Teen researchers in suburban Atlanta may have cracked one of diagnostics’ toughest challenges: early Lyme detection. Their CRISPR test shows promise for identifying infection long before standard tools can.
For laboratory leaders navigating a rapidly shifting diagnostics landscape, a new signal of future innovation is emerging from an unexpected place: a suburban high school lab in Georgia. Lambert High School’s student researchers have engineered a CRISPR-based prototype that may detect Lyme disease days after infection—a potential breakthrough that, if validated, underscores how quickly synthetic biology is advancing and how early the next generation is entering the field.
Clinical laboratory professionals will be happy to note the promising work that the next generation of lab scientists has started.
The students, all part of Lambert High School’s elite synthetic biology team near Atlanta, set out to solve what senior Claire Lee called one of medicine’s most stubborn blind spots. “We’re doing something in our high school lab that could potentially have a huge impact for, like, millions of people,” she said. “This thing could help save lives.”
Using CRISPR, the powerful gene-editing tool, the teens developed a prototype test that appears capable of detecting Lyme disease just two days after infection, far earlier than the two-week window required by current assays. Although based on simulated blood serum and still in proof-of-concept stages, their findings were compelling enough to earn praise from scientists and secure a top-10 finish at the International Genetically Engineered Machine (iGEM) competition in Paris.
High School Genetic Engineers With an Ambitious Plan
Led by team captains Sean Lee and Avani Karthik, the CRISPR-based system targets a protein produced in the earliest moments of Lyme infection. “One of the biggest problems with Lyme is the lack of, like, being able to diagnose it,” Karthik said. They even met one patient who went “15 years without a diagnosis.”
Their idea was to use CRISPR to cut away extraneous DNA, revealing the protein so it could be detected with a rapid, kit-style test which is much like the COVID-19 diagnostic format. The students also explored using a different CRISPR system to block Lyme-causing bacteria as a potential therapeutic alternative to antibiotics.
But the team’s vision initially met resistance. Biotechnology teacher Kate Sharer said she warned students, “This project in particular, I told them: this is very high risk, high reward.” She admitted, “I couldn’t imagine any of this working,” though she supported their efforts. External experts were similarly cautious. As co-captain Sean Lee recalled,
“They did tell us in the beginning that this might not be so feasible because you’re trying to tackle such a big thing.”
A Top-Notch Lab Inside a Public School
Lambert’s program stands out nationally. Its county-funded, corporate-supported lab rivals those at universities, and the school draws families who relocate specifically for opportunities like iGEM. The team—entirely Asian-American this year and mostly children of immigrants—accepts roughly 10 members from about 100 applicants. Students pitch project ideas, test into the program, and endure what the team calls “insanely long hours.”
In September, after months of work, the students saw the data they had hoped for. Their system flagged early Lyme markers in as little as two days. It wasn’t human-blood–validated, but it was enough to push the project forward.
They spent the last weeks before the competition building a website, compiling results and pulling all-nighters to finalize their presentation.
Showdown in Paris
Arriving in Paris in late October, Lambert joined more than 400 teams from around the globe. Projects ranged from designing Mars-ready crops to developing enzymes to fight indoor mold. Janet Standeven, who oversees iGEM’s high school division and founded Lambert’s program, said she believes synthetic biology education is essential.
Janet Standeven noted that when federal funding for statewide programs was cut, she felt “absolutely devastated” and “angry,” though a judge has since temporarily restored the support. (Photo credit: Engineering Biology Research Consortium)
Stanford professor and iGEM co-founder Drew Endy warned that the U.S. risks losing ground in biotechnology as China accelerates national investment. “It’s urgent that leadership of the next generation of biotechnology has a strong presence in America,” he said. After seeing Lambert’s work, he added, “They appear to have developed a better diagnostic for Lyme disease than anything I’ve seen before.”
China’s Great Bay team ultimately won the grand prize. Lambert, nominated in five categories, earned the award for best software tool and finished among the top 10 high school teams worldwide—the only American team to do so.
For the Lambert students, the recognition mattered, but the mission mattered more. As Claire Lee put it, working on a test with the potential to save lives made every long night “worth it.”
A new open-source platform enhances the interpretability of CBC-based machine-learning models for sepsis prediction, offering improved transparency and clinical utility.
Laboratory leaders watching the evolution of clinical AI tools now have a new development to track: a fully open-source web application designed to make machine-learning–based sepsis prediction more interpretable and accessible.
A new study in The Journal of Applied Laboratory Medicine introduces SBC-SHAP, an interactive platform that visualizes how complete blood count (CBC) values influence individual patient risk scores.
The researchers say the tool was created to address a longstanding barrier: although CBC-based sepsis prediction models have shown promise, clinicians often struggle to understand why those models flag a patient as high-risk. As the study notes, prior lab approaches “do not explain how a specific value, such as white blood cell count, contributes to risk predictions.” Compounding the issue, some existing tools “required programming expertise that many clinicians lack.”
A New Way to View CBC-Based Sepsis Risk
Early sepsis detection remains a priority for hospitals, given that faster recognition leads to earlier intervention and improved outcomes. CBC parameters—white blood cells, red blood cells, hemoglobin, mean corpuscular volume, platelets—are routinely available and could serve as early indicators. Yet, the complexity of machine-learning (ML) algorithms has limited the usefulness of CBC-based prediction.
To tackle this issue, the research team developed a graph-based approach that incorporates time-series information into ML models, enabling predictions that account for trends rather than isolated values. The authors also evaluated whether adding specific ratios to a healthy reference baseline could bolster performance.
According to the paper, the new approach “increased the sensitivity at 80% specificity across all ML models from 78.2% to 82.9% on an internal dataset.” When tested on an external dataset from an independent tertiary-care center, sensitivity improved “from 65.4% to 73.4%.”
Interpretable Outputs Meant for Real Clinical Use
The web tool itself, dubbed SBC-SHAP, was built to interpret the ML predictions. It offers clinicians an interactive view showing how age, sex, and specific CBC values contribute to a risk score.
In an example, the authors highlight that the tool “breaks out patient age, sex, and hemoglobin values and how white blood cells, red blood cells, and mean corpuscular volume indicate patient risk.” Another example shows how clinicians can adjust or “correct prior values for a more accurate estimate of sepsis risk.”
Users can drill into individual CBC measurements, view explanations for each predicted risk value, and filter cases depending on whether particular test results are available. As the authors put it, the platform allows clinicians to “investigate how specific feature values contribute to predicted sepsis risks” and tailor the view for “diverse use cases.”
The tool is open-source and freely accessible, which researchers say is central to making
ML-enhanced diagnostics feasible for everyday practice.
For laboratory directors and diagnostic strategy teams, SBC-SHAP illustrates where AI in laboratory medicine is heading. Leaders are now seeing tools that not only predict, but also explain. As clinical teams grow increasingly cautious about “black-box” algorithms, transparent ML models that show their work may gain faster adoption.
This study also reinforces the ongoing importance of well-curated CBC data. By leveraging widely available hematology parameters, the authors demonstrate that meaningful AI-driven risk stratification does not always require advanced or specialty assays.
As labs plan their digital and clinical decision-support strategies, tools like SBC-SHAP signal a shift toward accessible, clinician-friendly ML applications. The researchers highlight the tool’s potential to support real-time decision-making, noting that it allows users to explore predictions and feature contributions without needing specialized programming skills.
Researchers from the London School of Hygiene and Tropical Medicine project that bloodstream infections caused by resistant bacteria will spike among adults aged 74 and older by 2030.
For laboratory leaders, new modeling research underscores a mounting challenge in infectious disease surveillance: the rise of drug-resistant bloodstream infections (BSIs) across Europe. According to a study published in PLOS Medicine, the rate of BSIs caused by antimicrobial-resistant bacteria is expected to climb sharply over the next five years—driven largely by an aging population.
A news release from CIRAP explained that researchers from the London School of Hygiene and Tropical Medicine analyzed data from more than 12 million blood cultures collected across 29 European countries between 2010 and 2019. Using those findings, they projected BSI rates through 2050 across 38 bacteria–antibiotic combinations, revealing what they called a “clear and consistent relationship” between infection rates, age, and sex. “With substantial sub- and national-variation, the consistency and clear shape of some relationships provide evidence for the inclusion of age and sex in any predictions of future AMR burden,” the authors wrote.
BSI Rates Expected to Increase
The study’s forecasts are sobering. By 2030, BSI rates are expected to increase dramatically among older adults (74 years and up), while stabilizing or even declining among younger groups. Incidence is also predicted to rise faster in men than in women across most bacterial species. Even under optimistic public health scenarios, the team found that achieving a 10% reduction in infections by 2030 would only be feasible for about two-thirds of bacteria–antibiotic pairings.
Senior study author Gwen Knight, PhD, noted, “Combining these factors with demographic and infection trends really highlighted how challenging it will be to reverse the steady rise in bloodstream infections across Europe.” (Photo credit: London School of Hygiene and Tropical Medicine)
For laboratories, the findings highlight the growing importance of targeted surveillance, age-stratified reporting, and real-time resistance data to guide treatment and public health interventions. As Knight and her colleagues conclude, intervention strategies must account for demographic shifts—because the burden of resistance, much like the population it affects, is rapidly aging.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
The IVD industry’s consolidation surge continues unabated, as advances in AI-driven genomics and a flurry of private equity deals reshape the sector for a data-driven decade ahead.
The in vitro diagnostics (IVD) market is entering a new phase of transformation, defined by innovation at the technology level and consolidation at the corporate level, as strategic buyers and investors reshape the competitive landscape.
In the latest move, QIAGEN announced plans to acquire Parse Biosciences for up to $280 million, a deal that will expand QIAGEN’s Sample technologies into the rapidly growing single-cell sequencing market. The acquisition gives QIAGEN access to Parse’s Evercode technology and massive-scale datasets—critical assets as AI-driven drug discovery and predictive biology become central to life sciences. The move underscores QIAGEN’s bet that future diagnostic and therapeutic breakthroughs will hinge on scalable, data-rich technologies rather than traditional instrument-based models.
The Dark Report noted recently in its ranking of top IVD companies that Qiagen was #10, a jump of three spots up from its prior ranking.
Alex Rosenberg, PhD, CEO and co-founder of Parse Biosciences added, “As our team joins QIAGEN, we want to accelerate that mission and extend the reach of our technology to more customers around the world. QIAGEN’s strong commitment to Sample technologies and its global infrastructure make it an ideal partner for our next stage of growth.” (Photo credit: Parse Biosciences)
M&A Highlights
The QIAGEN–Parse deal follows months of high-profile M&A activity reshaping the diagnostics sector.
In October, Hologic agreed to an $18.3 billion buyout by Blackstone and TPG, marking one of the largest private equity transactions in healthcare this year. The move takes a top-15 IVD and imaging company private, reflecting both investor confidence in the steady revenues of women’s health diagnostics and a broader pattern of capital consolidation in the space. Analysts suggest that private equity firms are seeking predictable, cash-generating platforms while large corporations increasingly focus on growth through specialization or divestment.
That strategy is on display at Siemens Healthineers, which is reportedly exploring a $7 billion divestiture of its diagnostics division to firms including Blackstone, KKR, and CVC Capital Partners. Such a sale would streamline Siemens’ portfolio around imaging and oncology technologies, while potentially placing one of the world’s largest IVD suppliers under new ownership.
Taken together, these deals highlight a defining moment for the diagnostics industry. Major corporations are repositioning their portfolios around data, AI, and precision medicine, while investors are moving aggressively to capture value in an industry that proved its resilience during and after the pandemic.
For laboratory leaders, the implications are clear: consolidation is accelerating, supply chains and vendor relationships may shift, and innovation is increasingly concentrated among fewer, but more powerful, players.
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This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
A new KFF poll shows Americans’ trust in the CDC has dropped to its lowest point since COVID-19, creating an opportunity for clinical laboratories to become trusted local voices in public health.
An article from CIDRAP recently reported that public trust in the Centers for Disease Control and Prevention (CDC) has fallen to its lowest level since the start of the COVID-19 pandemic, according to a KFF poll. The decline comes amid renewed misinformation about vaccines and autism and reflects growing skepticism toward the agency from both sides of the political spectrum.
The survey, conducted September 23–29 among more than 1,300 adults, found that only 18% of respondents have “a great deal” of trust in the CDC to provide reliable vaccine information, and 32% have “a fair amount.” That means just half of Americans have at least some trust in the CDC—down from 63% in 2023 and 57% as recently as mid-2025.
The findings followed remarks by President Donald Trump linking acetaminophen use in pregnancy to autism and calling for the measles, mumps, and rubella (MMR) vaccine to be split into three separate shots, claims that lack scientific evidence.
The erosion of trust, however, extends beyond political statements. While conservatives have long viewed the CDC with suspicion over perceived government overreach during COVID-19, many liberals now express frustration with what they see as inconsistency and political influence within the agency.
Higher Trust in Professional Medical Organizations
Interestingly, trust remains higher in professional medical organizations. Sixty-nine percent of parents polled said they trust the American Academy of Pediatrics, and 64% said they trust the American Medical Association.
“It’s encouraging, if far from ideal, that as trust in our nation’s scientific agencies crumbles, the public does trust the professional associations who have stepped forward,” said KFF president and CEO Drew Altman, PhD, in the organization’s press release. (Photo credit: KFF)
Support for Health and Human Services Secretary Robert F. Kennedy Jr. and his “Make America Health Again” (MAHA) movement was also low, with 62% disapproving of his handling of vaccine policy and 59% disapproving of his overall job performance.
What Labs Can Do
Amid this erosion of trust in federal health leadership, local clinical and public health laboratories may be poised to fill an emerging gap. Because labs are often the first to detect spikes in testing volume or positive results, they have a front-line view of disease trends—sometimes days or weeks before such patterns are visible nationally. If skepticism toward the CDC continues to grow, local labs could play an increasingly vital role in identifying and communicating outbreaks, especially during flu season or in the event of a new respiratory virus surge.
Beyond surveillance, labs can also help rebuild confidence in science by engaging their communities directly. Educational outreach, transparent data sharing, and collaboration with local healthcare providers can position laboratories as trusted sources of public health information, at a time when trust in national institutions is faltering.
As the CDC works to rebuild its credibility, laboratories across the country have a unique opportunity to step into the information void by translating data into understanding, and helping restore the link between diagnostics, public awareness, and trust in science.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
Drug-resistant infections are outpacing treatments, and WHO says laboratory leaders are vital to protecting antibiotic effectiveness.
For laboratory leaders, the latest WHO report on antimicrobial resistance (AMR) underscores just how critical diagnostic testing, data accuracy, and surveillance capacity have become in the global fight against drug-resistant infections. With one in six bacterial infections now resistant to antibiotics, labs stand on the front lines. They are responsible not only for detecting resistant strains but also for generating the data that informs national and international response strategies.
According to a press release, the “Global antibiotic resistance surveillance report 2025”warns that between 2018 and 2023, “antibiotic resistance rose in over 40% of the pathogen-antibiotic combinations monitored,” with “an average annual increase of 5–15%.”
Data from over 100 countries reported to the WHO Global Antimicrobial Resistance and Use Surveillance System (GLASS) show that growing resistance to essential antibiotics “poses a growing threat to global health.” For the first time, the report presents “resistance prevalence estimates across 22 antibiotics used to treat infections of the urinary and gastrointestinal tracts, the bloodstream and those used to treat gonorrhea.” It examines eight common bacterial pathogens—Acinetobacter spp., Escherichia coli, Klebsiella pneumoniae, Neisseria gonorrhoeae, non-typhoidal Salmonella spp., Shigella spp., Staphylococcus aureus, and Streptococcus pneumoniae—each linked to these major infections.
Resistance Highest in South-East Asia and Eastern Mediterranean
WHO found that the “risk of antibiotic resistance varies across the world.” The highest resistance levels are in the WHO South-East Asian and Eastern Mediterranean Regions, “where 1 in 3 reported infections were resistant.” In the African Region, “1 in 5 infections was resistant.”
According to the report, resistance “is also more common and worsening in places where health systems lack capacity to diagnose or treat bacterial pathogens.”
Tedros Adhanom Ghebreyesus, PhD, WHO director-general noted, “As countries strengthen their AMR surveillance systems, we must use antibiotics responsibly, and make sure everyone has access to the right medicines, quality-assured diagnostics, and vaccines. Our future also depends on strengthening systems to prevent, diagnose and treat infections and on innovating with next-generation antibiotics and rapid point-of-care molecular tests.” (Photo credit: WHO)
Gram-Negative Bacteria Present the Greatest Threat
The WHO report highlights that drug-resistant Gram-negative bacteria are becoming increasingly dangerous worldwide, with the heaviest impact seen in countries least equipped to manage the threat. Among these pathogens, E. coli and K. pneumoniae remain the most common causes of drug-resistant bloodstream infections—serious conditions that can lead to sepsis, organ failure, and death.
Globally, resistance to third-generation cephalosporins—the standard treatment for these infections—has climbed above 40% for E. coli and 55% for K. pneumoniae, and in parts of Africa, it exceeds 70%. Other essential antibiotics, including carbapenems and fluoroquinolones, are also losing effectiveness against E. coli, K. pneumoniae, Salmonella, and Acinetobacter. Once rare, carbapenem resistance is now emerging more frequently, reducing available treatment options and forcing reliance on last-resort antibiotics that are expensive, difficult to obtain, and often unavailable in low- and middle-income countries.
Progress in Surveillance but Major Gaps Remain
Despite these concerning trends, the report noted progress in global surveillance.
“Country participation in GLASS has increased over four-fold, from 25 countries in 2016 to 104 countries in 2023.” However, challenges persist: “48% of countries did not report data to GLASS in 2023,” and “about half of the reporting countries still lacked the systems to generate reliable data.” Many nations facing the highest burden of resistance “lacked the surveillance capacity to assess their antimicrobial resistance (AMR) situation.”
The report links its findings to the “political declaration on AMR adopted at the United Nations General Assembly in 2024,” which set global targets for combating antimicrobial resistance.
The declaration emphasizes strengthening health systems and working with a ‘One Health’ approach coordinating across human health, animal health, and environmental sectors.
WHO is calling on countries to strengthen laboratory systems and build reliable surveillance networks, particularly in underserved regions, to better guide treatment decisions and public health policies. The organization has set a goal for all nations to submit high-quality data on antimicrobial resistance and antibiotic use to the GLASS platform by 2030. Achieving this target will require coordinated efforts to improve data quality, expand geographic coverage, and enhance information sharing. WHO also encourages countries to implement comprehensive strategies to address antimicrobial resistance across all levels of healthcare and to ensure that treatment guidelines and essential medicines lists reflect local resistance trends.
The report is accompanied by expanded digital content available in the WHO’s GLASS dashboard, offering global and regional summaries, country profiles based on unadjusted surveillance coverage and AMR data, and detailed information on antimicrobial use.
With resistance trends worsening across regions, laboratory leaders are pivotal to turning the tide on AMR. Expanding diagnostic capabilities, improving data quality, and sharing timely resistance information will be key to shaping effective treatment guidelines and national policies. By advancing surveillance and stewardship from within the lab, clinical professionals can help preserve the power of antibiotics for future generations.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
