UNC’s novel way to visualize the human proteome could lead to improved clinical laboratory tests along with the development of new therapies
Diagnostic testing based on proteomics is considered to be a field with immense potential in diagnostics and therapeutics. News of a research breakthrough into how scientists can visualize protein activity within cells will be of major interest to the pathologists, PhDs, and medical laboratory scientists who specialize in clinical laboratory testing involving proteins.
Proteins are essential to all life and to the growth, maintenance, and repair of the human body. So, a thorough understanding of how they function within living cells would be essential to informed medical decision-making as well. And yet, how proteins go about doing their work is not well understood.
That may soon change. Scientists at the University of North Carolina (UNC) School of Medicine have developed an imaging method that could provide new insights into how proteins alter their shapes within living cells. And those insights may lead to the development of new therapies and medical treatments.
Dubbed “binder-tag” by the UNC scientists, their new technique “allows researchers to pinpoint and track proteins that are in a desired shape or ‘conformation,’ and to do so in real time inside living cells,” according to a UNC Health news release.
Two labs in the UNC School of Medicine’s Department of Pharmacology collaborated to develop the binder-tag technique:
“No one has been able to develop a method that can do, in such a generalizable way, what this method does. So, I think it could have a very big impact,” said lead author of the UNC study Klaus Hahn PhD (above), in the news release. “With this method we can see, for example, how microenvironmental differences across a cell affect, often profoundly, what a protein is doing,” he added. This research may enlarge scientists’ understanding of how the human proteome works and could lead to new medical laboratory tests and therapeutic drugs. (Photo copyright: UNC School of Medicine.)
How Binder-Tag Works
During their study, the UNC scientists developed binder-tag “movies” that allow viewers to see how the binder-tag technique enables the tracking of active molecules in living cells.
The technique involves two parts: a fluorescent binder and a molecular tag that is attached to the proteins of interest.
When inactive, the tag is hidden inside the protein, but when the protein is ready for action it changes shape and exposes the tag.
The binder then joins with the exposed tag and fluoresces. This new fluorescence can easily be tracked within the cell.
Nothing else in the cell can bind to the binder or tag, so they only light up when in contact on the active protein.
This type of visualization will help researchers understand the dynamics of a protein in a cell.
“The method is compatible with a wide range of beacons, including much more efficient ones than the interacting beacon pairs required for ordinary FRET [fluorescence resonance energy transfer]. Binder-tag can even be used to build FRET sensors more easily. Moreover, the binder-tag molecules were chosen so that nothing in cells can react with them and interfere with their imaging role,” Hahn said in the news release.
“Only upon exposure can the peptide specifically interact with a reporter protein (the binder). Thus, simple fluorescence localization reflects protein conformation. Through direct excitation of bright dyes, the trajectory and conformation of individual proteins can be followed,” the UNC researchers wrote in Cell. “The simplicity of binder-tag can provide access to diverse proteins.”
The UNC researchers’ binder-tag technique is a way to overcome the dire challenge of seeing tiny and hard-working proteins, Cosmos noted. Typical light microscopy does not enable a view of molecules at work. This paves the way for the new binder-tag technique, UNC pointed out.
“With this method, we can see, for example, how microenvironmental differences across a cell affect—and often profoundly—what a protein is doing,” Hahn said. “For a lot of protein-related diseases, scientists haven’t been able to understand why proteins start to do the wrong thing. The tools for obtaining that understanding just haven’t been available.”
More Proteins to Study
More research is needed before the binder-tag method can be used in diagnostics. Meanwhile, the UNC scientists intend to show how binder-tag can be applied to other protein structures and functions.
“The human proteome has between 80,000 and 400,000 proteins, but not all at one time. They are expressed by 20,000 to 25,000 human genes. So, the human proteome has great promise for use in diagnostics, understanding disease, and developing therapies,” said Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report.
Medical scientists and diagnostics professionals will want to stay tuned to discover more about the tiny—though mighty—protein’s contributions to understanding diseases and patient treatment.
Device could pave the way for real-time, noninvasive breath analysis to detect and monitor diseases and be a new service medical laboratories can offer
Breathalyzer technology is not new, but until now human breath detection devices have not been comparable to clinical laboratory blood testing for disease detection and monitoring. That may soon change and there are implications for clinical laboratories, partly because breath samples are considered to be non-invasive for patients.
Scientists with JILA, a research center jointly operated by the National Institutes of Standards and Technology (NIST) and the University of Colorado Boulder, recently increased the sensitivity of their laser frequency comb breathalyzer one thousand-fold. This created a device that can detect four disease biomarkers simultaneously, with the potential to identify six more, according to an NIST news release.
Medical laboratory scientists will understand the significance of this development. JILA’s enhanced breathalyzer device could pave the way for real-time, noninvasive breath analysis to detect and monitor diseases, and potentially eliminate the need for many blood-based clinical laboratory tests.
During their research, physicist Jun Ye, PhD, and David Nesbitt, PhD, both Fellows at JILA and professors at University of Colorado Boulder, detected and monitored four biomarkers in the breath of a volunteer:
These chemicals can be indicators of various health conditions. Methane in the breath, for example, can indicate intestinal problems.
The researchers say the JILA breathalyzer also could detect six additional biomarkers of disease without any further modifications to the device. They would include:
NIST/JILA Research Fellows Jun Ye, PhD (left), and David Nesbitt, PhD (right) of the University of Colorado Boulder, “built a breathalyzer that identifies biomarkers of disease by measuring the colors and amounts of light absorbed as a laser frequency comb passes through breath samples inside a glass tube,” according to an NIST news release. Should they succeed in creating a portable version, their noninvasive device could become an option compared to conventional clinical laboratory blood testing methods used to identify and monitor diseases. (Photos copyright: University of Colorado Boulder.)
“Determining the identity and concentration of the molecules present in breath is a powerful tool to assess the overall health of a person, analogous to blood testing in clinical medicine, but in a faster and less invasive manner,” the researchers wrote in PNAS.
“The presence of a particular molecule (or combination of molecules) can indicate the presence of a certain health condition or infection, facilitating a diagnosis. Monitoring the concentration of the molecules of interest over time can help track the development (or recurrence) of a condition, as well as the effectiveness of the administered treatment,” they added.
How the JILA Breathalyzer Detects Biomarkers
According to a 2008 NIST news release, JILA researchers had developed a prototype comb breathalyzer in that year. However, the research did not continue. But then the COVID-19 pandemic brought the JILA/NIST laboratories focus back to the breathalyzer with hopes that new research could lead to a breath test for detecting the SARS-CoV-2 coronavirus and other conditions.
“We are really quite optimistic and committed to pushing this technology to real medical applications,” Ye said in the 2021 NIST news release.
Analytical Scientist explained that JILA’s new and improved breathalyzer system “fingerprints” chemicals by measuring the amount of light absorbed as a laser frequency comb passes back and forth through breath samples loaded into a mirrored glass tube.
JILA’s original 13-year-old prototype comb analyzed colors and amounts of light in the near-infrared band. However, JILA’s recent improvements include advances in optical coatings and a shift to analyzing mid-infrared band light, allowing detection sensitivity up to parts-per-trillion level, a thousand-fold improvement over the prototype.
Corresponding study author Jutta Toscano, PhD, postdoctoral researcher at the University of Basel in Switzerland and previously Lindemann fellow at JILA, told Physics World the new frequency comb can “probe the molecular fingerprint region where fundamental, and more intense, spectroscopic transitions are found.
“By matching the frequency of the comb teeth with the cavity modes—the ‘standing modes’ of the cavity—we can increase the interaction path length between molecules inside the cavity and laser light by a factor of around 4000, equivalent to an effective path length of a few kilometers,” she added. “We then probe the light that leaks out of the cavity by sending it into an FTIR [Fourier-transform infrared] spectrometer to find out which exact comb teeth have been absorbed and by how much. In turn, this tells us which molecules are present in the breath sample and their concentration.”
Even Hippocrates Studied Breath
Ye noted in the NIST statement that JILA is the only institution that has published research on comb breathalyzers.
In their PNAS paper, the researchers wrote, “Breath analysis is an exceptionally promising and rapidly developing field of research, which examines the molecular composition of exhaled breath. … Despite its distinctive advantages of being a rapid, noninvasive technique and its long history dating back to Hippocrates, breath analysis has not yet been as widely deployed for routine diagnostics and monitoring as other methods, such as blood-based analysis.
“We have shown that this technique offers unique advantages and opportunities for the detection of light biomarkers in breath,” the researchers noted, “and it is poised to facilitate real-time, noninvasive monitoring of breath for clinical studies, as well as for early detection and long-term monitoring of temporary and permanent health conditions.”
Validation of these findings and further design research to make the system portable are required before JILA’s frequency comb breathalyzer can become a competitor to clinical laboratory blood tests for disease identification and monitoring. Nevertheless, JILA’s research brings breathalyzer technology a step closer to offering real-time, non-invasive analysis of human biomarkers for disease.
CDC asks physicians and clinical laboratories to be on the lookout and report symptoms of hepatitis to state health departments
Growing incidences of hepatitis in children are perplexing medical professionals and researchers in several countries around the world. The mysterious outbreak is occurring in otherwise healthy children and, to date, is of unknown origin, though an adenovirus may be involved.
Microbiologists and clinical laboratory scientists who perform virology testing may want to prepare for increased numbers of children presenting with hepatitis symptoms in the US.
On April 21, the Centers for Disease Control and Prevention (CDC) issued a nationwide health alert to notify the public about a cluster of children in Alabama who presented with hepatitis and adenovirus infections. The CDC asked physicians to watch for symptoms in children and to inform local and state health departments of any new suspected cases.
Also in April, the World Health Organization (WHO) issued its own alert to an outbreak of acute hepatitis of unknown etiology among young children in several countries. In addition to the United States, cases were reported in the United Kingdom, Spain, Israel, Denmark, Ireland, the Netherlands, Italy, Norway, France, Romania, and Belgium.
All the cases reported to the WHO involved children between one month and 16 years of age with the majority of cases occurring in children under five.
According to NBC News, as of May 19, the worldwide number of cases “under investigation” had reached 600 in more than 25 countries. In the US, more than 90% of the patients required hospitalization and 14% of those patients needed a liver transplant. The CDC is investigating five pediatric deaths that may be attributed to the mysterious hepatitis outbreak.
“Fifteen days ago, CDC issued a nationwide health alert to notify clinicians and public health authorities about an investigation involving nine children in Alabama identified between October of 2021 and February of 2022 with hepatitis or inflammation of the liver and adenovirus infection,” said pediatrician and epidemiologist Jay Butler, MD (above), Deputy Director for Infectious Diseases at the CDC. “We’re casting a broad net to increase our understanding,” he added. “As we learn more, we’ll share additional information and updates.” Hospital-based clinical laboratories that support emergency departments and urgent care centers with testing for hepatitis will want to monitor for upcoming CDC alerts. (Photo copyright: John Amis/AP/CNN.)
Adenovirus/SARS-CoV-2 May Be Linked to Hepatitis Outbreak
The cause of the hepatitis outbreak is as yet undetermined, but the pre-eminent theory among disease experts points to the presence of an adenovirus, which often causes cold and flu-like symptoms in addition to stomach issues.
NBC News reported that more than half of the US patients, 72% of the UK patients, and 60% of the affected patients across Europe tested positive for human adenovirus type 41. This virus, however, is generally not associated with hepatitis in healthy children, and rarely impacts the liver so severely.
Medical experts are also considering the possibility that COVID-19 infections could somehow be an underlying cause since the hepatitis outbreak occurred during the pandemic. The WHO is investigating whether exposure to the SARS-CoV-2 coronavirus might have prompted the immune systems in the infected children to react abnormally to adenoviruses that are typically non-life threatening.
“The big focus over the next week is really looking at the serological testing for previous exposure and infections with COVID,” Phillipa Easterbrook, MD, a senior scientist at the WHO headquarters in Geneva, told NBC News.
Hepatitis, or inflammation of the liver, is typically caused by heavy alcohol use, exposure to toxins, certain medical conditions and medications, or a virus.
The most recent children diagnosed with hepatitis presented with some or most of these symptoms, particularly stomach issues and fatigue. However, one symptom was present in all the children.
“The big symptom that made all of these kids different was that they all showed signs of jaundice, which is the yellowish coloration of the skin and eyes,” Markus Buchfellner, MD, a pediatric infectious disease fellow at the University of Alabama, told NBC News.
Buchfellner was the first person in the US to notice an unusual pattern of hepatitis among children. He reported his findings to the CDC last fall in 2021.
“We were able to uncover the possible association with the adenovirus 41 strain because it is our standard practice to screen patients diagnosed with hepatitis for adenovirus,” he said. “For us to dig deeper into this medical mystery and see if this strain is the cause of these severe hepatitis cases, we first need more data on how widespread the outbreak is.”
Adenovirus 41 is usually spread through fecal matter, which makes hand washing critical, especially after visits to the bathroom or diaper changes. This type of adenovirus typically presents as diarrhea, vomiting, and fever, and is often accompanied by respiratory issues.
Clinical Labs Performing Gene Sequencing Can Help
Medical scientists around the world are responding to this threat to the youngest and most vulnerable among us. Research is underway into identifying additional cases, determining what is causing the hepatitis globally among children, and establishing preventative measures.
Pathologists and clinical laboratory managers in the US will want to be on the alert for positive hepatitis tests in children whose specimens were tested at their facilities. With advances in gene sequencing that make testing economical and expeditious, more labs have the ability to not only detect hepatitis, but also to identify any genetic variants that may be associated with the increased number of pediatric hepatitis cases appearing around the world.
Federal agents allege ‘healthcare fraud abuses erode the integrity and trust patients have with those in the healthcare industry’
Here’s yet another example of how federal and state law enforcement agencies intend to further crack down on fraud involving COVID-19 testing, financial relief programs, vaccination cards, and other pandemic-related programs.
The United States Department of Justice (DOJ) announced it has charged the owners of a Calif. clinical laboratory—as well as 19 other defendants—for their roles in fraudulent billing, kickbacks, and money laundering schemes to defraud Medicare of more than $214 million.
Imran Shams and Lourdes Navarro—owners of Matias Clinical Laboratory, Inc., in Baldwin Park, Glendale, Calif.—which was doing business as Health Care Providers Laboratory, Inc. (Matias)—were charged along with the other defendants with participating in fraud that took place in nine federal court districts.
The indictment alleges the pair paid kickbacks to marketers to obtain specimens and test orders. The lab company owners then laundered their profits through shell corporations in the US, transferred the money to foreign countries, and used it to purchase “real estate, luxury items, and goods and services for their personal use,” according to court documents.
“While millions of Americans were suffering and desperately seeking testing and treatment for COVID-19, some saw an opportunity for profit,” said Assistant Attorney General for the Criminal Division Kenneth A. Polite Jr., JD, during a news conference at the Justice Department, The New York Times reported.
“The actions of these criminals are unacceptable, and the FBI, working in coordination with our law enforcement partners, will continue to investigate and pursue those who exploit the integrity of the healthcare industry for profit,” said Luis Quesada of the Federal Bureau of Investigation’s (FBI) Criminal Investigative Division in a press release.
“Throughout the pandemic, we have seen trusted medical professionals orchestrate and carry out egregious crimes against their patients all for financial gain,” said Assistant Director Luis Quesada (above) of the FBI’s Criminal Investigative Division in a DOJ press release. “These healthcare fraud abuses erode the integrity and trust patients have with those in the healthcare industry, particularly during a vulnerable and worrisome time for many individuals.” Clinical laboratories throughout the US should be aware of increased scrutiny to Medicare billing by the DOJ. (Photo copyright: El Paso Times.)
According to the DOJ’s Summary of Criminal Charges, “Matias” Clinical Laboratory also “performed and billed Medicare for urinalysis, routine blood work, and other tests, despite the fact that Shams had been excluded from all participation in Medicare for several decades.” The indictment alleges that Shams and Navarro fraudulently concealed Sham’s role in the clinical laboratory and his prior healthcare-related criminal convictions.
“She always tried to follow the law and provide appropriate and quality testing services to the laboratory’s patients. She looks forward to clearing her name in court,” Werksman said.
However, both Navarro and Shams have a checkered past with law enforcement agencies. According to a State of California Department of Justice news release, in 2000, the two were convicted in California on felony counts of Medi-Cal fraud, grand theft, money laundering, and identity theft for using the names of legitimate physicians without permission and filing thousands of false claims with the state for medical tests never performed.
The Calif. Attorney General’s Division of Medi-Cal Fraud and Elder Abuse (DMFEA) seized approximately $1.1 million in uncashed warrants, which were returned to the Medi-Cal program. Since the 2000 case, Shams has been barred from filing for Medicare reimbursement, the New York Times reported.
Other Felony Indictments and Criminal Complaints for Healthcare Fraud
In a separate case, the DOJ announced Ron K. Elfenbein, MD, 47, of Arnold, Md., was charged by indictment with three counts of healthcare fraud in connection with an alleged scheme to defraud the US of more than $1.5 million in claims that were billed in connection with COVID-19 testing. Elfenbein is owner and medical director of Drs Ergent Care, LLC, which operates as FirstCall Medical Center. Elfenbein allegedly told his employees to submit claims to Medicare and other insurers for “moderate-complexity office visits” even though the COVID-19 test patients’ visits lasted five minutes or less.
And in April, the DOJ filed a criminal complaint against Colorado resident, Robert Van Camp, 53, for allegedly forging and selling hundreds of fake COVID-19 vaccination cards, which he sold to buyers and distributors in at least a dozen states.
“Van Camp allegedly told an undercover agent that he had sold cards to ‘people that are going to the Olympics in Tokyo, three Olympians and their coach in Tokyo, Amsterdam, Hawaii, Costa Rica, Honduras,’” the DOJ said in a news release, CNBC reported.
Van Camp also allegedly told that agent, “I’ve got a company, a veterinary company, has 30 people going to Canada every f— day, Canada back. Mexico is big. And like I said, I’m in 12 or 13 states, so until I get caught and go to jail, f— it, I’m taking the money, (laughs)! I don’t care,” the DOJ stated.
Clinical laboratory directors and pathologists know these fraud charges provide another example of how the misdeeds of a few reflect on the entire healthcare industry, potentially causing people to lose trust in organizations tasked with providing their healthcare.
InspectIR COVID-19 Breathalyzer identifies a chemical signature associated with SARS-CoV-2 in about three minutes with 91.2% sensitivity and 99.3% specificity
One company is hoping that it can make breathalyzers a viable, easier way to screen for SARS-CoV-2. It will soon have the opportunity to learn if consumers will accept this form of screening for COVID-19, as its device recently obtained an Emergency Use Authorization from the FDA.
On April 14, 2022, InspectIR Systems, LLC, of Frisco, Texas, was granted the US Food and Drug Administration’s first-ever emergency use authorization (EUA202006) for a portable breath test device designed to screen for SARS-CoV-2 infection. Clinical laboratories that perform COVID-19 testing will want to compare the high-level sensitivity of this breath test compared to rapid antigen tests currently used for COVID-19 screening.
The device is about the size of a carry-on suitcase. It provides test results in less than three minutes and is currently authorized for use with subjects who are 18 or older.
The FDA’s EUA limits use of the device to “a qualified, trained operator under the supervision of a healthcare provider licensed or authorized by state law to prescribe tests,” the federal agency said. The test “can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals, and mobile testing sites.”
The InspectIR COVID-19 Breathalyzer device “is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeffrey Shuren, MD, JD (above), director of the FDA’s Center for Devices and Radiological Health (CDRH), in the news release. A portable device that can identify SARS-CoV-2 infections in a few minutes with 91% specificity may be of great interest to clinical laboratory companies operating COVID-19 popup testing sites around the nation. (Photo copyright: US Food and Drug Administration.)
In granting the authorization, the FDA cited results of a study with 2,409 participants in which the test had sensitivity (correct positive results) of 91.2% and specificity (correct negative results) of 99.3%. “The test performed with similar sensitivity in a follow-up clinical study focused on the Omicron variant,” the agency stated.
“The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the US for the next public health emergency,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health (CDRH), in the news release.
In its coverage of the EUA, CNET noted that the InspectIR breath test is more sensitive than rapid antigen tests but not as sensitive as PCR tests. The FDA advised that people who receive a positive test result with the InspectIR COVID-19 Breathalyzer should follow up with a PCR molecular test.
How the InspectIR COVID-19 Breathalyzer Works
InspectIR LLC was founded in 2017 by Tim Wing and John Redmond, Forbes reported. Their original goal was to develop a breathalyzer for detection of cannabis or opioid use. However, with the onset of the COVID-19 pandemic, the entrepreneurs decided to adapt the technology into a SARS-CoV-2 diagnostic test.
As described in the FDA’s EUA documents, a subject breathes into the device using a sterilized one-time-use straw. A pre-concentrator collects and concentrates the five targeted VOCs, all from the ketone and aldehyde families of organic compounds. These go to a Residual Gas Analyzer, and an algorithm determines whether the sample contains the chemical signature associated with a SARS-CoV-2 infection.
Redmond told Forbes that the specific mix of VOCs is proprietary. The article notes that Wing, Redmond, and Verbeck have patented the pre-concentrator technology.
The devices are manufactured at a Pfeiffer Vacuum Inc. facility in Indiana. The InspectIR founders told Forbes they expect to produce 100 units per week in a start-up phase with plans to ramp up as sales increase. They also plan to look at applications for other respiratory diseases.
InspectIR has not announced exact pricing, but Time reports that the company will lease the equipment to clients, and that pricing per test will be comparable to rapid antigen tests.
InspectIR’s first breathalyzer device is receiving much positive coverage from the media. Should it prove to effective at spotting COVID-19 at popup testing sites, it may supplant traditional clinical laboratory rapid antigen tests as the screening test of choice.
No explanation for the delay was provided by court after nine weeks of testimony in the prosecution of the former clinical laboratory executive
Former Theranos president/chief operating officer Ramesh “Sunny” Balwani’s often-delayed fraud trial was scheduled to resume on May 27 with a full day of defense witness testimony. It will now be delayed until June 7.
According to NBC Bay Area, a court assistant announced the delay but did not provide a reason for the postponement. A copy of the clerk’s notice posted on Twitter by Law360 also provided no further details. Pathologists and clinical laboratory managers must now wait several more months to learn what may be next revealed in testimony during this trial.
It is also yet one more delay in Balwani’s trial. His original trial date was January 2022 before being rescheduled for February. The needs for COVID-19 pandemic protocols further delayed the start multiple times until opening arguments began March 22 in a federal court room in San Jose, Calif.
One part of the trial has concluded. On May 20, the government rested its case against Balwani, who faces 12 counts of wire fraud and conspiracy to commit wire fraud while serving as second in command at Theranos, the now defunct Silicon Valley medical laboratory startup.
Former Theranos president and COO Ramesh “Sunny” Balwani (above) faces 12 charges of wire fraud and conspiracy to commit wire fraud while serving as chief operating officer of Theranos, the company that boldly declared it would disrupt the clinical laboratory testing industry. His trial, which began in March in US District Court in San Jose, Calif., is now delayed until June 7, when his defense attorneys will begin their first full day of witness testimony. (Photo copyright: Stephen Lam/Reuters/The New York Times.)
According to The Wall Street Journal (WSJ), nine weeks of testimony in US District Court in San Jose, Calif., included testimony from 24 witnesses. Prosecutors aimed to convince jurors Balwani controlled much of the day-to-day decision-making at Theranos and was a full participant in the fraud scheme.
NBC Bay Area stated prosecutors worked to link Balwani to two key decisions:
The rollout of the failed Edison blood testing device in Walgreens, and
The company’s improper use of the Pfizer logo on a report to Walgreens executives that appeared to validate Theranos’ technology.
Before this latest postponement, Balwani’s attorneys had begun their client’s defense by putting a naturopathic physician from Arizona on the stand. The witness testified to sending more than 150 patients to Theranos and to using the company’s blood tests for herself, the WSJ reported.
Bloomberg reported that prosecutors followed the previous outline used to gain the conviction of Elizabeth Holmes, founder and former CEO of Theranos, with many of the same witnesses from her trial reappearing on the stand to testify in the Balwani trial.
Prosecutors primarily focused their case on the injury to investors, which has angered some former Theranos customers.
“I feel like I belong to a group of people who were on the receiving end of a crime,” said Erin Tompkins—a Theranos customer who testified against both Holmes and Balwani—outside the courthouse shortly after finishing her testimony in the Balwani case, Bloomberg reported.
According to CNBC, Tompkins testified she was misdiagnosed as having HIV after having her blood drawn from a Theranos device at a Walgreens in Arizona.
“Despite the dedication and support of prosecutors, patient witnesses have been treated as peripheral” compared to the investors, Tompkins told Bloomberg. “We were defrauded because we trusted them with our blood and however many dollars for the test. But we weren’t robbed of millions of dollars.”
Susanna Stefanek, editorial manager at Apple Inc. who served on the Holmes jury, told Bloomberg, “[The prosecution] didn’t really prove that these patients were persuaded to get these blood tests by something she said or did, or even the advertising. The connection between Elizabeth Holmes and the patients was not that strong to us.”
Proving Patient Fraud
Michael Weinstein, JD, a former federal prosecutor turned Chair of White-Collar Litigation and Government at Cole Schotz in New Jersey, told Bloomberg that to convict Balwani of patient fraud, prosecutors must prove Balwani knew what was going on inside Theranos and that his misrepresentations caused patients to suffer.
“The government wants to show there was an inconsistency between what he was learning internally versus what he was saying externally,” Weinstein said.
With the Balwani trial likely to conclude this month, clinical laboratory directors and pathologists who have closely followed Theranos’ rise and fall should prepare for the final chapter in the saga.
