French labs show how global supply bottlenecks thwart effort to ramp up testing

By Richard Lough

PARIS (Reuters) – Mass testing was meant to be the answer to the second wave. Politicians promised that with enough tests, conducted quickly enough, they could keep the coronavirus in check, without having to resort to lockdowns that crippled economies six months ago.

But so far, with a surge sweeping Europe just as students return to school and university, it hasn’t quite worked out that way. There aren’t enough tests, and they are taking too long.

Pierre-Adrien Bihl, who runs four labs that together conduct 800 tests a day in eastern France, has one explanation for what has gone wrong: a global supply chain that can’t keep up.

“I spend my days checking orders have been made and received and hassling my supplier to deliver, deliver, deliver,” he said. “But all their clients demand the same thing.”

French President Emmanuel Macron, like other European leaders, has pressed for a swift increase in tests. His government promises that anyone who needs a test can get one.

But five companies that operate laboratories in Paris and eastern France told Reuters there was simply no way they could work any faster, as long as they are struggling to obtain chemicals and test kits that are mainly produced abroad.

This week, Bihl said, he had to take his diagnostic machine offline for nearly 24 hours, after a four-day delay in the delivery of some single-use parts.

The shutdown forced Bihl to reduce testing appointments until the backlog could be made up, he said, adding that such shutdowns were taking place three or four times a month.

Arthur Clement, who runs four laboratories, said the U.S. manufacturer of his diagnostic machine, Cepheid, was sending him just 300 test kits per month at the end of the summer, as cases surged.

With his labs performing 25,000 tests per month, Clement had to send nearly all of them out to a third party, where they were taking up to 7-10 days to get results. Cepheid did not respond to a request for comment.

Clement ordered a new diagnostic machine from a South Korean manufacturer two months ago, which finally arrived last Friday, and now he says he can perform all tests in-house and deliver results in a day.

GLOBAL MARKET

In Paris, queues snake out of testing centers each day, with lines forming before sunrise at some. People with COVID symptoms are waiting on average three days for their results, according to official data, though for some the wait can be double.

France is now conducting more than 1.2 million polymerase chain reaction (PCR) tests per week in response to the epidemic, which has killed more than 31,000 people in the country and infected nearly half a million.

The French health ministry denies that there is a nationwide shortage of chemicals. It says there have been localized shortages in some parts of the country, but the overall supply is adequate. Health Minister Olivier Veran has said France has access to supplies of reagents equivalent to double the actual demand for tests.

But laboratories can’t just order chemicals from anywhere: testing machines typically require proprietary chemical kits and tools, some of which can be obtained only from the manufacturer.

The ministry recommends laboratories diversify their suppliers of testing machines, to mitigate the risk of one supply chain becoming blocked. But that means buying extra machines to duplicate capacity, which costs more money and can take months.

Suppliers of the machines to French labs include Cepheid and Becton Dickinson in the United States, Switzerland’s Roche, and France’s Biomerieux and Eurobio Scientific.

Cepheid, Roche and Eurobio Scientific did not respond to requests for comment on the supply of COVID equipment and reagents.

Becton Dickinson told Reuters in an email it was delivering more than 1 million tests per month globally. It acknowledged that this has fallen short of demand, but said it aims to scale up to 1.9 million per month by late 2020.

Biomerieux said its sites in France had spare capacity.

Lionel Barrand, one of the five laboratory operators who spoke to Reuters, said the supply-chain crunch was partly rooted in France’s reliance on imported reagents. He estimated 90% of COVID-19 reagents used in France were sourced overseas.

“We depend heavily on the global market,” said Barrand, who heads a laboratory industry group, the Syndicat National des Jeunes Biologistes.

Some of the French laboratories worry that U.S. suppliers such as Cepheid and Becton Dickinson are prioritizing labs in the United States, where healthcare costs are higher and profit margins bigger.

Becton Dickinson said it allocates test kits using quotas, which are set on the basis of the number of its testing machines in a country and the severity of outbreaks.

“We do not use pricing, margins or profit as a factor in our allocations,” the company said.

(Reporting by Richard Lough; Additional reporting by Matthias Blamont; Editing by Peter Graff)

Royal Caribbean, Norwegian Cruise submit health protocols to CDC looking to set sail again

By Nivedita Balu and Helen Coster

(Reuters) – Hoping to set sail again after a long halt due to the COVID-19 pandemic, Royal Caribbean Group and Norwegian Cruise Line Holdings Ltd. said on Monday they submitted a report to the U.S. Centers for Disease Control and Prevention (CDC) detailing health and safety protocols.

The cruise operators detailed 74 steps, including enhanced sanitation practices, controlling shore excursions and better protection for crew members, to protect guests once cruises resume.

Recommendations also include rigorous screening and testing before boarding and plans to address positive infection on board, the companies said.

In an interview with Reuters on Monday, which included the two cruise line chief executives and other members of a panel that developed the guidelines, Norwegian Chief Executive Frank Del Rio said he did not know how much Norwegian would need to pay to implement the panel’s recommendations.

“Put it in context, this is a drop in the bucket,” Del Rio said. “Whatever the number is, and I truly don’t know what it is and I don’t think [Royal Caribbean CEO] Richard [Fain] does either. We are at a zero revenue environment. This is a necessary step to return to service and we’re not really concerned about what the costs are.”

In July, the two companies announced a joint task force to help develop safety standards for restarting their businesses during the coronavirus pandemic.

The cruise industry has taken a major hit from the pandemic, with some of the earliest large clusters of COVID-19 occurring aboard cruise ships.

The CDC first issued a no-sail order on March 14 for all cruise ships and has been extending it since.

Cruise operators have lost about half to two-thirds of their value so far this year. Their shares were last down between 4% and 6% as worries of a second lockdown amid rising coronavirus cases shook broader markets.

(Reporting by Helen Coster in New York and Nivedita Balu in Bengaluru; Editing by Vinay Dwivedi and Dan Grebler)

U.S. NIH awards nine companies $129 million to scale up COVID-19 testing

(Reuters) – The National Institutes of Health is awarding $129.3 million to nine companies to support scaling-up coronavirus testing and manufacturing new testing technologies, the U.S. health agency said on Wednesday.

The funding is part of NIH’s Rapid Acceleration of Diagnostics (RADx) initiative that was launched in April to speed up innovation in the development, commercialization, and implementation of technologies for COVID-19 testing.

NIH said three of the selected companies, MatMaCorp, Maxim Biomedical Inc and MicroGEM International, offer point-of-care tests that produce immediate results.

The remaining six – Aegis Sciences, Broad Institute, Ceres Nanoscience Inc, Illumina Inc, PathGroup and Sonic Healthcare – offer lab-based tests.

The funding will help significantly expand national testing in September, with the laboratories managing collection, analysis and reporting of tens of thousands of tests a day, the agency said in a statement.

In July, NIH made a similar contribution of $248.7 million to seven companies.

“Diagnostic testing is a critical component of the nation’s strategy to meet the challenge of the COVID-19 pandemic,” said NIH Director Francis Collins.

(Reporting by Vishwadha Chander in Bengaluru; Editing by Shinjini Ganguli)

J&J to start mid-stage coronavirus vaccine trials in three European countries

By Nathan Allen

MADRID (Reuters) – Johnson & Johnson’s Janssen unit will begin mid-stage trials for its coronavirus vaccine in Spain, the Netherlands and Germany next week, Spain’s health minister said on Friday, as the U.S. drugmaker expands testing for its experimental shot.

The Phase II trial will last two months and include 550 participants across the three countries, including 190 people in Spain, Salvador Illa told a news conference in Madrid.

“It’s a vote of confidence in our health system,” Illa said, adding it was the first human trial for a coronavirus vaccine to be approved in Spain.

The study will focus on healthy people between the ages of 18 and 55 as well as people over 65.

Johnson & Johnson said the study will evaluate the safety and the ability to induce an immune response from single dose and two-dose regimens of the vaccine candidate, the company said in a statement.

Spain, which has western Europe’s highest tally of coronavirus cases, is also working with AstraZeneca via the European Union’s vaccine procurement program to secure sufficient doses.

J&J’s website says if the latest trials are successful, it will begin final Phase III studies, in which even more volunteers will receive the experimental vaccine.

More than 150 potential vaccines are being developed and tested globally to combat the COVID-19 pandemic, with 30 in human trials.

There is so far no approved vaccine, except one authorized in Russia before large-scale trials.

J&J is carrying out tests in the United States and Belgium, and this week added Chile, Argentina and Peru to the list of Latin American nations where it plans to conduct Phase III trials on 60,000 volunteers, in a study that will also cover Brazil, Colombia and Mexico.

The company’s potential vaccine uses “viral vectors” to generate immune responses, similar to the approach taken by the University of Oxford and AstraZeneca in their experimental vaccine, as well as China’s CanSino.

(Reporting by Nathan Allen and Jose Elías Rodríguez; editing by Mark Potter and Jason Neely)

What you need to know about the coronavirus right now

(Reuters) – Here’s what you need to know about the coronavirus right now:

Pelosi wants COVID-19 deal ‘now’

U.S. House of Representatives Speaker Nancy Pelosi said that Democrats in Congress are willing to cut their coronavirus relief bill in half to get an agreement on new legislation.

“We have to try to come to that agreement now,” Pelosi said in an online interview with Politico. “We’re willing to cut our bill in half to meet the needs right now.”

A senior House Democratic aide said Pelosi was reiterating a standing call by Democrats for the White House and Republicans to meet them “half way” on coronavirus relief.

The Democratic-led House passed legislation with more than $3 trillion in relief in May. Democrats offered this month to reduce that sum by $1 trillion, but the White House rejected it.

Mass testing in UK

Britain plans to bring in regular, population-wide testing for the novel coronavirus so it can suppress its spread and limit restrictions that have crippled one of the worst-hit countries in the world.

Health Secretary Matt Hancock said the government was carrying out trials of a range of new, faster tests that can give instant results and hoped to roll them out towards the end of the year.

Prime Minister Boris Johnson’s government has been heavily criticized for its handling of the pandemic, with critics saying it was too slow to go into lockdown and too slow to roll out testing to know how far the virus had spread.

Church outbreaks spread in South Korea

South Korea reported its highest daily rise in novel coronavirus cases since early March as outbreaks from churches around the capital spread, prompting a warning of a nationwide wave of infections.

The 297 new infections mark the sixth straight day of triple-digit increases in a country that has managed to blunt several previous outbreaks.

At least 166 of the new infections are linked to the Sarang Jeil Church, taking the number of cases from it to 623.

Some members of the church, which is run by a radical conservative preacher, are reluctant to come forward and get tested, or to self-isolate, officials have said.

Part of NZ lockdown illegal

A New Zealand court found the first nine days of a hard lockdown put in place by the government this year requiring people to isolate at home was justified, but unlawful, as an order imposing stay-at-home restrictions was not passed until April 3.

“In the end, the measures taken by the government worked to eliminate COVID-19, save lives and minimize damage to our economy,” Attorney General David Parker said after the ruling.

Prime Minister Jacinda Ardern said on Wednesday she would increase the number of defense personnel at quarantine facilities and borders to beat any spread of the virus, as five new cases in the community were reported.

A warning from the Pope

Rich countries should not hoard a coronavirus vaccine and should only give pandemic-related bailouts to companies committed to protecting the environment, helping the most needy and the “common good”, Pope Francis said on Wednesday.

“It would be sad if the rich are given priority for the COVID-19 vaccine. It would be sad if the vaccine becomes property of this or that nation, if it is not universal and for everyone,” Francis said at his weekly general audience.

The World Health Organization said on Tuesday that any nation that hoards possible vaccines while excluding others would deepen the pandemic.

“The pandemic is a crisis and one never exits from a crisis returning to the way it was before,” Francis said.

(Compiled by Linda Noakes and Karishma Singh; Editing by Robert Birsel)

3M, MIT partner to make rapid COVID-19 antigen test

By Carl O’Donnell

(Reuters) – U.S. industrial conglomerate 3M Co has partnered with the Massachusetts Institute of Technology to develop a rapid antigen test for COVID-19, the company said on Tuesday.

The test would produce results within minutes and could be administered on a low-cost, paper-based device, similar to a home pregnancy test, that could be delivered at the point of care.

“We are seeking to improve the speed, accessibility and affordability of testing for the virus, a major step in helping to prevent its spread,” said John Banovetz, the chief technology officer at 3M.

The research effort is being aided by a grant from the National Institutes of Health, which is running a project called Rapid Acceleration of Diagnostics (RADx) that funds the development of new testing technologies in academia and business.

The program aims to have the new tests available for use by late summer or early fall.

Antigen tests scan for proteins that can be found on or inside a virus. They can detect the virus very quickly and can potentially be produced at a lower cost than other tests.

3M says it could scale manufacturing to millions of tests per day once it is developed.

(Reporting by Carl O’Donnell; Editing by Leslie Adler)

U.S. tops 3 million known infections as coronavirus surges

By Callaghan O’Hare and Lisa Shumaker

HOUSTON (Reuters) – The U.S. coronavirus outbreak crossed a grim milestone of over 3 million confirmed cases on Tuesday as more states reported record numbers of new infections, and Florida faced an impending shortage of intensive care unit hospital beds.

Authorities have reported alarming upswings of daily caseloads in roughly two dozen states over the past two weeks, a sign that efforts to control transmission of the novel coronavirus have failed in large swaths of the country.

California, Hawaii, Idaho, Missouri, Montana, Oklahoma and Texas on Tuesday shattered their previous daily record highs for new cases. The biggest jumps occurred in Texas and California, the two largest U.S. states, with more than 10,000 each. About 24 states have reported disturbingly high infection rates as a percentage of diagnostic tests conducted over the past week.

In Texas alone, the number of hospitalized patients more than doubled in just two weeks.

The trend has driven many more Americans to seek out COVID-19 screenings. The U.S. Department of Health and Human Services said on Tuesday it was adding short-term “surge” testing sites in three metropolitan areas in Florida, Louisiana and Texas.

In Houston, a line of more than 200 cars snaked around the United Memorial Medical Center as people waited hours in sweltering heat to get tested. Some had arrived the night before to secure a place in line at the drive-through site.

“I got tested because my younger brother got positive,” said Fred Robles, 32, who spent the night in his car. “There’s so many people that need to get tested, there’s nothing you can do about it.”

Dean Davis, 32, who lost his job due to the pandemic, said he arrived at the testing site at 3 a.m. Tuesday after he waited for hours on Monday but failed to make the cutoff.

“I was like, let me get here at 3, maybe nobody will be here,” Davis said. “I got here, there was a line already.”

In Florida, more than four dozen hospitals across 25 of 67 counties reported their intensive care units had reached full capacity, according to the state’s Agency for Health Care Administration. Only 17% of the total 6,010 adult ICU beds statewide were available on Tuesday, down from 20% three days earlier.

Additional hospitalizations could strain healthcare systems in many areas, leading to an uptick in lives lost from the respiratory illness that has killed more than 131,000 Americans to date. At least 923 of those deaths were reported Tuesday, the biggest single-day toll since June 10 but still far fewer than the record 2,806 tallied back in April.

A widely cited mortality model from the University of Washington’s Institute for Health Metrics and Evaluation (IHME) projected on Tuesday that U.S. deaths would reach 208,000 by Nov. 1, with the outbreak expected to gain new momentum heading into the fall.

A hoped-for summertime decline in transmission of the virus never materialized, the IHME said.

“The U.S. didn’t experience a true end of the first wave of the pandemic,” the IHME’s director, Dr. Christopher Murray, said in a statement. “This will not spare us from a second surge in the fall, which will hit particularly hard in states currently seeing high levels of infections.”

‘PRESSURE ON GOVERNORS’

President Donald Trump, who has pushed for restarting the U.S. economy and urged Americans to return to their normal routines, said on Tuesday he would lean on state governors to open schools in the fall.

Speaking at the White House, Trump said some people wanted to keep schools closed for political reasons. “No way, so we’re very much going to put pressure on governors and everybody else to open the schools.”

New COVID-19 infections are rising in 42 states, based on a Reuters analysis of the past two weeks. By Tuesday afternoon, the number of confirmed U.S. cases had surpassed 3 million, affecting nearly one of every 100 Americans and a population roughly equal to Nevada’s.

In Arizona, another hot spot, the rate of coronavirus tests coming back positive rose to 26% for the week ended July 5, leading two dozen states with positivity rates exceeding 5%. The World Heath Organization considers a rate over 5% to be troubling.

The surge has forced authorities to backpedal on moves to reopen businesses, such as restaurants and bars, after mandatory lockdowns in March and April reduced economic activity to a virtual standstill and put millions of Americans out of work.

The Texas state fair, which had been scheduled to open on Sept. 25, has been canceled for the first time since World War Two, organizers announced on Tuesday.

In Ohio, Governor Mike DeWine said the state was ordering people in seven counties to wear face coverings in public starting Wednesday evening.

(Reporting by Callaghan O’Hare in Houston and Lisa Shumaker in Chicago; Additional reporting by Maria Caspani, Gabriella Borter, Caroline Humer and Peter Szekely in New York and Susan Heavey and Jeff Mason in Washington Writing by Paul Simao and Steve Gorman; Editing by Bill Berkrot, Cynthia Osterman, Tom Brown and Leslie Adler)

How sewer science could ease testing pressure and track COVID-19

By Kate Kelland

LONDON (Reuters) – The science of sewage surveillance could be deployed in countries across the world to help monitor the spread of national epidemics of COVID-19 while reducing the need for mass testing, scientists say.

Experts in the field – known as wastewater epidemiology – say that as countries begin to ease pandemic lockdown restrictions, searching sewage for signs of the SARS-CoV-2 coronavirus could help them monitor and respond to flare-ups.

Small early studies conducted by scientific teams in The Netherlands, France, Australia and elsewhere have found signs that the COVID-19-causing virus can be detected in sewage.

“Most people know that you emit lots of this virus through respiratory particles in droplets from the lungs, but what’s less well known is that you actually emit more small virus particles in feces,” said Davey Jones, a professor of environmental science at Britain’s Bangor University.

This suggests that on a wider scale, sewage sampling would be able to estimate the approximate number of people infected in a geographic area without having to test every person.

“Every time a person becomes infected with COVID-19, they start shedding virus into the sewer system,” Jones said. “We’re using that (knowledge) and tracking people’s toilet movements.”

The practice has been used to monitor health threats and viral diseases before.

It’s a crucial tool in the global fight to eradicate polio, and scientists in Britain and elsewhere also use it to monitor antibiotic resistance genes from livestock farming.

“Wastewater epidemiology has been part of monitoring of polio infection across the world, so it’s not completely new,” said Alex Corbishley, a veterinary scientist at the Roslin Institute in Edinburgh who is running a three-month pilot project to track SARS-CoV-2 in wastewater in Scotland. “But it’s never really been applied to an outbreak in this way.”

“The idea here is that you could potentially use this as a relatively cheap, but much more importantly, scaleable, way of saying ‘there’s X amount of transmission’ in a community.”

NOT INFECTIOUS

Scientists conducting initial COVID-19 sewage studies in Europe and Australia stress that what they are picking up is not live, infectious virus, but dead particles or fragments of the virus’s genetic material that are not infectious.

In a pilot trial in Queensland, Australia, scientists were able to detect a gene fragment of SARS-CoV-2 in sewage from two wastewater treatment plants.

In the Netherlands, sewage epidemiologists acted ahead of the COVID-19 outbreak there and took samples from seven cities and a major airport in February and March.

While they found no detectable virus three weeks before the first COVID-19 case was detected, by March 5 – barely a week after the first case was confirmed there – they were able to detect virus fragments.

“The detection of the virus in sewage, even when the COVID-19 prevalence is low, indicates that sewage surveillance could be a sensitive tool to monitor the circulation of the virus,” the researchers wrote in a paper posted online on MedRxiv.

Researchers in Paris posted findings in April that showed how sampling wastewater in the city for a month tracked the same curve of the rising and falling epidemic there.

Few countries have the resources or capacity to test each person individually, with most only able to test healthcare workers or people with symptoms severe enough to mean they need hospitalization. This means authorities have only limited information about how widespread the new coronavirus is or whether it is affecting some communities more than others.

“You can use this type of surveillance as a public health tool,” said Andrew Singer, a researcher at the UK Centre for Ecology and Hydrology who is working with Davey and others on pilot coronavirus sewage testing plans in Britain.

“And the utility of this approach is that it’s so cheap and the investment that you make … will reap rewards, not just for (this) coronavirus pandemic,” but for future outbreaks too.

(Editing by Janet Lawrence)

What you need to know about the coronavirus right now

(Reuters) – Here’s what you need to know about the coronavirus right now:

Trade deal in doubt?

U.S. President Donald Trump said he opposed renegotiating the “Phase 1” trade deal on Monday after Chinese-run state newspaper The Global Times reported some government advisers in Beijing were urging fresh talks.

Rising U.S.-China tensions over the coronavirus outbreak have cast the trade deal between the two countries, and proposed talks on a Phase 2 deal, into doubt.

The Global Times said that malicious attacks by the United States have ignited a “tsunami of anger” among Chinese trade insiders after China made compromises in the Phase 1 pact.

Dangerous calculation

WHO officials urged “extreme vigilance” on Monday as countries began to exit from lockdowns, stressing that early studies point to lower-than-expected antibody levels against the COVID-19 disease within the general population, meaning that most people remain susceptible.

Dr Mike Ryan, head of the WHO’s emergencies program warned countries that have “lax measures” in place to be wary of counting on herd immunity to halt the spread of COVID-19, saying: “This is a really dangerous, dangerous calculation.”

Economic boost

Once Australia removes most social distancing restrictions by July, its GDP will rise by $6.5 bln each month, Treasurer Josh Frydenberg was expected to tell lawmakers on Tuesday in a speech updating them on his budget planning.

Britain’s finance minister Rishi Sunak is similarly due to answer questions about the economic response to COVID-19 in parliament on Tuesday afternoon.

There, the focus is how Britain plans to continue the Coronavirus Job Retention Scheme, which is paying employers 80% of the wages of more than 6 million workers who are on temporary leave from businesses affected by the coronavirus. The scheme is due to run until the end of June.

Prime Minister Boris Johnson said on Monday that coronavirus infections had peaked, and that people who could not work from home should return to their workplaces if possible.

Testing 11 million in 10 days

The Chinese city of Wuhan, the epicenter of China’s coronavirus outbreak, plans to conduct nucleic acid testing over a period of 10 days, an internal document seen by Reuters showed and two sources familiar with the situation said, with every district told to submit a detailed testing plan by Tuesday.

The city of 11 million people reported its first cluster of new infections over the weekend after a months-long lockdown was lifted on April 8.

These plans come as the global alarm was sounded on Monday over a potential second wave of coronavirus infections after Germany reported that the reproduction rate of the pathogen had risen above 1.

Canceled Cannes

“It breaks my heart,” said Joseph Morpelli, leading member of the so-called ‘stepladder gang’ of ardent autograph-hunters and amateur paparazzi, as he stood across the street from the venue of the canceled Cannes Festival on Monday.

Usually, a hive of activity, the location where Morpelli and his fellow diehard fans could get a glimpse of celebrities walking down the red carpet is now deserted, as the film festival which was meant to start on Tuesday has been called off.

It was only the third time in its history that the festival has failed to take place. The two previous occasions were the outbreak of World War Two and 1968, when France was roiled by violent protests.

(Compiled by Karishma Singh)

Some White House staff to wear masks after valet tests positive: Trump

WASHINGTON (Reuters) – U.S. President Donald Trump on Friday said certain White House staff members have started wearing face masks, one day after the White House said his personal valet had tested positive for the novel coronavirus.

Trump, asked whether those who serve him food would now cover their faces, told Fox News in an interview that such White House staff would now be covering their faces.

“They’ve already started,” he said on the network’s “Fox and Friends” morning program.

The White House on Thursday said Trump and Vice President Mike Pence tested negative for the virus and were feeling well after the staffer – a U.S. military service member who works at the White House as a valet – came down with the virus. It also said the two leaders would now be tested daily, versus weekly.

Trump has said he would not wear a mask and has not publicly worn a mask to any of his events so far amid the COVID-19 pandemic, but told reporters this week that he tried some on behind the scenes during his visit to a Honeywell face mask factory in Arizona.

He is scheduled to attend a public event at the World War Two memorial later on Friday before meeting with Republican members of Congress at the White House, according to the White House.

The Republican president also told Fox News that he has not yet been tested for antibodies to the novel coronavirus but probably would be soon. Such a test could confirm previous exposure to the virus.

(Reporting by Susan Heavey; additional reporting by Lisa Lambertl editing by Chizu Nomiyama and Jonathan Oatis)