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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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

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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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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

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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

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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,

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COVID vaccine trials are on hold. Why experts say that’s reassuring.

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It takes a lot of people to develop a COVID-19 vaccine. Volunteers may be one of the most important.

Wochit

Recent pauses to two large-scale COVID-19 vaccine trials and a treatment study should reassure people — not frighten them — vaccine experts said, though it is a reminder of the messiness of science.

“This is an indication that the system is working as it was designed to work to protect human subjects in clinical trials,” Lawrence Gostin, a public health and legal expert at Georgetown and Johns Hopkins universities, said Tuesday. “It demonstrates that the ethical guard rails on vaccine trials are working.”

It’s not unusual for late-stage trials of drugs and vaccines to be stopped briefly to examine safety concerns, he and others said.

The discovery of an adverse event and a pause in the clinical trial is actually reassuring, said Dr. Bali Pulendran, a professor of immunology and vaccine design at Stanford University.

“Let’s say they got to the end of the clinical trial and there had not been one single report of any adverse event in the tens of thousands of people involved in the trial. That,” he said, “would worry me. That would be extraordinarily unusual.”

Eli Lilly announced Tuesday it was pausing a trial of an experimental drug similar to one President Donald Trump recently claimed cured him of COVID-19. On Monday, Johnson & Johnson halted a large-scale trial of a candidate COVID-19 vaccine. And, in September, British regulators put a hold on another trial of a candidate vaccine by AstraZeneca. They lifted the hold a week later, but it has continued in the American arm of the study.

COVID-19 vaccine trial on Aug. 5, 2020, in Detroit. (Photo: Henry Ford Health System/AFP via Getty Images)

These occurrences should serve as a reminder that scientific research can be unpredictable, disappointing and time-consuming, specialists said.

“After four decades in vaccines, I expect the unexpected,” said Dr. Gregory Poland, director of the Mayo Vaccine Research Group and editor-in-chief of the journal Vaccine. “The nature of vaccine development is there are always surprises and the unexpected. Everybody’s looking for them, but time has to pass before you actually know.”

According to a new poll from Informa Pharma Intelligence, a business intelligence provider, and research firm YouGov, 35% of Americans don’t trust how quickly the COVID-19 vaccine clinical trials are moving and 23% don’t think pharmaceutical companies have consumers’ best interests in mind.

The public may have unrealistic expectations of avaccine that’s “100% effective and 150% safe,” said Alan Barrett, director of the Sealy Institute for Vaccine Sciences at The University of Texas Medical Branch at Galveston.

USA TODAY Editorial Board: Don’t inject politics into vaccine policy

But he thinks the companies have shown an impressive attention to safety, including the trial pauses. “We can’t afford to have a mistake,” Barrett said. “The public has to have confidence that any vaccine given to them is going to be safe and effective.”

Only about 31% of all vaccine candidates

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Fusion IV Pharmaceuticals INC Finds Functional Medicine Can Help With COVID Care

Los Angeles, CA – ( NewMediaWire ) – October 12, 2020 –  Fusion IV Pharmaceuticals INC provides functional medicine care for many patients and is focused on providing high-quality care during the Covid-19 pandemic. Their functional medicine approach has helped to identify many new treatment methods that can boost a person’s health and provide a substantial barrier to infection.

The Functional Approach Applied by Fusion IV Pharmaceutical INC

Functional medicine is a unique branch of treatments that Fusion IV Pharmaceutical INC has helped expand over the years. It focuses heavily on managing a person’s health through natural changes, such as adjusting their diet and their exercise routines.

In this way, functional medicine provides a unique opportunity to strengthen a person’s immune system against Covid-19. The worst symptoms of this disease are found to occur in those with weaker bodies or underlying conditions. Fusion IV Pharmaceutical INC seeks to help those with these problems by making their bodies more substantial and more resistant to diseases.

And Fusion IV Pharmaceutical INC has pioneered many care methods to make this process more streamlined and efficient. By understanding these techniques, those who are at more risk during this pandemic can decrease their potential risk and avoid severe symptoms.

Methods Used By Fusion IV Pharmaceuticals INC

At Fusion IV Pharmaceuticals INC, patients are being asked to follow the basic COVID prevention methods. These include social distancing – staying six feet away from others at all times – and washing and sanitizing hands whenever possible. Washing hands with soap for up to 20-30 seconds can help to kill many germs, including the COVID virus.

Fusion IV Pharmaceuticals INC is also creating dietary plans for patients that include healthy and unprocessed foods, cutting down on starches and unhealthy grains, and focusing on medicinal foods like spinach, cabbage, oranges, olives, and apples. These foods have flavonoids that help fight viruses, including kaempferol, hesperidin, and quercetin.

And Fusion IV Pharmaceuticals INC also provides immune-boosting treatments to help fight Covid and other conditions. These treatments include various types of supplements, such as 1,000-2,000 mg of Vitamin C, 20 mg of Zinc a day, 1-2 mg of sustained-released melatonin, and 1,200 mg of NAC every day. These supplements help keep the immune system functional and healthy.

Fusion IV Pharmaceuticals INC implements breakthrough techniques and delivery methods to enhance supplemental delivery. These include multiple infusion methods that work supplements directly into the bloodstream, making their delivery more comprehensive. Those who cannot tolerate this type of care may receive oral supplements that they can take at home.

About Fusion IV Pharmaceuticals INC

Fusion IV Pharmaceuticals INC is a compounding pharmacy that focuses on functional medicine, a patient-centered approach, and science-based care. Located in Los Angeles, California, they have helped promote wellness, better health, and medical science advances for over five years. They are led by Dr. Navid Vahedi, a passionate compounding pharmacist.

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