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Theranos is history, but big blood testing breakthroughs are coming

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Medical researchers say within a few years major breakthroughs in blood testing technology that use immune system response and genetic analysis to identify disease quickly and cost-effectively will be on the market.

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One morning last May, Tayah Fernandes’s mother Shannon realized her four-year-old daughter was seriously unwell, and rushed her to the nearest ER in the English city of Manchester. The coronavirus had crashed onto Britain’s shores weeks earlier, and emergency doctors were initially uncertain how best to treat Tayah’s constellation of symptoms, which included stomach pains and a bright red rash.

They gave her antibiotics for a suspected bacterial infection, but her condition only worsened, her fever spiking. For her parents, for any parents, this was the ultimate medical nightmare; doctors in the dark for days over the cause of their daughter’s illness.

Eventually, after further blood tests, physicians decided Tayah was suffering from an unusual inflammatory syndrome that pediatric infectious disease specialists had only just started to see, but suspected had links to Sars-COV-2.

Young patients across the U.K. and U.S. were arriving in intensive care units with symptoms similar to another disease doctors already recognized, called Kawasaki. But they had no guarantee that the same course of treatment — injecting a solution of donors’ antibodies into the bloodstream — would prove successful.

In Tayah’s case the antibodies solution, known as immunoglobulin, worked, to her parents’ relief. But at around that same time last May a team of researchers at Imperial College, London confirmed through complex analyses of blood samples, taken from patients like Tayah, that this was indeed a new disease, distinct from Kawasaki.

Hunting inside immune system response to bacteria, virus

A related breakthrough in that same laboratory, focused specifically on the way individual genes behave, could have seismic implications for a multi-billion dollar diagnostics sector that has received unprecedented attention from patients, regulators and the business world over the course of this pandemic.

A new method for identifying a specific illness from blood samples relies on the correlation between the activity in small set of genes, which represents the immune response, and specific pathogens that cause a specific disease — just as the poliovirus causes polio, the coronavirus (SARS-COV-2, a pathogen) causes Covid-19. Scientists believe that by studying a small number of genes, they can quickly discern which pathogen is in a patient’s system, what disease they have, and so how best to treat them. 

Companies from small research university spin-offs to industry giants like Abbott Laboratories and Danaher‘s Cepheid are looking to build on two decades of research into the way our own immune systems naturally respond to foreign substances in our bodies, including pathogens like bacteria or viruses. A current technology like Cepheid’s GeneXpert technology is able to distinguish between the different RNA of various viruses, such as SARS-COV-2, or a particular influenza strain, but experts say it’s become increasingly clear that our body’s immune systems can be faster, more accurate detection systems. 

Historically, doctors have had to rely on a patient’s case history and symptoms to narrow down the cause of an illness and develop a treatment plan. More recently, laboratory inspections at the molecular level such as the Cepheid technology have allowed clinicians to identify specific pathogens in nasal mucus, throat swabs or blood samples that might have caused an illness. But hunting for bacteria or a virus in this way can be time-consuming, costly and sometimes simply ineffective. The specific RNA signature of a virus can be hard to detect.

Abbott and Cepheid did not respond to requests for comment.

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The team at Imperial College, London, working separately but at the same time as several counterparts around the world, are now convinced that future diagnoses can soon be conducted using table-top tests that will take just a matter of minutes.

These tests would not explicitly screen for a specific pathogen, but instead, allow scientists and medical professionals to simply watch how specific genes in the body are behaving as an indication of how an immune system is already responding to a pathogen that may not be easily otherwise detectable. 

Imperial College professor Mike Levin currently leads an ongoing European Union-funded study focused on this potential, called “Diamonds.” In recent years he and other scientists have shown how the observed activity in a small number of our genes can work as a kind of shorthand for our body’s immune response to a pathogen. If a handful of specific genes out of thousands in a blood sample are seen to be activated — or the opposite, inhibited — it can indicate that a person is preparing to fight off a specific pathogen.

We think this is a completely revolutionary way of doing medical diagnosis.

Imperial College professor Mike Levin

Levin and colleagues already have a proof of concept for this diagnostic approach after studies involving thousands of patients with fever caused by tuberculosis, and hundreds of Kawasaki patients. And his Imperial College team’s work with the “Diamonds” study are starting to bear fruit and could help identify the distinct immunological markers of illnesses like the coronavirus-linked multi-system inflammatory syndrome in children like Tayah Fernandes, now commonly known as MIS-C. 

When Covid-19 turned up in multiple locations, with MIS-C in its wake, it presented Levin and his researchers with an unprecedented opportunity to test this technique on an entirely new disease.

In the future, these tests — by relying on huge amounts of data and machine learning — should be able to produce multi-class rather than just binary results. This means they could confirm not only if a pathogen is bacterial or viral, or whether someone has a specific disease or not, but could distinguish which one of a multitude of illnesses is afflicting their patient.

In short, Levin expects that by examining the behavior of a relatively small number of genes, clinicians will be able to assign patients to all the major disease classes within an hour.

“We think this is a completely revolutionary way of doing medical diagnosis,” Levin said. He expects the research will provide the basis for new technology, but has no financial interest in any business related to it. 

Rather than what he calls the “stepwise process” of first eliminating bacterial infections, treating for the most common conditions, and then doing more investigation, “this idea is the very first blood test can tell you, has the patient got an infection or not an infection, and what group of infection that is, right down to the individual pathogens.”

Purvesh Khatri, an associate professor at the Stanford Institute for Immunity, Transplantation and Infection and Department of Medicine, says our immune systems have been evolving for millennia to combat pathogens, and so it may prove more effective, and efficient, to examine the response of our bodies.

“We didn’t have a technology, until now, that could measure a set of genes in a rapid point of care way,” he said. “But in the last couple of years, there have been enough technologies available that now allow us to measure a few genes in a rapid multiplex point of care assay way.”

While neither the FDA nor any European regulators have approved these kinds of gene-based pathogen detection systems, Khatri, who is helping launch a related commercial venture, says they’re coming soon. “In the next year or two, there will be several that will be available on the market.”

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House committee passes broad tech antitrust reforms

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A House committee passed a series of sweeping antitrust reforms Thursday after roughly 23 hours of debate.

While the advancement of the six tech-focused bills considered by the House Judiciary Committee beginning Wednesday is a victory for the bipartisan members who introduced them, the markup surfaced rifts within parties that could ultimately hamper the bills’ chances of becoming law.

Several lawmakers made it clear they thought the process from introduction to markup in less than two weeks felt rushed, despite a lengthy investigation preceding the bills. Some said they hoped to see further changes before the legislation reaches the House floor.

Still, the last leg of the debate offered some signs of optimism for those hoping to advance the bills further. Fresh from a recess after passing the fifth bill after 5 a.m. on Thursday, lawmakers returned to the committee room to discuss the Ending Platform Monopolies Act around 11:30 a.m.

The bill — sponsored by antitrust subcommittee Vice Chair Pramila Jayapal, D-Wash., and co-sponsored by Rep. Lance Gooden, R-Texas — would prevent dominant platforms from owning business lines that present conflicts of interest, such as by incentivizing them to favor their own products over rivals’ dependent on their services.

The bill was one of the most aggressive in the package, which also included updates to merger filing fees for dominant platforms, a shift of burden of proof in acquisitions and provision to let state attorneys general have more say in the venue of their antitrust cases. It could essentially force break-ups of businesses like Amazon and Apple, which both sell products or services on their own marketplaces that also serve third-parties. Both stocks closed slightly lower for the day.

Despite the major implications of the bill, it was not the most controversial of the bunch. Lawmakers spent much longer arguing over the data portability mandate under the Access Act as they assessed potential security issues, for example.

Jayapal’s bill also inspired lively debate. Ultimately, the vote fell along similar lines as the others (it passed 21-20, supported by Democrats and Reps. Ken Buck, R-Colo., and Matt Gaetz, R-Fla., and opposed by Republicans backed by Rep. Greg Stanton, D-Ariz., and California Democrats Lou Correa, Zoe Lofgren and Eric Swalwell). But throughout the discussion, it was clear many in the group broadly agreed with the principles of the bill, even if they felt it could use some fine-tuning.

“I will tell you, I’m not 100% there to break up Big Tech, but I’m close,” said Rep. Dan Bishop, R-N.C. “And this is the bill that if it were done right, would be the vehicle to put that on the table.”

Though an amendment he introduced failed, antitrust subcommittee Chairman David Cicilline, D-R.I. and Jayapal expressed a willingness to work with Bishop on potentially including a nod to his idea in the bill. Bishop essentially sought to try to expedite antitrust cases to the courts by removing a regulatory step. Cicilline had called it “the most interesting amendment of the markup” even though he did not support it, and Judiciary Committee Chairman Jim Jordan, R-Ohio called it “the amendment.”

In an interview after the markup on Thursday, Buck, the ranking member on the antitrust subcommittee who supported the legislation, told CNBC he expects more work will be done before the bills move forward.

“I don’t think the bills are going to be on the floor for a couple of months because of the August recess, so I think that the opportunity to work together is certainly there,” he said.

It’s clear that even after such a long debate, the bill authors still have a lot of work to do. After the markup adjourned, bipartisan members of the California delegation on the committee released a joint statement, urging further revision to the bills despite their passage from the committee. They also said the committee members did not have enough time to properly consider the bills prior to the markup.

“The bill text as debated is not close to ready for Floor consideration,” wrote Correa, Swalwell, Lofgren and Reps. Darrell Issa, R-Calif., and Tom McClintock, R-Calif. “We urge the sponsors of the bills to take the necessary time, commit to a comprehensive approach, and work with their bipartisan colleagues of this Committee to address the concerns articulated during markup to further develop these bills.”

Buck responded to criticism from his colleagues who felt they didn’t have enough time to review the bills, saying “it’s a common objection” but that “the ideas in the bill were summarized in reports that were written last October.”

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Nike (NKE) reports Q4 2021 earnings beat

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A man walks in front of Nike products exhibit, on February 22, 2021 in New York City.

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Nike on Thursday reported fiscal fourth-quarter earnings and sales that topped analysts’ estimates, fueled by record revenue in its largest market, North America.

The company continues to benefit from consumers seeking out comfortable clothing to wear for workouts but also around the house. Even as people return to schools, offices and other social settings, many are still searching for relaxed options like sneakers and stretchy pants.

Nike also saw a boost to its wholesale business — something that was largely inactive a year earlier during the Covid pandemic, when shopping malls and department stores had to temporarily shut their doors and put orders for merchandise on pause.

Nike shares jumped more than 4% in after-hours trading.

Here’s how the company did during its fiscal fourth quarter, compared with what analysts were anticipating, using Refinitiv estimates:

  • Earnings per share: 93 cents vs. 51 cents expected
  • Revenue: $12.34 billion vs. $11.01 billion expected

Nike’s net income for the period ended May 31 rose to $1.5 billion, or 93 cents per share, compared with a loss of $790 million, or 51 cents per share, a year earlier. That topped analysts’ forecast of 51 cents per share, using Refinitiv data.

Total revenue rose to $12.34 billion from $6.31 billion a year earlier, topping estimates for $11.01 billion.

In North America, Nike’s biggest market, sales more than doubled to a record $5.38 billion as the company surged from a year earlier when the Covid pandemic was hitting the retail industry the hardest. The region’s sales were up 29% on a two-year basis.

In Greater China, sales were up just 17% at $1.93 billion. Typically one of the fastest-growing markets for Nike, consumers in China have threatened a boycott after some Western brands like Nike expressed concern about allegations of forced labor in Xinjiang.

Digital sales were up 41% compared with the prior year, and rose 147% compared with the same period in 2019.

“Fueled by our momentum, we continue to invest in innovation and our digital leadership to set the foundation for Nike’s long-term growth,” said Nike CEO John Donahoe.

Find the full earnings press release from Nike here.

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Federal Reserve gives U.S. banks a thumbs up as all 23 lenders easily pass 2021 stress test

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The Federal Reserve announced Thursday that the biggest U.S. banks could easily withstand a severe recession, a milestone for the once-beleaguered industry.

The Fed, in releasing the results of its annual stress test, said that all 23 institutions in the 2021 exam remained “well above” minimum required capital levels during a hypothetical economic downturn.

That scenario included a “severe global recession” that hits commercial real estate and corporate debt holders and peaks at 10.8% unemployment and a 55% drop in the stock market, the Fed said. While the industry would post $474 billion in losses, loss-cushioning capital would still be more than double the minimum required levels, the Fed said.

If there was an anticlimactic note to this year’s stress test, it’s because the industry underwent a real-life version in the past year when the coronavirus pandemic struck, leading to widespread economic disruption. Thanks to help from lawmakers and the Fed itself, banks fared extremely well during the pandemic, stockpiling capital for expected loan losses that mostly didn’t materialize.

Nevertheless, during the pandemic, banks had to undergo extra rounds of stress tests and had restrictions imposed on their ability to return capital to shareholders in the form of dividends and buybacks. Those will now be lifted, as the Fed has previously stated.

“Over the past year, the Federal Reserve has run three stress tests with several different hypothetical recessions and all have confirmed that the banking system is strongly positioned to support the ongoing recovery,” Vice Chair for Supervision Randal K. Quarles said in a statement.

Dividend increases and buybacks coming

After passing this latest exam, the industry will regain a measure of autonomy it lost since the last crisis. After playing a key role in the 2008 financial crisis, banks were forced to undergo the industry exam, and had to ask regulators for permission to boost dividends and repurchase shares.

Now, under something called the stress capital buffer framework, banks will gain flexibility in how they want to dole out dividends and buybacks. The stress capital buffer is a measure of capital each firm needs to carry based on the riskiness of their operations. The new regime was supposed to start last year, but the pandemic intervened.

“So long as they stay above that stress capital buffer requirement and all their other requirements every quarter, a bank can technically do whatever it chooses to do with regards to buybacks and dividends,” Jefferies bank analyst Ken Usdin told CNBC this week.

During a background call with reporters, senior Fed officials pushed back against the idea that the new regime resulted in a free-for-all. Banks are still subject to restrictions, and the Fed is confident that the stress capital buffer framework will protect their ability to support the economy during a downturn, they said.

While analysts have said they expect the industry can hike buybacks and dividends by tens of billions of dollars starting in July, the Fed has instructed lenders to wait until Monday afternoon to disclose their plans, according to people with knowledge of the situation. That’s when a flurry of press releases is expected.

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