Target to $180 from $135
Friday, January 21, 2022
Applied DNA Requests Emergency Use for At-Home Test Kit
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, announced today that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), has submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for its Linea™ 2.0 COVID-19 Assay (the "Linea 2.0 Assay") and Linea™ Unsupervised At-Home Sample Collection Kit (the "Linea Collection Kit").
If approved, the Company’s request for EUA positions ADCL to pursue an expansion of its established safeCircle™ COVID-19 testing platform nationally to meet the needs of enterprises seeking to protect workforce health and avoid disruptions to operations by mass staff absences due to Omicron’s high transmissibility and ability to evade vaccination immunity. ADCL's safeCircle program is a fully integrated testing platform for enterprise and educational institutions that provides a full range of COVID-19 diagnostic testing and associated services, including sample collection, test site infrastructure design and management, results tracking, and vaccination status management.
The Linea 2.0 Assay is a high-throughput multiplex RT-PCR assay targeting the E and N genes of SARS-CoV-2. The Assay is variant agnostic, can detect all known SARS-CoV-2 variants, and is validated for single sample and robotic pooled testing. The Assay previously received conditional approval from the New York State Department of Health in late December 2021. The Linea Collection Kit is designed to enable the simple self-collection of nasal swab specimens without supervision by medical personnel. Once collected, individual samples can be mailed directly back to ADCL or aggregated by a testing client and bulk shipped back to ADCL. Results are typically returned within 24-to-48 hours of a sample’s arrival at ADCL’s clinical lab.
Thursday, January 20, 2022
‘Some people may not make it’: athletes risk failing Beijing COVID-19 tests – IOC
Strict COVID-19 testing requirements for the Beijing Winter Olympics could see more athletes from high-risk Omicron regions banned from participating, but the system in place will be as flexible as possible, an Olympic medical adviser told Reuters.
Experts have warned that China’s strict “zero-COVID” strategy, as well as its more sensitive testing protocols, could see more athletes excluded from the Games scheduled to take place between Feb. 4 and Feb. 20 – especially from regions that have seen a spike in the highly infectious Omicron variant.
“Some people might not make it, but we are trying to put in place ways in which they can prove with extra testing that although they did have Omicron, they are no longer infectious and can be allowed into China,” said Brian McCloskey, a member of the International Olympic Committee’s Medical Expert Panel advising on health measures.
“But it is the countries that saw the early spike in cases that will be the most engaged with it (the testing system),” he told Reuters.
The Games will proceed in a “closed loop” that will keep overseas athletes from mingling with the Chinese population, and China has also as a precaution restricted spectator ticket allocations.
While some countries are trying to manage the transition from “pandemic” to “endemic”, China has focused on stamping out new transmission chains as soon as they arise.
That involves a stringent quarantine policy, city-wide lockdowns and mass testing programmes that kick in as soon as any outbreaks occur, and hosting the Winter Olympics is a major test, said McCloskey.
“They are taking a risk on their zero-COVID strategy that they wouldn’t have had to take if they didn’t have the Olympics,” he said.
Still, the handling of Swiss snowboarder Patrizia Kummer, who is not vaccinated, shows that China is showing some flexibility, with the athlete allowed to quarantine for three weeks instead, McCloskey added.
The risks of hosting international sports events during the pandemic have come under fresh scrutiny this week after Australia deported the unvaccinated tennis star Novak Djokovic on Sunday for violating the country’s COVID-19 entry rules.
McCloskey said that while COVID-19 was a particular challenge, public health risks have long been a major concern for Olympic organisers, with the Zika virus also testing organisers in Brazil in 2016.
“My expectation is that we will not be dealing with COVID in the same way for 2024,” he said. “But we will have to have surveillance systems in place to make sure that should anything happen either in the build up to the games or during them, that we will recognise it very quickly and respond very quickly.”
Omicron highlights fading hope of herd immunity
As Omicron spread quickly across the globe, some experts had hoped there could be a silver lining – that it would help finally deliver the promise of herd immunity against Covid-19.
But herd immunity – in which enough people become immune to a virus through vaccination or infection – won’t come with Omicron, experts now say, as the variant has proven even better than its predecessors at infecting people who were vaccinated or had a prior infection.
“A really unanticipated challenge I think is how quickly the virus has mutated in ways that are relevant for the immune system.”
Erin Mordecai is an Associate Professor of Biology at Stanford University.
“We thought it could have been possible in the longer term, but I think most people didn't expect, most scientists didn't expect to see those immune evading variants arising so quickly."
Experts say Omicron has provided further evidence that the coronavirus will continue to find ways to break through our immune defenses.
Dr. David Wohl is an infectious disease specialist at the University of North Carolina School of Medicine in Chapel Hill.
“And so that reinfection as well causes us some concerns because it means even if you don't get sick, you can still transmit it to others. And given the way that these viruses are spreading and there's such a sizable population that can get infected and get ill, that's just too concerning for us."
Instead of herd immunity, many experts interviewed by Reuters said there was growing evidence that vaccines and prior infection would still provide the population some level of immunity - making the disease less serious for those who get infected, or reinfected.
ERIN MORDECAI: “And so I think the coronavirus, some form of SARS-CoV-2 is likely to be with us for the long term, but hopefully we'll see outbreaks that are more moderated, that have less hospitalization and death and that are more seasonal and kind of associated with the cold and flu season."
While hope for herd immunity is still hard for many to shake, health experts say there’s a future where COVID, while not eradicated, is more of a manageable challenge and less of a crisis.
https://www.yahoo.com/now/omicron-highlights-fading-hope-herd-154140530.html
Decoy vesicles protect against COVID-19 from coronavirus variants in mice
Evolving variants of the SARS-CoV-2 coronavirus are threatening the efficacy of existing COVID-19 vaccines and therapeutics. Now, a group of scientists from Northwestern University and the University of Texas MD Anderson Cancer Center showed that some naturally occurring tiny vesicles isolated from COVID-19 patients could fight off an infection from various subtypes of coronaviruses.
The team identified tiny cell-released lipid particles that expressed a protein called ACE2 from COVID-19 patients’ blood. These circulating extracellular vesicles that express ACE2 (evACE2) blocked infections from different coronavirus variants in lab dishes. Delivered via the nose, the nanoparticles also protected mice from COVID-19. The results were published in Nature Communications.
The researchers believe evACE2 could be developed as a biological product for prevention and treatment of COVID-19 caused by current and future SARS-CoV-2 variants and potentially other coronaviruses as well. Two of the studies’ co-senior authors, Huiping Liu, M.D., Ph.D., and Deyu Fang, Ph.D., at Northwestern University have formed a startup company, Exomira, to pursue that idea. They are currently looking for industry partners to develop the therapy.
The team’s optimism is based on evACE2’s mechanism. SARS-CoV-2, the coronavirus behind the ongoing pandemic, uses the spike (S) protein on its surface to bind to ACE2 on human cells to gain entry and achieve infection. But evACE2, thanks to its strong binding ability, can act as a decoy to lure the virus away from human cells.
The researchers noted the ACE2-expressing extracellular vesicles in blood samples of COVID patients but not in healthy controls. The more severe the disease, the higher the levels of evACE2 detected, suggesting that the production is part of the natural response to an infection in COVID patients.
In lab dishes, evACE2 blocked coronavirus S protein binding to human cells and was 120 to 135 times more efficient than recombinant human ACE2, which has been proposed as potential COVID treatment, the team showed.
By using SARS-CoV-2 pseudoviruses, the researchers showed evACE2 could neutralize the viruses, protecting human cells from infections, while control vesicles without ACE2 expression showed no activity. Similarly, upon SARS-CoV-2 infection, the addition of evACE2 decreased viral loads and stopped the loss of viable human cells, whereas control vesicles failed to do so.
What’s more important, evACE2 showed comparable or greater efficacy in blocking the infection of pseudoviruses mimicking the alpha, beta and delta variants when compared with the original SARS-CoV-2 virus.
The researchers then tested evACE2 in a well-established COVID-19 mouse model with human ACE2 expression. Within a week of a high dose infection, nearly all mice showed severe disease with over 20% weight loss when treated with control vesicles. By comparison, treatment with nasal evACE2 protected 80% of animals, with a significant reduction of viral load detected in lung tissues.
Existing COVID vaccines and antibody drugs are being challenged by emerging coronavirus variants. A fourth dose of the Pfizer-BioNTech vaccine, Comirnaty, couldn’t protect healthcare workers from infection by the rapid-spreading omicron variant despite the shot being able to trigger increased antibodies, preliminary findings from a real-world study in Israel showed.
The U.S. government in December paused distribution of COVID-19 antibody drugs from Eli Lilly and Regeneron, citing their reduced efficacy against omicron.
evACE2 holds the potential to avoid that pitfall. Almost all existing vaccines and antibody therapies target the S protein, but SARS-CoV-2's variants include mutations to the S protein. Despite the mutation, the coronavirus still needs the ACE2 receptor to infect human cells. By competing with host cell surface ACE2, evACE2 can theoretically act as a bait to attract coronavirus away, regardless of the S protein mutations.
“It remains urgent to identify novel therapeutics,” Northwestern’s Liu said in a statement. “We think evACE2 can meet the challenges and fight against broad strains of SARS-CoV-2 and future emerging coronaviruses to protect the immunocompromised (at least 2.7% of U.S. adults), the unvaccinated (94% in low-income countries and more than 30% in the U.S.) and even the vaccinated from breakthrough infections.
SIEMENS HEALTHINEERS : Goldman Sachs raises its recommendation from Sell to Buy
Goldman Sachs upgrades his rating from Sell to Buy. The target price remains set at EUR 76
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