Apple reopening some U.S. stores next week

Starting next week, Apple (NASDAQ:AAPL) will reopen retail stores in Alabama, Alaska, Idaho, and South Carolina.

Apple has 271 stores in the United States, but only six in the reopening states.

The stores will have safety measures in place, including temperature checks, social distancing requirements, limits on the number of customers inside, and face masks for employees.

Most Apple stores outside of China have been closed since March due to the coronavirus pandemic. The tech giant has recently reopened a few locations in South Korea, Australia, and Germany.

For now, the retail stores will focus on fixing products rather than pushing the sales of new products like the low-cost iPhone SE or the new MacBook and iPad models.

Despite the closure, Apple’s recent earnings report included record retail sales, bolstered by “off the charts” online sales.

https://seekingalpha.com/news/3572313-apple-reopening-u-s-stores-next-week

Copper takes aim at COVID-19 with virus-killer coatings

At an outer suburban manufacturing plant, engineer Byron Kennedy is resetting a machine to spray-print a layer of copper on to a door handle, aiming to use the metal’s antiviral properties to counter the threat of the COVID-19 pandemic.

His firm Spee3D is better known as a producer of 3D printers for copper and aluminium, used by customers including the Australian defence force and U.S. Marines to rapidly print new parts to get broken equipment back in action without waiting days for spares to arrive.
“Up until the end of last year, our business was building the 3D printers, which were then used to build parts,” Spee3D co-founder Kennedy told Reuters.
“Come 2020, and the epidemic hits. We know about the antimicrobial properties of copper, so we thought ‘Can we do something, can we help out here?’”
Copper’s disinfectant powers have long been known and its antibacterial, antiviral and anti-fungal properties have been supported by scientific studies.
Spee3D commissioned Melbourne laboratory 360biolabs to look at how SARS-CoV-2, which causes COVID-19, reacts to copper surfaces.
The results showed that 96% of the virus was killed off in two hours and 99.2% in 5 hours, compared to no change on stainless steel surfaces over the same period, Kennedy said.
This is in line with a U.S.-government funded study bit.ly/2WdhxZR published in March that found SARS-CoV-2 remained viable for up to 4 hours on copper, compared with 2 to 3 days on plastic and stainless steel.
Spee3D then reset some of its machines to be able to coat surfaces such as door handles and push plates, and has already received orders from two Australian government departments to resurface door handles before staff return to work.
The Northern Territory’s Trade, Business and Innovation Department said in a statement it was thrilled to adopt the technology to make its workplace safer.
The firm is also speaking with a big miner and several major door handle manufacturers about additional applications, Kennedy said.
SLOW TAKE-UP

Copper had already been making some inroads into the healthcare sector after trials in hospitals, including in the U.S. state of Virginia here(16)30696-4/fulltext, in recent years.
However, attempts by fabricators in Japan, South Korea and Taiwan to sell copper alloy products into the sector resulted in only a modest take-up, partly due to costs, said John Fennell, Chief Executive of the International Copper Association Australia.
“We are seeing outcrops of people adopting this, but not as much as you would have thought,” he said.
COVID-19 looks set to give the metal a boost.
In major copper producer Chile, the country’s mines minister recently touted the use of copper in face masks, such as those produced by a U.S.-Chilean company, while U.S. miner Freeport McMoRan believes the pandemic will shine a light on how copper can help improve public health.
“Copper’s use in health care equipment and facilities and in public places will undoubtedly grow significantly when the cost of copper, which has been a barrier in the past, is measured by the enormous cost to society that is being brought on by this pandemic,” Freeport Chief Executive Richard Adkerson told a briefing last week.
New manufacturing techniques like 3D printing are also a potential game-changer as they can allow ultra-thin coatings to be applied quickly, while still taking advantage of copper’s antimicrobial properties and cutting the amount of metal used, and therefore the cost.

The price of coating a standard office door handle is about A$50-A$100 ($33-$65), says Kennedy, although costs will fall over time.
Disappointing copper bulls, it’s likely the new coating methods will keep a lid on the amount of metal used in healthcare, said analyst Lachlan Shaw of National Australia Bank in Melbourne.
“I think we can confidently say demand for copper for those uses will go up, quite possibly by a lot. Is that going to shift the dial for global demand? At this stage I doubt it,” he said.
https://www.reuters.com/article/us-health-coronavirus-copper-antimicrobi/copper-takes-aim-at-covid-19-with-virus-killer-coatings-idUSKBN22K0RX

NIH begins study of remdesivir with anti-inflammatory drug to treat COVID-19

The National Institutes of Health said on Friday it has started a clinical study to test a combination of Gilead Sciences Inc’s antiviral drug remdesivir and anti-inflammatory drug baricitinib in COVID-19 patients.
The trial is currently enrolling adults hospitalized with COVID-19 in the United States and is expected to study the treatment combination in more than 1,000 participants. (bit.ly/2YM0tfp)
Baricitinib, which is marketed under brand name Olumiant by Eli Lilly and Co, was being tested as a potential treatment for hospitalized patients diagnosed with COVID-19.
https://www.reuters.com/article/us-health-coronavirus-remdesivir/nih-begins-study-of-remdesivir-with-anti-inflammatory-drug-to-treat-covid-19-idUSKBN22K2M7

Study suggests Abbott COVID-19 antibody test highly likely to give correct result

Abbott Laboratories’ antibody test for the new coronavirus is highly likely to correctly determine whether people have ever been infected with the fast-spreading virus, the company said, citing a U.S. study.
Researchers at the University of Washington School of Medicine report in the Journal of Clinical Microbiology (bit.ly/2SKTVcQ) that Abbott’s test had a specificity of 99.9% and a sensitivity of 100%, suggesting very few false positives and no false negatives.
Antibody tests can tell whether a person has ever been infected and are considered crucial in efforts to get Americans back to work safely as the presence of antibodies to the virus indicates possible immunity to future infection.
Abbott’s test was launched last month under the U.S. Food and Drug Administration’s relaxed rules for some coronavirus tests, allowing their distribution before regulatory clearance. It has since received emergency use authorization from the FDA.
Abbott has already shipped more than 10 million antibody tests to hospitals and labs.

Roche Holding AG has said its antibody test has a specificity rate of more than 99.8% and sensitivity rate of 100%, and expects to ramp-up production to make more than 100 million tests a month by the end of the year.
Roche’s test has also received emergency use authorization from the FDA.
https://www.reuters.com/article/us-health-coronavirus-abbott/study-suggests-abbott-covid-19-antibody-test-highly-likely-to-give-correct-results-idUSKBN22K24M

Trying out LA’s new coronavirus testing regime

Last week, after Mayor Eric Garcetti announced that Los Angeles was offering COVID-19 tests to all city and county residents, I decided to get one myself—and test Garcetti’s bold new promise in the bargain.
I was surprised how easily I was able to log on to L.A.’s testing website. I answered a few questions about myself, including whether I had any symptoms of the disease—the answer was no—and within three minutes, I had a same-day appointment at one of eight city-run testing sites.
In fact, it was a same-hour appointment. I rushed out of the house unshowered to drive across a large swath of the county to the site—a Los Angeles Fire Department training center next to Dodger Stadium.

The trip would easily take 90 minutes in non-pandemic times, but I got to the designated freeway off-ramp in under half an hour. That’s when the traffic jam began: It took 75 minutes to snake my way the additional half-mile to a red tent, where a masked fire department employee handed me a zip-close bag containing the testing materials.
She directed me to one of three lanes up ahead, where I sat in my car and performed the test on myself.
I rolled a cotton swab in my mouth for 30 seconds, dropped it into a clear liquid inside a test tube, twisted the cap onto the tube and placed it back in the plastic bag. A protectively swathed attendant plucked the bag from my hand with metal tongs as I held it out of my car window, and deposited it in a large blue bin.
It was all very simple. I was now among 10,000 L.A. County residents who visited a city testing site that day—triple the number of previous days, when tests were limited to those with coronavirus symptoms or those considered high-risk even if asymptomatic.
The mayor is clearly proud of his new strategy. At a news conference last week, he spoke of the praise he had received from doctors, public health officials and other mayors who, he said, told him, “Thank you for leading the way.”
At a time when a shortage of tests still impedes efforts to grapple with the virus in many parts of California and the rest of the U.S., it is noteworthy that Garcetti is now offering testing to all 10 million-plus residents of the nation’s largest county.
“That’s a story in and of itself: that they have the availability and they can make this effort,” Ronald Brookmeyer, dean of the Fielding School of Public Health at UCLA, told me.
But Garcetti’s plan is not a silver bullet. Though public health experts say it is vital to know how many people without symptoms are virus carriers, millions of people may choose not to get tested. And even if you don’t have the virus when you take the test, that’s no protection against future infection.
What officials do with the results is crucial, said Brookmeyer. They need to follow up on the positive cases to reach friends, family members, colleagues and other contacts who may have been exposed—a process known as “contact tracing.” They must also find ways to safely isolate those who test positive and protect vulnerable people in their lives. “We have to get the most bang for the buck of every single test that we do,” Brookmeyer said.
Garcetti said he would hand over COVID-positive cases for contact tracing and other follow-up to public health officials from L.A. County, which includes the city of L.A. and nearly 230 smaller communities.
Testing sites run by the county are sticking to the more restrictive policy of accommodating only those who are symptomatic or at high risk, which now includes people in essential jobs, such as health care employees, first responders and food supply workers.
That decision was made in part because testing capacity is still constrained, Dr. Christina Ghaly, director of L.A. County’s Department of Health Services, said at a news conference.
Garcetti promised the city’s test sites will continue to give priority to those groups, even as testing is opened up to the general population, but he said the city has stockpiled 300,000 tests, with more on the way. Kyle Arteaga, a spokesperson for the supplier, San Dimas, California-based Curative Inc., said the company can meet L.A.’s expanded demand.
The city is paying an average of about $120 for each test, but the price could drop as much as 10% if there were a significant increase in volume. If L.A. ended up doing a million tests, it would likely cost the city between about $110 million and $120 million.
Wider testing of the population will ultimately be critical to subdue the virus, largely because a significant number of infected people have no symptoms and need to know so they can avoid infecting others.
But the testing program has limitations. First, any results will provide a biased sample, since the Angelenos who make and keep appointments will be skewed toward those with the time, inclination and transportation required.
And while Garcetti suggested that negative test results could ease worried minds, any such relief is only temporary. “A negative test one day doesn’t mean that you won’t get infected the next day, or the one after that,” said L.A. County’s Ghaly.
Finally, the accuracy of the self-administered mouth-swabbing tests used in L.A. has not been fully proved. Having a health care worker in full protective regalia plunge a swab all the way to the back of your nose is still the officially preferred method.
The reliability of the L.A. test suffers if you don’t cough forcefully a few times to bring up potentially virus-laden sputum before rolling that cotton tip around in your mouth. A four-minute video I watched before driving to the test site instructed me to do so, but there was no reminder when I got there and no staffers watched me to make I sure I did.
I think I did it correctly, though, so I am confident in the result: negative. But that only means I was “probably not infected” at the time of the test, the notice told me. And it cautioned that I can still be exposed to the virus at any time.
I still see lots of hand-washing and social distancing in my future.
https://www.fiercebiotech.com/medtech/trying-out-la-s-new-coronavirus-testing-regime

FDA publishes first validation results of 12 COVID-19 antibody tests

The FDA published results from the first batch of COVID-19 antibody diagnostics to have their accuracy independently evaluated by federal laboratories—starting with the 12 blood tests the agency has already authorized for emergency use against the pandemic.

The data illustrates each test’s approximate ability to avoid false-positive and false-negative results, known as specificity and sensitivity, as well as their overall predictive value—essentially, how much a clinician could trust the likelihood of a correct reading when discussing the results with a patient, based on the test’s performance as well as the estimated prevalence of the novel coronavirus throughout the community.

The validation work is part of a project launched last month in collaboration with the Centers for Disease Control and Prevention and the National Institutes of Health, and the results come just days after the agency clamped down on the broad marketing of antibody tests across the country.

Conducted by the National Cancer Institute’s Frederick National Laboratory for Cancer Research, the test data was also used by the FDA as it decided whether to grant the products a green light. In addition, the FDA last month issued a broad authorization for antibody tests that are voluntarily submitted and pass review by the program.

It is currently unknown how many people in the U.S. have been exposed to the novel coronavirus and have developed antibodies against the disease. In addition, this percentage varies among the groups of people being tested—healthcare workers, for example, are at greater risk and show higher rates of infections compared to the broader population.

To calculate the tests’ positive and negative predictive values, the FDA assumed a baseline 5% prevalence rate—which, taken nationwide, would amount to over 16.4 million people. However, the agency said that any single antibody test, when put up against a largely asymptomatic general population, “is not likely to be sufficiently accurate to make an informed decision,” and that additional tests focusing on different aspects of the virus would be needed.

The FDA also posted a simple calculator that shows predictive values based on different levels of prevalence, which may change over time or across different locations.

The first COVID-19 serology test granted an Emergency Use Authorization by the FDA—Cellex’s lateral flow rapid test, using drops of blood and a test strip similar to a pregnancy test—showed a combined sensitivity of 93.8% and a specificity of 96.0% when searching for two different antibodies linked to the coronavirus.

At 5% prevalence, that equates to a positive predictive value of 55.2%. At 10% prevalence, that estimate of performance increases to 72.3%, while at 2.5%, it drops to 37.6%. In short, the more likely it is that a person has been exposed to the disease, the more likely the test is giving a correct positive result. Cellex’s test was more accurate at ruling out cases, showing a 99.7% negative predictive value at 5% prevalence.

Other products use different testing technologies and examine larger blood samples—such as the high-throughput ELISA tests developed by Abbott, Roche and other companies.

Roche’s recently authorized Elecsys test showed 100% sensitivity and 99.8% specificity across multiple antibody types, with a positive predictive value of 96.5% and a negative predictive value of 100% at 5% prevalence. Similarly, Abbott’s Architect test for IgG antibodies showed a sensitivity of 100%, specificity of 99.6%, and positive and negative predictive values of 92.9% and 100%, respectively.

Meanwhile, a separate, two-step ELISA test developed by clinical laboratories at the Mount Sinai Health System in New York showed a sensitivity and specificity of 92.5% and 100%, resulting in positive and negative predictive values of 100% and 99.6%.

The full list of test results from all 12 FDA-authorized tests is available here.
https://www.fiercebiotech.com/medtech/fda-publishes-first-validation-results-12-covid-19-antibody-tests

Cadila shutters Indian ingredients plant as workers test positive for COVID-19

Global drugmakers are working overtime to keep supplies coming amid the novel coronavirus pandemic. But in manufacturing facilities packed with workers, COVID-19 presents a particularly difficult challenge—and now one Indian plant has been forced to shutter due to a rash of infections.
Cadila Pharmaceuticals has shut down an active pharmaceutical ingredients (API) plant in Dholka, Ahmedabad, India, after 26 employees tested positive for COVID-19, Reuters reported.
Cadila ordered the facility closed Thursday and required 95 of its employees be quarantined at home. The drugmaker had also begun sanitizing the site, Reuters said.

The shutdown at the Cadila plant comes just weeks after another Indian manufacturing hub was temporarily locked down as a COVID-19 hotspot and underscores the dangers the novel coronavirus has posed for the global supply chain.

In late April, a manufacturing hub in Baddi, India—responsible for 35% to 40% of the nation’s pharmaceutical output—came back online after weeks on lockdown as a COVID-19 containment zone, Business Standard reported.
Some of the world’s biggest generics and API providers have factories in Baddi that were shut down partially or in full as part of the lockdown, including Sun Pharma, Abbott Laboratories and Dr. Reddy’s.
To help keep the facilities running at full capacity, the Indian government allowed a one-time movement of employees from Chandigarh state to Baddi to help staff the plants, according to Business Standard, as well as a resumption of intradistrict movement within Himachal Pradesh, where Baddi resides.

Cadila’s decision to shut down its Dholka facility highlighted concerns Sanofi CEO Paul Hudson raised in early April when he said that one worker with a fever at a drugmaker’s manufacturing site could require “a half dozen” to go into quarantine.
At the time, Sanofi was working to scale production of Plaquenil, a branded version of antimalarial hydroxychloroquine, but had to work at reduced capacity to prevent the spread of COVID-19 infections, Hudson told Reuters.
https://www.fiercepharma.com/manufacturing/cadila-shutters-indian-ingredients-plant-after-26-workers-test-positive-for-covid-19