The CDC’s Traveler-Based Genomic Surveillance program has surpassed one million voluntary participants, strengthening border-based genomic monitoring that helps clinical, molecular, and public health laboratories detect emerging variants—often days before they appear in community testing, hospital admissions, or public sequence databases.
The CDC announced that its Traveler-Based Genomic Surveillance (TGS) program has surpassed one million voluntary participants, marking a significant expansion of the nation’s upstream pathogen surveillance infrastructure. For clinical, molecular, and public health laboratories, the milestone highlights how border-based genomic monitoring is increasingly being used to identify emerging variants before they appear in community testing or hospital admissions.
Launched in 2021, TGS collects anonymous nasal swabs from arriving international travelers at select U.S. airports and complements this data with aircraft wastewater sampling. Sequencing and analysis are conducted through public-private partnerships with companies such as Ginkgo Biosecurity and XWell, allowing the CDC to generate actionable genomic data even when testing and sequencing capacity may be limited in other parts of the world. The approach reflects a shift toward proactive surveillance models that rely on rapid sequencing and data sharing rather than traditional case-based reporting alone.
Photo credit: CDC
In 2023, Dark Daily reported that San Francisco International Airport became the first US airport to partner with the CDC to test aircraft wastewater for SARS-CoV-2, sending samples to clinical laboratories for PCR testing and genomic sequencing as an early warning system for emerging variants.
Early Genomic Signals Give Laboratories Critical Lead Time on Emerging Variants
CDC officials say the program has already demonstrated practical value for laboratories. In one example, TGS identified new influenza H3N2 subclades and submitted sequences to public databases several days before they were detected elsewhere. For laboratory leaders, early awareness of emerging variants can inform assay validation, test menu planning, reagent procurement, and staffing decisions—particularly during respiratory virus season when demand can shift quickly.
The program also signals a growing role for nontraditional specimen sources in public health surveillance. In addition to traveler samples, CDC has analyzed more than 2,600 aircraft wastewater samples, reinforcing interest in wastewater-based epidemiology as a complementary tool for laboratories and public health agencies seeking earlier signals of emerging threats.
Participation in TGS remains voluntary and anonymous, but its scale suggests increasing acceptance of genomic surveillance as part of routine public health operations. For laboratories, the program offers a preview of how future surveillance systems may operate—integrating high-throughput sequencing, public-private partnerships, and unconventional sampling to deliver earlier warning of pathogens likely to impact diagnostic testing and clinical workflows nationwide.
The Theranos case continues to resonate in the lab community, reminding professionals of the importance of validation, transparency, and accountability.
Elizabeth Holmes, the former CEO of Theranos whose company became synonymous with laboratory fraud, has formally requested an early release from federal prison, renewing attention on one of the most consequential scandals in modern diagnostics.
According to filings with the US Department of Justice’s Office of the Pardon Attorney, Holmes has asked President Donald Trump to commute her sentence, a request that remains under review. If granted, the commutation could shorten her 11-year sentence by nearly six years.
Holmes was convicted in 2022 on multiple counts of wire fraud and conspiracy for misleading investors about Theranos’ blood-testing technology. She began serving her sentence in 2023 at a minimum-security federal prison camp in Bryan, Texas, and is currently scheduled for release on December 30, 2031. Both CNN and ABC News report that a federal appeals court last year upheld Holmes’ conviction, sentence, and a $452 million restitution order that she shares with former Theranos President Ramesh “Sunny” Balwani.
When Hype Outruns the Science
For clinical laboratory professionals, the case remains a stark reminder of the consequences when scientific validation is subordinated to hype.
Theranos claimed it could run hundreds of diagnostic tests using only a few drops of blood—assertions that, if true, would have dramatically reshaped laboratory workflows, patient access, and cost structures. Instead, investigations revealed that the company relied heavily on conventional analyzers while misrepresenting the performance and use of its proprietary technology.
Elizabeth Holmes is currently serving an 11-year sentence at the Federal Prison Camp in Bryan, Texas, for defrauding investors in her company, Theranos; she began her sentence in May 2023 and is eligible for release in December 2031, though she recently asked President Trump to commute her sentence for early release. (Photo credit: Wikimedia Commons.)
The appeals court ruling reinforced a critical principle for the diagnostics industry: financial success, celebrity boards, and political connections do not insulate companies from accountability when analytical validity and transparency are lacking. Judges rejected arguments that legal errors tainted the trial and upheld restitution based on the full amount investors lost, underscoring how severely courts view deception tied to medical testing claims.
As noted by The Dark Report during Holmes’ trial in 2021, testimony provided a series of lessons about how directors of a CLIA-certified labs can be held accountable for violations of federal and state laws.
Why Theranos Still Matters
Holmes’ renewed online visibility has also drawn renewed attention within the laboratory and diagnostics community. According to the CNN article, in recent months, posts have reappeared on her X account, including messages praising Trump’s healthcare affordability efforts and asserting her innocence. While the White House does not comment on pending clemency petitions, the optics of a high-profile fraud case intersecting with presidential pardons, particularly in a second Trump term marked by several controversial commutations, has revived debate about accountability in healthcare innovation.
For laboratories navigating patient expectations, evolving regulatory oversight, and the growth of direct-to-consumer testing, the Theranos case remains a relevant point of reference. The case is frequently cited by regulators and payers as justification for stricter oversight of laboratory-developed tests, more aggressive enforcement actions, and heightened expectations for data integrity.
Regardless of whether Holmes’ sentence is ultimately commuted, her request serves as a reminder that trust in laboratory medicine is hard-won and easily lost. For professionals, the case underscores the importance of scientific rigor, transparent validation, and strong governance in maintaining credibility and trust.
Federal health officials have updated cervical cancer screening guidelines to add HPV self-collection and require insurer coverage starting in 2027, a shift that could significantly impact testing volumes and workflows for clinical laboratories.
In a move that could significantly reshape testing volumes, workflows, and access strategies for clinical laboratories, the US Health Resources and Services Administration (HRSA) said in a press release that it has issued updated cervical cancer screening guidelines that formally introduce patient self-collection as a new screening option..
Under the updated guidance, high-risk human papillomavirus (hrHPV) testing—using either clinician-collected or patient-collected samples—is now the preferred screening method for average-risk women ages 30 to 65, while Pap testing remains an option. For women ages 21 to 29, Pap testing continues to be recommended.
The guideline also includes a major payer-facing provision that lab leaders should note. HRSA said most insurance plans will be required to cover not only the screening itself, but also any additional testing needed to complete the diagnostic process following an abnormal result. That coverage requirement takes effect January 1, 2027, reducing patient cost barriers that have historically limited follow-up testing volumes.
“These updates represent a significant step forward in cervical cancer screening and will improve screening rates and save lives,” HRSA Administrator Tom Engels said, adding that expanded options and reduced financial barriers allow more women to “take an active role in protecting their health and their future.” (Photo credit: HRSA)
HRSA Update Sets Stage for Insurer-Covered At-Home Testing Starting in 2027
An article from ABC News said the HRSA update aligns federal preventive guidance with recent FDA approvals that now allow both in-clinic and at-home self-collection for HPV testing. The January 2027 deadline for private insurers is expected to accelerate adoption of home-based and alternative specimen collection models.
“The addition of self-collection really empowers women to make this choice for themselves,” Ann Sheehy, MD, HRSA’s chief medical officer, told ABC News. “We do retain the option for Pap smear … this is just an additional choice for women.”
ABC News stated the preferred screening cadence for women ages 30 to 65 is now primary hrHPV testing every five years, whether the sample is collected by a clinician or by the patient. Alternative pathways—co-testing every five years or Pap testing every three years—remain in place if HPV testing is unavailable, preserving flexibility for labs at different stages of HPV test adoption.
HRSA officials emphasized that the goal is expanded access, not replacement of existing workflows. Engels told ABC News that self-collection could help reach women who have “been falling through the cracks,” adding, “By doing that, we’re going to save lives.”
ABC News noted the guidance also clarifies insurer obligations for follow-up diagnostics, including Pap testing, biopsy, and laboratory work, a move designed to prevent cost-sharing from disrupting care pathways. Separate HRSA rules now also require coverage of patient navigation services, which may further increase completed diagnostic testing after abnormal screens.
The American Cancer Society’s (ACS) December 2025 guideline update helped shape the federal move, ABC News said, citing evidence that self-collection improves access without sacrificing accuracy. “The combination of good evidence of the benefits of self-collection, which include increased access to cervical cancer screening, combined with FDA approval, led the ACS and HRSA to include self-collection,” said Robert Smith PhD, senior vice president of early cancer detection science at the ACS.
For lab professionals, HRSA’s announcement underscores a coming shift: broader HPV test demand, increased importance of validated self-collection workflows, and potentially higher follow-up testing volumes as cost barriers fall and screening gaps narrow.
New recommendations highlight the limited impact of routine urine drug testing in the ED while calling on laboratories to refine test menus, expand fentanyl screening, and improve clinician education to better support trauma care, behavioral health referrals, and evolving regulatory demands.
Emergency department (ED) drug testing remains a common but often misunderstood tool. New guidance from the Association for Diagnostics & Laboratory Medicine (ADLM) underscores the need for laboratories to take a more deliberate, evidence-based role in how testing is ordered, performed, and interpreted.
“Toxicology testing in the emergency department (ED) is generally performed to detect either drugs with recreational or misuse potential, or a broad array of toxic or poisonous compounds,” the guidance notes. This document focuses on the first category, historically referred to as “drugs of abuse” (DOA). While the term “abuse” “can imply a stigma, and is not a comprehensive term given the range of intended uses for these compounds,” it remains “a well-known historical term and description.”
Although resources exist for language describing individuals who use these substances, the document emphasizes that “there is no single preferred term to describe nonmedical use of these drugs.” Alternatives such as “recreational,” “controlled,” “illicit,” or “non-prescribed” drugs were considered, but “none of these terms fully captures the range of clinically relevant scenarios involving use of these compounds.” For this guidance, the term “drugs of misuse” is used “as a parallel to the historical DOA terminology,” while acknowledging that “future efforts should prioritize development of less-stigmatizing language that more accurately reflects the range of uses for these compounds.”
Urine Drug Testing
According to ADLM’s guidance, ED and laboratory staff should work collaboratively to establish objective protocols or clearly defined clinical rationales for ordering drug testing in both adult and pediatric patients, keeping in mind that urine drug testing (UDT) results rarely alter acute emergency management. Experts note that UDT is most often used in adults to assess trauma cases, altered mental status, or possible substance use contributing to psychiatric symptoms, yet routine testing has limited clinical value.
Studies indicate that UDT can prolong ED length of stay without significantly improving detection of substance use disorders beyond patient self-report. The American College of Emergency Physicians advises against routine drug screening in alert patients or delaying psychiatric evaluation while awaiting results, though some state regulations still require testing prior to involuntary commitment. These regulatory requirements place additional responsibility on laboratories to provide rapid reporting and maintain clear communication with receiving facilities.
Laboratories should educate ED and specialty providers regarding the limitations of UDT, including the potential for false positives and false negatives, and emphasize that detection of a substance may indicate past exposure rather than current impairment or clinical effect. Assessment of which drug testing methods best support pediatric care is particularly important, given the unique clinical considerations in this population.
Ongoing collaboration between ED and laboratory teams is essential to ensure that testing practices are aligned with clinical needs, patient populations, and available resources, while supporting downstream decisions such as resource allocation, behavioral health referrals, and patient safety.
Trauma Screening and Test Menus: Balancing Clinical Value, Regulation, and Evolving Drug Use
ADLM’s new guidance document also states that trauma care represents another frequent use case for ED drug testing, with the American College of Surgeons supporting substance use screening for all adult trauma patients. Yet laboratories are cautioned against overinterpretation. A positive drug test does not necessarily indicate impairment at the time of injury, and a negative result does not rule out intoxication. For lab professionals, this reinforces the importance of educating ED clinicians on test limitations, particularly detection windows and assay cross-reactivity.
Test menu design is a central operational issue. Strongly recommended assays for all EDs include opioids and opiates—specifically fentanyl and oxycodone—along with benzodiazepines, amphetamine-type stimulants, and cocaine. Despite decades of opioid-related morbidity and mortality, proficiency testing data show many laboratories have been slow to add fentanyl testing, which is not detected by traditional opiate immunoassays. Some states now mandate fentanyl inclusion, signaling a broader trend toward regulatory pressure as drug use patterns evolve. The guideline from ADLM recommends adding fentanyl to the test menu if the lab supports an ED.
Streamlining Panels and Specimens: Focusing ED Drug Testing on What Matters Most
At the same time, laboratories are encouraged through ADLM’s new guidance to remove assays with minimal clinical utility, such as propoxyphene and tricyclic antidepressants, which are prone to false positives and reflect outdated prescribing patterns. Testing for emerging drugs, toxic adulterants like xylazine, or novel psychoactive substances is generally not recommended due to rapidly shifting prevalence and limited impact on ED management.
The inclusion of tetrahydrocannabinol (THC) and its metabolites in ED drug testing remains debated, according to the guidance. Challenges include “evolving laws for drug scheduling, legalization or decriminalization of recreational use, and provisions for regulated medicinal use,” as well as increasing use of products containing other cannabinoids like CBD or delta-8-THC. A positive THC result can occur in patients using CBD products “due to the presence of THC in the preparation.” Overall, cannabinoid testing “provides limited clinically actionable information in the ED, except in specific populations such as pediatrics.”
Evidence shows that most studies “reported increased cannabinoid-related poisonings post-legalization, particularly in children.” THC use is also associated with conditions prompting ED visits, including “cannabinoid hyperemesis, psychosis, and trauma,” though providers should note that “THC metabolites can be detected in urine long after last use.” While some research has found negative outcomes such as “increased mortality or need for mechanical ventilation after trauma,” findings are inconsistent. Legalization appears to influence testing practices, as studies show “increasing rates of positivity as legalization progressed,” and drug test results may affect healthcare utilization, with one Canadian study reporting “fewer ED orders for imaging and laboratory testing, and increased use of observation units in THC screen-positive patients.”
The laboratory should “be aware of local and national regulations when designing panels” and provide flexible options, such as “separate drug panels with and without THC, and/or having THC as a standalone orderable test.”
Urine remains the preferred testing matrix due to availability and ease of use, though oral fluid testing offers potential advantages in witnessed collection and shorter detection windows. Blood-based testing is rarely useful for acute care outside of ethanol but retains value for epidemiological and forensic analysis. Specialized matrices, such as meconium or umbilical cord tissue, continue to play a role in newborn drug exposure assessment.
Overall, the guidance calls on laboratory leaders to move beyond passive test provision. Collaboration with EDs, regular review of test menus, provider education, and alignment with local drug trends are essential to ensuring drug testing supports patient care without adding unnecessary cost or complexity to emergency services.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
Nearly 90% of patients express interest in predictive lab tests, according to a new national survey—creating new opportunities and challenges for clinical laboratories navigating consumer demand, data fragmentation, and Medicare payment cuts.
A new national survey of 1,000 US patients points to a significant shift in how consumers view diagnostic testing—one that has direct implications for clinical laboratories navigating financial pressure, patient engagement, and changing care models.
The YouGov survey, commissioned by Siemens Healthineers, found that patients increasingly expect greater control over when and why lab tests are ordered. Among adults who have had lab work in the past two years, 93% said they expect their physician to order a test upon request. More than a third (37%) have asked for testing based on information from personal research, such as advice from family, friends, or online sources, and 17% have made requests influenced by social media content. For lab leaders, the data signal a move away from strictly symptom-driven, clinician-initiated testing toward more consumer-driven demand.
Patients Push for Predictive Testing, Testing Provider Authority
Interest in predictive and proactive testing is especially high. Nearly nine in 10 respondents (89%) said they are interested in lab tests that can help predict future health risks. That interest is already translating into action: 27% of patients reported pursuing blood testing from a trusted lab provider out of curiosity, without a physician’s recommendation. Another 22% said they had used at-home or self-tests—such as genetic, fertility, or hormone tests—out of curiosity. While self-testing remains less common than lab-based bloodwork, the trend underscores a growing appetite for earlier insights into health status.
Despite this increased autonomy, trust in clinicians remains strong, though not absolute. While 95% of respondents said they trust their provider to order the most appropriate tests, that confidence drops when a requested test is declined. Thirteen percent said they do not trust their doctor’s guidance if advised against a test they asked for, highlighting a delicate balance for providers and laboratories as patient satisfaction and evidence-based medicine increasingly intersect.
“It’s clear: patients want more control over their health and information about their health earlier,” said Michele Zwickl, head of laboratory solutions for Diagnostics at Siemens Healthineers North America. (Photo credit: Siemens Healthineers)
Data Gaps and Cost Pressures Challenge Labs
The survey also raises concerns about data fragmentation. Nearly half (49%) of patients who pursued testing out of curiosity said they did not share their results with a healthcare provider. Additionally, 20% reported they would not disclose to their doctor if they had followed medical advice from social media. For laboratories, this lack of transparency can complicate result interpretation, particularly when undisclosed supplements, diets, or alternative therapies may influence lab values.
Cost remains a major fault line. While many patients are willing to pay out of pocket for elective or curiosity-driven testing, affordability remains a barrier for essential care. Among respondents with unpaid medical bills, 52% said their debt included unpaid lab testing fees. Still, patients clearly value laboratory diagnostics: 98% said lab results provide meaningful health insights, and 94% reported they are more likely to follow a physician’s advice when it is supported by test results. Notably, patients are far less willing to delay bloodwork due to cost than other services—only 5% would postpone lab tests, compared with 22% who would delay imaging.
These expectations come as laboratories face mounting reimbursement pressure. Upcoming Medicare payment cuts of up to 15% for roughly 800 tests, combined with prior reductions under PAMA affecting 72% of commonly used assays, threaten to widen the gap between patient demand and lab capacity. Industry leaders warn that continued cuts could stifle innovation and limit access. Legislative efforts such as the RESULTS Act are gaining attention as potential mechanisms to stabilize reimbursement and preserve testing access.
For lab leaders, success will hinge on aligning growing patient demand for access and insight with operational and financial sustainability.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
AI-designed molecular sensors could enable ultra-early cancer detection through simple urine tests, signaling major shifts ahead for clinical laboratories and diagnostic workflows.
Artificial intelligence (AI) is beginning to reshape how cancer could be detected and that shift may carry significant implications for clinical laboratories. Researchers at MIT and Microsoft have developed an AI-driven system that designs molecular sensors capable of detecting cancer-linked enzyme activity at extremely early stages, potentially through a simple urine test that could one day be used at home.
The approach centers on proteases, enzymes that are often overactive in cancer and play a role in tumor growth and metastasis. For more than a decade, researchers have explored the idea of using protease activity as a biomarker. Now, AI is accelerating that work by improving the precision and scalability of sensor design.
“We’re focused on ultra-sensitive detection in diseases like the early stages of cancer, when the tumor burden is small, or early on in recurrence after surgery,” said Sangeeta Bhatia, professor of health sciences and technology at MIT and senior author of the study, published in Nature Communications.
From Trial-and-Error Peptides to AI-Optimized Protease Sensors
The researchers coat nanoparticles with short protein sequences, or peptides, that are engineered to be cleaved by specific proteases. When these nanoparticles travel through the body and encounter cancer-associated proteases, the peptides are cut and excreted in urine, where the signal can be detected using a simple paper strip. The pattern of signals could indicate not only the presence of cancer but also its type.
Earlier versions of this technology relied on trial-and-error methods to identify peptides,
often resulting in signals that were not specific to a single protease. While multiplexed peptide panels still produced diagnostic signatures in animal models, they lacked enzyme-level specificity—an important limitation for clinical translation.
The new AI system, called CleaveNet, is designed to overcome that challenge. Using a protein “language model,” CleaveNet can generate peptide sequences optimized for both efficiency and specificity against a target protease.
“If we know that a particular protease is really key to a certain cancer, and we can optimize the sensor to be highly sensitive and specific to that protease, then that gives us a great diagnostic signal,” said Ava Amini, a principal researcher at Microsoft Research. (Photo credit: Microsoft)
For lab leaders, the implications are significant. AI-designed sensors could reduce assay complexity, improve signal clarity, and lower development costs by narrowing the number of biomarkers needed for reliable detection. They also hint at a future where decentralized, at-home testing complements centralized laboratory diagnostics, shifting labs toward validation, data interpretation, and longitudinal disease monitoring.
Bhatia’s lab is now part of an Advanced Research Projects Agency for Health–funded effort to develop an at-home diagnostic capable of detecting up to 30 cancer types in early stages. Beyond diagnostics, the same AI-designed peptides could be incorporated into targeted therapeutics, releasing drugs only within tumor environments.
As AI-driven biomarker discovery advances, clinical laboratories may find themselves at the center of integrating these technologies into regulated testing pathways—reshaping early cancer detection and redefining the lab’s role in precision oncology.
