of 16 percent. Quidel’s is just above 3 percent. The directive from Nevada’s department of health did not report whether the negative antigen test results from nursing homes — there were nearly 3,700 such results — had been confirmed by P.C.R.

In a call with LeadingAge members on Monday, Adm. Brett Giroir, who has been leading the nation’s testing efforts, said antigen tests were “clearly a lifesaving option,” and for many facilities the best test available, given the delays, expenses and shortages that had plagued P.C.R. tests.

“It is perfectly acceptable for congregate care, particularly nursing homes, to use an antigen test, even if they are, quote, off-label,” Dr. Giroir said in the interview. “Just because they don’t have an authorization doesn’t mean they’re not good for it.”

In response to questions about false positives, Dr. Giroir reminded LeadingAge members that in places where the coronavirus is scarce, false positives should be expected to outnumber true positives and do not necessarily invalidate the usefulness of a test. “That’s a function of the way life is,” Dr. Giroir said.

The halt to antigen testing in Nevada’s nursing homes comes just days after health experts criticized the White House, which is now in the midst of a coronavirus outbreak, for a misguided overreliance on rapid testing. For months, officials used two products made by Abbott Laboratories, the ID NOW and the BinaxNOW, to test people without symptoms — another off-label use — while eschewing masks and physical distancing. In September, the White House also began distributing millions of BinaxNOW tests to communities across the country, including nursing homes around the country.

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Problem at Roche warehouse raises fears over UK COVID tests

LONDON (AP) — Swiss pharmaceutical firm Roche said Wednesday that problems at a U.K. warehouse are delaying shipments of testing products to clinics and hospitals, triggering concerns that COVID-19 testing may be disrupted as infection rates rise around Britain.

Roche informed doctors about the problem at its U.K. distribution center in Sussex, southern England, in a letter that advised customers to “prioritize essential services only.”

Roche said the problem arose after it moved to a new automatic warehouse in September.

The company said that it was “prioritizing the dispatch of COVID-19 PCR and antibody tests and doing everything we can to ensure there is no impact on the supply of these” to the National Health Service.


The glitch affects materials needed to conduct blood tests and screening for diseases including diabetes and cancer. Roche said it could take two weeks to fix the problem.

British doctors have already raised concerns about the number of procedures, tests and screening programs that were put on hold as the health service focused on battling COVID-19 earlier this year.

While normal service has begun to resume, there is still a backlog, and long waiting lists for non-emergency operations.

Britain, which already has the highest virus death toll in Europe at over 42,500, is now facing a second surge in coronavirus cases. A total of 2,883 coronavirus patients were in U.K. hospitals on Tuesday, up from 2,291 a week earlier. A further 76 deaths of people with COVID-19 were recorded Tuesday, compared to 41 a week earlier.

Both figures are well below the peaks seen at the height of the U.K. outbreak in the spring.

Scotland is set to announce tightened social restrictions Wednesday in an attempt to slow the spread of the virus, and the British government is considering whether to follow suit.

___

Follow AP’s pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

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Marines may waive combat fitness tests for service members at risk for coronavirus – U.S.

Marines may waive combat fitness tests for service members at risk for coronavirus


Stars and Stripes is making stories on the coronavirus pandemic available free of charge. See other free reports here. Sign up for our daily coronavirus newsletter here. Please support our journalism with a subscription.


Marine Corps commanders may issue waivers for Marines, or even whole units, for semi-annual combat fitness tests if the testing sites cannot accommodate safety measures to protect against the coronavirus, a spokesman for III Marine Expeditionary Force on Okinawa said Monday.


The Corps is putting mitigating steps in place, such as screening Marines and taking their temperatures before the tests, disinfecting equipment and mandating face masks, said 1st Lt. Pawel Puczko by email to Stars and Stripes. He said Marines who are at a higher risk of contracting the coronavirus or share quarters with someone who is at a higher risk may apply for waivers.


In April, Marine Corps Commandant Gen. David Berger ordered a halt to all fitness testing due to the coronavirus. Last month, the Corps announced it will resume its physical fitness and combat fitness tests despite the ongoing pandemic.


Marines will have until the end of December to complete both tests, according to a Sept. 21 memo.


Individual waivers will be evaluated on a case-by-case basis, Puczko said.


“The health and safety of our Marines is always a top priority,” he said. “Commands across III MEF have demonstrated their dedication to keeping Marines and families safe from COVID-19 through diligent planning and implementation of safety protocols.”


The allowance for commanders to issue both combat fitness test and physical fitness test waivers will extend across the Marine Corps, according to a Marine administrative order.


COVID-19 is the respiratory disease caused by the coronavirus.


Social distancing may prove difficult during the combat fitness test, in which one event requires Marines to drag and carry each other to simulate maneuver under fire, according to the official Marine Corps website.


The Air Force in September postponed its physical fitness assessments until January 2021. Body composition measurements — waist, height and weight — are postponed until further notice, according to last month’s announcement.


All airmen will receive maximum points for the so-called “abdominal circumference” component as part of their official score, including those with exemptions to that waist measurement, the statement said.


“We know people are staying fit regardless, but we want to give our Airmen enough time to prepare,” Air Force Chief of Staff Gen. Charles Q. Brown Jr. said in the statement.


The Navy also postponed sailors’ physical fitness tests until further notice in an administrative message in July.


“Although the Navy PFA Cycle 2, 2020 has been excused, Sailors are reminded to make good choices for a healthy diet and are to continue a level of fitness to maintain Navy physical fitness standards,” the message said.


Thursday, the Army adopted its long-planned, six-event physical fitness

Marines may waive combat fitness tests for service members at risk for coronavirus – Pacific

Marines may waive combat fitness tests for service members at risk for coronavirus


Stars and Stripes is making stories on the coronavirus pandemic available free of charge. See other free reports here. Sign up for our daily coronavirus newsletter here. Please support our journalism with a subscription.


Marine Corps commanders may issue waivers for Marines, or even whole units, for semi-annual combat fitness tests if the testing sites cannot accommodate safety measures to protect against the coronavirus, a spokesman for III Marine Expeditionary Force on Okinawa said Monday.


The Corps is putting mitigating steps in place, such as screening Marines and taking their temperatures before the tests, disinfecting equipment and mandating face masks, said 1st Lt. Pawel Puczko by email to Stars and Stripes. He said Marines who are at a higher risk of contracting the coronavirus or share quarters with someone who is at a higher risk may apply for waivers.


In April, Marine Corps Commandant Gen. David Berger ordered a halt to all fitness testing due to the coronavirus. Last month, the Corps announced it will resume its physical fitness and combat fitness tests despite the ongoing pandemic.


Marines will have until the end of December to complete both tests, according to a Sept. 21 memo.


Individual waivers will be evaluated on a case-by-case basis, Puckzo said.


“The health and safety of our Marines is always a top priority,” he said. “Commands across III MEF have demonstrated their dedication to keeping Marines and families safe from COVID-19 through diligent planning and implementation of safety protocols.”


The allowance for commanders to issue both combat fitness test and physical fitness test waivers will extend across the Marine Corps, according to a Marine administrative order.


COVID-19 is the respiratory disease caused by the coronavirus.


Social distancing may prove difficult during the combat fitness test, in which one event requires Marines to drag and carry each other to simulate maneuver under fire, according to the official Marine Corps website.


The Air Force in September postponed its physical fitness assessments until January 2021. Body composition measurements — waist, height and weight — are postponed until further notice, according to last month’s announcement.


All airmen will receive maximum points for the so-called “abdominal circumference” component as part of their official score, including those with exemptions to that waist measurement, the statement said.


“We know people are staying fit regardless, but we want to give our Airmen enough time to prepare,” Air Force Chief of Staff Gen. Charles Q. Brown Jr. said in the statement.


The Navy also postponed sailors’ physical fitness tests until further notice in an administrative message in July.


“Although the Navy PFA Cycle 2, 2020 has been excused, Sailors are reminded to make good choices for a healthy diet and are to continue a level of fitness to maintain Navy physical fitness standards,” the message said.


Thursday, the Army adopted its long-planned, six-event physical fitness