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UK Raises Payroll Taxes to Record Levels to Recover COVID-19 Costs for State-Funded National Health Service

Under-resourced British healthcare system faces a record high backlog of care with 5.61 million people in England waiting for hospital-based medical procedures

Healthcare in the United Kingdom (UK) is about to become much more expensive. The UK government has announced plans to substantially increase payroll taxes to fund the surging demand for care due to the COVID-19 pandemic. But that may only be the part of the healthcare-funding iceberg visible above the surface. Below the surface is a healthcare system where wait times for access to many types of care—including cancer diagnoses—are already unacceptable.

Some pathologists and medical laboratory executives in the US who have long questioned healthcare reformers’ desire to introduce an NHS-like single-payer healthcare system in this country will not be surprised to learn that the UK’s notoriously underfunded National Health Service (NHS) is facing a record waitlist for hospital-based medical diagnostic tests and procedures.

Consequently, Reuters reported, the high cost of fighting the COVID-19 pandemic has pushed British Prime Minister Boris Johnson into breaking with election promises and announcing plans to raise payroll taxes to record levels so that more money can be funneled into the struggling government-run healthcare system.

British Prime Minister Boris Johnson

Speaking to lawmakers in the House of Commons, British Prime Minister Boris Johnson (above) acknowledged his tax plan breaks his Conservative Party’s election year pledge to not raise VAT (value-added tax), income, or national insurance taxes. He insists that the COVID-19 pandemic created unprecedented challenges for the national health system. “I accept that this breaks a manifesto commitment, which is not something I do lightly, but a global pandemic was in no one’s manifesto,” he told lawmakers, Reuters reported. (Photo copyright: The Independent.)

5.6M People on Growing NHS Waiting List for Treatments and Procedures

When the COVID-19 pandemic struck the UK in March 2020, the NHS suspended elective surgeries such as hip or knee replacements and cataract removal and postponed many patients’ medical laboratory diagnostic tests.

In “Record 5.6M People in England Waiting for Hospital Treatment,” The Guardian estimated that 1.4 million patients were added to the waiting lists during the pandemic’s first 18 months. More than one-third of the 5.6 million people waiting for care in July 2021 had been on a waitlist for at least 18 months, the paper noted. Since then, the waiting list has grown by 150,000 people per month, as more people who did not seek or could not access NHS treatments during the pandemic returned to their doctors’ offices.

Johnson’s tax hike formula for fixing the record NHS backlog and improving social care for the elderly created shockwaves in the UK’s Conservative Party, which, like the Republican Party in this country, has championed low taxes. But Johnson maintains the government is out of options.

“It would be wrong for me to say that we can pay for this recovery without taking the difficult but responsible decisions about how we finance it,” Johnson told Parliament. “It would be irresponsible to meet the costs from higher borrowing and higher debt,” he added.

But Johnson’s proposal drew the wrath of some members of his own party and provided the opposition Labor Party with ammunition to denounce the prime minister’s leadership during the pandemic.

In “U.K. Is Among First Western Nations to Increase Taxes to Cover COVID-19 Costs,” The Wall Street Journal (WSJ) reported that Labor Party leader Keir Starmer compared Johnson’s tax increases to putting a bandage “on gaping wounds that his party inflicted,” and questioned why they weren’t levied more directly on the rich. The UK government says the wealthiest 14% will pay about half of the extra tax revenues, the WSJ noted.

“This is a tax rise that breaks a promise that the prime minister made at the last election … Read my lips, the Tories can never again claim to be the party of low tax,” Starmer told Reuters.

BBC Graphic

The BBC graphic above illustrates how the tax hikes, which were approved by the Parliament on September 8 by a 319 to 248 vote, will increase the national insurance payroll tax paid by workers and employers by 1.25% each. CNBC reported that the UK government projects the increased taxes will raise £36 billion (US$49.6 billion) over the next three years. (Graphic copyright: BBC.)

Politics versus Hard Facts

According to The Guardian, in 2023-2024, national insurance contributions will be rebranded as a health and social care levy, with more of the money raised going to social care. The added funding will enable the UK government to implement a new cap on total care costs so that no individual will pay more than £86,000 (US$117,142) over their lifetime for social-care programs. Currently, many seniors are forced to sell their homes to meet unexpected care costs, the newspaper noted.

In “Britain’s Tax Warning to America,” the WSJ editorial board criticized Johnson’s plan as a “new middle-class entitlement.”

“One message to voters and investors is that taxes are set to rise for years to come,” the WSJ editorial board wrote, predicting the cost of social care will escalate as the UK’s population ages, and that the planned diversion of future taxes for social care will be presented as a “cut” in NHS funding. They maintained that the danger in Johnson’s decision goes deeper than breaking an election campaign pledge or nationalizing more of the UK’s healthcare economy.

“The larger problem is that national healthcare and other entitlements become ever more unaffordable even as they are politically impossible to reform,” the newspaper stated. “The Tories are becoming tax collectors for the entitlement state, which is deadly for parties of the right.”

Bloomberg noted that the UK Institute for Fiscal Studies predicts the planned April 1 tax increase will “raise the UK tax burden to its highest-ever sustained level since records began in 1955—about 35% of national income.”

But, according to the UK-based The Health Foundation, at £2,646.95 (US$3,648.43) per person in 2019, the United Kingdom spends less on healthcare than many developed countries. Less per person than the:

  • US (£6,782.80),
  • Germany (£4,131.21),
  • France (£3,307.54),
  • Japan (£2,949.19) and
  • Canada (£2,823.07).

And when healthcare costs are viewed as a percentage of a country’s gross domestic product (GDP), the UK (8% GDP) lags behind the US (13.9%), Germany (9.9%), Japan (9.3%) and France (9.3%) and exceeds only Canada (7.6%) and Italy (6.4%).

While US hospitals, healthcare systems, and patients continue to struggle with ever-increasing healthcare costs, reformers who promote a single-payer healthcare system as an answer to this nation’s healthcare ills may want to take a hard look at the outcomes of the UK’s model.

Clinical laboratory managers and pathologists interested in how the US healthcare system can be improved might be well-served to study the experience of the National Health Service in the UK, that, like all other health systems in the world, has its own unique methods for how it serves its population.

Andrea Downing Peck

Related Information:

U.K. Is Among First Western Nations to Increases Taxes to Cover Covid-19 Costs

Britain’s Tax Warning to America

Taxes and Healthcare Funding: How Does the UK Compare?

Record 5.6M People in England Waiting for Hospital Treatment

UK PM Johnson Raises Taxes to Tackle Health and Social Care Crisis

UK’s Boris Johnson to Hike Taxes to Tackle Covid and Social-Care Crises

Johnson Wins Healthcare Vote to Push UK Taxes to Highest Ever

What Has Boris Johnson Announced in His Social Care Plan?

UK Continues to Use Innova’s SARS-CoV-2 Antigen Rapid Test Despite Recall and FDA Warning Letter

FDA cites ‘risk of false results’ and concerns about labeling and ‘performance claims’ in its official warning letter to Innova, a company with connections to Chinese firms

By many standards, the US government’s response to the COVID-19 pandemic has been phenomenal. However, the many emergency use authorizations (EUAs) awarded by the US federal Food and Drug Administration (FDA) to bring as many COVID-19 tests to market as quickly as possible means some of those tests in use today at clinical laboratories nationwide have not undergone the normal pre-market review and clearance typically required by the FDA. 

Thus, Innova Medical Group’s recent recall of its SARS-CoV-2 Antigen Rapid Test is not a complete shock considering the circumstances.

But in its recall announcement, the FDA described Innova’s recall of its SARS-CoV-2 Antigen Rapid Test as a “Class 1 recall” and gave the stern warning, “Use of these devices may cause serious injuries or death.”

And in its public Safety Communication, the federal agency wrote, “The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health. In addition, labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests. Finally, the test has not been authorized, cleared, or approved by the FDA for commercial distribution or use in the United States, as required by law.”

So, it is odd that the UK government’s Medicines and Healthcare Products Regulatory Agency (MHRA) would disregard the FDA’s warning and extend its own exceptional use authorization (EUA) of the Innova COVID-19 antigen test through late August. Nevertheless, that is exactly what the MHRA did.

Innova's COVID-19 SARS-CoV-2 Antigen Rapid test kit

In May 2021, Innova Medical Group of Pasadena, Calif., announced it would start producing millions of its COVID-19 SARS-CoV-2 Antigen Rapid test kits (above) per day in the United Kingdom by opening a production facility in Rhymney, South Wales. (Photo copyright: Innova Medical Group, Inc.)

FDA Warns Public to Stop Using Innova’s Rapid Antigen COVID-19 Test

Widescale COVID-19 testing has been viewed as key to containing community spread of the SARS-CoV-2 coronavirus, and fast, inexpensive rapid COVID-19 testing is a necessity in that fight.

However, as clinical laboratory scientists know, rapid tests are not as specific as molecular polymerase chain reaction (PCR) tests, which means there is a higher chance of false negatives and false positives with a COVID-19 rapid test than with a molecular test. When diagnosing COVID-19, a PCR test is considered the gold-standard, though results can take multiple days to produce.  

Nevertheless, according to the Innova Europe website, the Innova rapid antigen test has a sensitivity on symptomatic individuals of 97% and a specificity of 99% and is the most widely used test in the world. More than 500 million units are in circulation.

Regardless, in its June 10th warning, the FDA called for the public to stop using the Innova Medical Group SARS-CoV-2 Antigen Rapid test for diagnostic use.

“The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health,” the FDA stated. “In addition, labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests. Finally, the test has not been authorized, cleared, or approved by the FDA for commercial distribution or use in the United States, as required by law.”

In its warning, the FDA recommended anyone in possession of Innova tests “destroy the tests by placing them in the trash” or return the tests to Innova.

The Innova SARS-CoV-2 Antigen Rapid test is also distributed under the names:

  • Innova COVID-19 Self-Test Kit (3T Configuration),
  • Innova Medical Group SARS-CoV-2-Antigen Rapid Test (7T Configuration), and
  • Innova Medical Group SARS-CoV-2-Antigen Rapid Test (25T Configuration).

Innova Medical Group was formed in March 2020 by Charles Huang, PhD, founder and chairman of private-equity firm Pasaca Capital. The Pasaca website states Innova worked with its primary contract manufacturer, China-based Xiamen Biotime Biotechnology Co., for several months to design “a highly accurate rapid antigen test for COVID-19.”

“The simple test takes less than five minutes to administer and generates results in as little as 20 minutes without the need for a machine,” the website states. “Equally important, Innova and its partner have been able to manufacture the product at scale, presently in excess of ten million kits per day.”

However, The Los Angeles Times claims that in September 2020 Innova “secured a vast supply of rapid coronavirus tests from an obscure Chinese manufacturer before established pharmaceutical companies could do so.” The LA Times adds that Innova distributed more than 70,000 tests in the United States even though the FDA had not acted on Innova’s application to sell its tests domestically.

This may have contributed to the FDA’s dire warning to discontinue use and discard the Innova tests.

UK’s MHRA Disagrees with FDA Warning

But in the UK, it is a different story. According to The Guardian, Innova’s lateral flow tests are the cornerstone of “Operation Moonshot”, the government’s mass testing plan aimed at reducing community transmission by identifying asymptomatic COVID-19 positive people using an inexpensive, quick-response test distributed for home use and to workplaces, schools, and test centers.

In “Rapid COVID Tests Used in Mass UK Programme Get Scathing US Report,” The Guardian reports that “criticism of the Innova test has been fierce” in the UK following the FDA’s “scathing review” of its rapid antigen test. However, after investigating the concerns raised by the FDA, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) reiterated that the Innova lateral flow tests were safe to use.

“We have now concluded our review of the risk assessment and are satisfied that no further action is necessary or advisable at this time,” said Graeme Tunbridge, MHRA Director of Devices, in a UK government response statement which announced that the MHRA was extending the Exceptional Use Authorization (EUA) for the tests use in its national asymptomatic testing program through Aug. 28, 2021. “This has allowed us to extend the EUA to allow ongoing supply of these [lateral flow devices] over the coming months. People can be assured of the MHRA’s work to continuously monitor the tests in use; as is our standard process.”

Innova Defends Its Test, FDA Repeats Its Warning

An Innova spokesperson told The Guardian: “The Innova rapid antigen test has been widely used, studied, tested, scrutinized and analyzed with data supporting the efficacy of the test from the largest mass testing program out of the UK. Innova is confident about the quality of its product.”

However, the FDA maintains Innova’s COVID-19 lateral flow test included labeling that provided “false and misleading” estimates of the test’s clinical performance. In its warning letter to Innova, the FDA also pointed out that the clinical study data Innova submitted as part of its EUA request was “identical to data previously provided by other manufacturers in their EUA requests. The data reliability and accuracy issues noted herein raise significant concerns that the performance of the SARS-CoV-2 Antigen Rapid Qualitative Test has not been adequately established, and that the products distributed by Innova without FDA approval, clearance, or authorization could present a serious risk to the public health.”

Pathologists and clinical laboratory professionals in this country will want to watch carefully to see if efforts to increase regulatory scrutiny of diagnostic tests in the UK spills across the Atlantic.

—Andrea Downing Peck

Related Information

Following a Satisfactory Review, MHRA Extends Authorisation of NHS Test and Trace Lateral Flow Devices

Stop Using Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety Communication

What Is No 10’s ‘Moonshot’ COVID Testing Plan and Is It Feasible?

UK Extends OK of Innova COVID-19 Test Criticized by FDA in Warning Letter

Rapid COVID Tests Used in Mass UK Programme Get Scathing US Report

Warning Letter: Innova Medical Group, Inc. MARCS-CMS 614819–June 10, 2021

The Royal Statistical Society Calls for New Standards for Diagnostic Tests, to Address Testing Problems During the Pandemic

A Pasadena Startup Got Billions Selling COVID Tests. Then Came Questions

Innova Medical Group Recalls Unauthorized SARS-CoV-2 Antigen Rapid Qualitative Test with Risk of False Test Results

Stop Using Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety Communication

How Likely Is a Positive COVID-19 Lateral Flow Test to be Wrong?

Asymptomatic Lateral Flow Testing: What’s the Verdict?

Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

UK Researchers Create Analytical Algorithm That Identifies Patients with Advanced Liver Disease by Analyzing Routine Clinical Laboratory Blood Test Results

By mining results of unrelated blood tests, the CIRRUS algorithm can inform doctors and patients earlier than usual of liver disease

For years Dark Daily and its sister publication The Dark Report have predicted that the same type of analytical software used on Wall Street to analyze bundles of debt, such as car loans, mortgages, and installment loans, would eventually find application in healthcare and clinical laboratory medicine. Now, researchers at the University of Southampton in England have developed just such an analytical tool.

The UK researchers call their algorithm CIRRUS, which stands for CIRRhosis Using Standard tests. It can, they say, accurately predict if a patient has cirrhosis of the liver at a much earlier stage than usual and produce information that is clinically actionable, using results from several common, routinely-ordered medical laboratory tests.

The University of Southampton scientists published their findings in BMJ Open.

Currently, the leading edge for this in clinical laboratory medicine is analysis of digital pathology images using image analysis tools and artificial intelligence (AI). However, CIRRUS is an example that analytical software is advancing in its ability to mine data from a number of clinically-unrelated lab tests on a patient and identify a health condition that might otherwise remain unknown.

The UK researchers designed the CIRRUS algorithm using routine clinical laboratory blood tests often requested in general practice to identify individuals at risk of advanced liver disease. These tests include:

Reversing Liver Disease through Lifestyle Changes

“More than 80% of liver cirrhosis deaths are linked to alcohol or obesity and are potentially preventable,” noted Nick Sheron, MD, FRCP, Head of Population Hepatology at University of Southampton, and lead author of the study, in a press release. “However, the process of developing liver cirrhosis is silent and often completely unsuspected by GPs [general practitioners]. In 90% of these patients, the liver blood test that is performed is normal, and so liver disease is often excluded.

“This new CIRRUS algorithm can find a fingerprint for cirrhosis in the common blood tests done routinely by GPs,” he continued. “In most cases the data needed to find these patients already exists and we could give patients the information they need to change their lifestyle. Even at this late stage, if people address the cause by stopping drinking alcohol or reducing their weight, the liver can still recover.”

Mining Clinical Laboratory Blood Test Results

To perform the study, the research team analyzed data on blood test results for nearly 600,000 patients. Unlike most diagnostic liver algorithms, the CIRRUS model was created using a dataset comprised of patients from both primary and secondary care without the main intent of preselecting for liver disease. This renders it better suited for detecting liver disease outside a secondary care hepatology environment.

“Whilst we are all preoccupied with the coronavirus pandemic we must not lose sight of other potentially preventable causes of death and serious illness,” said Michael Moore, BM, BS, MRCP, FRCGP, Professor of Primary Health Care Research and Head of Academic Unit Primary Care and Population Sciences at University of Southampton, in the press release. Professor Moore co-authored the CIRRUS study.

“This test using routine blood test data available, gives us the opportunity to pick up serious liver disease earlier, which might prevent future emergency admission to hospital and serious ill health,” he said.

Cirrhosis micrograph showing scaring of liver tissue
Cirrhosis (shown above in a trichrome stained micrograph) is a condition in which the liver is scarred and permanently damaged. As the condition progresses, more scar tissue replaces healthy liver tissue. This accumulated scar tissue prevents the liver from doing its primary job of regulating chemical levels in the blood and excreting bile, a substance which helps eliminate toxins from the body and breaks down fats during digestion. As cirrhosis worsens, the liver begins to fail. (Photo copyright: Wikipedia.)

According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), cirrhosis is most common in adults ages 45 to 54 and about 1 in 400 adults in the US live with the disease. However, the actual number may be much higher as many people are not aware they have cirrhosis, because they do not experience symptoms until the liver is badly damaged. 

The NIDDK reports complications from cirrhosis include:

  • Portal Hypertension, a condition where scar tissue partially blocks the normal flow of blood through the liver,
  • Infections,
  • Liver Cancer,
  • Liver Failure,
  • Bone diseases, such as osteoporosis,
  • Gallstones,
  • Bile duct issues,
  • Malabsorption and malnutrition,
  • Bruising and bleeding easily,
  • Sensitivity to medicines,
  • Insulin resistance, and
  • Type 2 diabetes.

“Liver cirrhosis is a silent killer. The tests used most by GPs are not picking up the right people and too many people are dying preventable deaths. We looked at half a million anonymous records and the data we needed to run CIRRUS was already there in 96% of the people who went on to have a first liver admission,” stated Sheron in the press release. “With just a small change in the way we handle this data it should be possible to intervene in time to prevent many of these unnecessary deaths.”

“Alcohol-related liver diseases are far and away the most significant cause of alcohol-specific deaths, yet currently the vast majority of people find out that their liver is diseased way too late,” said Richard Piper, PhD, Chief Executive of Alcohol Change UK, a British charity and campaign group dedicated to reducing harm caused by alcohol abuse. “What is needed is a reliable means of alerting doctors and their patients to potential liver disease as early as possible. The CIRRUS process shows real promise, and we want to see it further developed, tested and implemented, to help save hundreds of thousands, if not millions, of lives.”

CIRRUS is a true milestone in the development of computer-assisted healthcare diagnostics. It will need more research, but the University of Southampton study shows that analytical software tools can mine clinical laboratory test results that were ordered for unrelated diagnostics and identify existing health conditions that might otherwise remain hidden to the patient’s physicians.

—JP Schlingman

Related Information:

Routine Blood Tests Could Be Key to Stopping the Silent Killer of Liver Disease

Can Routine Blood Tests be Modelled to Detect Advanced Liver Disease in the Community: Model Derivation and Validation Using UK Primary and Secondary Care Data

New Algorithm Can Predict Advanced Liver Disease

Routine Blood Tests Contain ‘Hidden Fingerprint’ Indicating Liver Cirrhosis

Common DNA Testing Method Using SNP Chips Struggles to Find Rare Variants Associated with BRCA Test, UK Researchers Find

Results of the UK study confirm for clinical laboratory professionals the importance of fully understanding the design and function of SNP chips they may be using in their labs

Here is another example of a long-established clinical laboratory test that—upon new evidence—turns out to be not as accurate as once thought. According to research conducted at the University of Exeter in Devon, UK, Single-nucleotide polymorphism (SNP) chips (aka, SNP microarrays)—technology commonly used in commercial genetic testing—is inadequate at detecting rare gene variants that can increase breast cancer risk.  

A news release announcing the results of the large-scale study states, “A technology that is widely used by commercial genetic testing companies is ‘extremely unreliable’ in detecting very rare variants, meaning results suggesting individuals carry rare disease-causing genetic variants are usually wrong.”

Why is this a significant finding for clinical laboratories? Because medical laboratories performing genetic tests that use SNP chips should be aware that rare genetic variants—which are clinically relevant to a patient’s case—may not be detected and/or reported by the tests they are running.

UK Researchers Find ‘Shockingly High False Positives’

The objective of the Exeter study published in British Medical Journal (BMJ), titled, “Use of SNP Chips to Detect Rare Pathogenic Variants: Retrospective, Population Based Diagnostic Evaluation,” was “To determine whether the sensitivity and specificity of SNP chips are adequate for detecting rare pathogenic variants in a clinically unselected population.”

The conclusion reached by the Exeter researchers, the BMJ study states, is that “SNP chips are extremely unreliable for genotyping very rare pathogenic variants and should not be used to guide health decisions without validation.”  

Leigh Jackson, PhD, Lecturer in Genomic Medicine at University of Exeter and co-author of the BMJ study, said in the news release, “The number of false positives on rare genetic variants produced by SNP chips was shockingly high. To be clear: a very rare, disease-causing variant detected using [an] SNP chip is more likely to be wrong than right.” 

Caroline Wright, PhD, Professor in Genomic Medicine at the University of Exeter Medical School
In the news release, Caroline Wright, PhD (above), Professor in Genomic Medicine at the University of Exeter Medical School and senior author of the BMJ study, said, “SNP chips are fantastic at detecting common genetic variants, yet we have to recognize that tests that perform well in one scenario are not necessarily applicable to others.” She added, “We’ve confirmed that SNP chips are extremely poor at detecting very rare disease-causing genetic variants, often giving false positive results that can have profound clinical impact. These false results had been used to schedule invasive medical procedures that were both unnecessary and unwarranted.” (Photo copyright: University of Exeter.)

Large-Scale Study Taps UK Biobank Data

The Exeter researchers were concerned about cases of unnecessary invasive medical procedures being scheduled by women after learning of rare genetic variations in BRCA1 (breast cancer type 1) and BRCA2 (breast cancer 2) tests.

“The inherent technical limitation of SNP chips for correctly detecting rare genetic variants is further exacerbated when the variants themselves are linked to very rare diseases. As with any diagnostic test, the positive predictive value for low prevalence conditions will necessarily be low in most individuals. For pathogenic BRCA variants in the UK Biobank, the SNP chips had an extremely low positive predictive value (1-17%) when compared with sequencing. Were these results to be fed back to individuals, the clinical implications would be profound. Women with a positive BRCA result face a lifetime of additional screening and potentially prophylactic surgery that is unwarranted in the case of a false positive result,” they wrote.

Using UK Biobank data from 49,908 participants (55% were female), the researchers compared next-generation sequencing (NGS) to SNP chip genotyping. They found that SNP chips—which test genetic variation at hundreds-of-thousands of specific locations across the genome—performed well when compared to NGS for common variants, such as those related to type 2 diabetes and ancestry assessment, the study noted.

“Because SNP chips are such a widely used and high-performing assay for common genetic variants, we were also surprised that the differing performance of SNP chips for detecting rare variants was not well appreciated in the wider research or medical communities. Luckily, we had recently received both SNP chip and genome-wide DNA sequencing data on 50,000 individuals through the UK Biobank—a population cohort of adult volunteers from across the UK. This large dataset allowed us to systematically investigate the performance of SNP chips across millions of genetic variants with a wide range of frequencies, down to those present in fewer than 1 in 50,000 individuals,” wrote Wright and Associate Professor of Bioinformatics and Human Genetics at Exeter, Michael Weedon, PhD, in a BMJ blog post.

The Exeter researchers also analyzed data from a small group of people in the Personal Genome Project who had both SNP genotyping and sequencing information available. They focused their analysis on rare pathogenic variants in BRCA1 and BRCA2 genes.

The researchers found:

  • The rarer the variant, the less reliable the test result. For example, for “very rare variants” in less than one in 100,000 people, 84% found by SNP chips were false positives.
  • Low positive predictive values of about 16% for very rare variants in the UK Biobank.
  • Nearly all (20 of 21) customers of commercial genetic testing had at least one false positive rare disease-causing variant incorrectly genotyped.
  • SNP chips detect common genetic variants “extremely well.”

Advantages and Capabilities of SNP Chips

Compared to next-gen genetic sequencing, SNP chips are less costly. The chips use “grids of hundreds of thousands of beads that react to specific gene variants by glowing in different colors,” New Scientist explained.

Common variants of BRCA1 and BRCA2 can be found using SNP chips with 99% accuracy, New Scientist reported based on study data.

However, when the task is to find thousands of rare variants in BRCA1 and BRCA2 genes, SNP chips do not fare so well.

“It is just not the right technology for the job when it comes to rare variants. They’re excellent for the common variants that are present in lots of people. But the rarer the variant is, the less likely they are to be able to correctly detect it,” Wright told CNN.

SNP chips can’t detect all variants because they struggle to cluster needed data, the Exeter researchers explained.

“SNP chips perform poorly for genotyping rare genetic variants owing to their reliance on data clustering. Clustering data from multiple individuals with similar genotypes works very well when variants are common,” the researchers wrote. “Clustering becomes more difficult as the number of people with a particular genotype decreases.”

Clinical laboratories Using SNP Chips

The researchers at Exeter unveiled important information that pathologists and medical laboratory professionals will want to understand and monitor. Cancer patients with rare genetic variants may not be diagnosed accurately because SNP chips were not designed to identify specific genetic variants. Those patients may need additional testing to validate diagnoses and prevent harm.

—Donna Marie Pocius

Related Information:

Large-scale Study Finds Genetic Testing Technology Falsely Detects Very Rare Variants

Use of SNP Chips to Detect Rare Pathogenic Variants: Retrospective, Population-Based Diagnostic Evaluation

The Home DNA Kits “Falsely Warning of High Risk of Cancer”: DIY Genetic Tests are “Extremely Unreliable” at Detecting Rare Genetic Variants, Major New Study Warns

SNP Chips Perform Poorly for Detecting Rare Genetic Variants

Chip-based DNA Testing Wrong More than Right for Very Rare Variants

Common Genetic Tests Often Wrong When Identifying Rare Disease-Causing Variants Such as BRCA1and BRCA2, Study Says

UK’s NHS Will Use Amazon Alexa to Deliver Official Health Advice to Patients in the United Kingdom

Since Alexa is now programed to be compliant with HIPAA privacy rules, it’s likely similar voice assistance technologies will soon become available in US healthcare as well

Shortages of physicians and other types of caregivers—including histopathologists and pathology laboratory workers—in the United Kingdom (UK) has the UK’s National Health Service (NHS) seeking alternate ways to get patients needed health and medical information. This has prompted a partnership with Amazon to use the Alexa virtual assistant to answer patients healthcare inquiries.

Here in the United States, pathologists and clinical laboratory executives should take the time to understand this development. The fact that the NHS is willing to use a device like Alexa to help it maintain access to services expected by patients in the United Kingdom shows how rapidly the concept of “virtual clinical care” is moving to become mainstream.

If the NHS can make it work in a health system serving 66-million people, it can be expected that health insurers, hospitals, and physicians in the United States will follow that example and deploy similar virtual health services to their patients.

For these reasons, all clinical laboratories and anatomic pathology groups will want to develop a strategy as to how their organizations will interact with virtual health services and how their labs will want to deploy similar virtual patient information services.

Critical Shortages in Healthcare Services

While virtual assistants have been answering commonly-asked health questions by mining popular responses on the Internet for some time, this new agreement allows Alexa to provide government-endorsed medical advice drawn from the NHS website.

By doing this, the NHS hopes to reduce the burden on healthcare workers by making it easier for UK patients to access health information and receive answers to commonly-asked health questions directly from their homes, GeekWire reported. 

“The public needs to be able to get reliable information about their health easily and in ways they actually use. By working closely with Amazon and other tech companies, big and small, we can ensure that the millions of users looking for health information every day can get simple, validated advice at the touch of a button or voice command,” Matthew Gould, CEO of NHSX, a division of the NHS that focuses on digital initiatives, told GeekWire

The Verge reported that when the British government officially announced the partnership in a July press release, the sample questions that Alexa could answer included:

  • Alexa, how do I treat a migraine?
  • Alexa, what are the symptoms of the flu?
  • Alexa, what are the symptoms of chickenpox?

“We want to empower every patient to take better control of their healthcare and technology like this is a great example of how people can access reliable, world-leading NHS advice from the comfort of their home, reducing the pressure on our hardworking GPs (General Practitioners) and pharmacists,” said Matt Hancock, Secretary of State for Health and Social Care, in the press release.

MD Connect notes that the NHS provides healthcare services free of charge to more than 66-million individuals residing in the UK. With 1.2 million employees, the NHS is the largest employer in Europe, according to The Economist. That article also stated that the biggest problem facing the NHS is a staff shortage, citing research conducted by three independent organizations:

Their findings indicate “that NHS hospitals, mental-health providers, and community services have 100,000 vacancies, and that there are another 110,000 gaps in adult social care. If things stay on their current trajectory, the think-tanks predict that there will be 250,000 NHS vacancies in a decade,” The Economist reported.

UK’s Matt Hancock, Secretary of State for Health and Social Care (above), defends the NHS’ partnership with Amazon Alexa, saying millions already use the smart speaker for medical advice and it’s important the health service uses the “best of modern technology.” Click here to watch the video. (Video and caption copyright: Sky News.)

“This idea is certainly interesting and it has the potential to help some patients work out what kind of care they need before considering whether to seek face-to-face medical help, especially for minor ailments that rarely need a GP appointment, such as coughs and colds that can be safely treated at home,” Professor Helen Stokes-Lampard, Chairman at the Royal College of General Practitioners, and Chair of the Board Of Directors/Trustees at National Academy of Social Prescribing, told Sky News.

“However,” she continued, “it is vital that independent research is done to ensure that the advice given is safe, otherwise it could prevent people seeking proper medical help and create even more pressure on our overstretched GP service.”

Amazon has assured consumers that all data obtained by Alexa through the NHS partnership will be encrypted to ensure privacy and security, MD Connect notes. Amazon also promised that the personal information will not be shared or sold to third parties.

Alexa Now HIPAA Compliant in the US

This new agreement with the UK follows the announcement in April of a new Alexa Skills Kit that “enables select Covered Entities and their Business Associates, subject to the US Health Insurance Portability and Accountability Act of 1996 (HIPAA), to build Alexa skills that transmit and receive protected health information (PHI) as part of an invite-only program. Six new Alexa healthcare skills from industry-leading healthcare providers, payors, pharmacy benefit managers, and digital health coaching companies are now operating in our HIPAA-eligible environment.”

Developers of voice assistance technologies can freely use these Alexa skills, which are “designed to help customers manage a variety of healthcare needs at home simply using voice—whether it’s booking a medical appointment, accessing hospital post-discharge instructions, checking on the status of a prescription delivery, and more,” an Amazon Developer Alexa blog states.

The blog lists the HIPAA-compliant Alexa skills as:

  • Express Scripts: Members can check the status of a home delivery prescription and can request Alexa notifications when their prescription orders are shipped.
  • Cigna Health Today by Cigna (NYSE:CI): Eligible employees with one of Cigna’s large national accounts can now manage their health improvement goals and increase opportunities for earning personalized wellness incentives.
  • My Children’s Enhanced Recovery After Surgery (ERAS) (by Boston Children’s Hospital: Parents and caregivers of children in the ERAS program can provide their care teams updates on recovery progress and receive information regarding their post-op appointments.
  • Swedish Health Connect by Providence St. Joseph Health, a healthcare system with 51 hospitals across seven states and 829 clinics: Customers can find an urgent care center near them and schedule a same-day appointment.
  • Atrium Health, a healthcare system with more than 40 hospitals and 900 care locations throughout North and South Carolina and Georgia: Customers in North and South Carolina can find an urgent care location near them and schedule a same-day appointment.
  • Livongo, a digital health company that creates new and different experiences for people with chronic conditions: Members can query their last blood sugar reading, blood sugar measurement trends, and receive insights and Health Nudges that are personalized to them.

HIPAA Journal notes: “This is not the first time that Alexa skills have been developed, but a stumbling block has been the requirements of HIPAA Privacy Rules, which limit the use of voice technology with protected health information. Now, thanks to HIPAA compliant data transfers, the voice assistant can be used by a select group of healthcare organizations to communicate PHI without violating the HIPAA Privacy Rule.”

Steady increases associated with the costs of medical care combined with a shortage of healthcare professionals on both continents are driving trends that motivate government health programs and providers to experiment with non-traditional ways to interact with patients.

New digital and Artificial Intelligence (AI) tools like Alexa may continue to emerge as methods for providing care—including clinical laboratory and pathology advice—to healthcare consumers.

—JP Schlingman

Related Information:

“Alexa, How Do I Treat a Migraine?” Amazon and NHS Unveil Partnership

Amazon’s Alexa Will Deliver NHS Medical Advice in the UK

NHS Health Information Available Through Amazon’s Alexa

UK’s National Health Service Taps Amazon’s Alexa to Field Common Medical Questions

What Happens When Amazon Alexa Gives Health Advice?

Alexa, Where Are the Legal Limits on What Amazon Can Do with My Health Data?

Amazon Alexa Offering NHS Health Advice

A Shortage of Staff Is the Biggest Problem Facing the NHS

Need Quick Medical Advice in Britain? Ask Alexa

Alexa Blogs: Introducing New Alexa Healthcare Skills

Amazon Announces 6 New HIPAA Compliant Alexa Skills

Amazon Alexa Is Now HIPAA-Compliant: Tech Giant Says Health Data Can Now Be Accessed Securely

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Apple Updates Its Mobile Health Apps, While Microsoft Shifts Its Focus to Artificial Intelligence. Both Will Transform Healthcare, But Which Will Impact Clinical Laboratories the Most?

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