Clinical laboratories and point-of-care settings may have a new diagnostic test if this novel handheld device and related technology is validated by clinical trials
Efforts to develop breath analyzers that accurately identify viral infections, such as SARS-CoV-2 and Influenza, have been ongoing for years. The latest example is ViraWarn from Opteev Technologies in Baltimore, Maryland, and its success could lead to more follow-up PCR tests performed at clinical laboratories.
“Breath is one of the most appealing non-invasive sample types for diagnosis of infectious and non-infectious disease,” said Opteev in its FDA Pre-EUA application. “Exhaled breath is very easy to provide and is less prone to user errors. Breath contains a number of biomarkers associated with different ailments that include volatile organic compounds (VOCs), viruses, bacteria, antigens, and nucleic acid.”
Further clinical trials and the FDA Pre-EUA are needed before ViraWarn can be made available to consumers. In the meantime, Opteev announced that the CES (Consumer Electronic Show) had named ViraWarn as a 2023 Innovation Award Honoree in the digital health category.
“ViraWarn is designed to allow users an ultra-fast and convenient way to know if they are spreading a dangerous respiratory virus. With a continued increase in COVID-19 and a new surge in RSV and influenza cases, we’re eager to bring ViraWarn to market so consumers can easily blow into a personal device and find out if they are positive or negative,” said Conrad Bessemer (above), Opteev President and Co-Founder, in a news release.
Opteev is a subsidiary of Novatec, a supplier of machinery and sensor technology, and a sister company to Prophecy Sensorlytics, a wearable sensors company.
The ViraWarn breath analyzer uses a silk-based sensor that “traces the electric discharge of respiratory viruses coupled with an artificial intelligence (AI) processor to filter out any potential inaccuracies,” according to the news release.
Here is how the breath analyzer (mouthpiece, attached biosensor chamber, and attached printed circuit board chamber) is deployed by a user, according to the Opteev website:
The user turns on the device and an LED light indicates readiness.
The user blows twice into the mouthpiece.
A carbon filter stops bacteria and VOCs and allows virus particles to pass through.
As “charge carriers,” virus particles have a “cumulative charge.”
Electrical data are forwarded to the AI processor.
The AI processer delivers a result.
Within 60 seconds, a red signal indicates a positive presence of a virus and a green signal indicates negative one.
“The interaction of the virus with a specially designed liquid semiconductive medium, or a solid polymer semiconductor, generates changes in the conductivity of the electrical biosensor, which can then be picked up by electrodes. Such electrical data can be analyzed using algorithms and make a positive or negative call,” explains an Opteev white paper on the viral screening process.
While the ViraWarn breath analyzer can identify the presence of a virus, it cannot distinguish between specific viruses, the company noted. Therefore, a clinical laboratory PCR test is needed to confirm results.
Other Breath Tests
Opteev is not the only company developing diagnostic tests using breath samples.
For clinical laboratory managers and pathologists, Opteev’s ViraWarn is notable in breath diagnostics development because it is a personal hand-held tool. It empowers people to do self-tests and other disease screenings, all of which would need to be confirmed with medical laboratory testing in the case of positive results.
Further, it is important to understand that consumers are the primary target for this novel diagnostic device. This is consistent with investor-funding companies wanting to develop testing solutions that can be used by consumers. At the same time, a device like ViraWarn could be used by clinical laboratories in their patient service centers to provide rapid test results.
Clinical laboratory scientist who aided in the investigation compared DNA test results with publicly available genetic information
In an interesting twist in the solving of crime, genetic test results—along with help from a clinical laboratory scientist (CLS) turned amateur genealogist—guided relatives of Melissa Highsmith to her whereabouts after she was allegedly kidnapped as a toddler over half a century ago. According to The Guardian, the CLS helped locate Melissa by “interpreting the key DNA results and mining publicly available records.”
Highsmith’s abduction was one of the oldest missing person cases in the country and demonstrates how clinical laboratory skills can be applied outside the laboratory to help solve other problems—in this case, helping a family search for a kidnapped daughter—using genetic testing technologies that until recently were not available to the general public.
Thanks to a 23andMe at-home DNA test—and a tenacious clinical laboratory scientist/amateur genealogist—Melissa Highsmith (shown above at time of kidnapping and today) has been reunited with her birth family. This shows how genetic testing is being used in remarkable ways outside of the clinical laboratory. (Photo copyright: Highsmith family/People.)
Thanksgiving Reunion
Back in 1971, Melissa’s mother, Alta Apantenco, placed an advertisement in a local newspaper in Fort Worth, Texas, to hire a babysitter to care for her 21-month-old daughter. Apantenco hired Ruth Johnson to babysit her daughter without meeting the woman in person. Because Apantenco had to be at work, the child was handed over to Johnson by Apantenco’s roommate. The babysitter then allegedly abducted Melissa and disappeared with her.
Melissa’s family reported her missing to the police and searched for the snatched baby for more than 51 years. The family even organized a Facebook page called “Finding Melissa Highsmith” and sought outside assistance from the National Center for Missing and Exploited Children (NCMEC) in locating their lost relative, according to the New York Post.
The police and the FBI also got involved in the case, but few leads emerged over the decades.
Then, in September of 2022, Melissa’s family received a new lead regarding her location based on her father’s 23andMe DNA test results. Those results, along with a birthmark and date of birth, confirmed that Melissa was alive and well and residing in the Charleston, South Carolina area.
Over Thanksgiving weekend, Melissa was reunited with her mother, her father Jeffrie Highsmith, and two of her four siblings at a church in Fort Worth. She hopes to meet her remaining two siblings over the Christmas holidays.
“I can’t describe my feelings. I’m so happy to see my daughter that I didn’t ever think I would see again,” Apantenco told Saint Paul, Minnesota, television station KSTP.
“I couldn’t stop crying,” said Melissa’s sister Victoria Garner in a family statement. “I was overjoyed, and I’m still walking around in a fog trying to comprehend that my sister [was] right in front of me and that we found her,” The Guardian reported.
Clinical Laboratory Scientist Aids in the Investigation
The 23andMe test results alerted the family to the existence of a few unknown relatives that could be connected to the DNA of Melissa’s father. The family then contacted a genealogist and clinical laboratory scientist from Minnesota named Lisa Jo Schiele to help them interpret the results and potentially locate the missing woman. Schiele compared the DNA results with public records to help find Melissa Highsmith.
“I was able to use what we call traditional genealogy to find marriage records and things like that to find where Melissa was right now,” Schiele told KSTP. “At first glance, you look at these matches, but I’m like, ‘Holy cow, is this too good to be true?’ I’m very happy to help them navigate all of this.”
One of Melissa’s sisters, Sharon Highsmith, stated that her mother experienced deep feelings of guilt after Melissa’s abduction and had even faced accusations that she had something to do with the disappearance of her daughter.
“My mom did the best she could with the limited resources she had. She couldn’t risk getting fired, so she trusted the person who said they’d care for her child,” Sharon said in a family statement. “I’m grateful we have vindication for my mom,” The Guardian reported.
“I keep having to pinch myself to make sure I’m awake,” Melissa, who now resides in Fort Worth, told KSTP.
“It’s a miracle,” Apantenco said.
“A Christmas miracle,” Melissa added.
Due to the statute of limitations, which expired 20 years after Melissa turned 18, the babysitter who allegedly took Melissa cannot be criminally prosecuted.
“I’m angry our family was robbed for 51 years,’’ Melissa told Fort Worth news station WFAA.
This remarkable story illustrates how clinical laboratory skills combined with genetic testing results can be used outside of medical laboratory testing purposes to aid in solving criminal cases and other mysteries involving missing people.
Further advances in DNA testing combined with genetic databases that include DNA from greater numbers of people could result in more reunions involving missing persons who were identified because of genetic matching.
Researchers at the university suggested their findings could lead to new genetic tests that could be offered by medical laboratories
New research conducted at the University of Utah suggests that clinical laboratories may someday be able to deploy genetic tests to indicate whether a couple has a higher-than-average risk of stillbirth.
This is yet another example of how researchers are cracking DNA’s code to understand how certain gene variants may affect the healthcare of offspring. The knowledge produced by this research, as confirmed by additional studies, may lead to genetic markers that medical laboratories can use to diagnose the risk of stillbirth using the parent’s DNA.
“Stillbirth is one of those problems that is so tragic and life-changing,” said study co-author Jessica Page, MD (above). “It is especially frustrating when you don’t have a good answer for why it happens. This knowledge may give us the opportunity to change how we risk stratify people and reduce their risk through prevention.” Should this research be validated, clinical laboratories may soon have new genetics tests to help doctors identify risk for stillbirth. (Photo copyright: Intermountain Healthcare.)
Can Stillbirth be Prevented?
Jessica Page, MD, an assistant professor in the Department of Obstetrics and Gynecology at the University of Utah School of Medical and co-author of the 2022 study, was lead author of a 2018 study that estimated nearly one-fourth of stillbirths are preventable.
“Stillbirth rate reduction has been slow in the US and we think many stillbirths may be potentially preventable,” she said in a university press release. “This is motivating us to look for those genetic factors so we can achieve more dramatic rate reduction.”
According to the press release, the University of Utah researchers found that stillbirth “can be inherited and tends to be passed down through male members of the family. That risk preferentially comes from the mother’s or father’s male relatives—their brothers, fathers, grandfathers, uncles, or male cousins. But the odds of a couple losing a baby to stillbirth are even greater when the condition comes from the father’s side of the family.”
The researchers made this discovery by analyzing data from the Utah Population Database (UPDB), which contains information on eight million people who were born in the state or have other connections there. The database is maintained by the Huntsman Cancer Institute at the University of Utah. It includes genealogical information and health records that allowed the researchers to trace incidence of stillbirths across multiple generations of families.
The researchers examined 9,404 stillbirth cases between 1978 and 2019, along with 18,808 live births that served as controls. They identified 390 multi-generational families with high numbers of stillbirths. Within that group, they looked at incidence of stillbirth among first-, second-, and third-degree relatives of stillborn babies. They then compared those numbers with data from unaffected families.
“We were able to evaluate multigenerational trends in fetal death as well as maternal and paternal lineages to increase our ability to detect a familial aggregation of stillbirth,” said genetic epidemiologist Tsegaselassie Workalemahu, PhD, lead author of the study. “Not many studies have examined inherited genetic risk for stillbirth because of a lack of data. The Utah Population Database allows for a more rigorous evaluation than has been possible in the past.”
Workalemahu described the research as “an important step toward identifying specific genes that increase the risk of stillbirth, which could one day lead to better diagnosis and prevention,” according to the university press release.
One caveat, the press release notes, is that Utah’s population is disproportionately of northern European descent. “Future studies will need to determine whether the trends hold true among people of different races and ethnicities,” it stated.
Call for More Testing
The University of Utah study is part of a larger effort to gain a greater understanding of the causes of stillbirths.
The story notes that “more than 20,000 pregnancies in the US end in stillbirth,” and in one in three of those cases, the cause is not determined.
Drucilla Roberts, MD, an obstetric and perinatal pathologist at Massachusetts General Hospital (MGH), told ProPublica that at a minimum, “the placenta should definitely be evaluated in every stillbirth.” But citing CDC data, the story notes that this is done in only 65% of stillbirths, and autopsies are performed in less than 20%.
“Experts blame the low rates on several factors,” the story states. “Because an autopsy often is performed in the days following a stillbirth, doctors and nurses have to ask families soon after they receive news of the death if they would like one. Many families can’t process the loss, let alone imagine their baby’s body being cut open. What’s more, many doctors aren’t trained in the advantages of an autopsy, or in communicating with parents about the exam.”
One consequence, ProPublica notes, is that clinicians are ill-equipped to advise patients on how to reduce risk in future pregnancies. The story describes the case of Karen Gibbins, MD, a maternal-fetal medicine specialist and an assistant professor of obstetrics and gynecology at the Oregon Health and Science University (OHSU) in Portland.
An Opportunity for Pathologists
Gibbins’ son was stillborn in 2018. She asked for an autopsy and learned that her son “had a rare disease caused by her antibodies attacking the cells in his liver,” the story states. When she became pregnant again, her doctor prescribed antibody infusions and she later gave birth to a healthy son. “If we had not had that autopsy, my third child would have died as well,” she told ProPublica.
This parent’s comment about the value of the autopsy done after her son’s stillbirth identifies an opportunity for the pathology profession. For several decades, health plans have become ever more reluctant to pay for autopsies. Yet, pathologists know the value that autopsies can provide.
The immediate value comes from revealing useful insights about all the health conditions of the deceased. The long-term value comes from the ability to gather the findings across a large number of autopsies that can contribute to new knowledge about health conditions that physicians use to improve the diagnoses of different health conditions.
Thus, with the publication of this peer-reviewed study about the connection between genetic variations and stillbirth, there is the opportunity for some of the nation’s pathology societies to advocate for funding a pilot program to fund more autopsies of stillborn babies, specifically to add more knowledge about the role of gene mutations as a causative factor in stillbirths.
OIG warns that without adequate clinical laboratory testing healthcare organizations could see more deaths and increased spending
Clinical laboratory leaders and pathologists know that lab test volume decreased dramatically during the early months of the COVID-19 pandemic. That was primarily because community lockdowns stopped people from seeing their doctors for the standard range of chronic health conditions, many of which require clinical laboratory tests for diagnosis and chronic disease management.
• 24% reduction in Medicare Part B test volumes in March • 53% in April • 30% in May
The decline of Medicare patients visiting clinical laboratories continued through the balance of 2020. During the first 10 months of the pandemic—March through December 2020—Medicare beneficiaries who pursued lab testing decreased by about 9% compared to the same 10-month period in 2019, according to a news release.
This is a strong indicator that the government’s response to the pandemic had a measurable effect on clinical laboratory testing volume among all age groups, especially among the elderly.
“The cumulative decline in lab test volume across all client labs for [March 9 to April 12] was just over 40%. But in that time, some of our lab customers were hit with a decline of maybe 50% to 60% in test volume,” Kyle Fetter (above), COO, XIFIN, told The Dark Report in 2020. Clinical laboratory testing that originates from a routine patient visit to a doctor—such as blood testing—may have been affected the most, Fetter explained. (Photo copyright: XIFIN.)
Clinical Laboratory Tests Key to Well-being of Patients with Chronic Conditions
The OIG study was limited to Medicare beneficiaries and thus did not provide information about testing fall-off among people who have private health insurance. But in “From Mid-March, Labs Saw Big Drop in Revenue,” Dark Daily’s sister publication The Dark Report reported early in 2020 on a 40% decline in test volumes and the pandemic’s varying effects on clinical labs, anatomic pathology (AP) groups, and AP subspecialties.
The OIG’s Report in Brief on its study recognized that medical laboratory testing is critical to helping healthcare providers manage chronic conditions that affect patients’ well-being and increase their healthcare costs.
“Lab tests are important for beneficiaries with chronic medical conditions, which are associated with hospitalizations, billions of dollars in Medicare costs, and deaths,” the OIG said.
“The information may be useful to stakeholders involved in ensuring that beneficiaries avoid the potential bad outcomes that may result from missing or delaying appropriate care,” the report noted.
Overall, 23.7 million Medicare beneficiaries received medical laboratory tests during the first 10 months of the pandemic, down 2.4 million from 26.1 million in 2019, the OIG reported.
Overall Medicare lab test volume and spending also declined during the reported period:
Part B clinical laboratory tests for Medicare beneficiaries decreased 15% from 419.9 million tests in 2019 to 358.4 million tests in the first 10 months of the pandemic.
Medicare spending for these tests decreased 16% from $6.6 billion in 2019 to $5.5 billion during the first 10 months of the pandemic.
“OIG’s audit of Part B clinical laboratory tests, reimbursed under the Clinical Laboratory Fee Schedule (CLFS) is a useful benchmark for how Medicare beneficiaries received fewer lab tests during the pandemic, especially during the early months,” said Robert Michel, Editor-in-Chief of Dark Daily and The Dark Report.
Medical Laboratory Tests That Were Down Most During COVID-19
The following 10 clinical laboratory tests experienced a 10% or more decline in Medicare beneficiaries seeking them during the pandemic period as compared to pre-pandemic, according to the OIG report:
Comprehensive urine culture test fell 16% to three million Medicare patients.
Uric acid level blood down 13% to 1.9 million Medicare beneficiaries.
Evaluation of antimicrobial drug decreased 17% to 1.74 million Medicare patients.
Folic acid level down 12% to 1.73 million Medicare beneficiaries.
Urinalysis manual test plunged 28% to 1.4 million Medicare patients.
Beyond Medicare, Clinical Laboratory Test Volume Dropped 40%
OIG was not the only organization to analyze medical laboratory testing volume during the pandemic’s early phase.
The Dark Report correlated data tracked by XIFIN, a San Diego-based health information technology (HIT) company providing revenue cycle management services to clinical laboratories and pathology groups. XIFIN’s collected data showed a steep drop in routine test volume as COVID-19 testing ramped up.
“Starting in the third week of March, we saw medical laboratories suffer a sharp drop in routine testing. But at about the same time, many labs began to offset those revenue losses with testing for the novel coronavirus,” Kyle Fetter, XIFIN’s then Executive Vice President and General Manager of Diagnostic Services told The Dark Report in 2020. Fetter is now XIFIN’S Chief Operating Officer.
“Over four weeks beginning March 9, we saw a cumulative drop of over 40% in test volume from all of our lab clients,” he added.
According to XIFIN’s data, lab specialty organizations experienced the following drop in routine testing during the period March 9 to April 16, 2020:
58% at clinical laboratories.
61% at hospital outreach laboratories.
52% at molecular and genetic testing laboratories.
44% at anatomic pathology (AP) groups.
70% to 80% at AP dermatology and other AP subspecialties.
Many medical laboratories are still recovering from the COVID-19 pandemic’s effects on testing volume.
Notably, the OIG’s report acknowledges the importance of adequate clinical laboratory testing and declares that—without these essential lab tests to manage some healthcare conditions—the healthcare industry could see increased morbidity, deaths, and Medicare spending.
The 2023 conference comes as clinical laboratories, diagnostics companies, and anatomic pathology practices wrestle with budgets that are strained by inflation, supply chain woes, and the faltering financial performance of parent hospitals and health systems. Meanwhile, lab hiring managers continue to face a severe staffing shortage of diagnostics employees.
“The current twin trends of hospitals losing money and labs struggling to maintain adequate staffing is without parallel in my 30 years of covering the clinical laboratory, diagnostics, and pathology sectors,” said Robert Michel, Founder of the Executive War College and Editor-in-Chief at Dark Daily. “This is a perfect storm that threatens the ability of labs to sustain high-quality testing services in a financially-sustainable manner. At the 2023 Executive War College, we are going to help participants get through this predicament by giving them innovative insights and best-in-class expertise they can take back and implement in their clinical labs and pathology groups.”
“Staffing and supply chain difficulties are not the only burdens facing clinical laboratories,” said Robert Michel (above), Founder of the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management. “Equally stressful forces are altering how providers, payers, and healthcare consumers access medical laboratory testing and pay for those services.” (Photo copyright: The Dark Intelligence Group.)
Earning New Revenue Will Take Center Stage at 2023 Executive War College
The full agenda for the 2023 Executive War College has not yet been released, but attendees can expect to see keynote presentations and sessions devoted to pressing topics in the diagnostics and laboratory industries. Among them is how to best position the clinical lab as a growing revenue source.
“With financial pressures mounting, we intend to present cutting-edge advice from innovative clinical laboratories, diagnostics companies, and pathology practices about how they earn new revenue—whether that be through creating business opportunities in the community, uncovering new test reimbursements, or using technology to improve existing processes,” Michel explained.
Last spring’s gathering of the Executive War College featured 10 keynotes, 55 sessions, and three post-conference workshops. Participants at the upcoming 2023 Executive War College conference can expect a similar bonanza of educational and professional development options, as well as collaborative networking breaks, luncheons, and receptions.
“The chance to meet innovative peers from across the country, share lab-related challenges with them, and compare effective solutions makes the Executive War College a cost-effective investment for any laboratory administrator, executive, or business-minded pathologist,” Michel added.
Diagnostics Services Will Be Better Reflected at 2023 Conference
For the first time, the conference’s moniker directly reflects the diagnostic work associated with clinical laboratories and pathology groups.
“Long-time attendees will notice that we tweaked the Executive War College’s full title to emphasize ‘diagnostics.’ That term is an important addition,” Michel noted.
“In the recent past, ‘clinical laboratory’ and ‘anatomic pathology’ were terms that sufficiently described the profession of laboratory medicine,” he continued. “However, a subtle but significant change has occurred in recent years. The term ‘diagnostics’ has become a common description for medical testing, along with other diagnostic areas such as radiology and imaging.”
Keep an eye on the conference’s website, ExecutiveWarCollege.com, for updates about the upcoming program and to see the session topics and speakers as they are confirmed and announced.
“The Executive War College is the top gathering for lab leaders to learn from the profession’s best innovators and gain insights they will need to keep their laboratories at the cutting edge of clinical excellence in a financially sustainable manner,” Michel concluded.
Register today to ensure places for you and your management team at the 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management. Click here for early registration discounts.
