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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Abbott wins U.S. emergency use authorization for new COVID-19 antibody test

(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)

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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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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 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 – and 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 had 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 had 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 had 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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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 Hutchinson 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 on 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 an 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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Study: New bedside test means faster diagnosis, treatment of COVID-19

Oct. 8 (UPI) — A rapid, bedside test for COVID-19 delivers results in less than two hours, meaning that appropriate treatment can be initiated earlier for those already hospitalized because of their symptoms, according to a study published Thursday by The Lancet Respiratory Medicine.

The standard COVID-19 test uses polymerase chain reaction, or PCR, technology, which amplifies small samples of DNA in order to identify the presence of virus in samples taken from an infected person’s nose or throat.

The PCR test requires samples to be sent to a centralized lab within the hospital for processing, typically takes more than 20 hours to produce results, the researchers said.

The enhanced speed of the bedside, or “point-of-care” tests, also means patients infected with the new coronavirus can be isolated earlier, reducing the risk for transmission to other patients and healthcare workers.

“Our findings are the first to suggest the clinical benefits of molecular point-of-care COVID-19 testing in hospitals, demonstrating reduced delays, bed moves and time in assessment areas, which all lead to better infection control,” study co-author Dr. Tristan William Clark, of Southampton General Hospital in England, said in a statement.

“We believe that [these] molecular [tests] should be urgently integrated … to reduce coronavirus transmission within hospitals to prevent the next wave of the pandemic overwhelming health services around the world,” Clark said.

Since the start of the global pandemic in March, healthcare systems worldwide have relied on PCR testing of patient samples in centralized hospital laboratories, an approach that is accurate, but also lengthy and resource intensive, according to Clark and his colleagues.

The longer time it takes to generate results with PCR testing means that patients often wait in mixed assessment rooms to be admitted to the correct COVID-19 or non-COVID ward, increasing the possibility of transmission, the researchers said.

However, with point-of-care tests, nasal and throat swab samples are collected and placed into small cartridges for analysis. Unlike PCR tests, which require specially trained lab personnel, the bedside tests can be performed by healthcare workers in the emergency room or other assessment area, they said.

For this study, Clark and his colleagues evaluated the QIA-stat-Dx point-of-care testing platform, manufactured by Dutch firm Qiagen, in 1,054 adults with COVID-19 symptoms being assessed in the acute medical unit and emergency department of Southampton General Hospital between March 20 and April 29.

Nose and throat swabs were taken from all patients and tested for COVID-19 infection, with 499 patients evaluated using the QIA-stat-Dx, while the rest were assessed using only PCR testing. All test results were confirmed using the standard PCR approach as well, the researchers said.

Among those tested with QIA-stat-Dx, 197, or 39%, were found to be positive for COVID-19, while 155, or 28%, of those evaluated by only PCR were positive for the virus, the data showed.

The point-of-care test produced results in roughly 1.7 hours on average, while PCR evaluation took approximately 21.3 hours per patient, according to the researchers.

After testing, patients were transferred to

India declines proposal to test Sputnik-V COVID-19 vaccine in large study

(Reuters) – India’s drug regulator has knocked back a proposal from Dr Reddy’s Laboratories Ltd <REDY.NS> to conduct a large study in the country to evaluate Russia’s Sputnik-V COVID-19 vaccine and has asked it to first test the vaccine in a smaller trial.

The recommendations by an expert panel of the Central Drugs Standard Control Organisation (CDSCO) noted that safety and immunogenicity data from early-stage studies being conducted overseas is small, with no inputs available on Indian participants.

India’s move comes as a setback for Russia’s plan to roll-out the vaccine even before full trials show how well it works, while pushing back its efforts to win approval for the vaccine in the country that leads the world on average number of new infections.

India is expected to overtake the United States over the next several weeks as the country with the world’s largest number of cases.

The Russian Direct Investment Fund (RDIF), which is marketing the Sputnik V, and Dr. Reddy’s Laboratories last month announced their partnership to run clinical trials and distribute the vaccine in India.

Russia was the first country to grant regulatory approval for a novel coronavirus vaccine, and did so before large-scale trials were complete, stirring concerns among scientists and doctors about the safety and efficacy of the shot.

RDIF and Dr. Reddy’s did not immediately reply to Reuters’ requests for comment outside business hours.

(Reporting by Manojna Maddipatla in Bengaluru; editing by Ankur Banerjee and Anil D’Silva)

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