Hospital laboratories are likely to see an increase in test orders for bacteria-borne infections, such as tuberculosis
The tuberculosis outbreak in Kansas City, Kan., is one of the largest in the US within a one-year period over the past several decades. Hospital laboratories are the front line for detecting these types of infectious diseases.
As of June 6, 2025, the number of reported active cases of tuberculosis (TB) since 2024 was 69 with 62 cases in Wyandotte County and seven cases in nearby Johnson County, both in Kansas, according to the latest available data as of this writing from the Kansas Department of Health and Environment.
An active TB infection is one in which patients are symptomatic, in need of immediate treatment, and contagious. These patients have typically had a positive TB blood or skin test and may have had an abnormal chest x-ray or positive sputum smear or culture.
The latest statistics show there are 97 cases of latent TB infections reported in the same counties. Latent TB infections are those where patients are asymptomatic but have had a positive TB test, a normal chest x-ray, and a negative sputum smear.
Although individuals with latent infections cannot transmit the illness to others, these cases may become active without treatment, rendering them potentially dangerous.
“You can think of TB outbreaks like a canary in the coalmine of our public health infrastructure,” David Dowdy, MD, PhD, professor of epidemiology at Johns Hopkins Bloomberg School of Public Health, told The Guardian. “What causes them to happen is a weakening of our public health infrastructure.” (Photo copyright: Johns Hopkins Medicine.)
Cause of Outbreak Remains Unknown
This TB outbreak was first identified in Kansas last year and its origin is unknown. Two people have died from the infection, but the risk to the public remains low.
“It’s definitely more than just a little blip,” David Dowdy, MD, PhD, professor of epidemiology at Johns Hopkins Bloomberg School of Public Health, told The Guardian. “It’s one of the largest outbreaks of tuberculosis that we’ve seen in the country in the past 30, 40, 50 years.”
TB in humans can be caused by two types of mycobacteria: Mycobacterium tuberculosis and Mycobacterium bovis. The former is the most common cause of the disease. The pathogen is airborne and is transmitted via respiratory droplets produced by coughing, sneezing, or speaking.
TB usually attacks the lungs, but other parts of the body can be affected as well. According to the Centers for Disease Control and Prevention, symptoms of the disease include:
Cough that lasts more than three weeks.
Coughing up blood or sputum.
Fever and chills.
Loss of appetite.
Weight loss.
Night sweats.
Weakness or fatigue.
Chest pains.
Each patient in the Kansas outbreak has been screened and contact traced. Testing is being provided free of charge. TB is treatable via antibiotics, and more than 85% of infected individuals fully recover with treatment.
TB is Relatively Common
Although curable and preventable, TB is one of the world’s deadliest infectious diseases. According to the World Health Organization, an estimated 10.8 million people contracted TB in 2023, and 1.25 million people died from the disease that year. Fewer than 10,000 of the cases occurred in the US.
“I think the first misconception about TB is that it’s a rare and uncommon disease. We think of it as something that doesn’t really impact us anymore in 2025, but TB has been here, is here, and it’s something that’s relatively common,” said Michael Bernstein, MD, director of pulmonary and critical care at Stamford Health, Stamford, Conn., in the American Journal of Managed Care. “So, the fact that we would see a TB outbreak doesn’t surprise most pulmonologists.”
Clinical laboratories should monitor localized TB outbreaks as they are at the forefront for testing and detecting infectious diseases. Hospital labs may want to prepare for an upsurge in patients arriving with tuberculosis and other bacterial infections in the future.
NPR reports that the shamed Theranos founder/CEO is providing advice to Evans, but the startup denies that claim
Prison bars can’t block Elizabeth Holmes from finding her way back into the news spotlight. The disgraced founder and former CEO of Theranos is reportedly advising her partner Billy Evans on his new artificial intelligence (AI) diagnostic startup company, named Haemanthus after the blood lily.
According to sources who spoke with NPR, Evans’ new company Haemanthus, Inc. is developing a blood testing device and has patented a process that uses Raman spectroscopy, which, according to NPR, “has been shown to help diagnose ALS, also called Lou Gehrig’s disease, as well as some forms of cancer. It has also been used to discover improvised explosive devices on battlefields.”
Evans has already raised millions of dollars for the fledgling startup, NPR reported, adding that a source claimed finances for the company have come from “mostly friends, family, and other supporters so far.”
According to Newsweek, Evans’ goal is to raise $50 million toward the development of a “medical testing product.”
The company will “do medical tests using bodily fluids,” Newsweek reported, adding, “An image of the alleged device published by The New York Times is eerily similar to Theranos’ ‘Edison’ testing machine.”
Elizabeth Holmes is currently housed in a federal facility in Bryan, Texas. Sources told NPR that she has been “providing advice” to Billy Evans, her partner, on his new AI/medical testing company Haemanthus, which denied those claims stating on X that Holmes “has no role, now or future.” (Photo copyright: Wikimedia Commons.)
Haemanthus Denies Holmes’ Involvement
Holmes has reportedly been providing insight to Evans throughout her prison term, though her role with his budding company is unclear, NPR noted.
As previously reported by Dark Daily, Holmes is “barred from receiving payments from federal health programs for services or products, which significantly restricts her ability to work in the healthcare sector.”
Haemanthus denied Holmes’ involvement with the company, claiming that she “has no formal role” and that “Haemanthus is not Theranos 2.0,” Fortune reported.
Previous lengthy posts by Haemanthus on social media platform X fully denied any involvement with Holmes but have since been deleted. The company now uses their platform to curtly retort the significance of Holmes’ involvement, leaning on their advancements and high standards. “Skepticism is rational. We must clear a higher bar,” they said. “When The NY Times contacted us, we invited them to see our lab, tech, and team. They declined. The headline was already written. Our reality inconvenient.”
Further posts on X showcase Haemanthus’ desire to have the same groundbreaking prowess Holmes clung to throughout her Theranos venture. The company claims to have developed “the world’s first AI-native sensors for health,” adding, “Our technology captures thousands of biomarkers simultaneously.”
And the Holmes Saga Continues
Haemanthus is comprised of about a dozen people, including individuals who “worked with Evans at Luminar Technologies, which develops sensor technology for autonomous vehicles, according to the company’s patent and Delaware incorporation paperwork,” NPR reported.
Holmes is currently serving an 11-year federal prison sentence for her role in fraud involving Silicon Valley startup Theranos, which boasted clinical laboratory blood-test breakthroughs that turned out to be riddled with faulty equipment and fraudulent results.
Though whistleblowers brought Holmes scheme to the light, she has never admitted wrongdoing for her actions and continues to claim her innocence. In May, the Ninth Circuit of Appeals denied her request for a rehearing of her case.
Findings may lead to new clinical laboratory testing and treatments for Parkinson’s patients
Gut bacteria have repeatedly been proven to perform critical roles in the development of certain diseases. And many clinical laboratory tests use human microbiota as biomarkers.
Now, researchers at Nagoya University Graduate School of Medicine in Japan have discovered a link between microbes in the gut and the brain. The connection may play a part in the development of Parkinson’s disease, according to a Nagoya University news release.
The researchers found that a reduction in the genes responsible for synthesizing riboflavin (vitamin B2) and biotin (vitamin B7) may increase the likelihood of developing Parkinson’s.
They also determined that the lack of these genes may lessen the integrity of the intestinal barrier that prevents toxins from entering the bloodstream causing the inflammation often seen in Parkinson’s patients.
“Supplementation therapy targeting riboflavin and biotin holds promise as a potential therapeutic avenue for alleviating Parkinson’s symptoms and slowing disease progression,” said lead researcher Hiroshi Nishiwaki, PhD, Division of Neurogenetics, Center for Neurological Diseases and Cancer, Nagoya University Graduate School of Medicine, in a news release. (Photo copyright: Nagoya University.)
Key Deficiencies in Parkinson’s Patients
According to the Parkinson’s Foundation, nearly one million people in the US are living with Parkinson’s and that number is expected to increase to 1.2 million by the year 2030. Approximately 90,000 new cases of Parkinson’s are diagnosed in the US each year, and more than 10 million people are living with the disease worldwide.
To perform their research, the Nagoya University team analyzed stool samples from 94 Parkinson’s patients from Japan, the US, Germany, China, and Taiwan. They also included 73 relatively healthy controls from Japan. They then used shotgun sequencing (a laboratory technique for determining the DNA sequence of an organism’s genome) to gain a better understanding of the microbial community and genetic makeup of each sample.
The scientists discovered a decrease in B2 and B7 vitamins in patients diagnosed with Parkinson’s. B vitamins promote the production and functions of short-chain fatty acids (SCFA) and polyamines.
“Supplementation of riboflavin and/or biotin is likely to be beneficial in a subset of Parkinson’s disease patients, in which gut dysbiosis plays pivotal roles,” the authors wrote in NPJ-Parkinson’s Disease.
The examination of fecal metabolites in Parkinson’s patients revealed a reduction in both components.
“Deficiencies in polyamines and SCFAs could lead to thinning of the intestinal mucus layer, increasing intestinal permeability, both of which have been observed in Parkinson’s,” said Hiroshi Nishiwaki, PhD, a professor at Nagoya University Graduate School of Medicine and a lead researcher for the study, in the news release.
“This higher permeability exposes nerves to toxins, contributing to abnormal aggregation of alpha-synuclein, activating the immune cells in the brain, and leading to long-term inflammation,” he added.
The team surmises that the weakened protective layer in the gut exposes the intestinal nervous system to more of the toxins people experience in everyday life, such as chemicals, pesticides, and herbicides. These types of toxins lead to the overproduction of alpha-synuclein fibrils. These molecules are aggregates of the α-synuclein protein that form into long, thread-like structures which are primarily found in the brains of individuals with neurodegenerative diseases like Parkinson’s.
Alpha-synuclein fibrils amass in dopamine-producing cells in the brain and increase the type of inflammation that leads to the debilitating motor skills and dementia symptoms of Parkinson’s.
Precision Medicine Analysis Suggested
Due to their research, the team proposes that high doses of vitamin B may help reduce the damage of toxins on the gut microbiome, help protect against neurodegenerative diseases like Parkinson’s, and aid in the creation of personalized therapy plans for patients.
“We could perform gut microbiota analysis on patients or conduct fecal metabolite analysis,” Nishiwaki noted. “Using these findings, we could identify individuals with specific deficiencies and administer oral riboflavin and biotin supplements to those with decreased levels, potentially creating an effective treatment.”
The results of the Nagoya University study illustrate the importance of a healthy gut microbiome in the prevention of disease. Altering the bacterial level in the gut may enable doctors to stave off the progression of neurodegenerative illnesses like Parkinson’s disease.
Artificial intelligence tools for radiology, clinical laboratory, and pathology diagnostics continue to advance and improve
Researchers in Germany have developed a fully automated, artificial intelligence (AI) tool that improves the diagnosis of prostate cancer. Developed by mediaire, a company that creates AI-based tools for radiologists, the software reduces clinical workloads and could be beneficial in counteracting issues associated with variability in magnetic resonance imaging (MRI) reporting. This is another example of AI’s growth in the clinical diagnostic industry, including clinical laboratory and pathology medicine.
The software, called mdprostate, has received the mandatory certification mark (CE or European Conformity) for products sold within the European Economic Area (EEA). It is now commercially available in those countries and was recently incorporated into the picture archiving and communications system (PACS) of some healthcare organizations and applied to a group of patients who had undergone a multiparametric prostate MRI (mpMRI).
The goal was to compare the overall performance of mdprostate against radiologists who executed the initial interpretations of the mpMRIs, according to Health Imaging.
“Mdprostate is intended to support radiologists by automating time-consuming processes and improving the objectivity of diagnosis through data quantification,” said Tonia Michaely, chief of staff at mediaire, in a news release.
“By providing objective assessments and standardizing lesion detection and classification, AI has the potential to augment radiologists’ performance throughout the PCa [prostate cancer] diagnostic pathway,” Nadine Bayerl, Dr. med., a radiologist with the Institute of Radiology at University Hospital Erlangen and corresponding author of the mediaire study, told Health Imaging. (Photo copyright: University Hospital Erlangen.)
Scoring Cancer Risk
To perform the comparison, a team of researchers applied the AI tool to 123 prostate MRI exams followed by systematic and targeted biopsies. The software was instructed to automatically segment the prostrate, calculate prostate volume, and classify lesions per the Prostate Imaging Reporting and Data System (PI-RADS).
PI-RADS, according to the America College of Radiology, is a reporting method that indicates how likely a lesion is to be clinically significant cancer on a score of one to five:
PI-RADS 1: very low (clinically significant cancer is highly unlikely to be present).
PI-RADS 2: low (clinically significant cancer is unlikely to be present).
PI-RADS 3: intermediate (the presence of clinically significant cancer is equivocal).
PI-RADS 4: high (clinically significant cancer is likely to be present).
PI-RADS 5: very high (clinically significant cancer is highly likely to be present).
For PI-RADS scores greater than two, mdprostate generated 100% sensitivity and dismissed all cancers for lesions that were below that threshold. For PI-RADS scores of four or higher, the AI tool yielded 85.5% sensitivity and specificity of 63.2% for clinically significant cancers.
Deep Learning in Diagnostic Pathway
“In practical terms, these results indicate that when a case falls below the PI-RADS ≥ 2 cutoff, clinicians can rule out malignancy with a high degree of confidence,” the authors explained in the European Journal of Radiology. “This capability is particularly valuable in clinical decision-making, as it allows for the safe avoidance of unnecessary biopsies or further invasive procedures in these patients.”
“Recent advances in deep learning algorithms, facilitated by larger labeled datasets, improved computing hardware, and refined training techniques, have led to several studies highlighting the diagnostic value of deep learning algorithms in prostate imaging,” radiologist Nadine Bayerl, Dr. med., Institute of Radiology at University Hospital Erlangen and corresponding author of the study, told Health Imaging.
The software “demonstrated high diagnostic performance in identifying and grading prostate lesions, with results comparable to those reported in meta-analyses of expert readers using PI-RADS,” the researchers noted in their published study.
“Its ability to standardize evaluations and potentially reduce variability underscores its potential as a valuable adjunct in the prostate cancer diagnostic pathway. The high accuracy of mdprostate, particularly in ruling out prostate cancers, highlights its clinical utility by reducing workload and enhancing patient outcomes,” they concluded.
AI in Clinical Laboratories and Pathology
Dark Daily has frequently covered AI’s expanding role in clinical laboratory testing and pathology diagnostics. At the recent Executive War College, a dozen sessions explored its growth in the industry. During one session, Sam Terese, CEO and president at Alverno Laboratories said, “AI is allowing us to drive our business. It is really resonating that we need to use AI in the future.”
Members who could not attend the 2025 Executive War College can order audio recordings of these valuable sessions by clicking here.
At least a dozen sessions at the 2025 Executive War College explored artificial intelligence use in clinical labs
Although not explicitly stated, it was clear at the 2025 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management conference that artificial intelligence must be a path forward for labs to control costs in an unfavorable economic environment.
Even though the technology is largely unproven in clinical lab settings, the potential of artificial intelligence (AI) in labs is enough reason for laboratory leaders to explore it further.
“AI is allowing us to drive our business,” said Sam Terese, CEO and president at Alverno Laboratories, during a general session at the Executive War College. “It is really resonating that we need to use AI in the future.”
Clinical laboratory leaders should constantly ask themselves whether there is an AI solution to a problem, advised Sam Terese (above), CEO and president at Alverno Laboratories. Terese spoke at the 2025 Executive War College. (Photo copyright: LabX.)
‘Not a Lot of Trust’ in AI from Patients
Terese acknowledged that patients do not yet feel comfortable with the technology. “When you throw AI and healthcare together, from the public’s perspective, there’s not a lot of trust,” he said.
That said, Alverno is committed to increased use of AI in clinical labs in 2025, including for:
Terese urged laboratory owners and executives to not underestimate how quickly AI adoption could spread within the clinical lab industry. Digital pathology took half a century to evolve into its current state, but “AI took five years. The timeline is moving rapidly,” he observed.
Don’t Move Blindly Forward with AI, Experts Warn
At least a dozen sessions at this week’s Executive War College addressed an aspect of AI in labs.
Lab leaders must advise their staff to use AI with systems or processes that can tolerate mistakes because AI will get things wrong, Cecchini added.
“I treat AI like an eager intern where you have to check everything it does,” he said.
Presenter Ankit Ranjan, PhD, founder of AI company Sample Healthcare, agreed with that sentiment. He suggested that clinical laboratories should consider AI as a copilot until its algorithms can prove to lab staff that conclusions or predictions are accurate. The long game for AI in labs is not to cut a few staff from the budget but instead act as a revenue driver.
“Inserting AI into end-to-end processes is what really addresses problems,” Ranjan said.
Watch for much more coverage about the state of AI in clinical laboratories in upcoming issues of The Dark Report. If you’re not a subscriber, it’s a great time to take a free trial of our business intelligence briefings.
Study is expected to result in new clinical laboratory test biomarkers based on proteins shown to be associated with specific diseases
In January, the UK Biobank announced the launch of the “world’s most comprehensive study” of the human proteome. The study focuses on proteins circulating throughout the human body. Researchers involved in this endeavor hope the project will transform disease detection and lead to clinical laboratory blood tests that help diagnosticians identify illnesses earlier than with conventional diagnostics.
Building on the results of a 2023 pilot project that studied “the effects of common genetic variation on proteins circulating in the blood and how these associations can contribute to disease,” according to a UK Biobank news release, the 2025 UK Biobank Pharma Proteomics Project (UKB-PPP) plans to analyze up to 5,400 proteins in 600,000 samples to explore how an individual’s protein levels changes over time and how those changes may influence the existence of diseases in mid-to-late life.
The specimens being analyzed include 500,000 samples extracted from UK Biobank participants and an additional 100,000 set of second samples taken from volunteers up to 15 years later.
“The data collected in the study will allow scientists around the world to conduct health-related research, exploring how lifestyle, environment, and genetics lead through proteins to some people developing particular diseases, while others do not,” Sir Rory Collins, FMedSci FRS, professor of medicine and epidemiology at University of Oxford and principal investigator and chief executive of the UK Biobank, told The Independent.
“That will allow us to identify who it is, who’s likely to develop disease well before they do, and we can then look at ways in which to prevent those conditions before they develop,” he added.
“It really might be possible to develop simple blood tests that can detect disease much earlier than currently exists,” said Naomi Allen, MSc, DPhil (above), chief scientist for UK Biobank and professor of epidemiology at Oxford Population Health, University of Oxford, in an interview with The Independent. “So, it adds a crucial piece in the jigsaw puzzle for scientists to figure out how disease develops and gives us firm clues on what we can do to prevent and treat it.” Clinical laboratories may soon have new test biomarkers that help identify proteins associated with specific diseases. (Photo copyright: UK Biobank.)
Developing New Protein-based Biomarkers
A proteome is the entire set of proteins expressed by an organism, cell, or tissue and the study of the proteome is known as proteomics. The proteome is an expression of an organism’s genome, but it can change over time between cell types and growth conditions.
The human genome contains approximately 20,000 genes and human cells have between 80,000 and 400,000 proteins with specific cells having their own proteomes. Proteomics can help ascertain how proteins function and interact with each other and assist in the identification of biomarkers for new drug discoveries and development.
“This is hugely valuable, because it will enable researchers to see how changes in protein levels within individuals over mid- to late-life influence the development of a whole range of different diseases,” said Naomi Allen, MSc, DPhil, chief scientist for UK Biobank and professor of epidemiology at the Oxford Population Health, University of Oxford, in The Independent. “It will accelerate research into the causes of disease and the development of new treatments that target specific proteins associated with those diseases.
“The pilot data is already showing that specific proteins are elevated in those who go on to develop many different types of cancers up to seven years before a clinical diagnosis is made. And for dementia, up to 10 years before clinical diagnosis is made,” she added.
According to the project’s website, the UK Biobank’s proteomics dataset will allow researchers to:
Examine proteomic and genetic data from half a million people to provide a more detailed picture of the biological processes involved in disease progression.
Examine how and why protein levels change over time to understand age-related changes in healthy individuals.
Utilize proteomic data together with imaging data to understand disease mechanisms.
“Data from the pilot study has shown that specific proteins are substantially elevated in individuals with autoimmune conditions like multiple sclerosis and Crohn’s disease and so on,” Allen noted. “So, you can see how a simple blood test could be used to complement existing diagnostic measures in order to diagnose these types of diseases more accurately and perhaps more quickly.”
An Invaluable Resource of Knowledge
The initial UK Biobank started in 2006 and, to date, has collected biological and medical data from more than half a million individuals. The subjects of the UKB-PPP study are between the ages of 40 and 69 and reside in the UK. The database is globally accessible to approved researchers and scientists engaging in research into various diseases.
The full dataset of the latest research is expected to be added to the UK Biobank Research Analysis Platform by the year 2027. The newest study is backed by a consortium of 14 pharmaceutical firms.
Allen also noted that evidence from the research has emphasized how some drugs may be useful in treating a variety of conditions.
“Some proteins that are known to be important for immunity are related to developing a range of psychiatric conditions like schizophrenia, depression, bipolar disorder and so on,” she told The Independent. “And given there are drugs already available that specifically target some of these proteins that are used for other conditions, it presents a real opportunity for repurposing those existing drugs for these neuropsychiatric conditions.”
This type of comprehensive study of the human proteome may have a great impact on patient diagnosis and treatment once the study is completed and the results are disclosed.
“The data will be invaluable. The value of the data is infinite,” Collins told The Independence.
Since it is clinical laboratories that will be engaged in testing for proteins that have become associated with specific diseases, this new UK Biobank study has the potential to expand knowledge about useful protein markers for both diagnosis and therapeutic solutions (prescription drugs).
