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Fighting the COVID-19 pandemic through testing

Fighting the COVID-19 pandemic through testing

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Credit: National Institute of Allergy and Infectious Diseases, NIH

The world is now in the grips of a historic pandemic. The death toll from the novel coronavirus has climbed to more than 117,000 in the United States and 448,000 around the world. Total cases of the disease, called COVID-19, have soared past 2 million in the US and 8.3 million globally. Debates are now raging about whether US states have begun to move too quickly to reopen restaurants, stores, barbershops, and the myriad other engines of life and commerce after weeks of lockdown.

But there is one area of widespread agreement, says Robert Tjian, a Howard Hughes Medical Institute Investigator at the University of California, Berkeley: the safe path out of the pandemic requires enormous amounts of testing. In the May 1, 2020, issue of the journal RNA, Tjian, study coauthor Meagan Esbin, and their colleagues reviewed recent advances in COVID-19 testing techniques and highlighted barriers facing widespread testing. To trace the pathogen’s spread and stop the chain of transmission, it’s crucial to test both for the SARS-CoV-2 virus itself and for evidence that people have previously been infected, Tjian explains.

The countries that have so far successfully quashed their outbreaks, such as New Zealand, Taiwan, South Korea, and Iceland, have done the best job of identifying cases. In contrast, “the United States has done quite poorly,” says Lawrence Gostin, professor of medicine and public health expert at Georgetown University.

That failing is not for lack of effort in the scientific community. Scores of researchers around the country have dropped what they were doing to tackle the challenge in the US, Tjian says. In fact, he adds, in compiling the many studies described in his group’s paper, he was “surprised at how quickly so many labs have converted to working on COVID-19.”

These labs have devised innovative new approaches for testing, as well as for overcoming the bottlenecks that hampered testing efforts early in the pandemic. Some labs, like at Berkeley, have set up their own rapid testing operations to serve local communities, quickly publishing their methods “so that everyone doesn’t have to reinvent the wheel,” says Tjian. These and many other efforts are helping to answer some of the basic questions about fighting the pandemic.

Why is testing so important?

SARS-CoV-2 is an especially pernicious virus. It is both highly contagious and relatively lethal, with a mortality rate that’s still uncertain but higher than that of flu – 10 times or more higher, some data suggest. But the virus’s wiliest feature is that it can be spread by people who don’t even know they are infected. In contrast, victims of the original SARS virus in 2003 weren’t contagious until severe symptoms struck, making it easy to isolate those people and cut the chain of transmission.

In the United States, the number of confirmed coronavirus cases has surpassed two million. Case density shown in red. View full dashboard with case tally by country. Credit: Johns Hopkins University

“That people can have COVID-19 without symptoms is one of the most challenging aspects of preventing spread,” explains Eric Topol, founder and director of the Scripps Research Translational Institute. One unknowingly infected person can infect dozens of others, as shown by “superspreading” events like a choir practice in Washington state, with 32 confirmed cases, and a man who visited several South Korean nightclubs, infecting more than 100 people.

In addition, testing may spot SARS-CoV-2 only when an infected person is actively producing lots of the virus, says Tjian. That’s why three types of testing are vital, he says. People with any COVID-19 symptoms should be tested, to spot new cases as soon as possible. People who have been in contact with an infected person also should be tested, even if they have no symptoms. And finally, he says, health care providers should test people for antibodies to the virus, to identify those who may have already been infected.

How do scientists test for the new coronavirus?

SARS-CoV-2 reproduces by getting into human cells, then hijacking the cells’ machinery to make many copies of its genetic material, called RNA. Scientists have designed several testing methods to spot this distinctive viral RNA. The method used in almost all testing to date and considered the “gold standard” relies on a technique for amplifying tiny amounts of viral genes. First, a swab collects infected cells from a person’s throat, gathering bits of viral RNA. That genetic material is typically purified and then copied from RNA into complementary DNA. The DNA is then copied millions of times using a standard method known as polymerase chain reaction (PCR). Finally, a fluorescent probe is added that emits a telltale glow when DNA copies of the viral RNA are present.

PCR isn’t the only viable approach. Scientists at MIT and other universities have also repurposed the gene editing technique called CRISPR to quickly detect SARS-CoV-2. CRISPR uses engineered enzymes to cut DNA at precise spots. The testing approach harnesses that ability to hunt for a specific bit of genetic code, in this case a viral RNA, using an enzyme that fluoresces when it finds the distinctive SARS-CoV-2 target. In early May, the Food and Drug Administration gave emergency authorization to the test developed by the MIT team, which is led by HHMI Investigator Feng Zhang.

Another testing technique quickly reads each RNA “letter” of the viral genome, using a process called genetic sequencing. That’s overkill for detecting the virus, but it has been particularly helpful at charting the virus’s relentless march around the globe. And some researchers are experimenting with clever DNA “nanoswitches” that can flip from one shape to another and generate a fluorescent glow when they spot a piece of viral RNA.

Scientists can also see telltale signs of infection in the blood. Once people have been infected, their immune systems respond by creating antibodies designed to neutralize the virus. Antibody tests detect that immune response in blood samples using a protein engineered to bind to SARS-CoV-2 antibodies. Creating an antibody test that’s both sensitive and accurate can be tricky, however.

Though coronavirus testing in the US has struggled to reach the levels needed, “the science is not the complicated part,” says Tjian. “Like anything else in research, there is more than one solution.” Instead, the real problem has been accelerating the pace of testing.

What is the US’s track record on testing?

Even as the virus rampaged through Wuhan, China, in January 2020 and started to kill Americans in February (or perhaps even earlier), the US government failed to prepare for the spreading pandemic. There was essentially “no response” from the federal government, Tjian says. “You could not have imagined a worse leadership team to be dealing with this worldwide pandemic.”

The Trump Administration declined to use a PCR-based test developed by the World Health Organization (WHO), for example, and a test produced by the U.S. Centers for Disease Control and Prevention (CDC) turned out to be faulty. The lack of a coordinated national effort left states, companies, and university labs scrambling to fill the gap.

As labs and states in the US raced to boost their testing capabilities, they ran into bottlenecks and roadblocks. For example, “only a few supply houses were providing the reagents [needed for the PCR reactions] and supplies were woefully inadequate,” says Tjian. Even basic equipment, like the swabs used for collecting samples, was hard to find. “That was one thing that caught us by surprise,” recalls Tjian. “Who would have imagined that the most rate-limited piece of this whole puzzle was the swab?” It turned out that the major producer of swabs approved by the CDC was a factory in northern Italy, a region among those hardest hit by the virus.

Without sufficient testing, there was a “tragic data gap undermining the U.S. pandemic response,” writes health service researcher Eric C. Schneider in a commentary in the May 15 issue of the New England Journal of Medicine. Instead of being able to test every person with symptoms and all those they had been in contact with, as countries like South Korea did, the shortage meant reserving tests for hospitalized patients and for helping prevent health care workers from transmitting COVID-19, he explains.

The lack of data on case numbers has made it challenging to model the path of the pandemic, writes Schneider, of the Commonwealth Fund, a private foundation aimed at improving the health care system. As a result, it has been difficult to anticipate where emergency medical services, hospital beds, and ventilators are most needed.

By mid-May, the testing capacity in the US had finally risen from a few thousand a day to about 300,000 a day. Still, that’s far short of what’s needed. The Harvard Roadmap to Pandemic Resilience estimates, for example, that the country will require testing at a rate of “20 million a day to fully remobilize the economy.” To safely reopen, “we need massive testing capacities don’t currently exist,” says Georgetown’s Gostin, one of the authors of the report.

How can scientists overcome testing bottlenecks?

Scientists around the world have responded to the challenges posed by the novel coronavirus. The Berkeley group, for example, dramatically boosted its testing capacity and reduced costs to near $1 per test with improvements such as skipping one step – RNA purification – and making their own reagents. “It’s not rocket science, but it took us five weeks to figure out the details because commercial companies don’t tell you what’s in their reagents,” explains Tjian. The research team has made their home-brewed test freely available to any lab that wants to replicate it.

Meanwhile, groups at Rutgers, Yale (including HHMI Investigator Akiko Iwasaki), and other centers have eliminated the need for throat swabs by showing that saliva samples work just as well. That opens the door to home testing wider, since spitting into a tube and mailing it to a lab is far easier than swabbing.

Progress is also being made in testing for antibodies. Most of the dozens of so-called serology tests initially on the market didn’t have the sensitivity and specificity to pick out only those antibodies directed at SARS-CoV-2. The challenge is that the tests require using copies of a viral protein that binds to the antibodies. One key to solving that problem, it turns out, is using mammalian cells to make the viral protein with the precise shape needed to home in on just the SARS-CoV-2 antibodies.

How will testing help tame the pandemic?

The basic strategy for overcoming COVID-19 is identifying infected people, finding and testing anyone they came in contact with, and quarantining infected individuals. That’s not practical for big cities or entire countries, given the staggering numbers of needed tests, logistical challenges, and thorny privacy issues. But there are clever ways to cast a wider net without so many individual tests.

One is lumping together many samples in a pool, so that large groups of people can be monitored with only one test. Then, if the virus does show up in the pool, public health officials can test the individuals in that group to pinpoint the infections.

Perhaps even more powerful is monitoring sewage. The virus can appear in a person’s feces within three days of infection – far earlier than the onset of first symptoms. Scientists could use the standard PCR test on sewage samples to detect the virus. And by collecting samples from specific locations, such as manholes, scattered throughout a community, it would be possible to narrow down the location of any infections to a few blocks or even individual buildings, like an apartment complex or a college dorm. “You can determine the viral load and how it is changing over time with one test a day,” says Tjian. “That would be amazing.”

Tjian and many others are now figuring out how these approaches might be used to safely reopen a university or a business. Large-scale testing efforts would be labor-intensive and not inexpensive, he says, but far cheaper than locking down a whole economy – and far safer than reopening without adequate testing, as some states are now doing. And as scientists continue to increase testing capacities and create cheaper and better tests, this strategy should soon be within reach.

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Citation

M.N. Esbin et al. “Overcoming the bottleneck to widespread testing: A rapid review of nucleic acid testing approaches for COVID-19 detection.” Published online in RNA May 1, 2020. doi: 10.1261/rna.076232.120.

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Meghan Rosen
rosenm2@hhmi.org

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https://www.hhmi.org/news/fighting-the-covid-19-pandemic-through-testing

Related Journal Article

http://dx.doi.org/10.1261/rna.076232.120

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Economics

Braxia and KetaMD, CEOs McIntyre and Gumpel Speak on Acquisition

Last week, the Canadian company Braxia Scientific acquired 100% of the issued and outstanding stock of KetaMD, Inc. This is an exciting acquisition, and…

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Last week, the Canadian company Braxia Scientific acquired 100% of the issued and outstanding stock of KetaMD, Inc. This is an exciting acquisition, and in today’s interview, The Dales Report’s Nicole Hodges talks with CEOs Dr. Roger McIntyre and Warren Gumpel of Braxia Scientific and KetaMD respectively.

For some background information, KetaMD is a U.S. based, privately-held, innovative telemedicine company, with a mission to address mental health challenges via access to technology-facilitated ketamine-based treatments. Braxia Scientific is Canada’s first clinic specializing in ketamine treatments for mood disorders. They recorded revenue of $1.49m for 2022 fiscal year, ended March 31. On a year-over-year basis, revenue increased 47.5%.

Here’s some highlights from the interview.

KetaMD gives Braxia a presence in the US

Dr. McIntyre says that KetaMD gives Braxia what they’ve had as their vision from the beginning: a US presence. KetaMD is a living program. It’s already running, has infrastructure, and patients. McIntyre believes that a program like KetaMD is something Braxia’s needed to scale and obtain commercial success.

With telemedicine, Braxia has a potential to serve a gap in access. The zeitgeist of “patient going to medicine” has flipped, McIntyre says. “Now it’s medicine goes to the patient, and that is long overdue.”

COVID speeding a trend that was already happening

In 2020, 80% of physicians indicated they had virtual visits. That’s a number up from 22% the year before. But this is something that many doctors, McIntyre included, believe always should have happened. The pandemic only was the catalyst for innovation and making the option viable.

While some treatments will always need a clinic or a hospital, McIntyre believes some treatments can be done safely at home. And they are, for many chronic diseases. He feels implementing ketamine and psychedelics would be among these treatments where service could be expanded into the home. It would require careful SOPs in place, best practices, and surveillance. But he believes Braxia Scientific could deliver this with KetaMD.

Gumpel to stay as CEO of KetaMD

Gumpel says that KetaMD benefits in this acquisition from being part of the world’s most prominent researchers in depression, psychedelics, and ketamine. In the acquisition, he’ll stay on as CEO. He admits that Dr. McIntyre has been a huge part of collecting the data on the safety of ketamine treatment, and has a strong motivation to “see this thing through until most of society can access that – or at least the people that need it and want it.”

Gumpel admits he has a personal connection to ketamine treatment. As a person who has experienced bouts of depression for years, it saved his life, he says. He is grateful he was living within walking distance of ketamine treatment in Manhattan. It made him extremely aware of the accessibility gap, which in part inspired KetaMD.

Be sure to tune in for the full interview regarding Braxia and KetaMD, right here on The Dales Report!

The post Braxia and KetaMD, CEOs McIntyre and Gumpel Speak on Acquisition appeared first on The Dales Report.

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Spread & Containment

How to Use Dividends to Find the Best Tech Stock

Investors Alley
How to Use Dividends to Find the Best Tech Stock
When we talk about tech stock investing, we hear discussions of all sorts about different…

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Investors Alley
How to Use Dividends to Find the Best Tech Stock

When we talk about tech stock investing, we hear discussions of all sorts about different measures used for picking stocks.

For example, some tech investors use year-over-year revenue growth. Others subscribe to a theory that has been floating around for many years, that the secret to picking tech stocks was looking at the percentage of cash flows spent on research and development.

All too often, tech stock analysis consists of storytelling and searching for ideas that will change the world, something I’ve heard thousands of times during my career. The number of companies that actually did change the world probably totals up to a few dozen over three decades.

Some of those beat the market. Others did not.

I have found a variable that can help tech investors spot promising opportunities to identify technology companies that have higher probabilities of providing market-beating returns: dividends.

Note a stock’s dividend yield: investors who want higher dividends with an overall total return would be smart to look into high-yield tech stocks as part of their income strategy. The key to using dividends to find market-beating tech stocks is to look at the rate of their dividend growth. It doesn’t matter how high the dividend is at any given time. We want to see companies that are consistently growing their dividends.

A tech company that pays a dividend is making a statement. It tells the world: “We are generating enough cash to pay the bills, hire great people, and fund our future growth plans as well as R&D. In fact, we are generating so much cash we have some left over to pay out to our investors.”

Ideally, we want to limit our universe of companies to those who are increasing their payout by at least 20% annually. Growing a dividend at that high a rate says that things are just continuing to get better.

Once we have a universe of tech companies that are growing their payouts at high levels, we want to make sure we only own those that really do have a wonderful business that just keeps getting better. We want to use a financial checklist to make sure our companies are in excellent financial shape and have what it takes to keep growing the business.

I prefer the nine-point checklist developed by Professor Joseph Piotroski when he was at the University of Chicago – known as the “Piotroski F-Score”. This is a list of nine criteria of profitability, leverage, and efficiency. On each criterion, a firm can either get one or zero points – pass or fail.

I limit my universe of tech stocks with paid dividend growth to just two to three with the highest scores on the Piotroski checklist.

Using this simple method for picking tech stock winners has crushed the S&P 500 over the past decade and even edged at the tech-heavy NASDAQ 100.

Texas Instruments (TXN) makes the current list of technology companies with high dividend growth and outstanding fundamentals and prospects. The company makes most of its revenues from semiconductors, but it does still have some revenues from its calculators and other business machines. (I have had one of these, a Texas BAII calculator, within arm’s reach for most of my career.)

Texas Instruments had a solid second quarter and increased its guidance for the third quarter. The company has not suffered the China slowdown problems that have plagued some of their competitors so far. The brightest spot in the recent report was semiconductors being sold to the automobile industry, which were up 20%.

Although we have seen some slowdown in semiconductors due to the supply chain issues created by the pandemic, Texas Instruments has powerful tailwinds from all the developments we see in technology over the next decade.

Every one of the hottest trends in the economy—from renewable energy to artificial intelligence and everything in between—is going to increase demand for semiconductor chips. There are thousands of semiconductors in every electric vehicle, which will be another massive source of demand for the industry.

Texas Instruments has a yield of 2.5% right now, and has been growing that payout by 20.5% annually.

Another semiconductor company, Broadcom (AVGO) has the fastest-growing payout on our list right now. The company makes chips for smartphones, networking, broadband, and wireless connectivity. Broadcom’s recent purchase of Symantec’s Enterprise Business also puts it in the cybersecurity business.

Broadcom’s shares currently yield 2.97% and the payment has risen by an average of 49% annually for the past five years.

Most investors will never think of using dividends as part of the stock selection process. Rigorous testing shows that dividend growth is actually an important part of identifying companies with the potential to be huge winners.

My favorite way to invest in those companies isn’t to buy their stock, though. Instead, I like to use a special, little-known investment that lets me invest in these companies for up to 18% less than what others pay…

While collecting twice or more the dividend yield!

All without any more risk. I’m tracking 5 opportunities like that right now, and I lay them all out right here.

Only 3% of investors even know these funds exist

But using them, I can beat the market 2-to-1 while collecting 2-10X MORE yield from regular dividend stocks.

I learned this trick while I was rubbing elbows with some of the biggest fund managers in US history.

They too are buying these little known funds, cashing in huge discounts and collecting income while they do it.

Click here to learn the secret yourself.

 

How to Use Dividends to Find the Best Tech Stock
Tim Melvin

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Government

Where Carnival, Norwegian, Royal Caribbean Sit on Covid Vaccines

Do You still need to be vaccinated to go on a Royal Caribbean, Carnival, or Norwegian Cruise?

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Do You still need to be vaccinated to go on a Royal Caribbean, Carnival, or Norwegian Cruise?

Cruise line covid-19 vaccination and testing rules, which were imposed by the Centers for Disease Control and Prevention at the beginning of the pandemic, have been stricter than most. After the pandemic started in early 2020, the CDC signed a No Sail Order on March 14, 2020, which was finally lifted after nearly eight months on Oct. 30, 2020.

After the No Sail Order was lifted, the CDC enacted extremely restrictive rules and regulations to help keep passengers safe with the covid pandemic still raging throughout the world. The rules and regulations were set forth to begin to return cruise lines to operational status.

The cruise lines first had to be staffed accordingly and set up with the ability to test, treat and quarantine for covid medical emergencies. Testing for crew and passengers before embarkment and before dis-embarkment was required. The testing at pre-embarkment was a measure to protect those boarding, while the post-trip testing was for determining if an infection started on the cruise line itself. Being able to track the virus was very important in the prevention of spreading the virus and protecting patrons.

Image source: Shutterstock

Vaccination Still Not a Free Pass to Board

Once the vaccination was developed and approved, it became part of the CDC guidelines for cruise line adult passengers to have their vaccination before boarding. Even with a vaccination, guests still needed to test before they boarded the cruise lines. As the vaccine was approved for younger age groups, those age groups were then also required to have the vaccine to travel. Passengers were required to be fully vaccinated unless they are exempt by some status.

Before boarding, cruise line passengers who tested positive, as well as their travel companions, were not allowed to board, depending on the cruise line and how long the cruise may be. Some passengers were allowed to board and then isolate, others would have to reschedule their trip. Trip insurance is a good buy these days.

Cruise Lines Letting Loose on Vaccine Policies

Carnival Cruise Line  (CCL) - Get Carnival Corporation Report has now removed pre-cruise testing for vaccinated guests and also welcomes unvaccinated guests to travel. Fully vaccinated guests traveling less than 16 nights with the cruise line will no longer be subjected to testing, but still must provide proof of their vaccination status. Unvaccinated travelers will only need to provide a negative covid test result to board the ships. All rules and regulations are still subject to the destination country’s guidelines.

According to the Healthy Sail Center for Royal Caribbean  (RCL) - Get Royal Caribbean Group Report, the cruise line has updated its covid vaccination protocol. The cruise line will now allow passengers regardless of vaccination status to board in some ports if the travelers meet the testing requirements. Testing requirements vary by cruise departure and destination. Check the cruise lines port departure for updated information on requirements.

There is, however, a major exception, at least for now, which is obvious when you look at the specific wording shared by the cruise line:

"Starting with September 5 departures, all travelers regardless of vaccination status can cruise on the following itineraries, as long as they meet any testing requirements to board.

  • Cruises from Los Angeles, California.
  • Cruises from Galveston, Texas.
  • Cruises from New Orleans, Louisiana.
  • Cruises from a European homeport.

Notice that Florida, a major port for the cruise line, is not currently on the list.

In the U.S. aside from Florida, any guest with a valid negative covid test within the last three days will be able to board. These guests will also not be required to take a second test at the boarding terminal. Fully vaccinated guests do not need to provide proof of a negative covid test for shorter cruises. See the cruise line website for all updated information as it is subject to change.

Beginning Sept. 3, Norwegian Cruise Line  (NCLH) - Get Norwegian Cruise Line Holdings Ltd. Report is dropping its covid vaccine requirements for all its cruises. The cruise line stated that it is continuing to follow requirements for all destination countries, so guests traveling will want to check on destination vaccine and testing requirements. All guests 12 and older regardless of vaccination need to show proof of a negative test within 72 hours. Check NCL online for further instructions prior to travel.

The CDC has taken the stance that travelers are now well informed enough to make their own decisions when it comes to traveling on cruise lines. The travelers are taking their own assumed risk for their health and well-being. Cruise lines are now welcoming this new freedom for their passengers. 

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