Analyst David Risinger reiterated Overweight rating and $217.00 price target.
Saturday, March 6, 2021
COVID Tester Fulgent Higher on Earnings Beat and Guidance
Fulgent Genetics (FLGT) - Get Report shares were higher on Friday after the provider of large-scale COVID-19 testing services, beat Wall Street's fourth-quarter earnings expectations.
Shares of the Temple City, Calif., company at last check were rising 2.4% to $87.57.
Fulgent Genetics swung to adjusted earnings of $6.20 a share from a loss of 4 cents in the year-earlier period. The FactSet consensus called for earnings of $3.94 a share.
Revenue totaled $295 million, up from $8.4 million a year earlier and beating the FactSet consensus of $199.5 million.
The company delivered about 2 million billable tests in the quarter.
Looking ahead, company expects to generate revenue of at least $325 million in the first quarter.
It forecasts full-year 2021 revenue of about $800 million, growth of 90% from 2020.
FactSet's consensus calls for first-quarter revenue of $287.9 million and full-year revenue of $708.6 million.
Fulgent Genetics expects about $70 million of 2021's sales to come from next-generation-sequencing testing, with the remaining $730 million coming from non-NGS testing.
NGS technology is a genetic testing technique that enables millions of DNA fragments to be sequenced in parallel, which the company said has dramatically lowered the cost and improved the quality of genetic testing.
"While we did not envision 2020 to unfold in the way that it did, I am proud of our team for supporting the pivot of our business to rapidly scale to become one of the top providers of COVID-19 testing in the country," Ming Hsieh, chairman and CEO, said in a statement.
Hsieh said that although the majority of the company's business was "from COVID-19 testing, we believe we have laid a very strong foundation for continued growth in the years ahead."
In December, the company said that it had extended its contract to provide daily COVID-19 testing to New York City public-school students throughout the 2021 school year.
https://www.thestreet.com/investing/fulgent-genetics-stock-higher-on-earnings-beat-and-outlook
Awareness of delayed skin reactions to Moderna COVID vaccine urged
As the speed and scale of vaccinations against the SARS-CoV-2 virus ramps up globally, researchers at Massachusetts General Hospital (MGH) are calling for greater awareness and communication around a delayed injection-site reaction that can occur in some patients who have received the Moderna mRNA-1273 vaccine.
In a letter to the editor published online in The New England Journal of Medicine (NEJM), the authors note Phase 3 clinical data from the Moderna vaccine trial did show delayed skin hypersensitivity in a small number of the more than 30,000 trial participants. However, the authors say the large, red, sometimes raised, itchy or painful skin reactions were never fully characterized or explained, and they warn clinicians may not be prepared to recognize them and guide patients on treatment options and completion of the second dose of the vaccine.
"Whether you've experienced a rash at the injection site right away or this delayed skin reaction, neither condition should prevent you from getting the second dose of the vaccine," says Kimberly Blumenthal, MD, MSc, lead author of the letter and co-director of the Clinical Epidemiology Program in the division of Rheumatology, Allergy and Immunology at MGH. "Our immediate goal is to make physicians and other care providers aware of this possible delayed reaction, so they are not alarmed, but instead well-informed and equipped to advise their patients accordingly."
In the letter, Blumenthal and her co-authors also note their own clinical observations of the delayed, large, local reactions to the Moderna vaccine, and report on a series of 12 patients with the reactions. In that group, symptom onset ranged from four days after the first dose up to 11 days post-vaccination, with a median onset of symptoms on day eight. Photographs show the varied size and severity of the reactions. Most patients were treated with ice and antihistamines, although some required corticosteroids and one was erroneously treated with antibiotics.
"Delayed cutaneous hypersensitivity could be confused - by clinicians and patients alike - with a skin infection," says letter co-author Erica Shenoy, MD, PhD, associate chief of the MGH Infection Control Unit. "These types of reactions, however, are not infectious and thus should not be treated with antibiotics."
On average, symptoms cleared up after nearly a week for the group of 12 reported in the letter. Half of the patients went on to experience a reaction after the second dose - at or around 48 hours post-vaccination. No patient experienced a dose two reaction that was more severe than their dose one reaction.
The authors also say samples taken from skin biopsies confirmed their suspicion of a delayed allergic immune response that is commonly seen in drug reactions.
"For most people who are experiencing this, we believe it's tied to the body's immune system going to work," says Esther Freeman, MD, PhD, director of Global Health Dermatology at MGH and co-author of the NEJM letter. "Overall, this data is reassuring and should not discourage people from getting the vaccine."
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To learn more about potentially allergic reactions after COVID-19 vaccination, MGH Allergy is collecting all immediate and delayed reactions in a designated registry.
Additional co-authors of the NEJM letter were Aleena Banerji, MD, Ruth Foreman, MD, PhD, Dean Hashimoto, MD, Lacey Robinson, MD, MPH, Rebecca Saff, MD, and Anna Wolfson, MD, all from MGH; Lily Li, MD, of Brigham and Women's Hospital; and Sara Anvari, MD, MSc, Baylor College of Medicine, Texas Children's Hospital.
https://www.eurekalert.org/pub_releases/2021-03/mgh-rug030321.php
When more Covid-19 data doesn't equal more understanding
Since the start of the Covid-19 pandemic, charts and graphs have helped communicate information about infection rates, deaths, and vaccinations. In some cases, such visualizations can encourage behaviors that reduce virus transmission, like wearing a mask. Indeed, the pandemic has been hailed as the breakthrough moment for data visualization.
But new findings suggest a more complex picture. A study from MIT shows how coronavirus skeptics have marshalled data visualizations online to argue against public health orthodoxy about the benefits of mask mandates. Such "counter-visualizations" are often quite sophisticated, using datasets from official sources and state-of-the-art visualization methods.
The researchers combed through hundreds of thousands of social media posts and found that coronavirus skeptics often deploy counter-visualizations alongside the same "follow-the-data" rhetoric as public health experts, yet the skeptics argue for radically different policies. The researchers conclude that data visualizations aren't sufficient to convey the urgency of the Covid-19 pandemic, because even the clearest graphs can be interpreted through a variety of belief systems.
"A lot of people think of metrics like infection rates as objective," says Crystal Lee. "But they're clearly not, based on how much debate there is on how to think about the pandemic. That's why we say data visualizations have become a battleground."
The research will be presented at the ACM Conference on Human Factors in Computing Systems in May. Lee is the study's lead author and a PhD student in MIT's History, Anthropology, Science, Technology, and Society (HASTS) program and MIT's Computer Science and Artificial Intelligence Laboratory (CSAIL), as well as a fellow at Harvard University's Berkman Klein Center for Internet and Society. Co-authors include Graham Jones, a Margaret MacVicar Faculty Fellow in Anthropology; Arvind Satyanarayan, the NBX Career Development Assistant Professor in the Department of Electrical Engineering and Computer Science and CSAIL; Tanya Yang, an MIT undergraduate; and Gabrielle Inchoco, a Wellesley College undergraduate.
As data visualizations rose to prominence early in the pandemic, Lee and her colleagues set out to understand how they were being deployed throughout the social media universe. "An initial hypothesis was that if we had more data visualizations, from data collected in a systematic way, then people would be better informed," says Lee. To test that hypothesis, her team blended computational techniques with innovative ethnographic methods.
They used their computational approach on Twitter, scraping nearly half a million tweets that referred to both "Covid-19" and "data." With those tweets, the researchers generated a network graph to find out "who's retweeting whom and who likes whom," says Lee. "We basically created a network of communities who are interacting with each other." Clusters included groups like the "American media community" or "antimaskers." The researchers found that antimask groups were creating and sharing data visualizations as much as, if not more than, other groups.
And those visualizations weren't sloppy. "They are virtually indistinguishable from those shared by mainstream sources," says Satyanarayan. "They are often just as polished as graphs you would expect to encounter in data journalism or public health dashboards."
"It's a very striking finding," says Lee. "It shows that characterizing antimask groups as data-illiterate or not engaging with the data, is empirically false."
Lee says this computational approach gave them a broad view of Covid-19 data visualizations. "What is really exciting about this quantitative work is that we're doing this analysis at a huge scale. There's no way I could have read half a million tweets."
But the Twitter analysis had a shortcoming. "I think it misses a lot of the granularity of the conversations that people are having," says Lee. "You can't necessarily follow a single thread of conversation as it unfolds." For that, the researchers turned to a more traditional anthropology research method -- with an internet-age twist.
Lee's team followed and analyzed conversations about data visualizations in antimask Facebook groups -- a practice they dubbed "deep lurking," an online version of the ethnographic technique called "deep hanging out." Lee says "understanding a culture requires you to observe the day-to-day informal goings-on -- not just the big formal events. Deep lurking is a way to transpose these traditional ethnography approaches to digital age."
The qualitative findings from deep lurking appeared consistent with the quantitative Twitter findings. Antimaskers on Facebook weren't eschewing data. Rather, they discussed how different kinds of data were collected and why. "Their arguments are really quite nuanced," says Lee. "It's often a question of metrics." For example, antimask groups might argue that visualizations of infection numbers could be misleading, in part because of the wide range of uncertainty in infection rates, compared to measurements like the number of deaths. In response, members of the group would often create their own counter-visualizations, even instructing each other in data visualization techniques.
"I've been to livestreams where people screen share and look at the data portal from the state of Georgia," says Lee. "Then they'll talk about how to download the data and import it into Excel."
Jones says the antimask groups' "idea of science is not listening passively as experts at a place like MIT tell everyone else what to believe." He adds that this kind of behavior marks a new turn for an old cultural current. "Antimaskers' use of data literacy reflects deep-seated American values of self-reliance and anti-expertise that date back to the founding of the country, but their online activities push those values into new arenas of public life."
He adds that "making sense of these complex dynamics would have been impossible" without Lee's "visionary leadership in masterminding an interdisciplinary collaboration that spanned SHASS and CSAIL."
Combining computational and anthropological insights led the researchers to a more nuanced understanding of data literacy. Lee says their study reveals that, compared to public health orthodoxy, "antimaskers see the pandemic differently, using data that is quite similar. I still think data analysis is important. But it's certainly not the salve that I thought it was in terms of convincing people who believe that the scientific establishment is not trustworthy." Lee says their findings point to "a larger rift in how we think about science and expertise in the U.S." That same rift runs through issues like climate change and vaccination, where similar dynamics often play out in social media discussions.
To make these results accessible to the public, Lee and her collaborator, CSAIL PhD student Jonathan Zong, led a team of seven MIT undergraduate researchers to develop an interactive narrative where readers can explore the visualizations and conversations for themselves.
Lee describes the team's research as a first step in making sense of the role of data and visualizations in these broader debates. "Data visualization is not objective. It's not absolute. It is in fact an incredibly social and political endeavor. We have to be attentive to how people interpret them outside of the scientific establishment."
This research was funded, in part, by the National Science Foundation and the Social Science Research Council.
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Paper: "Viral Visualizations: How Coronavirus Skeptics Use Orthodox Data Practices to Promote Unorthodox Science Online"
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https://www.eurekalert.org/pub_releases/2021-03/miot-wmc030421.php
New evidence COVID-19 antibodies, vaccines less effective against variants
New research at Washington University School of Medicine in St. Louis indicates that three new, fast-spreading variants of the virus that cause COVID-19 can evade antibodies that work against the original form of the virus that sparked the pandemic. With few exceptions, whether such antibodies were produced in response to vaccination or natural infection, or were purified antibodies intended for use as drugs, the researchers found more antibody is needed to neutralize the new variants.
The findings, from laboratory-based experiments and published March 4 in Nature Medicine, suggest that COVID-19 drugs and vaccines developed thus far may become less effective as the new variants become dominant, as experts say they inevitably will. The researchers looked at variants from South Africa, the United Kingdom and Brazil.
"We're concerned that people whom we'd expect to have a protective level of antibodies because they have had COVID-19 or been vaccinated against it, might not be protected against the new variants," said senior author Michael S. Diamond, MD, PhD, the Herbert S. Gasser Professor of Medicine. "There's wide variation in how much antibody a person produces in response to vaccination or natural infection. Some people produce very high levels, and they would still likely be protected against the new, worrisome variants. But some people, especially older and immunocompromised people, may not make such high levels of antibodies. If the level of antibody needed for protection goes up tenfold, as our data indicate it does, they may not have enough. The concern is that the people who need protection the most are the ones least likely to have it."
The virus that causes COVID-19, known as SARS-CoV-2, uses a protein called spike to latch onto and get inside cells. People infected with SARS-CoV-2 generate the most protective antibodies against the spike protein.
Consequently, spike became the prime target for COVID-19 drug and vaccine developers. The three vaccines authorized by the Food and Drug Administration (FDA) for emergency use in the U.S. -- made by Pfizer/BioNTech, Moderna and Johnson & Johnson -- both target spike. And potent anti-spike antibodies were selected for development into antibody-based drugs for COVID-19.
Viruses are always mutating, but for nearly a year the mutations that arose in SARS-CoV-2 did not threaten this spike-based strategy. Then, this winter, fast-spreading variants were detected in the United Kingdom, South Africa, Brazil and elsewhere. Sparking concern, the new variants all carry multiple mutations in their spike genes, which could lessen the effectiveness of spike-targeted drugs and vaccines now being used to prevent or treat COVID-19. The most worrisome new variants were given the names of B.1.1.7 (from the U.K.), B.1.135 (South Africa) and B.1.1.248, also known as P.1 (Brazil).
To assess whether the new variants could evade antibodies made for the original form of the virus, Diamond and colleagues, including first author Rita E. Chen, a graduate student in Diamond's lab, tested the ability of antibodies to neutralize three virus variants in the laboratory.
The researchers tested the variants against antibodies in the blood of people who had recovered from SARS-CoV-2 infection or were vaccinated with the Pfizer vaccine. They also tested antibodies in the blood of mice, hamsters and monkeys that had been vaccinated with an experimental COVID-19 vaccine, developed at Washington University School of Medicine, that can be given through the nose. The B.1.1.7 (U.K.) variant could be neutralized with similar levels of antibodies as were needed to neutralize the original virus. But the other two variants required from 3.5 to 10 times as much antibody for neutralization.
Then, they tested monoclonal antibodies: mass-produced replicas of individual antibodies that are exceptionally good at neutralizing the original virus. When the researchers tested the new viral variants against a panel of monoclonal antibodies, the results ranged from broadly effective to completely ineffective.
Since each virus variant carried multiple mutations in the spike gene, the researchers created a panel of viruses with single mutations so they could parse out the effect of each mutation. Most of the variation in antibody effectiveness could be attributed to a single amino acid change in the spike protein. This change, called E484K, was found in the B.1.135 (South Africa) and B.1.1.248 (Brazil) variants, but not B.1.1.7 (U.K.). The B.1.135 variant is widespread in South Africa, which may explain why one of the vaccines tested in people was less effective in South Africa than in the U.S., where the variant is still rare, Diamond said.
"We don't exactly know what the consequences of these new variants are going to be yet," said Diamond, also a professor of molecular microbiology and of pathology & immunology. "Antibodies are not the only measure of protection; other elements of the immune system may be able to compensate for increased resistance to antibodies. That's going to be determined over time, epidemiologically, as we see what happens as these variants spread. Will we see reinfections? Will we see vaccines lose efficacy and drug resistance emerge? I hope not. But it's clear that we will need to continually screen antibodies to make sure they're still working as new variants arise and spread and potentially adjust our vaccine and antibody-treatment strategies."
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The research team also included co-corresponding author Ali Ellebedy, PhD, an assistant professor of pathology & immunology, of medicine, and of molecular microbiology at Washington University; and co-corresponding author Pei-Yong Shi, PhD, and co-first author Xianwen Zhang, PhD, of the University of Texas Medical Branch.
https://www.eurekalert.org/pub_releases/2021-03/wuso-nec030421.php
Legal wildlife trade needs monitoring to cut risk of new pandemic
With three out of four newly emerging infectious human diseases originating in animals*, there is an urgent need to monitor the legal trade in wildlife, according to new research by Vincent Nijman, Professor in Anthropology at Oxford Brookes University.
Professor Nijman, who has been involved in monitoring and regulating the legal wildlife trade for over two decades, said: "Covid-19 more than anything else has put a spotlight on emerging infectious diseases and how this is linked to the trade in wild animals. Few people are aware of its scale. With literally hundreds of millions of live wild animals being shipped around the world each year, it seems unlikely that diseases are spread through illegal channels only. After all, parasites, bacteria and viruses do not read legal documents or check if they have received the correct stamp."
Dangerous to only focus on illegal wildlife trade
The illegal wildlife trade is often seen as one of the major gateways to zoonotic diseases, that spread from animals to humans. While the illegal trade in tigers, ivory, rhino horn, pangolins and primates is of paramount concern for public health, Professor Nijman says the legal wildlife trade should be of equal concern: "Given that in many instances the legal wildlife trade is several orders of magnitude larger than the illegal trade, it is ineffective and possibly dangerous to focus on the illegal wildlife trade only."
Lack of hygiene in wet markets could drive infection transmission
The Covid-19 pandemic threw attention onto wet markets, now associated closely with zoonotic diseases. But in the wet market of Wuhan, the vast majority of non-domesticated animals (crocodiles, bats, civets, bamboo rats) were legally offered for sale. Professor Nijman notes that "a lack of appropriate hygiene conditions (handwashing, sanitation, separation of wildlife and their parts), make wildlife markets drivers for the transmission of infections."
Dr Chris R. Shepherd, an expert on wildlife trade and the Executive Director of the Monitor Conservation Research Society added: "This study clearly illustrates that there are incredibly serious risks associated with the trade in wildlife, regardless of whether the species involved are traded legally or illegally.
"Clearly the risk of spreading harmful zoonotic disease must be considered when regulating the trade in wildlife, and much more research and preventative measures are essential if we are to avoid further pandemics."
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The study, Illegal and legal wildlife trade spread zoonotic diseases is published in the journal Trends in Parasitology.
https://www.eurekalert.org/pub_releases/2021-03/obu-lwt030421.php
Medical equipment services provider Agiliti files for a $100 million IPO
Agiliti, which provides medical equipment rental and maintenance services, filed on Friday with the SEC to raise up to $100 million in an initial public offering.
Agiliti believes it is one of the leading experts in the management, maintenance, and mobilization of medical devices, offering a comprehensive suite of medical equipment management and service solutions. Its customer base includes approximately 7,000 active national, regional, and local acute care hospitals, health system integrated delivery networks, and alternate site providers. The company delivers its solutions through its nationwide network of 98 service centers and 7 Centers of Excellence. Its fees are paid directly by its customers rather than by direct reimbursement from third-party payors.
Formerly Agiliti Health, Agiliti's holding company merged with Thomas H. Lee Partners' SPAC Federal Street Acquisition (FSAC) in 2019 to form Agiliti, Inc. FSAC and Agiliti waived the closing condition that would have required Agiliti to be listed on the Nasdaq following the merger, and as such, Agiliti was not be listed at closing of the transaction.
The Minneapolis, MN-based company was founded in 1939 and booked $773 million in revenue for the 12 months ended December 31, 2020. It plans to list on the NYSE under the symbol AGTI. BofA Securities, Goldman Sachs, Morgan Stanley, BMO Capital Markets, Citi, Jefferies, and UBS Investment Bank are the joint bookrunners on the deal. No pricing terms were disclosed.
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