Testing capacity has been boosted by inclusion of commercial laboratory companies and the fact that the virus spreads less easily than SARS-CoV-2
At the start of the SARS-CoV-2 pandemic, clinical laboratories were unprepared for unprecedented testing volumes. Fast forward to today, and the monkeypox outbreak has some clinical laboratory managers and pathologists wondering if they might again be faced with a surge in demand for monkeypox testing.
The good news is that so far the supply of tests appears adequate, especially compared to the early days of COVID-19.
“We’ve always had more capacity than we have had tests coming in,” Walensky noted. “To date, we’ve used about 14% to 20% of our capacity.”
During a hearing before the Senate Health, Education, Labor, and Pensions Committee on the current state of monkeypox testing capacity in the US, Rochelle Walensky, MD (above), Director at the CDC said, “We worked through commercial labs to expand testing across the country and simultaneously [offered] outreach and education to providers, clinicians, patients, and public health.” At the moment, access to clinical laboratory testing for monkeypox appears stable, but that could change as demand grows. (Photo copyright: CDC.)
Capacity Sits at 80,000 Tests Per Week in the US
When the monkeypox outbreak began, US medical laboratories could run 6,000 tests per week. At the time, this was more than sufficient, according to a White House press briefing.
However, since then, demand for testing has increased across the country to 80,000 tests per week. As part of that effort, the CDC partnered with five commercial laboratories to expand access to testing, according to the federal Department of Health and Human Services (HHS), Dark Daily reported in August.
Testing capacity also has kept up with demand thanks to biology. Monkeypox, which is in the same orthopoxvirus family of viruses as smallpox, has proven far less virulent than COVID-19, so fewer people are getting infected.
FDA Advises Against Monkeypox Saliva Test
Another boost to capacity in the future may come from new types of monkeypox tests.
Wired reported on Aug. 1 that Flow Health—a California company already distributing COVID-19 tests—has developed a monkeypox test that can detect the virus in saliva. This test would require patients to spit into a tube for a sample, and as such could be distributed for at-home use.
However, in a report released on July 15, the US Food and Drug Administration (FDA) advised providers to only take testing samples from lesions caused by the rash associated with monkeypox infection. The FDA stated that there is currently no clinical data to support the use of other monkeypox tests like Flow Health’s.
Monkeypox Testing Resources Scarce in Some Areas
At the moment, clinical laboratory testing capacity seems stable, however, roadblocks are appearing that may disrupt the availability of monkeypox tests for patients.
Although bringing on five commercial laboratories has increased US testing capacity, MedTech Dive reported on Aug. 10 that for some hospitals and laboratories, resources for monkeypox testing are scarce.
“Right now, there’s a lot of confusion in the community about where to get tested, where can people find treatment,” Robert Pitts, MD, an Infectious Diseases Specialist at Bellevue, told MedTech Dive. “There’s just no clear guidance because I think a lot of the different facilities and healthcare systems in New York are still trying to patch together pathways. … We’ve had to borrow space, borrow staff, which has been really, really challenging.”
During August, Bellevue took two primary care providers out of their normal clinical responsibilities to instead focus on monkeypox. And Pitts found himself dedicating four to five hours of his time to monkeypox-related issues, MedTech Dive reported.
“And so, I’m using my own time, because it’s a crisis, to respond to it,” he said.
The US healthcare system has been somewhat more efficient at getting monkeypox tests out to clinical laboratories than was the case with COVID-19. Moreover, new tests may be on the way. However, roadblocks exist that must be overcome to ensure monkeypox testing capability will meet growing demand.
An assay using mass spectrometry could go to clinical trial within two years
Dark Daily has regularly observed that humans generate a variety of volatile substances—particularly in breath—which can be used for diagnostic purposes. But what if people, like certain trained animals, could smell the presence of disease before the onset of symptoms? What types of clinical laboratory testing biomarkers could be developed based on human-generated volatile organic compounds?
Researchers at the University of Manchester (UM) in the United Kingdom (UK) say their “breakthrough” test to diagnose Parkinson’s disease “can diagnose disease from skin swabs in three minutes,” according to a university press release.
Perdita Barran, PhD (right), head of the University of Manchester research team that developed the mass spectrometry Parkinson’s test, is shown above with Joy Milne (left), the retired nurse from Scotland who inspired Barran’s team to develop a new Parkinson’s biomarker and method for identifying it. “We are tremendously excited by these results which take us closer to making a diagnostic test for Parkinson’s Disease that could be used in clinic,” she said in a press release. A viable clinical laboratory test for Parkinson’s disease is greatly needed, as more than 10 million people worldwide currently live with the neurodegenerative disorder. (Photo copyright: University of Manchester.)
Using Mass Spectrometry to Analyze Sebum
The UM scientists hypothesized that the smell could be due to sebum, a light oily substance on skin that was going through a chemical change due to the Parkinson’s disease, Hull Daily Mail explained.
Increased sebum, which is produced by the sebaceous glands, is a hallmark of Parkinson’s, the researchers noted.
Their new method involves analysis of sebum using mass spectrometry, according to the JACS AU paper. The method, the researchers claim, makes it possible to diagnose Parkinson’s disease from skin swabs in three minutes.
“There are no cures for Parkinson’s, but a confirmatory diagnosis would allow [Parkinson’s patients] to get the right treatment and get the drugs that will help to alleviate their symptoms,” Perdita Barran, PhD, told the Hull Daily Mail. Barran is Chair of Mass Spectrometry in the Department of Chemistry and Director of the Michael Barber Centre for Collaborative Mass Spectrometry at UM’s Manchester Institute of Biotechnology. “What we are now doing is seeing if (hospital laboratories) can do what we’ve done in a research lab in a hospital lab,” she added.
Sebum Analyzed with Mass Spectrometry
Parkinson’s disease—the world’s fastest growing neurodegenerative disorder—needs “robust biomarkers” that could advance detection and head off onset of motor symptoms such as tremor, rigidity, and postural instability, the researchers note in their paper.
Their recent study builds on earlier 2019 findings they published in ACS Central Science about volatile compounds in sebum possibly being used as Parkinson’s biomarkers.
“Sebum is an underexplored biofluid, which is readily obtained from non-invasive skin swabs, which primarily consists of a mixture of triglycerides, cholesterol, free fatty acids, waxy esters, and squalene,” the researchers explained in their JACS AU paper.
The scientists sought, “to develop a method to analyze sebum in its native state to facilitate rapid assessment of the Parkinson’s disease status. Paper spray ionization mass spectrometry, which allows the direct analysis of compounds from paper, has previously been demonstrated to detect small molecules from unprocessed biofluids, such as blood and urine, but not to date with sebum,” they wrote.
The UM researchers used mass spectrometry to analyze sebum collected on cotton swabs from the backs of 79 people with Parkinson’s and 71 healthy individuals, BBC Scotland News reported.
Depanjan Sarkar, PhD, Research Associate, University of Manchester, further explained the technique in the UM news release:
Sebum is taken from the swab to filter paper cut in a triangle.
Using a solvent and voltage, sebum compounds transfer into the mass spectrometer.
“When we did this, we found more than 4,000 unique compounds of which 500 are different between people with Parkinson’s compared to the control participants,” Sarkar said.
Fatty Acids Make Assay Possible
Could fatty acids pave the way to an assay? The UM researchers believe so.
“We have identified two classes of lipids, namely [triglycerides] and diglycerides, as components of human sebum that are significantly differentially expressed in PD,” the researchers wrote in JACS AU. “Non-invasive sampling followed by PS-IM-MS [paper spray-ion mobility–mass spectrometry] analysis targeting these compounds could provide an inexpensive assay to support clinical phenotyping for the confirmatory diagnosis of Parkinson’s disease.”
A clinical trial for their test, which costs about $20, may be done within two years in Manchester area, the Daily Mail reported.
When Dark Daily reported in 2020 on Joy Milne’s unique ability to smell her husband’s Parkinson’s disease before it was formally diagnosed, we predicted a diagnostic test for Parkinson’s may be years away. And here it is, albeit with regulatory clearance needed following clinical trials.
It may in fact be possible to leverage sebum analysis to detect other diseases, the UM researchers noted.
For diagnostics developers, this story of Joy Milne and her husband Les Milne is a useful example of how, in tracking the life of a specific patient with a specific disease and close family members, researchers were able to identify a new class of biomarkers that could be used in a diagnostic assay.
It will be interesting to follow the University of Manchester researchers in their quest for a diagnostic mass spectrometry clinical laboratory test for Parkinson’s disease. According to Parkinson’s Foundation statistics, about 10 million people worldwide live with the neurodegenerative disorder. Such a new diagnostic test could be vitally important to medical laboratory care, and to patients and their families.
South Asian nation aims to do what US, UK, and Europe failed to do during start of COVID-19 pandemic and slow spread of disease while case counts are low
With monkeypox quickly spreading around the world, India may be taking a lesson from western nations’ delayed response to COVID-19—including a sometimes slow availability of clinical lab testing for monkeypox—and preemptively increasing its national surveillance of the deadly social disease.
On Aug. 29, the Hindustan Times reported that in an attempt to slow the spread of monkeypox, India’s central government “has designated 15 viral research and diagnostic laboratories (VRDLs) spread across 13 states to monitor the incidence of monkeypox in the country.”
In the United States, the disease has spread with alarming speed, reaching all 50 states, as well as Washington, DC, and Puerto Rico. At 23,893 confirmed cases as of Sept. 14, the US now has the most cases in the world, according to the federal Centers for Disease Control and Prevention (CDC).
Reuters reported on Aug. 4 that the US Department of Health and Human Services (HHS) had declared a public health emergency. It was in May when monkeypox was detected in the United Kingdom (UK). Both the UK and several countries in Europe have struggled to control spread of the disease.
India hopes its decision to designate 15 VRDLs across 13 states to monitor the disease’s spread will enable it to do a better job than other countries at containing or eradicating monkeypox in the nation of 1.4 billion people, the Hindustan Times reported.
“The probability of containment is diminishing daily,” American infectious disease epidemiologist Anne Rimoin, PhD, a monkeypox expert at the UCLA Fielding School of Public Health, told STAT. “It’s really unfortunate because we do have the tools. This is not an unknown virus … We have vaccines that are already available, even vaccines with indications for monkeypox. Therapeutics. And we know what’s needed to be done.’’ Clinical laboratory testing for monkeypox will certainly increase over the coming months. (Photo copyright: KTLA.)
Keeping Up Their Guard
“Fortunately, India has not seen a surge in cases and the situation here is well under control. However, we cannot drop the guard just as yet. Therefore, a network of VRDLs has been established for surveillance purposes,” a top government expert told the Hindustan Times, seeking anonymity. “It will help pick signs early in case more cases get reported.”
As of Sept. 19, 2022, India reported just 12 cases of monkeypox resulting in one death, while, as noted above, the US had 23,892 confirmed cases and one death, according to CDC statistics. In the UK, confirmed cases totaled 3,552 with no deaths. And, as of that date, the European Union reported 19,379 confirmed cases.
Until recently, monkeypox was endemic only in West and Central Africa. India reported its first case of monkeypox on July 14. So far, most, but not all, of its cases have been related to international travel.
“The isolated cases of monkeypox reported in Delhi with no prior travel history emphasize the importance of tracing the source of the infection, perhaps transmission through rodent population,” Diwakar Kulkarni, PhD, former Director and Principal Scientist at the Indian Council of Agricultural Research, National Institute of High Security Animal Diseases, told Think Global Health.
Homosexuality a Vector in India
While India’s scientists are focused on containing the monkeypox outbreak, the country’s government may encounter societal roadblocks because of the disease’s connection with homosexuality. Gay sex is believed to be fueling the spread of the disease, ABC News reported. Until a Supreme Court of India ruling in 2018, gay sex was punishable by up to 10 years in prison in India.
Virologist and noted HIV expert Ishwar Gilada, MD, who opened India’s first AIDS clinic in 1986, told Bloomberg “anti-gay stigma” in India is causing male patients to avoid getting tested and treated for the disease. He said even before the first monkeypox cases were reported in India, two of his patients—a gay man and a man who identified as bisexual—refused to get tested because they feared being the first monkeypox case in the country.
“They are going underground,” Gilada told Bloomberg.
Did the US Wait Too Long to Begin Testing for Monkeypox?
The rapid growth in cases worldwide and the geographic spread of the disease has left global health experts pessimistic monkeypox can be contained.
NPR reported in June that some experts believe public health agencies ran too few tests in the early months of the outbreak because state health officials used a narrow definition of monkeypox when determining who qualified for testing, and that the US had “dropped the ball” on monkeypox testing.
As of Sept. 19, 2022, there were 62,406 confirmed cases worldwide, according to the CDC.
As clinical laboratories attempt to recover from the workload created by the COVID-19 pandemic, monkeypox appears to be the next endemic to test the mettle of lab professionals. Only time will tell if America and other western nations failed to act as expeditiously as India in curbing spread of this latest deadly disease.
Clinical labs should proactively investigate how a vendor will respond to a data security incident and how quickly, says expert
Clinical laboratory managers in New York and surrounding areas should be aware that almost one million protected health information (PHI) records from as many as 28 healthcare providers appear to have been stolen from a medical records company that services these providers.
Practice Resources LLC (PRL), a company that provides billing services for dozens of hospitals and medical providers in Central New York, announced in August they were the target of a ransomware attack that occurred on April 12 of this year. The Syracuse-based organization stated that hackers may have captured personally identifiable information (PII) such as names, home addresses, treatment dates, health plan numbers, and internal account numbers of 934,138 patients.
The data breach affected the patient records of dozens of medical providers and the clinical laboratories that service them, as well as physical therapists, pediatricians, gynecologists, orthopedic surgeons, and more.
“When a lab’s vendor has some type of breach, the lab entity that provided the compromised information could have some liability related to the breach,” explained Jim Giszczak, JD (above), McDonald Hopkins, in an interview with The Dark Report over a similar data breach in 2019. “That’s why every lab should be proactive and do a review to understand each vendor’s policies, procedures, training, and response in the event of a breach. Because your lab needs to know how a vendor will respond to a data security incident, and importantly, how quickly it will respond, it’s critical for lab officials to review the contracts they have with vendors that acquire, or have access to, PHI.” (Photo copyright: McDonald Hopkins.)
Not a Scam
“Unfortunately, it’s not a scam,” stated David Barletta, President and CEO of PRL, in an interview with local Syracuse news WSYR. “This really did happen in April—there was a ransomware attack on our system. We brought in forensic accountants and forensic information teams to come and look at what happened.”
PRL sent out more than 940,000 letters to potential victims of the cyberattack in August, noting that some patients may receive more than one letter.
The complete list of “healthcare entities on whose behalf Practice Resources LLC is providing notice of data incident,” according to PRL, includes:
Although their investigation did not uncover any evidence that personal data was misused, PRL has arranged credit monitoring services free of charge for one year from the date of enrollment. The company is also offering proactive fraud assistance to help people with any questions or in case they become a victim of fraud.
“There were no patient social security numbers that were taken. No medical record information was taken,” Barletta told WSYR. “We really, just out of an abundance of caution, felt that it was necessary that we provide them with credit monitoring for a year—just in case.”
Hundreds of Thousands of Patients Affected by Breach
When PRL discovered the data breach, the company took immediate steps to secure its systems and scrutinize the nature and extent of the incident. They then hired a forensic team to investigate what patient data may have been accessed by the hackers, a process that took several months.
“It does take a long time because each client has hundreds of thousands of patients maybe,” Barletta explained. “We have several large clients that really bore the brunt of this.”
According to Barletta, PRL bills about $450 million annually for its clients, which include some major institutions in Central New York. The New York state Attorney General’s office is investigating the hacking incident and delving into whether PRL’s data security was adequate.
As a result of the breach, FamilyCare Medical Group, which serves more than 80 physicians and thousands of patients, lost all of its laboratory data, according to the group’s CEO, Mitchell Brodey, MD. They had to close their lab for several months while their computer system was rebuilt. During this time, all their lab work was sent to another laboratory for analysis, MSN reported.
The PRL ransomware attack was what is commonly known as a third-party data breach. This type of breach occurs when sensitive data is stolen from a third-party vendor, or when their systems are used to access and steal sensitive information stored on other systems.
In the United States, the Federal Trade Commission (FTC) is responsible for enforcing federal privacy and data protection regulations. If a breach affects 500 or more individuals, the company must issue a press release and notify the FTC and all affected consumers within 60 days of the discovery of the breach.
Clinical Labs Should Proactively Review Member Agreements
In 2019, our sister publication The Dark Report covered a major data breach affecting more than 20 million patients. That breach occurred when hackers gained access to the data systems of a third-party bill collector and impacted four of the nation’s largest clinical laboratories:
At that time, The Dark Report asked James Giszczak, JD, Chair of the Litigation Department and Co-Chair of the Data Privacy and Cybersecurity Practice Group at McDonald Hopkins, to provide insight on what steps clinical laboratory leaders should take to avoid and handle data breaches.
“One important lesson from this data breach is how critical it is for clinical labs and pathology groups to be proactive in making sure they review their vendor agreements,” Giszczak stated. “In that review, labs need to know the specific measures each vendor is taking to protect the information the lab is providing to their vendors.”
Giszczak suggested that clinical laboratory leaders make sure they understand each vendor’s policies, procedures, training, and response in the event of a data breach. He reiterated that labs could have some liability related to the breach.
Will health monitoring with finger rings become more popular than wrist worn devices? One company hopes the answer is yes!
Personal health monitoring devices continue to grow smaller. Now there is a company selling a smart ring that fits on an individual’s finger. Clinical laboratory managers and pathologists may find this an interesting development, particularly because it shows progress in miniaturizing diagnostic capabilities and putting them into ever-smaller devices.
At the same time, health monitoring devices are becoming increasingly popular with consumers who want to track their overall health and certain medical conditions. However, devices currently on the market generally attach at the wrist like the Apple Watch and Fitbit.
Introduced by Movano, Inc. of Pleasanton, Calif., at the 2022 CES (Consumer Electronic Show) in Las Vegas, the Movano Ring tracks “sleep, heart rate variability, body temperature, and more,” according to the company’s website. Whether clinical laboratories will be involved with this data remains to be seen.
Primarily targeted at women, the Movano Ring offers “superior health-tracking technology and the convenient form,” according to Digital Trends.
The new smart ring device is expected to be released in beta form later this year. It is similar to the Oura Ring, which was launched in 2017 by OURA, located in Oulu, Finland (US office in San Francisco).
The Movano Ring (above) will come in four styles and be available later this year. The monitoring device “measures a user’s heart rate, temperature, SpO2, calories consumed, and steps taken, among other parameters generally tracked by smart wear. However, Movano’s app is the killer feature, as it can give actionable insights to users into their health so that they can make short-term, as well as long-term, changes,” Digital Trends reported. Clinical laboratories may one day be processing data streamed from these devices if the FDA grants class II medical device designation. (Photo copyright: Movano.)
Movano Seeks FDA Clearance
In an interview with MedTech Intelligence, Movano’s CEO John Mastrototaro, PhD, said the company saw a gap in the wearables market. “There was a real lack of solutions designed specifically for women and some of the unique health challenges women face as they age.”
Cuffless blood pressure testing and blood glucose monitoring are “holy grails for wearable tech,” and Movano plans to add them over time and testing of its radio frequency, The Verge reported.
“We’re taking the regulatory side of things very seriously,” Mastrototaro told The Verge.
In a news release, Movano announced completion of a study it conducted with University of California San Francisco “to assess the accuracy of the Movano Ring’s blood oxygen saturation (SpO2) and heart rate data.
“With results that exceeded the requirements of the industry standard used by FDA for evaluating SpO2 devices, this successful study is a promising step toward the company’s goal to provide medically-validated data to consumers and healthcare professionals,” the news release stated.
Seven participants wearing Movano Ring prototypes participated in the study to test the device’s accuracy during mild, moderate, and severe hypoxia, as well as heart rate changes while they were deprived of oxygen.
Comparing data to other reference devices, the researchers found the Movano Ring resulted in a 2% margin of error, which was well below the FDA’s 4% margin of error requirement for blood oxygen saturation, the news release stated.
Ring Works with Sensors, App
Sensors embedded in the Movano Ring collect data which is available to wearers through a smartphone application.
“Data from sensors that are embedded within the ring revolve around heart rate, heart rate variability, sleep respiration rate, temperature, blood oxygen, steps, calories, and other women-centric features. We want to have the app experience where all that sensor data is going to the app,” Mastrototaro explained in an interview with Medical Device and Diagnostic Industry.
“One of our goals is to translate those measures into what it means about your overall health. We don’t want to bombard people with data … we want to distill it all down to insights for people that help them understand how activities of daily living and their lifestyle affect their overall health,” he said.
Another Smart Ring
Meanwhile, wearable health device developer OURA recently released a third-generation ring model of its Oura Ring, which Engadget called a “technical marvel.”
“Taking the sensors from a smartwatch or fitness tracker and shrinking them into a ring is worthy of enormous praise … There’s much more tech crammed in this time around … including continuous heart rate tracking, temperature monitoring, blood oxygenation, and (menstrual) period prediction,” Engadget said.
OURA developed a new SpO2 feature to help ring wearers uncover problems in breathing while sleeping. In a blog post, scientists explained: “Typically, SpO2 is measured by placing a pulse oximeter on the tip of the finger … the Oura Ring measures light reflected back from the tissue. Fingertips provide good optical characteristics for this noninvasive measurement as blood vessels have thinner walls and are more diffused.”
The Oura Ring Generation 3 costs $299 and comes in silver, black, stealth, and gold finishes. There is a $5.99 monthly membership fee, and the app is compatible with Android and Apple iOS operating systems.
Wearable Health Monitoring Device Trend on the Rise
Over the years, Dark Daily and our sister publication The Dark Report have regularly covered the growing trend of consumers using wearable technologies to monitor their own health and the health of loved ones.
It should be clear to clinical laboratory leaders that popularity of wearable monitoring devices and digital healthcare is expanding among consumers. The data collected may soon find its way into new treatments for chronic illnesses and early warnings for diagnosticians.
