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Cue Health awarded $481 million to scale up production of COVID-19 test: HHS

(Reuters) – The U.S. government has awarded diagnostic testing company Cue Health Inc $481 million to scale up the production of rapid COVID-19 molecular test, the Department of Health and Human Services said on Tuesday.

The company will raise the domestic production of COVID-19 test kits to 100,000 per day by March 2021 under the deal and deliver 6 million tests and 30,000 instruments to the government to support its response to the pandemic, the health agency said.

The point-of-care test can detect the novel coronavirus in about 20 minutes with nasal swab samples collected using a Sample Wand from the lower part of the nose, the HHS said.

The system also allows results to be sent to a mobile phone via an app.

The company’s test kit was approved by the U.S. Food and Drug Administration (FDA) in June for emergency use in patient care settings under the supervision of qualified medical personnel.

The development of the company’s health platform was supported by funding from the Biomedical Advanced Research and Development Authority (BARDA) for a molecular influenza test, starting in 2018, the department said.

BARDA later expanded the collaboration with the company to include the development of Cue’s COVID-19 test, it added.

(Reporting By Mrinalika Roy and Vishwadha Chander in Bengaluru; Editing by Anil D’Silva)

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Trump campaign manager returns to office 10 days after positive COVID-19 test

President TrumpDonald John TrumpDes Moines mayor says he’s worried about coronavirus spread at Trump rally Judiciary Committee Democrats pen second letter to DOJ over Barrett disclosures: ‘raises more questions that it answers’ Trump asks campaign to schedule daily events for him until election: report MORE‘s campaign manager Bill StepienBill StepienTrump Jr. returning to campaign trail after quarantining The Memo: Trump searches for path to comeback Bob Dole claims no Republicans on debate commission support Trump MORE resumed working at the campaign’s Virginia headquarters on Monday, 10 days after he tested positive for COVID-19.

Stepien told reporters on a conference call that he was back in the office after his recent positive test, “in full accordance with” Centers for Disease Control and Prevention (CDC) guidelines.

The CDC guidelines say adults with mild to moderate COVID-19 cases can be around others 10 days after the onset of symptoms so long as they have gone 24 hours without a fever and other symptoms are improving. Severe cases require longer isolation periods. Public health experts have also encouraged individuals to obtain two negative tests before resuming regular activities.

Stepien, 42, tested positive on Oct. 2 and dealt with mild flu-like symptoms, the campaign said at the time. He went into quarantine and worked from home until Monday.

Stepien did not say on Monday’s call whether he had tested negative for the virus but cited being beyond the 10 day window from the onset of symptoms for his decision to return to the office.

“We take a lot of precautions here at the headquarters every single day,” Stepien said, pointing to signage about health protocols and noting that the campaign has a nurse on staff to ensure everyone is healthy.

Stepien’s decision to resume working in-person reflects the broader attitude of the president and his team toward the virus, which has killed more than 210,000 people in the U.S. and infected nearly 8 million.

Trump, who revealed that he had tested positive for the coronavirus on Oct. 2, is set to resume campaign rallies on Monday night in Florida despite the White House refusing to say when he last tested negative, and some top White House officials, such as chief of staff Mark MeadowsMark Randall MeadowsAdministration officials call on Congress to immediately pass bill to spend unused PPP funds Trump claims he is ‘immune’ from coronavirus, defends federal response Senate Republicans rip new White House coronavirus proposal MORE, have continued to work from the building despite being in close contact with the president, press secretary Kayleigh McEnany and others who have tested positive. 

The president’s physician said late Saturday that Trump is no longer a risk to spread the virus but stopped short of saying he had tested negative.

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Abbott Wins U.S. Emergency Use Authorization for New COVID-19 Antibody Test | Top News

(Reuters) – Abbott Laboratories said on Monday the U.S. Food and Drug Administration has issued an emergency use authorization for its lab-based COVID-19 antibody blood test.

The test, AdviseDx, can be used to identify a type of antibody called Immunoglobulin M (IgM) in blood samples to determine if someone has been exposure to the novel coronavirus, potentially indicating a recent or prior infection.

Abbott has already received emergency use authorization for seven tests, including molecular tests, a rapid antigen test and another test which can detect a type of antibody called IgG.

The FDA’s emergency use authorization allows the use of unapproved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases with no adequate or approved alternatives.

IgG is longer lasting in the body after an infection, but IgM is more useful for determining a recent exposure to the coronavirus as these antibodies become undetectable weeks to months following an infection, Abbott said http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20201012:nPn8KFxtXa.

Unlike molecular tests, which can detect whether someone has the coronavirus, antibody tests determine if someone has had a previous infection by detecting disease-fighting proteins called antibodies.

However, antibody tests are not recommended as the sole basis of diagnosis of COVID-19 as these antibodies may not be detected in the early days of the infection.

Shares of Abbott were up 0.5% at $110.21 in early trading.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Amy Caren Daniel)

Copyright 2020 Thomson Reuters.

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Zambia gave Kenya real test but ‘we passed despite our fitness level’

Harambee Stars coach Francis Kimanzi has admitted he was worried about the fitness levels of his charges heading into the friendly against Zambia, which they won 2-1.

Cliff Nyakeya’s strike and an own goal by Tandi Mwape handed Francis Kimanzi’s side the victory while a late goal by Emmanuel Chabula denied the East Africans a home clean sheet at the newly refurbished Nyayo Stadium.

“It’s a great game for us,” Kimanzi is quoted by Standard Sports. “I’m more than delighted for the result because I didn’t get enough time to prepare the players and I was even forced to use players with low fitness levels.

“I knew we would struggle in the last twenty minutes or so and that actually happened with a few players looking exhausted; this because of the situation we have gone through.

“But the important thing is that we’ve gotten the win against a very tough Zambian team. I think this victory has given us a good platform for the upcoming Afcon qualifiers against Comoros. If we had a bad game, it would have burdened us but since we struggled and got the result, it will motivate us.”

Kenya were due to play another friendly against Sudan on Tuesday but it will not take place after the Football Kenya Federation (FKF) president Nick Mwendwa confirmed to Goal that Sudan was not ready to travel to Kenya.

“We had planned to play two matches against Zambia and Sudan but because of many issues, Sudan have said they will not be able to play against us,” Mwendwa told Goal on Sunday. “They have given us many issues as to why they cannot come for the friendly and we accept their decision.

“The team will now break camp after the win against Zambia.”

Asked on his assessment of the team after the 2-1 win against the Chipolopolo, Mwendwa said: “It was a scrappy win but for me, a win is a win, we fought hard to get the win and finally got it.

“We had a squad of players who have not been active for the last six months owing to Covid-19 and getting a win against a big giant like Zambia is no mean achievement, I want to thank the players and the technical bench for a good job.”

Against Zambia, Kenya took the lead in the 21st minute when Tandi accidentally redirected Nyakeya’s cross from the right channel into his own net following a clever pass from Kenneth Muguna and 14 minutes later, Nyakeya powered home the second from another Muguna cross.

Second-half substitute Emmanuel Chabula pulled a goal back for the former African champions and there was drama in the dying minutes of the match when Zambia thought they had scored the leveller but it was disallowed.

Kenya used the friendly to gauge their fitness as they have an Africa Cup of Nations double-header coming up in November against Comoros.

Kenya started their campaign for the 2021 Afcon, with an impressive 1-1 draw away to 

China to test city of 9 million amid new cases

BEIJIJNG — China’s government says all 9 million people in the eastern city of Qingdao will be tested for the coronavirus this week after nine cases linked to a hospital were found.

The announcement Monday broke a string of weeks without any locally transmitted infections reported in China.

The National Health Commission said authorities were investigating the source of the infections found in eight patients at Qingdao’s Municipal Chest Hospital and one family member. The commission said the whole city will be tested within five days.

China, where the pandemic began in December, has reported 4,634 deaths and 85,578 cases, plus nine suspected cases that have yet to be confirmed.


The last reported virus transmissions within China were four patients found on Aug. 15 in the northwestern city of Urumqi in the far western Xinjiang region. All the cases reported since then were in travelers from outside the mainland.

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

— Supreme Court nominee Barrett faces Senate despite virus

— Trump insists he’s free of virus, ready for campaign trail

— COVID-19 coverage safety net has plenty of holes in U.S.

— DC charters lead the way on in-school teaching experiment

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

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HERE’S WHAT ELSE IS HAPPENING:

NEW DELHI — India has reported 66,732 new coronavirus cases, driving the country’s overall tally to more than 7.1 million.

The Health Ministry on Monday also reported 816 deaths in the past 24 hours, taking total fatalities to 109,150.

India is second in the world in number of infections, behind only the U.S., which has reported more than 7.7 million cases.

Maharashtra in the south continues to be the worst-hit Indian state, with over 1.5 million cases. Andhra Pradesh, Karnataka, Tamil Nadu and Uttar Pradesh are the next four worst-hit states, followed by the Indian capital, New Delhi, according to the Health Ministry.

India has seen the spread of the virus slow down since mid-September, when daily infections touched a record high of 97,894 cases. It’s averaging more than 70,000 cases daily so far this month.

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JAKARTA, Indonesia — Authorities in Indonesia’s capital have moved to ease coronavirus restrictions despite a surge in cases nationwide.

Jakarta previously imposed large-scale social restrictions from April to June, then eased them gradually. The city reimposed strict restrictions last month as the virus spread significantly and overwhelmed its health system.

Jakarta Gov. Anies Baswedan said Sunday that his administration decided to ease restrictions beginning Monday as the increase in infections had stabilized.

He said people can return to offices with limits on employee numbers, while transport services will run at half capacity. Cinemas, gyms and tourism sites can reopen at a maximum 25% of capacity.

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SEOUL, South Korea — South Korea has confirmed 97 new cases of the coronavirus, a modest uptick from the daily levels reported last week, just as officials ease social distancing restrictions after concluding that transmissions have slowed following a resurgence

China to test 9 million after fresh outbreak

BEIJING (AP) — Chinese health authorities will test all 9 million people in the eastern city of Qingdao for the coronavirus this week after nine cases linked to a hospital were found, the government announced Monday.

The announcement broke a two-month streak with no virus transmissions within China reported, though China has a practice of not reporting asymptomatic cases. The ruling Communist Party has lifted most curbs on travel and business but still monitors travelers and visitors to public buildings for signs of infection.

Authorities were investigating the source of the infections found in eight patients at Qingdao’s Municipal Chest Hospital and one family member, the National Health Commission said.


“The whole city will be tested within five days,” the NHC said on its social media account.

China, where the pandemic began in December, has reported 4,634 deaths and 85,578 cases, plus nine suspected cases that have yet to be confirmed.

The last reported virus transmissions within China were four patients found on Aug. 15 in the northwestern city of Urumqi in the Xinjiang region. All the cases reported since then were in travelers from outside the mainland.

The ruling party lifted measures in April that cut off most access to cities with a total of some 60 million people including Wuhan in central China.

Qingdao is a busy port and headquarters for companies including Haier, a major appliance maker, and the Tsingtao brewery. The government gave no indication whether the latest cases had contact with travel or trade.

Travelers arriving from abroad in China still are required to under a 14-day quarantine.

In other developments in the Asia-Pacific region:

— India has reported 66,732 new coronavirus cases in the past 24 hours, driving the country’s overall tally to 7.1 million. The Health Ministry on Monday also reported 816 deaths in the past 24 hours, taking total fatalities to 109,150. India is seeing fewer new daily cases of the virus since mid-September when the daily infections touched a record high of 97,894 cases. It’s averaging more than 70,000 cases daily so far this month. Health experts have warned that congregations during major festivals later this month and in November have the potential for the virus to spread. They also caution that coming winter months are expected to aggravate respiratory ailments.

— Authorities in Indonesia’s capital have moved to ease strict social restrictions despite a steady increase in cases nationwide. Jakarta previously imposed large-scale social restrictions from April to June, then eased them gradually. The city brought back strict restrictions last month as the virus spread. Jakarta Gov. Anies Baswedan said his administration decided to ease restrictions from Monday as the increase in infections had stabilized. The move came days after President Joko Widodo urged local administrations to refrain from imposing lockdown measures that could cause crippling economic damage in the Southeast Asia’s largest economy.

— South Korea has confirmed 97 new cases of the coronavirus, a modest uptick from the daily levels reported last week. The increase comes as officials

Qingdao to test nine million for coronavirus in five days

The Chinese city of Qingdao is testing its entire population of nine million people for Covid-19 over a period of five days.

The mass testing comes after a dozen cases were found linked back to a hospital treating coronavirus patients arriving from overseas.

In May, China tested the entire city of Wuhan – home to 11 million people and the epicentre of the global pandemic.

The country has largely brought the virus under control.

That’s in stark contrast to other parts of the world where there are still high case numbers and lockdown restrictions of varying severity.

In a statement posted to Chinese social media site Weibo, Qingdao’s Municipal’s Health Commission said six new cases and six asymptomatic cases had been discovered.

All the cases were linked to the same hospital, said the Global Times.

The Chinese authorities now have a strategy of mass testing even when a new coronavirus cluster appears to be relatively minor, correspondents said.

City-wide testing

The commission added that a citywide testing program had been launched, with five districts to be tested within three days – with the whole city to be tested within five days.

Some 114,862 people – including medical staff and newly hospitalised patients in the city’s hospitals – have already tested negative for the coronavirus, it said.

Videos circulating online showed local residents lining up late on Sunday to get tested, said the Global Times, adding that some of these test points were open from 07:00 to 23:00.

The new cases come a week after China’s Golden Week holiday – which saw millions travel across the country.

A Global Times report quoting the Qingdao Municipal Bureau of Culture and Tourism said the city received 4.47 million passenger trips over this period.

The nearby city of Jinan, which is also in the same province as Qingdao, called for anyone who has visited the city since 23 September to get tested for the virus, according to a report by The Paper.

Earlier last month, Qingdao announced that two port workers in the city who handled imported seafood tested positive for the virus. However, they were not known to have infected anyone else.

Daily coronavirus infections have fallen drastically in China, and for the most part the country appears to have recovered from the worst of the virus.

China currently has 85,578 virus cases and the death toll stands at 4,634.

Earlier this year, China completed a mass testing programme in Wuhan saying 11 million people had been tested in 10 days.

However, the BBC’s Reality Check later estimated that the figure was closer to 9 million over 10 days – still a significant number of people.

Hundreds of testing centres were opened, with thousands of testing staff involved.

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Why don’t you need a negative coronavirus test to leave isolation?

President Donald Trump’s doctor on Saturday said Trump has met criteria from the US Centers for Disease Control and Prevention to leave isolation after falling sick with the coronavirus.



a man wearing a suit and tie: US President Donald Trump walks to Marine One prior to departure from the South Lawn of the White House in Washington, DC, October 2, 2020, as he heads to Walter Reed Military Medical Center, after testing positive for Covid-19. - President Donald Trump will spend the coming days in a military hospital just outside Washington to undergo treatment for the coronavirus, but will continue to work, the White House said Friday (Photo by SAUL LOEB / AFP) (Photo by SAUL LOEB/AFP via Getty Images)


© Saul Loeb/AFP/Getty Images
US President Donald Trump walks to Marine One prior to departure from the South Lawn of the White House in Washington, DC, October 2, 2020, as he heads to Walter Reed Military Medical Center, after testing positive for Covid-19. – President Donald Trump will spend the coming days in a military hospital just outside Washington to undergo treatment for the coronavirus, but will continue to work, the White House said Friday (Photo by SAUL LOEB / AFP) (Photo by SAUL LOEB/AFP via Getty Images)

The White House didn’t say Trump had actually tested negative for the virus — but according to CDC guidelines, people don’t generally need a negative test to be around people again.

Here’s why:

People can test positive even if no longer infectious

Earlier in the pandemic, health officials said people should have two negative tests for coronavirus — taken 24 hours apart — before being around people again. That forced some people into isolation for weeks on end.

But coronavirus tests can’t necessarily determine whether someone is infectious. PCR tests, for example, just look for pieces of genetic material called RNA — and that can linger long after someone has recovered.

According to the CDC, research has shown that people aren’t likely to be infectious 10 to 20 days after symptoms first began, regardless of test results.

To figure that out, scientists have taken samples from coronavirus patients and tried to infect living cells. Even though PCR tests can come back positive, people don’t tend to be infectious after that 10- to 20-day window has passed.

Think of it this way: A PCR test is looking for the blueprint of the virus — its “genome” — and not for the virus itself. In fact, the test is just looking for fragments of that blueprint.

It’s like a recipe for chocolate cake; finding the recipe in someone’s kitchen doesn’t mean you’ll find a cake.

Why might Trump not need to isolate for 20 days?

People with mild to moderate Covid-19 are thought to remain infectious “no longer than 10 days after symptom onset,” according to the CDC.

For patients with severe Covid-19, the CDC says up to 20 days of isolation “may be warranted.” But the agency’s recommendations only require 10 days. “Consider consultation with infection control experts,” the CDC’s recommendations say.

The President’s physician, Dr. Sean Conley, released a memo Saturday that referenced “advanced diagnostic tests” and stated “there is no longer evidence of actively replicating virus” from Trump.

Still, the letter didn’t fully describe those advanced diagnostic tests or their exact findings.

The President’s doctor said Trump had undetectable “subgenomic mRNA.” Those are molecules produced when viruses replicate. Their absence may suggest Trump is no longer shedding live virus.

But Conley did not detail what “advanced diagnostic tests” the President had

A woman finished the Bar exam after having her baby between sections of the test

Brianna Hill, a recent graduate of the Loyola University School of Law in Chicago, knew she would be pregnant during her bar exam, but she wasn’t expecting a huge curveball in timing due to the Covid-19 pandemic.

“I thought I would only be 28 weeks pregnant when I took the bar,” Hill told CNN. “However, due to the pandemic, the test was pushed to October and I was going to be 38 weeks. I joked about taking the test from my hospital bed. Lesson learned!”

The remote version of the test is four 90-minute sections spread out over two days. Hill said the exam is proctored so you have to sit in front of the computer the entire time to make sure you aren’t cheating.

“I thought I felt something about 30 minutes into the test and actually thought, ‘I really hope my water didn’t just break,'” Hill said. “But I couldn’t go check and so I finished the first section. As soon as I stood up when I finished, I knew my water had broken.”

But even the realization of going into labor didn’t stop Hill from accomplishing her goal.

“I took my break, got myself cleaned up, called my husband, midwife, and mom, cried because I was a little panicked, then sat down to take the second part because my midwife told me I had time before I needed to go to the hospital.”

Hill said she got to the hospital around 5:30 p.m. and her new baby boy arrived just after 10 p.m.

“The whole time my husband and I were talking about how we wanted me to finish the test and my midwife and nurses were so on board. There just wasn’t another option in my mind,” Hill said.

So, the next day, hospital staff provided Hill with an empty room to finish the test and put a “Do Not Disturb” sign on the door. Hill took the rest of the exam in that room and even nursed her baby during breaks.

“I’m so thankful for the support system I had around me. The midwives and nurses were so invested in helping me not only become a mom but also a lawyer,” Hill said.

“My husband and law school friends provided me with so much encouragement so I could push through the finish line even under less than ideal circumstances. And my family, especially my sister, just kept reminding me how I could do it even when I wasn’t so sure myself.”

Hill hasn’t received her bar exam results, but she already has a job lined up.

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UW Medicine, Fred Hutch test experimental antibody treatment used on Trump for COVID-19

Regeneron Pharmaceuticals’ cocktail of two monoclonal antibodies was used to treat President Donald Trump for COVID-19.

SEATTLE — Researchers at UW Medicine are partnering with the Fred Hutch Cancer Research Center to lead a study of Regeneron Pharmaceuticals’ antibody cocktail as a way to prevent COVID-19 infections. 

The researchers are currently recruiting patients for the study. 

The same experimental Regeneron Pharmaceuticals cocktail of two monoclonal antibodies was used to lower the level of the COViD-19 virus in President Donald Trump after he became infected.

“It’s the same antibody cocktail, that can be used for both prevention and treatment,” said Dr. Ruanne Barnabas, co-principal investigator and associate professor of Global Health and Allergy and Infectious Diseases at University of Washington School of Medicine. “But trials for both prevention and treatment are ongoing.”

The trial, which also includes 100 additional sites and plans to recruit 2,000 patients, is focused on helping people stay healthy after a close member in their own household becomes sick with COVID-19. The antibody cocktail is called REGN-COV2.

If that’s the case, why not use this antibody in lieu of vaccines, a number of which are in the final trial phases? 

Dr. Barnabas said, “These antibodies last for a short time, for a number of weeks. But a vaccine will teach our bodies to make these antibodies that will last for years. That’s the plan.”

The presumption is someone given the cocktail would have enough antibodies immediately to last long enough to get through their housemates infection.

“Monoclonal antibodies could help us achieve and end to the pandemic,” said Dr. Shelly Karuna with Fred Hutch in a statement. 

People wanting to participate in the study must have a confirmed household member test positive for COVID-19 to qualify. To learn more about getting involved call (206) 773-7129 or visit the UW Medicine website. 

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