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Summit, Colorado Center for Personalized Medicine to Develop Saliva Tests for COVID, Head & Neck Cancer

AURORA, Colo., Oct. 14, 2020 /PRNewswire/ — Summit Biolabs, Inc., an early-stage molecular diagnostics company specializing in saliva-based testing for COVID-19 and head & neck cancer, and the Colorado Center for Personalized Medicine (CCPM) at the University of Colorado Anschutz Medical Campus announced today a broad strategic collaboration involving research, development and commercialization of saliva liquid-biopsy tests for early cancer detection and diagnosis of COVID-19 and other viral contagions.

The CCPM holds one of the largest research biobanks in the United States with clinical data from more than 8.7 million de-identified patient records and plans to integrate the data with personalized genomic information.

“This partnership brings two innovative programs together to optimize COVID testing at a time when it’s desperately needed,” says Kathleen Barnes, Ph.D., Professor and Director of CCPM at the University of Colorado Anschutz Medical Campus. “Collaborations like this are crucial in moving research forward and advancing and expanding clinical testing to as many members of our community as possible. Working with Summit Biolabs, and leveraging technology developed by our colleagues here at the Anschutz Medical Campus, will help us achieve these goals and establish a non-invasive testing process that will benefit patients in Colorado and beyond.”

Summit Biolabs is developing breakthrough tests to improve the detection of COVID-19 and to advance the early detection of human cancers, including head & neck cancer, using simple, non-invasive saliva liquid-biopsy technology developed by Dr. Shi-Long Lu and colleagues at the University of Colorado Anschutz Medical Campus. Head & neck cancer has been scientifically overlooked, yet is medically important. Summit Biolabs’ research foundation and competency in head & neck cancer diagnosis enabled the company’s pivot to saliva-based testing for coronavirus, COVID-19.

“We are excited to collaborate with CCPM to develop and commercialize Summit Biolabs’ portfolio of developmental saliva or non-blood liquid-biopsy tests.” said Bob Blomquist, Chief Executive Officer at Summit Biolabs. “This collaboration broadens and strengthens Summit Biolabs’ ability to bring to market life-changing saliva liquid-biopsy tests that ultimately enable better treatment and improved outcomes for patients.”

About Summit Biolabs

Summit Biolabs is harnessing the power of saliva-based diagnostics to address critical challenges in COVID-19 and head & neck cancer testing. Founded on the discoveries of Dr. Shi-Long Lu, Associate Professor of Otolaryngology, Summit Biolabs is being spun out from the University of Colorado Anschutz Medical Campus.

Summit Biolabs is pioneering early detection of head & neck cancer recurrence using a first of its kind saliva liquid-biopsy test, HNKlear. HNKlear is a proprietary, non-invasive saliva test that provides more effective, more accurate, and earlier detection of head and neck cancer recurrence than traditional diagnostic methods. Summit Biolabs is leveraging its core competencies in saliva-based molecular diagnostics and viral nucleic acid testing (i.e., oral oncogenic human papillomavirus detection) to diagnose COVID-19. Along with our clinical and laboratory partners, Summit Biolabs is developing the first comprehensive panel of highly-accurate saliva-based tests for COVID-19 infection, quantitation, and immune response. Summit Biolabs is headquartered in Aurora, Colorado.

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Council Rock North Shuts Down Athletics Amid Rising COVID Cases

NEWTOWN, PA — All athletics and activity programs for Council Rock North High School students are shut down until further notice, Principal Susan C. McCarthy told parents in an email Tuesday afternoon.

The move comes one day after the high school decided to cancel in-person classes for the week after three students reportedly tested positive for COVID-19.

Superintendent Robert Fraser’s decision to close the school went against the advice of Bucks County Health Director David Damsker, who did not recommend closing school.

The health department will only recommend closing a school when there is a clear indication that the district’s health and safety plan isn’t working, Damsker told Patch, and there’s no evidence at this point that transmission is happening within schools.

“School closures are very disruptive and don’t help stop people from getting sick outside of school,” Damsker said. “If people continue to have parties and gather, closing school won’t stop any of that from occurring.”

In a follow-up email sent late Tuesday afternoon, McCarthy said two people “from our Council Rock High School North community” reported testing positive for COVID-19, bringing the total number of cases this week to five.

The district is working with the Bucks County Department of Health to identify close contacts of the individuals who tested positive as part of the contact tracing process, she added.

“As always, please continue to monitor your health and that of your children,” McCarthy said. “If you notice a fever, cough, shortness of breath, or other symptoms of COVID-19, please remain home and contact your medical provider. Moreover, if you feel uncomfortable, you may keep your children home, and during this time your children may continue to access the classroom and curriculum through interactive livestream.”

Between Aug. 31 and Oct. 13, there have been 131 cases of COVID-19 throughout the 13 public school districts and private schools in Bucks County, Damsker said, with many of those cases linked to activities outside of school.

Parents or guardians concerned about family members are encouraged to contact their child’s physician or the county health department, she said.

This article originally appeared on the Newtown Patch

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Infection Control Problems Persist in Nursing Homes During COVID


The new analysis draws on self-reported data from nursing homes collected by the federal government over four weeks from late August to late September. While some states fared much worse than others, all 50 states and the District of Columbia had one or more nursing homes that reported inadequate PPE supply, staff shortages, staff infections and resident cases. Forty-seven states reported at least one COVID-19 death among residents.

The analysis found that more than 28,000 residents tested positive for COVID-19 during the four-week reporting period, and more than 5,200 residents died, showing that the virus is still raging in nursing homes. More than 84,000 long-term care residents and staff have died since January, and more than 500,000 residents and staff have contracted the disease, according to the Kaiser Family Foundation’s tally, accounting for roughly 40 percent of the national death toll. Long-term care providers include assisted living, adult day care centers and more, while AARP’s new analysis features just nursing home data.

“This is a nationwide crisis, and no state is doing a good job,” says Bill Sweeney, AARP’s senior vice president of government affairs, adding that the results of AARP’s analysis are “profoundly disappointing.”

“While the pandemic has been unexpected to all of us, basic infection control should have been going on in nursing homes for a long time,” he says. “These are places where people are vulnerable to infection, whether it’s COVID or something else, so for these facilities to still not have basic PPE, even now, with a deadly virus in the air, is outrageous and unacceptable.”

Staff infections nearly match resident infections

For months, providing adequate PPE and developing plans to mitigate staffing shortages have been “core principles” set out by the Centers for Disease Control and Prevention (CDC), for COVID-19 infection control in nursing homes, which generally house older adults with underlying conditions who are at increased risk of infection and severe illness from the disease. PPE stops the transfer of infectious droplets through the air, while adequate staffing ratios mean better care and less person-to-person contact.

Yet in 18 states, more than 30 percent of all nursing homes reported PPE shortages, and in 26 states and the District of Columbia, more than 30 percent of nursing homes are experiencing staff shortages. N95 respirators were the most in-demand PPE item across the country, with 11 percent of all nursing homes reporting shortages. And nursing home aides (certified nursing assistants, nurse aides, medication aides and medication technicians) were the most in-demand staff, with 27 percent of all nursing homes reporting shortages.


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COVID Cases Climbing in 36 States | Health News

By Robin Foster and E.J. Mundell
HealthDay Reporters

(HealthDay)

WEDNESDAY, Oct. 14, 2020 (HealthDay News) — Coronavirus outbreaks in the Midwest and Western United States have driven the national case count to its highest level since August, fueling fears of what the coming winter will mean for the country.

COVID-19 cases are starting to climb in 36 states, including parts of the Northeast, which is starting to backslide after months of progress, The New York Times reported. More than 820 new deaths and more than 54,500 new cases were announced across the country on Tuesday, the newspaper said. Idaho and Wisconsin set single-day records for new cases.

About 50,000 new cases are being reported each day in the United States for the week ending Monday, the Times reported. That is still less than in late July, when the country was seeing more than 66,000 cases each day.

But the trajectory is worsening, and experts fear what could happen as cold weather drives people indoors, where the virus can spread more easily, the newspaper said. The latest spike in cases shows up just before the increased mingling of people that comes with Halloween, Thanksgiving and Christmas.

Sixteen states each added more new cases in the seven-day period ending Monday than they had in any other weeklong stretch of the pandemic. North Dakota and South Dakota are reporting more new cases per person than any state has previously, the Times reported.

“A lot of the places being hit are Midwest states that were spared in the beginning,” William Hanage, a Harvard University infectious diseases researcher, told the Washington Post. “That’s of particular concern because a lot of these smaller regions don’t have the ICU beds and capacity that the urban centers had.”

COVID-19 hospitalizations have already begun rising in almost a dozen states, including Ohio and Pennsylvania, raising the probability that increasing death counts will soon follow, the Post reported.

Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, told CNN that he hopes the numbers “jolt the American public into a realization that we really can’t let this happen, because it’s on a trajectory of getting worse and worse.” He called the rising numbers “the worst possible thing that could happen as we get into the cooler months.”

It is unclear what is driving the climbing case count, but it could be the long-feared winter effect already taking place, or the reopening of businesses and schools, or just people letting down their guard on social distancing efforts, the Post reported.

Second COVID vaccine trial paused

A second coronavirus vaccine trial was paused this week after an unexplained illness surfaced in one of the trial’s volunteers.

Johnson & Johnson, which only began a phase 3 trial of its vaccine last month, did not offer any more details on the illness and did not say whether the sick participant had received the vaccine or a placebo. The trial pause was first reported by the health news website STAT

Med students on how COVID pushed them into action, highlighted health care inequities

It was on a Saturday in mid-March when Abby Schiff, then a third-year medical student at Harvard working through surgery clinical rotations, found out she wouldn’t be going back to the hospital.



a group of people on a sidewalk: Medical student Francis Wright (top left) during a mask drive early on in the pandemic with his classmates (clockwise) India Perez-Urbano, Kara Lau, Lane Epps, Ninad Bhat, Laeesha Cornejo and Hunter Jackson, the last of whom came up with the idea.


© Courtesy Francis Wright
Medical student Francis Wright (top left) during a mask drive early on in the pandemic with his classmates (clockwise) India Perez-Urbano, Kara Lau, Lane Epps, Ninad Bhat, Laeesha Cornejo and Hunter Jackson, the last of whom came up with the idea.

She had worked the day before, but with the coronavirus threat growing quickly, Schiff, like thousands of other medical students across the country, was sidelined when the Association of American Medical Colleges issued a temporary suspension of clinical rotations in hopes of protecting students and patients, and conserving personal protective equipment (PPE).

She didn’t sit around waiting, though. As nurses came out of retirement and medical school professors pressed pause on teaching to answer the call to action on the front lines, Schiff also got to work. Within hours, she and a group of other students started building a crash course on COVID-19 for medical professionals.

“At the time, a lot of Harvard medical students were talking about what was going on, and [it] felt like we suddenly had a lot of time on our hands,” Schiff told ABC News. “There was this crisis going on. How can we best contribute?”



a woman standing in front of a book shelf: Abby Schiff, a fourth-year medical student at Harvard Medical School, helped to create the school's COVID-19 curriculum and still keeps it updated on a regular basis.


© ABC News
Abby Schiff, a fourth-year medical student at Harvard Medical School, helped to create the school’s COVID-19 curriculum and still keeps it updated on a regular basis.

In less than a week, 70 of Schiff’s colleagues, including students and faculty, had put together a comprehensive, open-source COVID-19 curriculum.

“So we had about 80 pages of content — all referenced, all freely available — including things like thought questions, quiz questions… helpful information about how to put on masks and PPE, run ventilators,” she said. “And then also an explainer about basic epidemiological terms, about sort of the basics of virology and immunology and the clinical manifestations that were known at the time.”

Seven months later, the curriculum is still being updated with the latest science on a regular basis. Today, it includes modules on mental health, global health and communication, all meant to “dispel misinformation and myths,” said Schiff.



graphical user interface, application: Fourth-year Harvard medical student Abby Schiff (second from top left) attends a video meeting with her fellow students to discuss updates to their school's open-source COVID-19 curriculum.


© Courtesy Abby Schiff
Fourth-year Harvard medical student Abby Schiff (second from top left) attends a video meeting with her fellow students to discuss updates to their school’s open-source COVID-19 curriculum.

As co-chair for outreach, she said her role is to reach out to students and groups that are using the curriculum to get an idea of their needs and how they can best be met, as well as recruiting students to contribute. The curriculum has already been implemented in 32 medical schools across the country as either an elective or mandatory course, and it has been translated into 27 languages and used in at least 110 countries, Schiff said.

“It’s had a really wide reach, including in areas where

COVID fuels eating disorders, family stress

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Here are 4 tips on how to get your kids to wear masks during the coronavirus pandemic.

USA TODAY

Pediatricians and public health experts predict a potentially dramatic increase in childhood obesity this year as months of pandemic eating, closed schools, stalled sports and public space restrictions extend indefinitely.

About one in seven children have met the criteria for childhood obesity since 2016, when the federal National Survey of Children’s Health changed its methodology, a report out Wednesday by the Robert Wood Johnson Foundation found. 

While the percentage of children considered obese declined slightly in the last 10 years, it is expected to jump in 2020.

“We were making slow and steady progress until this,” said Diane Whitmore Schanzenbach, a Northwestern University economist and professor. “It’s likely we will have wiped out a lot of the progress that we’ve made over the last decade in childhood obesity.”

The trend, already seen in pediatric offices, is especially concerning as the Centers for Disease Control and Prevention this week expanded its definition of those at elevated risk of severe COVID-19 disease and death to include people with a body mass index of between 25 and 30. Previously, only those with a BMI 30 and higher were included. That could mean 72% of all Americans are at higher risk of severe disease based only on their weight.

Obesity is a top risk factor for nearly all of the chronic health conditions that make COVID-19 more dangerous, including diabetes, hypertension. heart disease and cancer. And childhood obesity is a leading predictor of obesity later in life.

BMI factors in weight and height to measure body fat. It can, however, overestimate body fat in people with muscular builds and underestimate it in those who have lost muscle, according to the National Institutes of Health. 

Children are “gaining not insignificant amounts of weight,” said Dr. Lisa Denike, who chairs pediatrics for Northwest Permanente in Portland, Oregon. “We’ve seen kids gain 10 to 20 pounds in a year, who may have had a BMI as a preteen in the 50 or 75th percentile and are now in the 95th percentile. That’s a significant crossing of percentiles into obesity.”

Eli Lilly and Johnson  Johnson have paused COVID-19 vaccine trials. Why experts say that’s reassuring, not frightening.

Denike said one 11-year-old patient at his recent physical was found to have gained 40 pounds. Type 2 diabetes rates in children are rising, and even though the boy doesn’t have it now, Denike said, “I suspect he will in the coming years as his parents already have it.”

“He’s home in an environment struggling with parents with same issues rather than learning in health class and having activity outside,” she said. “Kids are reflections of what their parents do.”

Racial, socioeconomic disparities  

Disparities in childhood obesity rates have existed for decades and now mirror the disproportionate way COVID-19 is affecting people of color and those with low incomes, said Jamie Bussel, a senior program officer at the Robert Wood Johnson

Anthony Fauci warns COVID surge as cases rise in north, weather cools

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Dr. Anthony Fauci says top U.S. college athletic programs and professional sports leagues are managing risks for COVID-19 infections far more professionally than the situation at the White House that led to President Donald Trump’s illness. (Oct. 6)

AP Domestic

The nation’s top infectious disease expert said the United States faces a “difficult situation” with a rise in positive coronavirus tests through a wide swath of northern states as the weather cools. 

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the share of positive coronavirus tests is increasing in the Northwest, Midwest and other northern states. 

The share of tests that detect the virus is a key indicator of whether the coronavirus is spreading or under control in a community. Public health officials want to see less than 3% of all tests return positive. An ideal rate is less than 1%, Fauci said Tuesday during a College of American Pathologists meeting.

“We’re starting to see a number of states well above that, which is often, and in fact invariably, highly predictive of a resurgence of cases,” Fauci said. A rise in the share of positive cases “we know leads to an increase in hospitalizations and then ultimately an increase in deaths.”

Data from the COVID Tracking Project shows 36 states have a higher rate of tests coming back positive than the previous week. Another 41 states have higher case counts in the past week compared to a week before, an analysis of Johns Hopkins University data shows.

As the fall weather cools and people spend more time indoors, public health experts hoped “we had rather good control over infection dynamics in the country,” Fauci said. “As a matter of fact, unfortunately, that’s not the case.”

Fauci said the nation is averaging between 40,000 and 50,000 new cases every day. The United States has reported more than 7.8 million cases and 215,085 deaths.

A USA TODAY analysis of Johns Hopkins data through late Monday shows 16 states set records for new cases in a week, while Kansas, North Dakota and South Dakota had a record number of deaths in a week. 

Fauci said shutting down the nation again to slow the virus’ spread is something “we do not want to do.” and urged Americans to commit to public health recommendations to slow SARS-CoV-2, the virus that causes COVID-19. People should wear masks, maintain a distance of at least six feet from others, avoid crowds and wash hands frequently.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, says a coronavirus vaccine could come earlier than expected. (Photo: AP)

The nation should know by the end of 2020 whether there is a safe and effective vaccine. With five vaccine candidates now in the late-stage clinical studies, Fauci said doses of any Food and Drug Administration-authorized vaccine could be shipped by the end of the year or early 2021, first to those who are most vulnerable.

And although the development has been speedy,

FDA faults quality control at Lilly plant making Trump-touted COVID drug

By Dan Levine and Marisa Taylor

(Reuters) – U.S. drug inspectors uncovered serious quality control problems at an Eli Lilly and Co pharmaceutical plant that is ramping up to manufacture one of two promising COVID-19 drugs touted by President Trump as “a cure” for the disease, according to government documents and three sources familiar with the matter.

The Lilly antibody therapy, which is experimental and not yet approved by regulators as safe and effective, is similar to a drug from Regeneron Pharmaceuticals that was given to the president during his bout with COVID-19.

Trump, who credits the Regeneron drug with speeding his recovery, has called for both therapies to become available immediately on an emergency basis, raising expectations among some scientists and policy experts that the administration will imminently release an Emergency Use Authorization (EUA) for the drug. The president’s push is key to his efforts to convince voters he has an answer to the pandemic that has killed more than 215,000 Americans.

But the findings by the U.S. Food and Drug Administration inspectors at the Lilly manufacturing facility, which have not been disclosed previously, could complicate the drugmaker’s bid for a so-called emergency use authorization (EUA) from the federal agency, two of the sources and two outside legal experts told Reuters. That’s because U.S. law generally requires compliance with manufacturing standards for authorization of a drug.

The three sources who spoke to Reuters requested that their names be withheld so they could speak freely without fear of retaliation.

Inspectors who visited the Lilly plant in Branchburg, New Jersey, last November found that data on the plant’s various manufacturing processes had been deleted and not appropriately audited, government inspection documents show.

“The deleted incidents and related audit trail were not reviewed by the quality unit,” the FDA inspectors wrote. Because the government inspection documents reviewed by Reuters were heavily redacted by the FDA it was not possible to see the inspectors’ more specific findings.

Following its November inspection, the FDA classified the problems as the most serious level of violation, resulting in an “Official Action Indicated” (OAI) notice.

That “means that the violations are serious enough and have a significant enough impact on the public health that something needs to be fixed,” said Patricia Zettler, a former associate chief counsel at the FDA who is now a law professor at Ohio State University.

Separately, Lilly said on Tuesday it had paused its clinical trial for the COVID drug in hospitalized patients “out of an abundance of caution” over a potential safety concern. The company did not release information on what the problem was and declined to say how the news might affect their EUA request.

In response to Reuters’ questions on Monday about the manufacturing issues, Lilly confirmed the OAI notice but declined to provide details on what prompted the FDA action. The drugmaker said it has launched a “comprehensive remediation plan,” has increased staffing at the site and was working “aggressively” to address all concerns raised during

Johnson & Johnson moves to buoy investors over paused Covid vaccine trial

US pharmaceutical giant Johnson & Johnson sought Tuesday to reassure investors after its stock slumped on an announcement that it was pausing a Covid-19 vaccine trial over a sick participant.

The company is one of several working on a vaccine, but on Monday it announced the unexplained illness, closing enrollment for the 60,000-patient trial while an independent patient safety committee is convened.

The announcement sent shares tumbling 2.3 percent at the close of trading Tuesday, even as the company reported healthy third-quarter results, with sales growing 1.7 percent to $21.08 billion.

In a conference call earlier in the day, J&J’s global research head Mathai Mammen said “our plan is to continue the study” following “a temporary pause” caused by the illness.

“It’s not at all unusual for unexpected illnesses (to occur) in large studies over their duration. In some cases, serious adverse events… may have something or nothing to do with the drug or vaccine being investigated,” he said.

The Phase 3 trial had started recruiting participants in late September, with a goal of enrolling volunteers across more than 200 US and international locations, the company and the US National Institutes for Health (NIH), which is providing funding, said.

The other countries where the trials were taking place are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.

The company’s chief financial officer Joe Wolk said it was unclear whether the participant who became ill was receiving the trial vaccine or the placebo.

“We are waiting for the independent drug safety monitoring board to do their analysis,” he said.

J&J is one of 11 organizations globally to begin a Phase 3 trial on a Covid-19 vaccine.

Washington has given the multinational about $1.45 billion in funding under Operation Warp Speed.

The vaccine is based on a single dose of a cold-causing adenovirus, modified so that it can no longer replicate, combined with a part of the new coronavirus called the spike protein that it uses to invade human cells.

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13-Year-Old Gave COVID To 11 Relatives Across 4 States During Family Vacation: CDC

Getty

Nearly a dozen people across four states were infected with the novel coronavirus by a 13-year-old girl during a three-week family vacation over the summer, according to a report from the Centers for Disease Control and Prevention.

The teenager, whose identity remains anonymous, was exposed to COVID-19 during a “large outbreak” in June, leading her to take a coronavirus test four days later. She tested negative and was not showing symptoms at the time, the report states.

But two days later, the teen began experiencing nasal congestion, a symptom of COVID-19, on the same day she, her parents and two brothers traveled to a family gathering at an unconfirmed location, where 14 of them stayed in a five-bedroom, two-bathroom house for between eight and 25 days.

The attendees ranged in age from 9 to 72 and belonged to five households in four states: Rhode Island, Illinois, Georgia and Massachusetts, according to the CDC report.

Six additional relatives (an aunt, an uncle, and four cousins) visited for 13 hours during the trip but maintained social distance and stayed outdoors. None of them tested positive for the virus.

Getty Coronavirus

RELATED: Johnson & Johnson Pause Their COVID Vaccine Trials for Participant’s ‘Unexplained Illness’

Including the teenage girl, 12 of the 14 relatives staying at the home – none of whom social distanced or wore masks — began exhibiting COVID-19-related symptoms and were subsequently found to have been infected with the virus.

One of the family members was hospitalized, according to the CDC, while another was treated at an emergency department care for respiratory symptoms. They have both recovered.

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Resident Doctor Dies of Coronavirus at 28 After Treating COVID-19 Positive Patients in the ER

Adeline Fagan, who was in her second year of residency, tested positive for COVID-19 in July

RELATED: Mayor of Tennessee City Home to Bonnaroo Music Festival Dies of Coronavirus

After the CDC investigated the cases throughout July and August, the 13-year-old girl was determined to be the “index patient” given that she began showing symptoms prior to any other family member that was infected.

The teen’s initial COVID-19 test, done before the trip, was likely a false negative, according to the CDC report, “because it was performed before symptom onset.”

The CDC said that the outbreak further proves that children and adolescents can serve as the source of COVID-19 spreading, even when their symptoms are mild. In addition, it shows that lack of social distancing will likely result in further spreading of the virus, per the CDC.

As of Tuesday, there are over 7.8 million confirmed cases of COVID-19 in the United States, while at least 214,900 people have died, according to the New York Times’ database.

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