Noninvasive diagnostic technology developed for space travelers and warfighters might eventually be used by clinical laboratories and physician office labs
To solve the problem of how to perform clinical laboratory tests on astronauts living for months at a time in the International Space Station (ISS), researchers associated with the National Aeronautics and Space Administration (NASA) are developing diagnostic tests that use human breath as the specimen. Last month, the research team unveiled the aptly named “E-Nose,” a prototype device designed to perform diagnostic tests using breath specimens
Clinical laboratory professionals and pathologists know that breath contains biological specimens which are useful biomarkers for detecting specific diseases, and that diagnostic tests based on breath have been around for a long time.
For example, the link between Helicobacter pylori (H pylori), a spiral bacterium, and stomach ulcers was discovered in the mid-1990s. Today, a diagnostic test that identifies the presence of ammonia and other volatile chemicals produced by H pylori is based on analysis of breath specimens.
Another biomarker is nitrogen oxide (NO), which when found in higher-than-normal concentrations in breath, could be an indicator of asthma. Other volatile biomarkers in breath may indicate infection, metabolic conditions, and inflammatory diseases.
Diagnosing a ‘Battery of Illnesses and Abnormalities’
In October, NASA demonstrated its new hand-held device—fully dubbed the E-Nose Breath Analyzer. Though still under development, the E-Nose device “will have the capability of analyzing compounds found within a person’s breath to diagnose a battery of illnesses and abnormalities including respiratory illnesses, infectious diseases, and cardiovascular conditions,” according to an Air Force news release.
If it develops into a standard diagnostic tool for doctors, could E-Nose have an impact on the revenue of clinical laboratories that perform traditional diagnostic testing?
“The [E-Nose] technology is designed to make rapid measurements—in less than five minutes, at the point of care—in a way that is completely non-invasive. When fully realized, the NASA E-Nose will open a new realm of medical care to both the warfighter and potential space travelers,” Loftus said.
Jing Li, PhD (above), Principal Investigator and Senior Scientist at NASA’s Ames Research Center, demonstrated the E-NOSE breathalyzer during a meeting with members of the 60th Medical Group at Travis Air Force Base. The smartphone-size medical device detects a wide range of volatile biochemicals linked to various diseases and illnesses and could pose competition for clinical laboratories that perform tradition diagnostic testing. (Photo copyright: US Air Force.)
Can NASA Advance E-Nose for Clinical Use?
According to NASA research presented at the DGMC, the E-Nose “utilizes an array of chemical sensors combined with humidity, temperature and pressure” for its real-time breath analysis. E-nose can detect 16 different chemicals in seconds at room temperature, including:
Methane
Hydrazine
Nitrogen dioxide
Hydrazoic acid
Sulfur trioxide
Hydrogen chloride
Formaldehyde
Acetone
Benzene
Chlorine gas
Hydrogen cyanide
Malathion
Diazinon
Toluene
Nitro toluene
Hydrogen peroxide
According to NASA’s presentation materials, the E-Nose underwent extensive research and development:
Work started at the NASA Ames Research Center in 2002.
The device includes the most well-developed Nano Chemical Sensor System in the world to date, which was tested aboard a Navy Satellite in 2007 for 12 months; deployed on the International Space Station (cabin air quality monitor); and field-tested by the Department of Homeland Security for various threats.
It was featured in 35 peer-reviewed journals, and
Involves nine United States patents.
“As with past technology that has been developed by the Air Force at DGMC, NASA medical research can improve civilian care throughout the country,” Bradley Williams, MD, 60th Medical Group Clinical Research Administrator, said in the Air Force statement. “The Air Force and NASA share the same altruistic medical research mission. Together, we seek to develop the future medical care which will be needed by the US Space Force, and which will also be very useful to the rest of the nation’s hospitals.”
Medical laboratory and pathology group managers would be wise to keep a close eye on the development of the E-Nose Breath Analyzer and similar technologies that have the potential to cut into diagnostic testing revenue streams. Especially if these devices can detect everything from infections to cancer.
Many companies want to adapt consumer wearables to monitor health conditions, including biomarkers tested by medical laboratories
Clinical laboratory managers know that wearable devices for monitoring biophysical functions or measuring biomarkers are becoming more complex and capable thanks to advances in miniaturization, informatics, software, and artificial intelligence machine learning that enable new functions to be developed and proved to be accurate.
In September, Fitbit (NYSE:FIT), took that a step further. The San Francisco-based maker of personal fitness technology, “received 510(k) clearance from the US Food and Drug Administration (FDA), as well as Conformité Européenne (CE marking) in the European Union, for its electrocardiogram (ECG) app to assess heart rhythm for atrial fibrillation (AFib),” according to a press release.
The fact that Google is currently in the process of acquiring Fitbit for $2.1 billion may indicate that wearable devices to help physicians and patients diagnose and monitor health conditions will be big business in the future.
The new ECG app is available on Fitbit Sense (above), an “advanced health smartwatch.” To use the app, wearers place their finger and thumb to the stainless-steel corners on the watch and remain still for 30 seconds. The app analyzes the heart’s rhythm for signs of AFib. Individuals can take readings of their heart rhythm at any time, monitor for irregularities, and save and share the data. (Photo copyright: Fitbit.)
Helping Doctors ‘Stay Better Connected’ to Their Patients
“Helping people understand and manage their heart health has always been a priority for Fitbit, and our new ECG app is designed for those users who want to assess themselves in the moment and review the reading later with their doctor,” said Eric Friedman, Fitbit co-founder and Chief Technology Officer, in the press release.
Prior to submitting the device for approval to regulatory agencies, Fitbit conducted the clinical trial in regions throughout the US to evaluate the device’s ability to accurately detect AFib from normal sinus rhythm and generate ECG traces. The researchers proved that their algorithm was able to detect 98.7% of AFib cases (sensitivity) and was able to accurately identify normal sinus rhythms (specificity) in 100% of the cases.
Venkatesh Raman, MD, interventional cardiologist and Medical Director of the Cardiac Catheterization Lab at 609-bed MedStar Georgetown University Hospital, was Principal Investigator for the clinical study on Fitbit’s ECG app. “Physicians are often flying blind as to the day-to-day lives of our patients in between office visits. I’ve long believed in the potential for wearable devices to help us stay better connected, and use real-world, individual data to deliver more informed, personalized care,” he said in the press release.
“Given the toll that AFib continues to take on individuals and families around the world,” Raman continued, “I’m very enthusiastic about the potential of this tool to help people detect possible AFib—a clinically important rhythm abnormality—even after they leave the physician’s office.”
Fitbit ECG App Receives European CE Marking
In addition to receiving approval for the Fitbit ECG app in the US, the device also received CE marking (Conformité Européenne) for use in some European countries.
In October 2020, the app was made available to Fitbit Sense users in the US, Austria, Belgium, Czech Republic, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Poland, Portugal, Romania, Spain, Sweden, Switzerland, and the United Kingdom. The device also received approval for use in Hong Kong and India.
It is estimated that more than 33.5 million people globally have AFib, an irregular heart rhythm (arrhythmia) that can lead to stroke, blood clots, or heart failure. The American Heart Association estimates that at least 2.7 million Americans currently live with the condition. The most common symptoms experienced by those with the condition are:
Irregular heartbeat,
Heart palpitations (rapid, fluttering, quivering or pounding),
Lightheadedness,
Extreme fatigue,
Shortness of breath, and
Chest pain.
Risk factors for AFib include advancing age, high blood pressure, obesity, diabetes, European ancestry, hyperthyroidism, chronic kidney disease, alcohol use, smoking, and known heart issues such as heart failure, ischemic heart disease, and enlargement of the chambers on the left side of the heart.
According to the Centers for Disease Control and Prevention (CDC), there are more than 454,000 hospitalizations annually in the US that list AFib as the primary diagnosis. In 2018, AFib was mentioned on 175,326 death certificates with the condition being the underlying cause of death in 25,845 of those cases.
The CDC reports that cases are increasing and projects that by 2030 12.1 million people in the US will have AFib. Many people are asymptomatic of the illness and do not know they have it, which can make AFib more difficult to diagnose.
“Early detection of AFib is critical, and I’m incredibly excited that we are making these innovations accessible to people around the world to help them improve their heart health, prevent more serious conditions, and potentially save lives,” Friedman said, in a statement.
Clinical laboratory managers should monitor these developments closely. Fitbit’s FDA clearance and CE Marking of its ECG app suggest this trend is accelerating.
Taft Foley, III, says he got the idea for the mobile lab after waiting on a COVID-19 testing line that went ‘around the entire building’
In a remarkable example of ingenuity and observation, Texas high school student Taft Foley, III, is bringing COVID-19 testing to underserved patients, wherever they may be. He launched a medical lab company, then developed a mobile clinical laboratory which performs rapid antigen tests that can detect the presence of antigen in about 15 minutes.
Foley—who recently became an EMT after graduating from the Texas EMS Academy—designed his mobile medical lab to use Quidel Sofia SARS Antigen FIA tests (nasal swabs). Results are sent to patients by text or e-mail. Foley also works with CLIA-certified Baylor Genetics Laboratories on COVID-19 (SARS-CoV-2) RT-PCR molecular testing, which gives his customers results in 24 to 48 hours, Forbes reported.
Foley, who is 18-years-old and an Eagle Scout, said he got the idea to launch the mobile COVID-19 testing business after he went for a coronavirus test and had to wait on a line that “wrapped around the entire building,” ABC13 reported. “I said to myself, ‘There needs to be a better way,’” Foley told ABC13.
Forbes reported that Texas Mobile Medical Labs allocates a portion of test fees paid ($100 to $150/test) to help provide tests to the homeless and others who need them, such as veterans and senior citizens.
“The (majority of) tests have been done at businesses who appreciate our mobile capabilities. We arrive and test all employees onsite and have their results back in 15 minutes,” Foley told Forbes.
After raising $60,000 through events and sale of personal items, Taft Foley, III (above), purchased a van and rapid antigen tests, reported The Kinkaid Falcon. “I think that that idea is hopefully going to galvanize a lot of good things, because we as humans, we’re good at learning from one another. If my idea is good enough to inspire others to create their own businesses and ideas for the betterment of the community, then I’m all for it,” Foley told the Falcon. (Photo copyright: Texas Mobile Medical Labs.)
Other States with Mobile COVID-19 Testing
Texas is not the only state where savvy entrepreneurs like Foley and health agencies are offering mobile COVID-19 testing.
In May, Florida Gov. Ron DeSantis announced Statlab Mobile, a COVID-19 mobile laboratory out of Miami that tests people in skilled nursing and long-term care facilities and other areas of the Sunshine State.
“We believe this will be a game-changer (in long-term care),” DeSantis told the Miami Herald.
“The idea was to bring help to those who are vulnerable, those who can’t otherwise get the kind of medical information they would otherwise love to have,” Bryan Wilson, Statlab Chief Executive Officer, told Patch, which noted the tests are free.
Mobile medical laboratories are being deployed to help handle surges of COVID-19 cases in Massachusetts, New Jersey, and Arizona, as well.
In Massachusetts, testing vans operated by American Family Care (AFC), an urgent care provider, started heading out in November to schools and businesses state-wide with a goal to test at least 100 to 150 people daily for COVID-19, according to The Reminder.
The vans are staffed by medical providers who test people with Abbott’s BinaxNOW COVID-19 Ag Card, AFC told The Reminder. The rapid antigen test offers results in 15 minutes.
In September, Dark Daily reported that the US federal Department of Health and Human Services (HHS) awarded a $760 million contract to Abbott for 150 million rapid antigen tests to aid in detection of COVID-19 as workplaces and schools reopen.
“We’ve had several companies who would like to schedule their employees to be tested on a regular basis. But they also want to be able to make sure that if there is a potential contamination within their businesses, they have a resource to utilize to make sure they can test people right away,” Jim Brennan, Owner/CEO of Medvest, LLC, AFC urgent care’s parent company, told The Reminder.
And in Phoenix, a COVID-19 mobile medical van provides testing to underserved communities. The City of Phoenix, along with staff from the Vincere Cancer Center, use Quidel’s Sofia SARS Antigen FIA test at public and private locations and at family services centers, AZ Central reported.
Clearly, mobile COVID-19 testing labs are here to stay. They serve seniors and vulnerable populations challenged to access clinical laboratory testing at traditional locations and at COVID-19 drive-through sites. And on larger scales, mobile medical laboratories have become key resources to address coronavirus case surges and to conveniently test people at businesses and schools to help identify symptomatic individuals who should be quarantined.
Clinical laboratory managers may be impressed by how quickly mobile testing companies and entrepreneurs form partnerships with public health agencies toward making COVID-19 tests available to all at places where people live and work.
While working to increase turn-around-times for STAT tests, Florida’s first coronavirus patient arrived, requiring SMH’s clinical laboratory team to adapt its plans
Despite the COVID-19 pandemic, the clinical laboratory team at 839-bed Sarasota Memorial Hospital, part of the Sarasota Memorial Health Care System (SMH) in Sarasota, Fla., not only implemented a new automated microbiology system, it also installed a new mass spectrometry analyzer, along with new instruments to support large volumes of SARS-CoV-2 testing.
How SMH’s microbiology laboratory team accomplished this while shelter-in-place directives in Florida caused many patients to stop visiting emergency departments and physicians’ offices—and as hospitals and medical laboratory facilities restricted access to staff and essential personnel—provides useful lessons for pathologists and clinical laboratory managers.
“Florida reported its first positive SARS-CoV-2 infection on March 2, marking the beginning of an outbreak that continues today,” he noted, adding, “This created the need to support the hospital in identifying infected patients in Sarasota County by having the microbiology lab acquire and set up more instruments. Also, the micro lab needed space for a new mass spectrometry analyzer to speed up pathogen identification this year.
In the same TDR interview, Olevia Fulkert, Microbiology Technical Supervisor at SMH said the microbiology lab had to reconfigure its layout to be prepared for the new COPAN system. “Our team had to arrange space for these new instruments, while protecting the space needed for the microbiology automation.”
“The WASPLab (above) literally went right into the middle of the busiest area of our lab,” said SMH’s Director of Laboratory Services, Harold Vore, MS, MT. “That’s the room we call COVID central, because that’s where we process all SARS-CoV-2 specimens.” SMH’s medical laboratory team began this implementation in the early months of the COVID-19 pandemic and relied on Lean processes to accomplish its goals. (Photo copyright: Sarasota Memorial Health Care System.)
Return of the ‘Snowbirds’
In August, SMH’s microbiology laboratory staff was busy validating the WASPLab instruments so the lab would be ready to process patient specimens when Florida’s snowbirds—out-of-state residents who arrive for the winter—return to Sarasota.
Vore knew several elements would be required for SMH’s microbiology automation project to succeed:
He had to assure the microbiology lab’s staff that adding automation would not cause any loss of jobs.
Timing of the implementation was critical, because lab test volume rises in the winter when tourists and part-time residents return.
Lean methods would be important because lab staff was familiar with them and they would help the vendor to arrange the physical layout and workflow to optimize productivity, reduce errors, and decrease turnaround times.
Vore needed documentation that showed automating the microbiology lab met and exceeded the return-on-investment projections he and his lab team used to persuade health system administrators of its value.
According to Vore, to date the installation has gone smoothly. “The staff in the microbiology lab has been phenomenal,” he commented. “They have continued to do what they always do, while at the same time we’re installing this large new system right in their midst.
“And they did not complain. In fact, they were eager to make progress in improving production,” he continued. “That attitude is common among our laboratory staff, because we saw the same thing happen when we automated our core lab.”
Increasing Microbiology Lab Capacity without Increasing Staff
Vore estimates automation will expand SMH’s microbiology laboratory capacity by up to 40%. “We measure that 40% in terms of the number of plates our techs can read per day with the WASPLab versus how we did it manually with our existing staff,” he explained. “We may still need to increase some staff. But even without adding staff, we thought we could move the peg further down the road in terms of throughput and improve our turnaround time too.
“We cannot make bacteria grow any faster and yet our specimen volume continues to increase,” he noted. “That makes automating microbiology the right strategy. Also, if we hadn’t automated the core lab starting in 2015, we might not have been able to handle the increased volume that we saw last year and this year’s additional surge in COVID-19 tests.”
How Lean Helped with the Implementation
Workflow in microbiology has traditionally been mostly manual. Therefore, combining Lean and automation can generate substantial benefits for a lab. “By definition, the design of the WASPLab is Lean,” Vore explained. “By that I mean the person who touches each specimen the least wins. That’s why the WASPLab is designed the way it is. Once we load a specimen in the front end, theoretically, no one needs to touch those plates until the testing is complete.”
“That’s the ideal we’re trying to reach,” he added. “At the moment, we still need to pull the plates to, as we say, ‘pick them.’ But we just introduced a way to improve that part of the process.
Adding Mass Spectrometry
“Along with the microbiology automation, we now read specimens digitally and we tell the machine to take a certain plate off so we can spot it,” Vore continued. “To speed up that process, we got some additional funding and bought a mass spec analyzer that uses MALDI-TOF to identify pathogens. Now we get the boost from the WASPLab, and we also use mass spec to cut six hours off our first read,” Vore added.
“The WASPLab and the mass spec give us higher quality incubation and better harvest of pathogens. Once we spot the plate, the mass spec can identify the pathogen in about two minutes,” he said.
“After going live with the mass spectrometry in August, we’ve made huge progress versus the normal process, where we would plate the specimen manually under a hood and then put the specimen in the incubator and pull it out to read 24 hours later,” he said.
“That whole step-by-step process to identify the pathogen could take 48 hours,” he continued. “But now we can move to a 24-hour, seven-day-a-week operation, where we can do first-in-first-out of pathogens in about 18 hours. That cuts six hours off the time to do the first plate read. Then we can spot it and get a result from the mass spec in two minutes. The impact for patient care can be tremendous.
“In a recent case, for example, we had to identify a specimen from an infant and used the mass spec to identify salmonella in two minutes,” Vore noted. “Normally that would take at least a day or more. That’s what I mean about making tremendous impact on patient care by using automation in microbiology.”
Clearly, this would be a challenging project for any medical laboratory to complete during the best of times, let alone during the early months of the COVID-19 pandemic. But through determination, the use of Lean, and a positive approach, SMH’s microbiology lab team implemented the first WASPLab in the state of Florida. And it will improve SMH’s ability to care for patients for years to come.
Sophisticated cyberattacks have already hit hospitals and healthcare networks in Oregon, California, New York, Vermont, and other states
Attention medical laboratory managers and pathology group administrators: It’s time to ramp up your cyberdefenses. The FBI, the federal Department of Health and Human Services (HHS), and the federal Cybersecurity and Infrastructure Security Agency (CISA) issued a joint advisory (AA20-302A) warning US hospitals, clinical laboratories, and other healthcare providers to prepare for impending ransomware attacks, in which cybercriminals use malware, known as ransomware, to encrypt files on victims’ computers and demand payment to restore access.
The joint advisory, titled, “Ransomware Activity Targeting the Healthcare and Public Health Sector,” states, “CISA, FBI, and HHS have credible information of an increased and imminent cybercrime threat to US hospitals and healthcare providers.” It includes technical details about the threat—which uses a type of ransomware known as Ryuk—and suggests best practices for preventing and handling attacks.
In his KrebsOnSecurity blog post, titled, “FBI, DHS, HHS Warn of Imminent, Credible Ransomware Threat Against U.S. Hospitals,” former Washington Post reporter, Brian Krebs, wrote, “On Monday, Oct. 26, KrebsOnSecurity began following up on a tip from a reliable source that an aggressive Russian cybercriminal gang known for deploying ransomware was preparing to disrupt information technology systems at hundreds of hospitals, clinics, and medical care facilities across the United States. Today, officials from the FBI and the US Department of Homeland Security hastily assembled a conference call with healthcare industry executives warning about an ‘imminent cybercrime threat to US hospitals and healthcare providers.’”
Krebs went on to reported that the threat is linked to a notorious cybercriminal gang known as UNC1878, which planned to launch the attacks against 400 healthcare facilities.
Clinical Labs, Pathology Groups at Risk Because of the Patient Data They Keep
Hackers initially gain access to organizations’ computer systems through phishing campaigns, in which users receive emails “that contain either links to malicious websites that host the malware or attachments with the malware,” the advisory states. Krebs noted that the attacks are “often unique to each victim, including everything from the Microsoft Windows executable files that get dropped on the infected hosts to the so-called ‘command and control’ servers used to transmit data between and among compromised systems.”
Charles Carmakal, SVP and Chief Technology Officer of cybersecurity firm Mandiant told Reuters, “UNC1878 is one of the most brazen, heartless, and disruptive threat actors I’ve observed over my career,” adding, “Multiple hospitals have already been significantly impacted by Ryuk ransomware and their networks have been taken offline.”
John Riggi (above), senior cybersecurity adviser to the American Hospital Association (AHA), told the AP, “We are most concerned with ransomware attacks which have the potential to disrupt patient care operations and risk patient safety. We believe any cyberattack against any hospital or health system is a threat-to-life crime and should be responded to and pursued as such by the government.” Hospital-based medical laboratories and independent clinical laboratories that interface with hospital networks should be assess their vulnerability to cyberattacks and take appropriate steps to protect their patients’ data. (Photo copyright: American Hospital Association.)
Multiple Healthcare Provider Networks Under Attack
Hospitals in Oregon, California, and New York have already been hit by the attacks, Reuters reported. “We can still watch vitals and getting imaging done, but all results are being communicated via paper only,” a doctor at one facility told Reuters, which reported that “staff could see historic records but not update those files.”
Some of the hospitals that have reportedly experienced cyberattacks include:
In October, the Associated Press (AP) reported that a recent cyberattack disrupted computer systems at six hospitals in the University of Vermont (UVM) Health Network. The FBI would not comment on whether that attack involved ransomware, however, it forced the UVM Medical Center to shut down its computer system and reschedule elective procedures.
Threat intelligence analyst Allan Liska of US cybersecurity firm Recorded Future told Reuters, “This appears to have been a coordinated attack designed to disrupt hospitals specifically all around the country.”
He added, “While multiple ransomware attacks against healthcare providers each week have been commonplace, this is the first time we have seen six hospitals targeted in the same day by the same ransomware actor.”
An earlier ransomware attack in September targeted 250 healthcare facilities operated by Universal Health Services Inc. (UHS). A clinician at one facility reported “a high-anxiety scramble” where “medical staff could not easily see clinical laboratory results, imaging scans, medication lists, and other critical pieces of information doctors rely on to make decisions,” AP reported.
Outside of the US, a similar ransomware attack in October at a hospital in Düsseldorf, Germany, prompted a homicide investigation by German authorities after the death of a patient being transferred to another facility was linked to the attack, the BBC reported.
CISA, FBI, HHS, Advise Against Paying Ransoms
To deal with the ransomware attacks, CISA, FBI, and HHS advise against paying ransoms. “Payment does not guarantee files will be recovered,” the advisory states. “It may also embolden adversaries to target additional organizations, encourage other criminal actors to engage in the distribution of ransomware, and/or fund illicit activities.” The federal agencies advise organizations to take preventive measures and adopt plans for coping with attacks.
The advisory suggests:
Training programs for employees, including raising awareness about ransomware and phishing scams. Organizations should “ensure that employees know who to contact when they see suspicious activity or when they believe they have been a victim of a cyberattack.”
Regular backups of data and software. These should be “maintained offline or in separated networks as many ransomware variants attempt to find and delete any accessible backups.” Personnel should also test the backups.
Continuity plans in case information systems are not accessible. For example, organizations should maintain “hard copies of digital information that would be required for critical patient healthcare.”
“Without planning, provision, and implementation of continuity principles, organizations may be unable to continue operations,” the advisory states. “Evaluating continuity and capability will help identify continuity gaps. Through identifying and addressing these gaps, organizations can establish a viable continuity program that will help keep them functioning during cyberattacks or other emergencies.”
Dark Daily Publisher and Editor-in-Chief, Robert Michel, suggests that clinical laboratories and anatomic pathology groups should have their cyberdefenses assessed by security experts. “This is particularly true because the technologies and methods used by hackers change rapidly,” he said, “and if their laboratory information systems have not been assessed in the past year, then this proactive assessment could be the best insurance against an expensive ransomware attack a lab can purchase.”
