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News Report Shows How Elizabeth Holmes Tricked VP Joe Biden into Endorsing Theranos’ Fake Blood Testing Technology

Former Vice President received an exclusive tour of a completely fake medical testing laboratory within Theranos, which he found “most impressive”

One thing clinical laboratory leaders and pathologists may still be curious about concerning the whole Theranos affair is how the company founder Elizabeth Holmes could fool so many high-ranking individuals—including then Vice President Joe Biden—into endorsing a completely fraudulent medical laboratory test process.

In “The Wild Way Elizabeth Holmes and Theranos Tricked Joe Biden,” MSN attempts to explain how Holmes and her partner, Theranos president Ramesh “Sunny” Balwani, “managed to hoodwink some of the biggest names in the political and investment world, including former President Bill Clinton, News Corp owner Rupert Murdoch, Henry Kissinger, and four-star General James ‘Mad Dog’ Mattis.”

But it was the lengths to which Holmes and Balwani went to “trick” Joe Biden into endorsing Theranos—and subsequently receive the positive press that followed—that MSN found most intriguing.

According to MSN, in July of 2015 Holmes and Balwani procured Biden’s endorsement by giving the VP a tour of a “completely fake, staged lab.”

Joe Biden with Elizabeth Holmes

“What’s most impressive to me is you’re not only making these lab tests more accessible, you’re charging historically low prices, which is a small fraction of what is charged now, while maintaining the highest standards, and empowering people whether they live in the barrio or a mansion, putting them in a position to help take control of their own health,” stated then VP Joe Biden (above with Elizabeth Holmes) in a Theranos press release. Sadly, many clinical laboratory leaders who were skeptical and outspoken about Theranos’ claims were ignored by the press. (Photo copyright: ABC News.) 

Wall Street Journal Reporter Exposes Theranos Fraud

According to a 2018 article by John Carreyrou which was part of his expose´ of Theranos published in The Wall Street Journal, “Ms. Holmes and Mr. Balwani wanted to impress Vice President Biden with a vision of a cutting-edge, automated laboratory. Instead of showing him the actual lab with its commercial analyzers, they created a fake one, according to former employees who worked in Newark. They made the microbiology team vacate a room it occupied, had it repainted, and lined its walls with rows of [Theranos] miniLabs stacked up on metal shelves.”

And the ruse worked. A 2015 Theranos press release outlined the visit at the time and stated that Biden found the facility inspiring and was impressed by the work being done by the company.

“I just had a short tour and I’m glad because you can see first-hand what innovation is all about just walking through this facility. This is the laboratory of the future,” Biden said in the press release.  

Joe Biden and Elizabeth Holmes

In 2015, then Vice President Joe Biden toured the Theranos facility with Elizabeth Holmes, observed their supposedly innovative finger stick test system, and met with several Theranos employees. Later reports exposing the fraud stated that Holmes and Balwani were desperate to obtain Biden’s approval as it would provide positive press for Theranos, a good reputation within the industry, and lure potential investors. Theranos later tweeted a photo (above) of the visit showing Biden and Holmes walking amongst numbered blood-testing machines with a huge Theranos logo banner in the background. (Photo copyright: Connor Radnovich/The Chronicle.)

Biden’s visit occurred just a few months before Carreyrou’s Wall Street Journal report questioned the efficacy of Theranos’ blood testing technology and alleged the lab testing company tried to cover up its failures and mislead investors and patients.

Prior to that hard-hitting exposé, Holmes was heralded by the media as a star in the field of medicine. She was even prominently featured on magazine covers of influential business periodicals such as Fortune, Forbes, and Inc.

Others Who Were Bamboozled by Holmes and Balwani

Biden was not the only high-profile individual who was fooled by Holmes, Balwani and their billion-dollar con job. Other high-profile people included:

Theranos ceased operations in September of 2018 amidst the exposing of the fraud and inability to locate a buyer for the company. The shutdown rendered all investments in the company worthless.   

Holmes to Receive New Hearing in Federal Court

In January of this year, Holmes was found guilty of three counts of wire fraud and one count of conspiracy to commit wire fraud for lying to investors about Theranos products. She faces up to 20 years in prison and a fine of $250,000 plus restitution for each count.

However her sentencing, originally scheduled for October 17, was delayed due to her request for a new trial based on comments by former Theranos laboratory director Adam Rosendorff, MD, that he regretted his testimony in Holmes’ fraud trial. Dark Daily covered this in “Clinical Pathologist Once Again at the Center of a National News Story as Theranos Founder Elizabeth Holmes Seeks New Trial.”

Holmes was granted her request and will now undergo a new hearing in federal court, which we covered in “Judge Grants Delay in Ex-Theranos’ CEO Elizabeth Holmes’ Sentencing to Consider Alleged Prosecutor Misconduct.”

And so, clinical laboratory leaders and pathologists now have a better idea as to how Joe Biden was hoodwinked and endorsed a completely fake blood testing laboratory at Theranos. Can he be blamed for his ignorance of clinical laboratory test technology? Probably not. But it makes for interesting reading.

—JP Schlingman

Related Information:

The Wild Way Elizabeth Holmes and Theranos Tricked Joe Biden

Theranos Hosts Vice President Biden for Summit on a New Era of Preventive Health Care

Joe Biden Visited Theranos, Called Elizabeth Holmes ‘Inspiring’

Biden Played Big Role in Promoting Convicted Fraudster Elizabeth Holmes and Theranos

Hot Startup Theranos Has Struggled with Its Blood-Test Technology

Clinical Pathologist Once Again at the Center of a National News Story as Theranos Founder Elizabeth Holmes Seeks New Trial

Ex-Theranos CEO Elizabeth Holmes Testifies She Made Mistakes, Shifts Blame for Some of the Now Defunct Clinical Laboratory Testing Startup’s Failures

Ex-Theranos CEO Elizabeth Holmes Takes Witness Stand in Her Own Defense: Admits to Using Pharma Giants’ Logos on Reports to Investors, But Claims No Intent to Deceive

PwC Survey Finds 50% of Companies Plan Layoffs and 83% Intend to Move Forward with Streamlined Workforces

Amid cost pressures, healthcare providers also plan to cut staff though some jobs are plentiful; adequate staffing at medical laboratories continues to be a challenge

Thanks to the COVID-19 pandemic and subsequent “Great Resignation,” masses of people have left the workforce and companies large and small in all industries are struggling to retain employees. Clinical laboratories have been particularly hard hit with no relief in sight.

Now comes the results of a PricewaterhouseCoopers (PwC) survey which shows 50% of US companies in various industries—including major healthcare providers—plan to lay off employees. And 83% of organizations intend to move forward with a “streamlined workforce,” according to the latest PwC Pulse: Managing Business Risks in 2022 report.

How this will affect the workload on remaining hospital and medical laboratory staff is clear. And healthcare consumers may not take well to healthcare provides running leaner and with fewer staff than they currently do.

Nevertheless, the PwC survey results “illustrate the contradictory nature of today’s labor market, where skilled workers can still largely name their terms amid talent shortages even as companies look to let people go elsewhere,” Bloomberg wrote on the  CPA Practice Advisor website.

Bhushan Sethi

“Organizations are still walking a tightrope when it comes to talent as we begin to see the longer-term impacts of the ‘Great Resignation.’ Finding the proper balance between investing in specialized talent, managing headcount costs, and driving productivity and morale will remain a top focus,” said Bhushan Sethi (above), People and Organization Joint Global Leader at PwC and an adjunct professor at NYU Stern School of Business in a PwC news release. Clinical laboratories are finding it particularly challenging to fill staff positions across all areas of lab operations. (Photo copyright: PwC.)

Healthcare Has Biggest Challenges, says PwC

Clinical laboratory leaders and pathologist groups are well aware of the unique financial pressures on healthcare systems and medical labs, as well as shortages of pathologists, medical technologists, clinical laboratory scientists, information technology (IT) professionals, and other healthcare workers.

“Healthcare is seeing bigger talent challenges than other industries and is more focused on rehiring employees who have recently left,” the PwC report acknowledged. This is the second Pulse survey PwC conducted in 2022. The 722 respondents included leaders working in human capital and finance.  

Finding Right Talent, Focusing on Growth, Automation

Finding the right employees is so important to companies that PwC ranks “talent acquisition” as the second highest risk (38%) behind cyber-attacks (40%).

“Finding the right talent continues to be a challenge for business leaders,” PwC said. “After a frenzy of hiring and a tight labor market over the past few years, executives see the distinction between having people and having people with the right skills.”

Unlike the high-touch and personal nature of healthcare, industries such as consumer technology, media, and telecommunications can turn to automation to alleviate staffing struggles. And that is what nearly two-thirds, or 63%, of companies in those sectors, aim to do, PwC said.

Other survey talent findings:

  • 50% of companies plan layoffs.
  • 46% are dropping or eliminating sign-on bonuses.
  • 44% are rescinding job offers.

Conversely, the surveyed executives also told PwC they are “cautiously optimistic” and plan on growing and investing even as the economy gives mixed signals:

  • 83% of companies are focused on growth.
  • 70% plan an acquisition.
  • 53% aim to invest in digital transformation, 52% in IT, 49% in cybersecurity and privacy, and 48% in customer experience.

“After more than two years dealing with uncertainty related to the pandemic, business leaders recognize the urgent need to focus on growth in order to compete, and they’re zeroing in on what they can control,” PwC said.

New Remote Work Programs, Reduction in Real Estate Investing, Big Tech

Although companies report having more than enough physical office space, many (42%) have launched remote work programs:

  • 70% have expanded or plan to increase “permanent” remote work options as jobs permit.
  • 22% are reducing real estate investment (financial services and healthcare industries lead the way with 30% and 29%, respectively, saying real estate buys are cooling off).

“While companies continue to invest in many areas of the business, they’re scaling back the most in real estate and capex ex [capital expenditure]. After two years of remote work, many companies simply need less space, and they’re allocating capital accordingly,” the PwC report noted.

In a somewhat parallel release to PwC’s findings, news sources are reporting reductions in real estate and staff at high-profile Big Tech companies.

Meta Platforms, Inc. in Menlo Park, Calif. (formerly Facebook Inc.), is closing one of its New York offices and cutting back on plans to expand two other locations in the city, the Observer reported.

Business Insider reported, “More than 32,000 tech workers have been laid off in the US till July, including at Big Tech companies like Microsoft and Meta (formerly Facebook), and the worst has not been over yet for the tech sector that has seen massive stock sell-off.”

According to Forbes, “San Francisco-based electronic signature company DocuSign will lay off 9% of its more than 7,400 employees (roughly 670 employees), the company announced in a Securities and Exchange filing Wednesday, saying the cuts are ‘necessary to ensure we are capitalizing on our long-term opportunity and setting up the company for future success.’”

And Bloomberg recently reported that Intel is planning to layoff thousands of people “around the same time as its third-quarter earnings report on Oct. 27.”

Healthcare Providers Plan Layoffs, Seek IT Pros

Meanwhile, major healthcare provider networks also are planning staff cuts amid service closures, rising costs, and other issues, according to Becker’s Hospital Review:

“Our health system, like others around the nation, is facing significant financial pressures from historic inflation, rising pharmaceutical and labor costs, COVID-19, expiration of CARES Act funding, and reimbursement not proportional with expenses,” BHSH said in a statement shared with Becker’s.

Amidst these layoffs, however, IT jobs in healthcare seem to be growing. According to Becker’s Health IT, some healthcare providers have posted information technology openings:

So, though it appears IT positions continue to expand, clinical laboratory leaders and pathology practice managers may want to prepare now for dealing with customers’ response to leaner healthcare systems overall.

Donna Marie Pocius

Related Information:

PwC Pulse: Managing Business Risks in 2022

Layoffs are Being Planned at Half of US Companies, PwC Survey Shows

Business Executives Remain Bullish about Their Ability to Manage Turbulent Conditions, according to New PwC Survey

Meta Is Closing a Manhattan Office as It Consolidates Its New York City Presence

50% of Companies Planning Job Cuts Amid Economic Downturn: Report

Ascension to Close Hospital, Lay Off 133 Workers

Microsoft Reportedly Cuts Nearly 1,000 Employees—Here Are the Biggest US Layoffs This Year

Intel Is Planning Thousands of Job Cuts in Face of PC Slump

Hospitals Cut Jobs to Resuscitate Finances

IT Job Openings at Mayo, Northwell, CommonSpirit, and Providence

Study Shows School-Aged Children Can Successfully Swab Themselves for COVID-19 Tests, But Is This Something That Can Help Short-Staffed Medical Laboratories?

Encouraging patients—even children—to be more directly involved in their own medical care may reduce the burden on healthcare workers and might even help those clinical laboratories struggling to hire enough phlebotomists to collect specimens

Researchers at Emory University School of Medicine have concluded a study which found that school-aged children can successfully use a nasal swab to obtain their own SARS-CoV-2 test specimens. This may come as a surprise to hospital and clinical laboratory personnel who have performed nasal swabbing for COVID-19 tests. Some people, adults included, find the procedure so uncomfortable it brings tears.

And yet, after being shown a 90-second how-to video and given a handout with written instructions and pictures, 197 Atlanta children who had COVID-19 symptoms between July and August of 2021 performed their own self-swabbing. A healthcare worker then collected a second swabbed sample. All samples were submitted to a clinical laboratory for PCR analysis.

The Emory study provides another example of how the healthcare system is engaging patients to be directly involved in their own medical care. Results of the study could positively impact clinical laboratories facing a shortage of personnel, as well as schools where children have to take repeated COVID-19 tests with the assistance of trained professionals.

The Emory researchers published their findings in the Journal of the American Medical Association (JAMA), titled, “Concordance of SARS-CoV-2 Results in Self-collected Nasal Swabs vs Swabs Collected by Health Care Workers in Children and Adolescents.”

Child self swabbing for COVID-19

In a study with 197 school-age children, researchers at Emory University School of Medicine found that children could self-swab themselves for COVID-19 testing after watching a 90-second instructional video. Clinical laboratory leaders who are short on personnel may find these results intriguing. (Photo copyright: Emory University.)

How Did the Children Do?

The self-collected swabs and those collected by a healthcare worker agreed 97.8% of the time for a positive result and 98.1% of the time for a negative result. The analysis showed that both collection methods identified the 44% of symptomatic kids who were positive for COVID-19.

“Seeing how closely the results line up between the children and trained healthcare workers is a strong indicator that these age groups are fully capable of swabbing themselves if given proper instruction,” said Jesse Waggoner, MD, an Assistant Professor of Infectious Diseases with the Emory University School of Medicine and one of the lead authors on the study, in an Emory University press release.

A higher percentage of children age eight and under needed assistance, such as more instruction before correctly completing self-collection—21.8% compared to 6.1% for children older—but SARS-CoV-2 detection among the two age groups did not differ.

Does FDA Approve of Self-Swabbing?

The US Food and Drug Administration (FDA) has not authorized COVID-19 tests that include self-swabbing by children under age 14. However, data from the Emory study, published in JAMA, is now available to test manufacturers seeking authorization for pediatric self-collection.  

“Pediatric self-swabbing will support expanded testing access and should make it even easier to test school age populations with fewer resources,” said Tim Stenzel, MD, PhD, Director of the Office of In Vitro Diagnostics at the FDA, in the Emory statement. “This study furthers our knowledge of test accuracy with these types of samples and provides test manufacturers with data to support their EUA (Emergency Use Authorization) requests to the FDA.”

Self-swabbing versus Clinical Laboratory Worker

While it has been longstanding medical practice to have healthcare workers collect samples for respiratory tract infection testing, the Emory researchers suggest that allowing children to collect their own COVID-19 samples could be one way to reduce the burden of a shortage of healthcare workers.

The researchers also believe pediatric self-swabbing would expand access to diagnostic tests and make it easier to test school-age populations.

“Every minute of a healthcare worker’s time is at a premium,” said senior study author Wilbur Lam, MD, Professor of Pediatrics and Biomedical Engineering, Emory University and Georgia Tech, in a National Institutes of Health (NIH) press release. “Why not allow a kid to self-swab? It’s a win-win! They would rather do it themselves and it frees up the healthcare worker to do other things,” he added.

In 2020, a Stanford University School of Medicine study published in JAMA showed test samples collected by adults who swabbed their own nasal passages were as accurate as those collected by healthcare workers. This study involved 30 participants who had previously tested positive for COVID-19.

Though the Emory University and Stamford University studies were small, they agreed in their findings which is significant. Clinical laboratory executives and pathologists should expect this trend toward direct-to-consumer and other forms of self-testing to continue, even among young patients.

Andrea Downing Peck

Related Information:

Can Children Swab Themselves for COVID-19? New Study Suggests Yes

Concordance of SARS-CoV-2 Results in Self-collected Nasal Swabs vs Swabs Collected by Health Care Workers in Children and Adolescents

NIH-Funded Pediatric COVID-19 Testing Study Finds School-Aged Children Can Self-Swab

Self-Swabbing Tests for COVID-19 Accurate and Safe, Study Reports

Assessment of Sensitivity and Specificity of Patient-Collected Lower Nasal Specimens for Severe Acute Respiratory Syndrome Coronavirus 2 Testing

Judge Grants Delay in Ex-Theranos’ CEO Elizabeth Holmes’ Sentencing to Consider Alleged Prosecutor Misconduct

Issues arose after a pathologist who once was the clinical laboratory director at Theranos suggested his testimony during the trial was misconstrued by federal prosecutors

Just when clinical laboratory directors and pathology group managers thought they could look forward to a world without an ongoing Theranos fraud trial, company founder and ex-CEO Elizabeth Holmes requested a new trial. Her request was based on comments by pathologist and former Theranos lab director Adam Rosendorff, MD, that he was remorseful about his testimony in Holmes’ fraud trial.

Dark Daily covered Holmes’ request in “Clinical Pathologist Once Again at the Center of a National News Story as Theranos Founder Elizabeth Holmes Seeks New Trial.”

Now, it appears the court will hear Holmes’ argument. On October 4, a federal judge agreed to delay Holmes’ sentencing to consider new evidence that was submitted to the court in a September filing and further evaluate her request for a new trial.

In that filing, Holmes claimed that Rosendorff visited her home on August 8 to express regret over his testimony. According to Holmes, Rosendorff alleged that his statements had been misconstrued by prosecutors at her trial. He stated that “he tried to answer the questions honestly, but that the prosecutors tried to make everyone look bad” and he now feels like “he had done something wrong,” The Guardian reported.

Theranos founder and ex-CEO Elizabeth Holmes

Theranos founder and ex-CEO Elizabeth Holmes (left) as she was seen entering the federal courthouse in San Jose, Calif., on Sept. 1 to argue that her trail verdict should be overturned due to new comments from pathologist and former lab director Adam Rosendorff, PhD, who expressed remorse over his original testimony. Clinical laboratory managers may want to track these new developments in the unfolding saga of Theranos and Elizabeth Holmes. (Photo copyright: AP/Daily Mail.)

Pathologist Rosendorff’s Testimony about Holmes

Rosendorff, the pathologist who served as the CLIA laboratory director at Theranos for several years, was a major witness for the prosecution in the Holmes trial which lasted nearly four months. During his four-day testimony, he contended that Holmes was cognizant of accuracy issues with Theranos’ blood-testing device and that she intentionally misled both investors and patients. 

In January, a jury found Holmes guilty of three counts of wire fraud and one count of conspiracy to commit wire fraud for lying to investors about Theranos products. The jury of eight men and four women deliberated for more than 50 hours over seven days to arrive at the verdict. She faces up to 20 years in prison and a fine of $250,000 plus restitution for each count.

In September, US District Judge Edward Davila, who presided over Holmes’ original fraud trial, declined to overturn the guilty verdict.

The new hearing regarding the issues with Rosendorff’s testimony will occur on October 17, the original date of Holmes’ sentencing. Davila stated that he has scheduled an entire day for hearing, but that he expects it to take less than the full allotted day. 

Judge Wants to Know If Former Theranos Lab Director Told the Truth

If her request for a new trial is denied, Holmes will be sentenced sometime between November and January. She is currently free on bail while awaiting her sentencing.

Regarding the latest development, Davila stated that it was unusual for a witness to appear at a convicted defendant’s home. “I will say I haven’t seen a case where this happened before,” Davila told CNN.

“What the court wants to know is, Dr. Rosendorff, do you feel the government manipulated you in the preparation or in any way in regards to your testimony?” Davila said about what will be covered in the October 17 hearing. “What I want to know is, did you tell the truth?”

After Holmes used Rosendorff’s appearance at her home to request a new trial, the former Theranos lab director filed a sworn declaration with the court on September 21 that he stands by his testimony “in every respect.”

“Nevertheless, I feel compassion for Ms. Holmes and Mr. Balwani, and even more so for the members of their families who were not responsible for their conduct but will be affected by the punishment they may receive,” he wrote.

Dark Daily covered Rosendorff’s original testimony in “Former Theranos Lab Director and Staff Testify in Ongoing Elizabeth Holmes Fraud Trial That They Voiced Concerns about Reliability and Accuracy of Edison Blood-Testing Device.”

And so, the saga of Elizabeth Holmes continues. Clinical laboratories will once again get a view into how a lab director’s responsibilities can alter testing outcomes—and fraud trials.

JP Schlingman

Related Information:

Theranos Founder Elizabeth Holmes Gets Hearing on New Trial

Judge Agrees to Delay Elizabeth Holmes’ Sentencing over Prosecutor Misconduct Concerns

Elizabeth Holmes Sentencing Reset as Judge Weighs New Trial Bid

Elizabeth Holmes Sentencing Date Delayed Amid Request for New Trial

Elizabeth Holmes’ Sentencing Date Has Been Pushed Back

Clinical Pathologist Once Again at the Center of a National News Story as Theranos Founder Elizabeth Holmes Seeks New Trial

Former Theranos Lab Director and Staff Testify in Ongoing Elizabeth Holmes Fraud Trial That They Voiced Concerns about Reliability and Accuracy of Edison Blood-Testing Device

Australia’s Severe Flu Season Could be a Harbinger of Increased Influenza Cases in US and Canada Straining Already Burdened Clinical Laboratories

End of social distancing, masking, and other COVID-19 pandemic mitigations may lead to more severe flu-like infections in northern hemisphere, experts say

Clinical laboratory professionals in the United States and Canada should prepare now for a severe flu season. That is according to infectious disease experts at Johns Hopkin’s Center for Health Security who predict the rise in influenza (flu) cases in Australia signals what will likely be higher than normal numbers of flu-like infections starting this fall in the Northern Hemisphere.

As a Southern Hemisphere nation, Australia experiences winter from June through August. The land down under just concluded its worst flu season in five years. The flu arrived earlier than usual and was severe. Surveillance reports from the Aussie government’s Department of Health and Aged Care noted that influenza-like illness (ILI) peaked in May and June, but that starting in mid-April 2022 the weekly number of flu cases exceeded the five-year average.

If the same increase in flu cases happens here, healthcare systems and clinical laboratories already burdened with continuing COVID-19 testing and increasing demand for monkeypox testing could find the strain unbearable.

Amesh Adalja, MD

Amesh Adalja, MD (above), Infectious Disease Expert and Senior Scholar at the Johns Hopkin’s Center for Health Security, told Prevention that Australia’s flu season is typically a harbinger of what will follow in the US, Canada, and other Northern Hemisphere countries. “The planet has two hemispheres which have opposite respiratory viral seasons,” he said. “Therefore, Australia’s flu season—which is just ending—is often predictive of what will happen in the Northern Hemisphere.” Clinical laboratories in the United States should review their preparations as North America enters its influenza season. (Photo copyright: Johns Hopkins Bloomberg School of Public Health.)

Consequences of Decline in Flu Vaccinations and Social Distancing, Masks

The New York Times noted that in 2017, when Australia suffered through its worst flu season since modern surveillance techniques were adopted, the US experienced a deadly 2017-2018 flu season a half-year later that took an estimated 79,000 lives.

While the number of flu cases in this country is currently low, according to the weekly US Centers for Disease Control and Prevention’s (CDC) “Flu View,” that is expected to change as temperatures cool.

During the height of the COVID-19 pandemic in the US, influenza was nearly nonexistent. Pandemic-mitigation efforts such as masking, social distancing, and quarantining slowed the spread of the annual respiratory illness. But pandemic mitigation efforts are no longer the norm.

“Many have stopped masking,” said Abinash Virk MD, an Infectious Diseases Specialist at Mayo Clinic College of Medicine and Science, in a Mayo Clinic news blog that urged patients to get vaccinated for flu. “For the large part, we will see the re-emergence of influenza in the winter. In comparison, in 2020 winter … there was literally no influenza. But now that has all changed.”

Diminished Immunity Will Lead to More Severe Flu Cases

A CDC report published in July also noted that last winter’s flu season broke from the traditional pattern of arrival of the flu in the fall followed by a peak in cases in February.

During the 2021-22 season, influenza activity began to increase in November and remained elevated until mid-June. It featured two distinct waves, with A(H3N2) viruses predominating for the entire season. But the overall case counts were the lowest in at least 25 years preceding the COVID-19 pandemic.

Thomas Russo, MD, Professor and Chief of Infectious Disease at the University at Buffalo in New York, said the past two mild flu seasons could set the stage for a difficult year in 2022-23.

“Immunity to respiratory viruses, including the flu, wanes over time,” Russo told Prevention. “People have not seen the virus naturally for a couple of years and many individuals don’t get the flu vaccine.” That, he says, raises the risk that people who are unvaccinated against the flu will develop more severe cases if they do happen to get infected.

“People are interacting closely again and there are very few mandates,” he added. “That’s a set-up for increased transmission of influenza and other respiratory viruses.”

Anthony Fauci, MD, Director of the National Institute of Allergy and Infectious Diseases (NIAID), warns the US could see higher than normal rates of influenza while COVID-19 is still circulating widely.

“The Southern Hemisphere has had a pretty bad flu season, and it came on early,” Fauci, told Bloomberg in late August. “Influenza, as we all have experienced over many years, can be a serious disease, particularly when you have a bad season.”

CNN reported that US government modeling predicts flu will peak this year in early December.

CDC Advises Public to Get Flu Vaccine

Because COVID-19 and Influenza have many symptoms in common, such as fever, cough, shortness of breath, fatigue, sore throat, runny nose, headache, and muscle aches, the Mayo Clinic points out on its blog that testing is the only way to discern between the two when symptoms overlap.

According to the CDC, the best way to reduce risk from seasonal flu and its potentially serious complications is to get vaccinated every year. The best time to get vaccinated for the flu is in September and October before the flu starts spreading in communities, the CDC states. However, vaccination after October can still provide protection during the peak of flu season.

Yet, many people fail to get the flu vaccine even though it is recommended for everyone over the age of six months. CNN reported that just 45% of Americans got their flu shots last season. Flu vaccination rates fell for several at-risk groups, including pregnant women and children.

Though flu seasons are often unpredictable, clinical laboratories should prepare now for an influx of influenza test specimens and higher case rates than the past two pandemic-lightened flu seasons. Coupled with COVID-19 and monkeypox testing, already strained supply lines may be disrupted.

—Andrea Downing Peck

Related Information:

Frequently Asked Influenza (Flu) Questions: 2022-2023 Season

Weekly US Influenza Surveillance Report

Australia Just Had a Bad Flu Season. That May Be a Warning for the US

Experts Are Predicting a Bad 2022-2023 Flu Season: How to Prepare Now

Australian Influenza Surveillance Report No 07-Fortnight Ending 03 July 2022

Fauci Warns of a Bad Flu Season Brewing as He Nears Office Exit

Australia’s Tough Flu Season Could Spell Trouble for the US This Winter, Especially with COVID-19 in the Mix

Expect a Different Flu Season: Why You’ll Want to Be Vaccinated for Flu

Influenza Activity and Composition of the 2022–23 Influenza Vaccine—United States, 2021–22 Season

Prevent Seasonal Flu

Discovery of Antibody that Neutralizes All Known Variants of SARS-CoV-2 Could Lead to New Vaccines and Clinical Laboratory Treatments for COVID-19

Though only in early stages, findings could lead to a ‘therapeutic against current and newly-arising variants,’ say researchers

As SARS-CoV-2 changes and mutates, some therapeutic antibodies that were once highly effective in fighting the virus have lost potency. But now, in a proof-of-concept study, researchers from Boston Children’s Hospital have identified one antibody that neutralizes all known variants of the coronavirus, including the omicron variant. Microbiologists and clinical laboratory managers will find this intriguing, as most medical labs perform serology testing for SARS-CoV-2 antibodies.

The new antibody appears to be robust. It triggers several other types of antibodies as part of the immune response. If validated by further research, this discovery, the researchers state, may lead to new vaccines, better therapies, and improved treatments for COVID-19.

The scientists published their findings in the journal Science Immunology, titled, “An Antibody from Single Human VH-rearranging Mouse Neutralizes All SARS-CoV-2 Variants Through BA.5 by Inhibiting Membrane Fusion.”

Frederick Alt, PhD

“We hope that this humanized antibody will prove to be as effective at neutralizing SARS-CoV-2 in patients as it has proven to be thus far in preclinical evaluations,” said geneticist Frederick Alt, PhD, Director of the Program in Cellular and Molecular Medicine at Boston Children’s Hospital and one of the leaders of the research. Clinical laboratories that perform serology testing for COVID-19 will be intrigued by this new line of research. (Photo copyright: PR Newswire.)

SP1-77 Antibody Outperforms All Others at Neutralizing SARS-CoV-2

To conduct their research, the team used genetically modified mice that basically have built-in human immune systems. These mice were originally utilized for seeking out antibodies to HIV, another virus that tends to mutate. Their immune systems can mimic what human immune systems encounter when a viral invader attacks. 

The scientists inserted two human gene segments into the mice, which quickly produced antibodies resembling those made by humans. The mice were then exposed to the SARS-CoV-2 spike protein from the original coronavirus strain. The scientists found that the mice produced nine different families of antibodies that could bind to the spike protein.

The researchers then tested the effectiveness of those antibodies and found that three of the nine antibody families strongly neutralized the original SARS-CoV-2 coronavirus. In addition, one of the antibody families—dubbed SP1-77—was much more powerful and could neutralize the Alpha, Beta, Gamma, Delta, and all known Omicron strains of the SARS-CoV-2 virus.

New Monoclonal Antibody Products and Vaccines

If their findings are validated through further research, SP1-77 “would have potential to be a therapeutic against current and newly-arising variants of concern” according to the Science Immunology study. It also could be useful as part of a cocktail containing other antibody treatments for COVID-19 variants. 

“SP1-77 binds the spike protein at a site that so far has not been mutated in any variant, and it neutralizes these variants by a novel mechanism,” said Tomas Kirchhausen, PhD, Senior Investigator, Program in Cellular and Molecular Medicine at Boston Children’s Hospital and one of the authors of the study in a statement announcing the study findings. “These properties may contribute to its broad and potent activity,” he added.

“This is very early-stage proof-of-concept work to illustrate that broadly neutralizing antibodies can be generated using a mouse model,” Amesh Adalja, MD, an infectious disease expert and senior scholar at the Johns Hopkins Center for Health Security, told Prevention. “Such work, if replicated and expanded, could form the basis of new monoclonal antibody products as well as a vaccine.”

The researchers have applied for a patent for the SP1-77 antibody as well as the mouse model they used to create it. Studies on the antibody are ongoing and have only been performed on mice and not humans. The scientists intend to execute further research on the innovative antibody and hope it will someday be used to help fight the COVID-19 virus and all its variants. 

“We’d love to have a vaccine that is active against all circulating variants, including those yet to come,” Thomas Russo, MD, Professor and Chief of Infectious Disease, Department of Medicine, University at Buffalo told Prevention. “It’s the holy grail of vaccines.”

Microbiologists and clinical laboratories working with monoclonal antibodies to treat for COVID-19 infections will no doubt want to follow the Boston Children’s Hospital research closely as it may lead to new treatments and vaccines.

JP Schlingman

Related Information:

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An Antibody from Single Human VH-rearranging Mouse Neutralizes All SARS-CoV-2 Variants Through BA.5 by Inhibiting Membrane Fusion

Boston Children’s Hospital Researchers Find Antibody That Neutralizes All Major COVID Variants in Tests on Mice

Scientists Discovered an Antibody That Can Take Out All COVID-19 Variants

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