Study shows clinical laboratories may one day use nanorobotic tests to help prevent spread of viral infections, cancer, and other diseases
Scientists from the University of Illinois Urbana-Champaign (U of I) have developed a tiny robotic “hand” made from structural DNA that “grabs” viruses—including the COVID-19 coronavirus—potentially preventing them from infecting cells. Such a nano-robotic antiviral technology could be used by anatomic pathologists and clinical laboratory managers in the future as a point-of-care type of test.
This is yet another example of out-of-the-box thinking by developers of diagnostic technology. Led by Xing Wang, PhD, professor of bioengineering and of chemistry at the U of I, the scientists dubbed their DNA device the NanoGripper.
Similar to a piece of origami (Japanese art of folded paper), the so-called hand has “four bendable fingers and a palm, all in one nanostructure folded from a single piece of DNA,” according to a U of I news release. The scientists found in their study that the hand was capable of doing a rapid test to identify the (COVID-19) virus and “prevented the viral spike proteins from infecting the cells,” Gizmodo reported.
“We are using DNA for its structural properties. It is strong, flexible, and programmable. Yet even in the DNA origami field, this is novel in terms of the design principle. We fold one long strand of DNA back and forth to make all of the elements, both the static and moving pieces, in one step,” said Wang in the news release.
“It would be very difficult to apply it after a person is infected, but there’s a way we could use it as a preventive therapeutic,” said Xing Wang, PhD (above), associate professor, bioengineering and chemistry, University of Illinois Urbana-Champaign, in a news release. “We could make an anti-viral nasal spray compound. The nose is the hot spot for respiratory viruses, like COVID or influenza. A nasal spray with the NanoGripper could prevent inhaled viruses from interacting with the cells in the nose.” Clinical laboratories may one day perform antiviral testing that uses U of I’s NanoGripper technology. (Photo copyright: University of Illinois.)
How a DNA Nanorobot Grabs a Virus
The U of I researchers wanted to leverage what has been discovered about DNA as a “material for constructing versatile nanorobots for biomedical applications,” they wrote in Science Robotics. However, previous studies had not achieved the current origami design of a nanoscale mechanism, the authors added.
With robotic precision and its DNA structure, the researchers’ NanoGripper moves and enables fingers to bend for “customized interactions with target molecules,” Interesting Engineering reported, adding that the technology also:
Employed DNA aptamers on the fingers which act as “molecular locks” to find and bind to specific targets.
In a demonstration, wrapped its fingers around the target spike protein of the COVID-19 coronavirus, essentially “disabling its ability to infect cells.”
“The aptamers are arranged into a spatial pattern that specifically matches that of the trimeric spike protein on the virus outer surface. Such pattern recognition-enabled multivalent interaction—a principle developed by my group—has induced ultrahigh NanoGripper virus-binding avidity, resulting in enhanced virus diagnosis sensitivity,” Wang said.
Taken from the U of I news release, the image above shows how “Inspired by the gripping power of the human hand and bird claws, the researchers designed the NanoGripper with four bendable fingers and a palm, all in one nanostructure folded from a single piece of DNA. Each finger has three joints, like a human finger, and the angle and degree of bending are determined by the design on the DNA scaffold.” Such nano-robotic technology could become a new clinical laboratory test for diagnosing viral infections, or even a preventative treatment if caught prior to infection. (Photo and caption copyright: University of Illinois.)
Developing a Test for COVID-19
The scientists discovered that when equipped with a photonic crystal sensor, NanoGripper detected the SARS-CoV-2 coronavirus in 30 minutes with sensitivity equal to RTqPCR tests, Gizmodo reported.
“The NanoGripper functions as a highly sensitive biosensor that selectively detects intact SARS-CoV-2 virions in human saliva with a limit of detection of 100 copies per milliliter, providing a sensitivity equal to that of reverse transcription quantitative polymerase chain reaction [RTqPCR],” the authors wrote in Science Robotics.
In fact, the NanoGripper test is reportedly faster and easier than RTqPCR testing, which requires sophisticated instruments.
“Our test is very fast and simple since we detect the intact virus directly,” said study collaborator Brian Cunningham, PhD, professor, electrical and computer engineering and bioengineering at U of I, in the news release.
“When the virus is held in the NanoGripper’s hand, a fluorescent molecule is triggered to release light when illuminated by an LED or laser,” he said, adding, “When a large number of fluorescent molecules are concentrated upon a single virus, it becomes bright enough in our detection system to count each virus individually.”
More Research and Applications
Gizmodo compared the NanoGripper to a “true Swiss army knife,” able to change and detect other viruses such as HIV and influenza (Flu).
The U of I researchers have already studied the NanoGripper’s ability to detect hepatitis B and plan to publish findings soon, Wang told The Pathologist. He also noted it’s possible the NanoGripper “can be integrated with a lateral flow assay paper strip platform for development of a rapid, sensitive, and inexpensive at home or point-of-care virus detection.”
There is “power in soft nanorobotics,” said Wang, who envisions potential for the NanoGripper beyond viruses to include programming the fingers to detect cancer markers and enabling the grippers to deliver treatment to target cells.
Clinical pathologists and laboratory managers may want to follow this research coming out of the University of Illinois Urbana-Champaign. Once put through additional clinical studies, such nanorobotic diagnostic technology might eventually be used at the point-of-care to help prevent viral infection and spread of disease.
Lawsuit is a strong reminder that clinical laboratories and pathology groups must take whatever steps necessary to secure their patients’ protected health information
Lehigh Valley Health Network (LVHN), one of the largest primary care groups in Pennsylvania, will pay out $65 million to settle a class-action lawsuit brought by the healthcare network’s own patients (identified only as “Jane Doe” in court documents) following a ransomware attack early last year in which LVHN refused to pay the ransom.
The payout may be the largest settlement for a single cyberattack to date and highlights the need for clinical laboratories and pathology groups to review their cyberattack defenses and incorporate steps to better secure patient protected health information (PHI), with one goal being to minimize the possibility of patients filing a class action lawsuit following a cyberattack.
LVHN blamed ransomware group ALPHV (a.k.a., BlackCat) for the attack, Fierce Healthcare reported. The hackers gained access to gigabytes of personal data belonging to 134,000 patients and staff members.
According to a news release LVHN issued in June, the private information the thieves obtained included, “names, addresses, phone numbers, medical record numbers, treatment and diagnosis information, including Current Procedural Terminology (CPT) codes, and health insurance information. For some individuals, the information included email addresses, banking information, Social Security numbers, and driver’s license numbers. The information for a limited number of individuals included clinical images of patients during treatment.”
The case is worth attention because it casts light on what the health system administration did/did not do to prevent the data breach that enabled the hackers to post nude photos of cancer patients undergoing treatment and other patient PHI on the Internet.
“When you go to the doctor’s office, that’s one place where you’re anticipating that everyone is working to maintain your privacy, even though you have to open yourself up to be treated,” said Patrick Howard, JD (above), partner at Philadelphia-based Saltz Mongeluzzi Bendesky P.C., who is representing the plaintiffs in the class action lawsuit. “It wasn’t lost on anyone that that was a very significant breach.” Clinical laboratories are particularly vulnerable since as much as 80% of a patient’s health record is lab test results and other data. (Photo copyright: Saltz Mongeluzzi Bendesky P.C.)
Lawsuit Details
The class action lawsuit was filed in March 2023 by a “Jane Doe” cancer patient whose data was hacked on behalf of herself and other victims of the cyberattack. The court documents recount how the unidentified plaintiff—a woman in her 50s—was “called by the hospital’s vice president of compliance on March 6, with news that that naked images of her were now online, before offering—‘with a chuckle’—two years of credit monitoring services. The Jane Doe plaintiff responded that she had no idea that the hospital had taken photographs of her while unclothed during her treatment for breast cancer, nor that it was storing them on corporate servers.”
“The pictures are really difficult to look at,” said Patrick Howard, JD, partner at Philadelphia-based Saltz Mongeluzzi Bendesky P.C. (SMB), who is representing the plaintiffs, in a news release. His legal team hired a cybersecurity expert who located the images the hackers had posted on the Dark Web, enabling them to “establish each person’s information that was actually online.”
The plaintiff’s attorney’s argued LVHN failed in its responsibility to protect patient information and were in violation of HIPAA (Health Insurance Portability and Accountability Act of 1996).
The class action lawsuit also alleges LVHN routinely took photos of naked cancer patients, sometimes without their knowledge. Some of those photos were published by BlackCat on the Dark Web.
“While LVHN is publicly patting itself on the back for standing up to these hackers and refusing to meet their ransom demands, they are consciously and intentionally ignoring the real victims,” the lawsuit states. “Rather than act in their patients’ best interest, LVHN put its own financial considerations first.”
The law firm also stated this settlement is “the largest of its kind, on a per-patient basis, in a healthcare data breach ransomware case,” The Register reported.
Patients affected by the security breach were placed in relief tiers based on the private information that was stolen and leaked. The compensatory breakdown for those patients is:
$50 to patients whose records were hacked.
$1,000 to patients who had their information posted online.
$7,500 to patients whose non-nude photos were posted online.
$70,000 to $80,000 for patients who had their nude photos posted online.
“We struck the right deal,” Howard told WHYY News. “The vast majority of that money is going to mostly women whose images were published online, in topless fashion, with both their face exposed and their name in the files.”
Game Changing Data Breach
LVHN originally announced an attack had been detected in February 2023. On March 4, 2023, the ALPHV hackers demanded a ransom in excess of $5 million from LVHN, threatening to distribute the stolen data unless the ransom was paid. LVHN refused to pay the ransom which led to the cybercriminals uploading the stolen data to the Dark Web.
“Attacks like this are reprehensible and we are dedicating appropriate resources to respond to this incident,” stated Brian Nester, DO, President and CEO, LVHN, in a news release.
“The type of data that was exposed, it’s a game changer,” said Carter Groome, founder and CEO of digital-risk firm First Health Advisory in the SMB news release. “This was so much more of a tangible, direct distress to those people who trusted the organization.”
“Pictures are part of medical care. That’s something that they do to track scarring and all sorts of things. But they are the most delicate and sensitive medical information,” Howard told WHYY News. “I think this case will be talked about in healthcare circles for some time in best practices in storing those types of images.”
Patients had until October 21, 2024, to exclude themselves from or object to the settlement. The deadline to submit a claim form was November 3, 2024, and the final approval hearing was held on November 15, 2024.
LVHN agreed to the terms of the settlement, whilst denying any wrongdoing on its part. Individuals in the settlement class who chose to participate in the lawsuit will be sent payment automatically.
LVHN has established a website for people seeking information about the cyberattack.
As ransomware attacks continue to increase, clinical laboratories and pathology groups should review their cyberattack defenses and determine how to better secure their patients’ protected health information. Taking necessary precautions could minimize the possibility of patient data being compromised and prevent another huge class-action lawsuit.
Strikes could lead to delays or cancelations of as many as 123,000 clinical laboratory test across the nation’s healthcare system
Once again, New Zealand medical laboratory workers are returning to the picket line. On March 6, APEX, a specialist union representing more than 4,000 allied, scientific, and technical health professionals throughout New Zealand, issued a strike notice to “three corporate laboratory companies—Awanui, Pathlab, and Medlab,” according to an APEX news release.
“Over 850 laboratory scientists and technicians across New Zealand will take rolling strike action over seven days beginning on 22 March, with at least 123,000 patient tests impacted. Over 70% of New Zealand towns and cities including Tauranga, Rotorua, Palmerston North, Gisborne, Wellington and Dunedin will lose access to medical laboratory testing for their public hospital, or primary care system, or both for a minimum of 72 hours,” the news release notes.
“Pathlab staff across Waikato, Bay of Plenty and Taupō will strike from March 24 until March 26, Awanui staff in Wellington and Canterbury will strike from March 25 until March 27, and Medlab workers in the MidCentral region will strike for a full week from March 22 until March 28. Auckland and the West Coast are the only regions where no labs are affected,” The Post reported.
“Those who use and rely on laboratory services need to brace for impact. We estimate that over 123,000 tests normally carried out as part of urgent or routine patient testing will not be performed during the week of strikes,” said Deborah Powell, MBChB, APEX National Secretary, in the news release.
“We are keen to work with the laboratory employers to resolve this dispute,” said Deborah Powell, MBChB (above), APEX National Secretary, in the news release. “Patients, clinicians, and laboratory workers are now stuck between the rock of underfunding and the hard place of corporate ownership of the medical laboratory sector. To avoid these rolling strikes, we need all parties to the dispute to work together to come up with a creative and sensible solution which works for everyone.” Clinical laboratories in the US may want to pay close attention to the struggles of their counterparts in New Zealand. (Photo copyright: New Zealand Doctor.)
Private Lab Ownership versus Public Funding
In February, more than 900 New Zealand medical laboratory workers nationwide walked off the job to protest “poor conditions and a lack of pay parity with the public sector,” according to the Otago Daily Times. Until now, that was the latest labor action in the ongoing struggle.
But those walkouts did not produce the results the union organizers had hoped.
“We didn’t get what we wanted at all,” Pathlab Tauranga senior medical laboratory scientist Steven Clements told NZ Herald. “We feel like there’s a lot of blame being passed between our employer and the government.”
Clements claimed the New Zealand government made its “standard statement” about it not being involved in private laboratory negotiations.
“They actually provide almost all of our funding, so we feel like the government hasn’t particularly listened. We also feel like our employer maybe isn’t really supporting us … so it’s led to another strike,” he said.
“We are in the weird situation where the employers agree with us,” said APEX National Secretary Powell, NZ Herald reported. “Pay parity between public and corporate employed lab scientists and technicians is the only fair, just, and sustainable solution to this dispute. Unfortunately, the lab triopoly are refusing pay parity without further government funding,” she added.
Disruptions in Care
As is the case with any strike, they are disruptive. During the February strikes, NZ Pathology Chairman, Peter Gootjes, DPH, director of the Awanui Group, told the New Zealand Doctor that they were trying to minimize any disruptions. The New Zealand Association of Pathology Practices (NZ Pathology), according to the organization’s website, is the “collective voice of New Zealand’s private sector laboratory providers, representing the views and aspirations of the funded pathology sector.”
“Our laboratories play an essential role in the provision of healthcare services, and we are working closely with the union, hospitals, and health professionals to ensure essential life-preserving services remain available and ongoing disruption to the community can be minimized,” Gootjes told New Zealand Doctor.
“Pathology sits at the heart of modern healthcare,” he continued. “Ensuring New Zealanders have access to quality, reliable, efficient and trusted pathology services is vital to patient care and public health. These services are a fundamental, yet often unseen, component of the clinical pathway for patients.
“We understand the concerns raised by APEX members and recognize the challenges posed by pay discrepancies following the previous government’s pay equity settlements for public sector employees. We are committed to working constructively with government and officials on this matter,” he said.
Pathlab, Health NZ Respond
In separate statements, Pathlab and Health NZ-Te Whatu Ora (New Zealand’s primary publicly funded healthcare system) attempted to address the APEX lab workers’ demands and assure the public.
“We value [APEX workers’] work and have engaged with APEX in good faith, doing everything we can within the funding we receive. … The problem is that private laboratories, including Pathlab, receive the vast majority of their funding through long-run bulk-funded contracts with Health NZ that pre-date the settlement and are inflexible when it comes to unforeseen cost increases, such as this one,” Pathlab’s chief executive Brian Millen stated, adding, “We remain committed to finding a workable solution while continuing to provide the high-quality services our communities rely on,” NZ Herald reported.
Health NZ, which, according to NZ Herald, “was aware Apex members were in collective bargaining … [but] not involved in this as they did not employ the private sector workforce,” sought to ensure that the strikes’ impact on hospitals and community healthcare services would be minimal.
“All our hospitals and emergency departments will remain open, and we are liaising with the private laboratories to ensure patients who require urgent and critical care receive the services they need, including testing carried out at hospitals and in the community,” said Health NZ, adding, “We respect the right of workers to take strike action and any questions about this matter should be directed to the employers or the union.”
Dark Daily has covered these ongoing strikes in many previous ebriefings. Clinical laboratory and pathology professionals in the United States should take note of their New Zealand counterparts’ recent and ongoing struggle for fair pay and safe working environments. America is no stranger to issues like these and our lab workers could find themselves in a similar situation.
Research could lead to new biomarkers for clinical laboratory tests that spot disease early in patients
As we have covered in previous Dark Daily ebriefs, there are ongoing efforts to develop diagnostic assays that use human breath as the specimen. One early example was the breath specimen for Helicobacter pylori (H. pylori) testing—the bacteria that causes peptic ulcers—in the 1990s. Thus, a new sensor developed by scientists at Zhejiang University in China that can detect the presence of lung cancer in human breath will be of interest to medical laboratory scientists and clinical laboratories working on such testing.
In a proof-of-concept study, the Zhejiang University researchers “developed ultrasensitive nanoscale sensors that in small-scale tests distinguished a key change in the chemistry of the breath of people with lung cancer,” according to an American Chemical Society (ACS) news release.
The new research exemplifies how instruments are becoming increasingly sensitive to detection of smaller specimen quantities, making it possible to even use exhaled breath to diagnose lung cancer, noted a review article published in Science Direct.
“This study presents a novel Pt@InNiOx [platinum (Pt), indium (In), nickel (Ni)] nanoflake isoprene sensor that achieves an exceptionally low limit of detection at two parts per billion (2ppb)—the lowest reported for isoprene sensor to date,” wrote study lead author, Pingwei Liu, PhD (above), distinguished research fellow, Zhejiang University, et al, in ACS Sensors. “Our work not only provides a breakthrough in low-cost, noninvasive cancer screening through breath analysis but also advances the rational design of cutting-edge gas sensing materials.” Clinical laboratories working with breath sample biomarkers will be intrigued by this new advancement in the technology. (Photo copyright: Zhejiang University.)
Finding the Breakthrough Sensor
The Zhejiang University researchers were motivated by the potential for rapid gas sensing in diagnostics. Many gases, including carbon dioxide, are exhaled. But one particular gas, isoprene, they found “can indicate the presence of lung cancer,” the news release states.
However, while breath is readily available, it is not easy to isolate breath biomarkers. That is because a detector needs to “differentiate between volatile chemicals, withstand the natural humidity of exhaled breath, and detect tiny quantities of specific chemicals,” New Atlas explained.
To detect small specimen quantities of isoprene, a highly sensitive sensor needed to be developed—one that would be a step up from standard indium oxide-based breath sensors.
The scientists experimented with a series of indium (III) oxide (In203)-based nanoflake sensors until they found the sensor that performed consistently in nine experiments. They called it Pt@InNiOx for the platinum (Pt), indium (In), and nickel (Ni) it contained.
According to the news release, the Pt@InNiOx sensor:
Had “sensitivity that far surpassed earlier sensors” as evidenced by detection of isoprene as low as 2ppb.
Emphasized isoprene attraction over other volatile compounds in breath.
Has advanced sensitivity due to “Pt nanoclusters uniformly anchored on the nanoflakes” activating the isoprene sensing.
Gadget Review described the innovation as a “significant advance in diagnostic capability” that uses nanoscale technology along with “indium oxide nanoflakes with platinum-based nanoclusters.”
Developing the Lung Cancer Diagnostic Device
The scientists put their Pt@InNiOx nanoflakes into a portable sensing device for breath analysis. They then inserted breath samples from 13 people including five who had lung cancer. They found that:
In samples from people with cancer, the device enabled detection of isoprene levels lower than 40 ppb.
In samples from cancer-free participants, the device found isoprene levels more than 60 ppb.
“We integrate these ultrasensitive Pt@InNiOx nanoflakes into a miniaturized portable electronic device that successfully distinguishes lung cancer patients with expiratory isoprene below 40ppb, from the healthy population with isoprene above 60 ppb, enabling an accurate diagnosis in clinics,” wrote study lead author, Pingwei Liu, PhD, distinguished research fellow, Zhejiang University, et al, in ACS Sensors.
“As the isoprene hits the nanoflakes, electron release is sparked in a way that can be measured,” MSN Health reported, adding that the nanoflakes were also able to find isoprene in other chemicals and operate even in humid conditions.
Breath as Lab Test Biomarker for Cancer
In the United States, more people die from lung cancer than any other form of cancer, according to US Centers for Disease Control and Prevention statistics. The CDC data show there were 209,500 new lung and bronchus cancer cases in 2022, the most recent year for available data.
The Zhejiang University scientists reportedly plan to continue their research on the sensing materials and link between isoprene and lung cancer.
Studies continue to show many components in human breath can be used as clinical laboratory test biomarkers. Assays that use the breath as specimen may one day play an important role in early diagnosis of lung cancer and other diseases.
Researchers find neanderthal blood did not evolve and may have contributed to their demise
Researchers out of France have identified a unique antigen in red blood cells that may have contributed to the downfall of Neanderthals, according to an article in Live Science. These findings will be of interest to clinical laboratorians in hospitals who operate blood banks and blood bankers who do daily testing for blood groups and specific antigens.
“We showed that all Neanderthal shared the same blood group profile,” Mazières told Discover magazine. “Such low diversity is the signal of small populations.” He added, “the study shows how different blood types can help fight against infectious disease,” and that, “it emphasizes the importance of monitoring blood during both transfusions and pregnancies. The presence of some rare subtypes that originated with the Neanderthals but outlived them can lead to complications,” Discover reported.
Clinical laboratories and pathologists will appreciate these new findings, as this unique look into Neanderthal physiology illustrates how the importance of proper blood typing has endured throughout time.
“For any case of inbreeding of a Neanderthal female with a Homo sapiens or Denisova male, there is a high risk of hemolytic disease of the newborn. The condition can lead to jaundice, severe anemia, brain damage and death. This could have contributed to the demise of the Neanderthal population,” Stéphane Mazières, PhD (above), a population geneticist at Aix-Marseille University who led the study into why Neanderthals did not survive, told Live Science. Clinical laboratories that run blood banks and perform blood type testing will find the study results interesting. (Photo copyright: X, formerly Twitter.)
‘Incompatible Blood Type
Mazières’ team studied ancient genomes to further understand the evolution from Neanderthals and Denisovans to Homo Sapiens. Genome sequencing was used to look at blood groups from “dozens of people who lived between 120,000 and 20,000 years ago.” This uncovered “a rare blood group that could have been fatal to their newborns,” Live Science reported.
The rare blood type discovered was not compatible with either Denisovans or early Homo Sapiens. Additionally, the more diverse blood found in Homo Sapiens may have attributed to a more robust immunity, Discover reported.
“Nowadays, certain blood groups confer an advantage against pathogens such as cholera, malaria, one of the gastroenteritis viruses and, as we’ve seen recently, COVID. We can therefore imagine that the blood groups found in the first Sapiens may have equipped them with a new arsenal to face the new environments encountered as they spread across the world,” Mazières told Discover.
“The contribution of this study is twofold. It enlightens the expansion patterns of Homo Sapiens and recalls the anthropological effectiveness of genetic polymorphisms currently being surveyed for transfusion safety and pregnancy monitoring,” the researchers wrote in Scientific Reports.
Knowing a patient’s blood type is key to ensure immune system acceptance of the blood, leading to successful blood transfusions and preventing fatalities. Focus is given to Rh (Resus) factor’s positive and negative typing and on the antigens responsible for segregating A, B, and O blood types. In the case of Neanderthals, a look at red blood cells was key, Live Science noted.
Modern-day Rh incompatibility, which can occur when an Rh-negative woman is pregnant with an Rh positive fetus, can be discovered during pregnancy and treated with prenatal administration of lab-made immunoglobulin to prevent hemolytic disease of the newborn, Live Science reported. It’s a whole system of healthcare that was certainly not available in Neanderthal times.
“Neanderthals have an Rh blood group that is very rare in modern humans. This Rh variant—a type of RhD, another red blood cell antigen—is not compatible with the variants the team found in the Denisovans or the early Homo Sapiens in their study,” Mazières told Live Science.
Looking Ahead
While this research may not change the way blood is handled today, the new findings serve as a reminder of just how important and varied antigens in human blood type can be and how significant the variances impact individuals. It also provides a window into how subtle differences shape the way civilization grows.
The complexity of red blood cells remains an area worthy of continued research, especially since many of these surface and internal antigens are passed down through generations, Live Science noted.
Also, study results may further the decades-long attempt to create artificial blood that has both an extensive shelf life and is accepted by the immune systems of many different patients. However, that will be a daunting challenge. Over the decades, blood bankers and clinical laboratory scientists have watched many attempts to develop artificial blood come close but fail to demonstrate safety while delivering benefits to patients.
Holmes says life in prison is ‘Hell’ and that Theranos was a failure but ‘not fraud’
For some reason disgraced Theranos founder and ex-CEO Elizabeth Holmes, in a lengthy interview with People magazine, described life in prison while raising her two children even as a three-judge panel of the US 9th Circuit Court of Appeals affirmed her conviction and 11.25-year sentence for fraud.
In June of 2024, Holmes’ defense team appealed to have her conviction overturned due to alleged errors in her trial. According to court documents containing the federal judges’ decisions, her attorneys argued that:
Former Theranos employees who testified as lay witnesses should not have been allowed to offer improper expert testimony.
The court abused its discretion by allowing testimony that Theranos voided all patient sample tests run on a device used in Theranos’s clinical laboratory.
Her rights were violated under the Confrontation Clause of the Sixth Amendment when she was prohibited from cross-examining a former Theranos laboratory director on aspects of his post-Theranos employment.
In February 2025, the judges rejected all points and denied her appeal. Holmes is serving her sentence in a minimum security federal prison camp in Texas and is currently scheduled to be released in 2032.
Elizabeth Holmes (above) taken backstage at TechCrunch Disrupt San Francisco 2014 when Holmes was at the height of her fame and popularity. At this point, Theranos’ Edison blood testing device had not yet been shown to be a fake. But as clinical laboratory scientists and anatomic pathologists studied the technology it was shown to be incapable of producing the results claimed by Holmes and her company president Ramesh Balwani. Today, both are serving lengthy prison sentences for defrauding investors. (Photo copyright: Max Morse/Wikimedia Commons.)
‘Nothing More than a Mirage’
Holmes was convicted in 2022 and sentenced to 135 months for her role in the Theranos fraud case. She was also ordered to pay approximately $452 million in restitution due to her offense, which resulted in significant financial losses to various entities and individuals.
Holmes’ one-time romantic partner and former president of Theranos Ramesh “Sunny” Balwani also was convicted of several fraud charges and sentenced to 155 months in prison.
Theranos claimed to have invented a device called Edison that could run a variety of fast, accurate, and affordable clinical laboratory diagnostic tests from a single finger prick of blood. That’s in contrast to traditional testing methods that require veinous blood drawn with a hypodermic needle. The reality, however, was that the Edison device did not work as described to investors.
“The vision sold by Holmes and Balwani was nothing more than mirage,” wrote 9th Circuit Judge Jacqueline Nguyen, JD, in the panel’s decision, adding that the “grandiose achievements touted by Holmes and Balwani were half-truths and outright lies.”
The judges continued: “Theranos’s blood-testing device failed to deliver faster and more accurate testing results than conventional technology. Pharmaceutical companies never validated the technology, as Holmes and Balwani had told investors. Contrary to the rosy revenue projections shared with investors and business partners, Theranos was running out of money.”
Life Behind Bars
Holmes told People she has adjusted to prison life, waking up every morning just after 5 AM. Her routine includes daily exercise and working as a reentry clerk. Holmes, who was once touted as having an estimated worth of $4.5 billion, now earns just 31 cents an hour teaching fellow inmates how to prepare resumes and apply for jobs and government benefits.
“So many of these women don’t have anyone, and once they’re in there, they’re forgotten,” she told People.
Holmes also teaches French and participates in cognitive and behavioral therapy for post-traumatic stress disorder (PTSD) to address past traumas, including the downfall of Theranos, which was once valued at $9 billion.
“It’s surreal,” she said. “People who have never met me believe so strongly about me. They don’t understand who I am. It forces you to spend a lot of time questioning belief and hoping the truth will prevail. I am walking by faith and, ultimately, the truth. But it’s been hell and torture to be here.”
Raising Children from Prison
Holmes’ trial was delayed three times due to the COVID-19 pandemic and then a fourth time due to a pregnancy. She gave birth to son William a few weeks before her trial began. She later gave birth to daughter Invicta. Both children are being raised by their father Billy Evans, Holmes’ current partner.
Critics allege Holmes only had children to gain sympathy and attempt to avoid prison time. In the People interview, she tried to dispel those claims.
“I know how the optics look, but I always wanted to be a mother,” she said. “I wanted to have children, be a mom. I truly did not think I would ever be convicted or found guilty. I kept talking to my lawyers and they also assured me we would never get this far.
“It wasn’t planned, and I can’t worry about what others think,” she added. “It’s just when the timing happened.”
Holmes’ children will be nine and 10 years-old when she’s slated for release in 2032. She continues to maintain her innocence and considers her trial and conviction a miscarriage of justice. She asserts that while Theranos was a flop, “failure is not fraud.”
“First it was about accepting it happened. Then it was about forgiving myself for my own part. [And] I refused to plead guilty to crimes I did not commit,” Holmes said.
Interestingly, Holmes intends to return to the healthcare industry upon her release. “There is not a day I have not continued to work on my research and inventions,” she told People. “I remain completely committed to my dream of making affordable healthcare solutions available to everyone.”
How she plans to do that given the federal government has banned her for life from operating a clinical laboratory and participating in federal health programs is anyone’s guess.
And thus the life and times saga of Elizabeth Holmes continues.
