Association for Molecular Pathology gathering also served up an advocacy push for RESULTS Act passage.
The Association for Molecular Pathology (AMP) 2025 Annual Meeting brought together just over 3,000 attendees, and an estimated 420 of them—an impressive 14% of total attendance—sought out information about cell-free DNA (cfDNA) testing.
Walking through the convention center in Boston that hosted AMP 2025 earlier this month, it was hard to ignore the standing-room only crowd that jammed into a session room to hear more about cfDNA diagnostics.
Cell-free DNA comprises fragments of DNA circulating in the blood, either from dying cells or infection. For clinical laboratory professionals and pathologists, cfDNA testing sits at the forefront of innovation for detecting cancer.
“We want to find these cancers early,” said presenter Trevor Pugh, PhD, a senior scientist at Princess Margaret Cancer Centre in Toronto and director of genomics at the Ontario Institute for Cancer Research.
At the AMP 2025 Annual Meeting in Boston, a session about cfDNA testing attracted more than 400 attendees. (Photo credit: Scott Wallask)
Machine Learning Will Play a Role in cfDNA Research
Part of the effort to advance cfDNA testing will involve datasets and mining, Pugh said. For example, one of his graduate students is working with him on training a cfDNA foundation model, which could lead to the ability to reconstruct the complete cancer genome.
“This is a machine learning person’s dream,” Pugh explained.
Foundation models are artificial intelligence (AI) networks trained on large datasets. The models allow for more specialized applications, such as those that can analyze digital diagnostic images.
AMP Pushes for Passage of the RESULTS Act
Elsewhere at the AMP 2025 conference, the association provided an update on delayed lab test reimbursement cuts under the Protecting Access to Medicare Act of 2014 (PAMA). Organizers also addressed the latest attempt to reform PAMA, the proposed Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act.
As Dark Daily previously reported, momentum for the RESULTS Act is growing. Congress delayed upcoming PAMA cuts from Jan. 1, 2026, to Jan. 30, 2026, and there is hope during this brief extension that the RESULTS can get a vote or least greater support among lawmakers.
AMP endorses the RESULTS Act. “Congress needs to act,” said Jay Patel, MD, MBA, a member of AMP’s board of directors, during the PAMA update.
AMP has asked the Centers for Medicare and Medicaid Services to delay PAMA-related reporting requirements for labs until Congress can vote on the RESULTS Act, Patel added.
AI Featured in AMP 2025 Poster Sessions
More than 500 posters presentations occurred during AMP 2025. The space to house that many posters took up nearly half of the exhibition hall allotted to AMP.
The association noted several poster sessions that centered on how AI is improving diagnostic processes and accuracy within molecular pathology:
Researchers from The Hospital for Sick Children developed a web-based AI platform to integrate RNA sequencing into clinical workflows. The model achieved 93% diagnostic accuracy on subtypes covered by the platform.
Scientists at Soonchunhyang University created two AI models to classify samples. Both models showed strong accuracy.
Researchers at Wake Forest University School of Medicine used an AI-trained algorithm to analyze chromosomal abnormalities in GATA2 deficiency syndrome-related leukemia. The technology can quickly review hundreds of images, improving detection.
Members of our sibling brand, The Dark Report, can read more about the state of AI in clinical labs in our three-part series.
Roche’s SBX technology just helped Broad Clinical Labs set a GUINNESS WORLD RECORD for the fastest DNA sequencing ever.
According to a recent press release, for laboratory leaders tracking the next wave of genomic innovation, Roche’s latest advancements in sequencing technology could signal a major shift in research capabilities. At the 2025 American Society of Human Genetics (ASHG) Annual Meeting, the company unveiled new data and collaborations around its Sequencing by Expansion (SBX) platform—a system designed to deliver faster, longer, and more flexible reads.
This technology’s growing adoption by research institutions suggests it could soon reshape how labs approach complex multiomic analysis, precision oncology, and translational research.
World Record Broken
A highlight of the 2025 ASHG Annual Meeting was the GUINNESS WORLD RECORD achievement by Broad Clinical Labs, which used SBX to complete the fastest human genome sequencing to date, processing a sample from DNA extraction to final variant call file in under four hours. This record, achieved in collaboration with Roche Sequencing Solutions and Boston Children’s Hospital, surpassed the previous mark of just over five hours, demonstrating SBX’s ability to deliver rapid, high-quality results.
Mark Kokoris, inventor of the SBX chemistry and head of SBX Technology at Roche commented, “Breaking the GUINNESS WORLD RECORD is a remarkable achievement.” (Photo credit: Roche)
Roche also announced a new collaboration with the Wellcome Sanger Institute, which will conduct multi-project evaluations of SBX across applications such as Bulk RNA sequencing, where longer reads and higher throughput could uncover complex features like spliced isoforms. This partnership adds to a growing network of collaborations that include the Hartwig Medical Foundation, Genentech, The University of Tokyo, and the Broad Institute, reflecting widespread scientific interest in applying SBX across diverse research domains.
Further innovations include progress in methylation mapping using SBX-Duplex, which reads both DNA strands simultaneously, paired with TET-assisted pyridine borane sequencing (TAPS) from Watchmaker Genomics. This workflow enhances accuracy in detecting DNA methylation and holds promise for applications such as liquid biopsy-based cancer detection and novel biomarker discovery.
In another collaboration, researchers at the University of Tokyo leveraged SBX’s speed and flexibility for spatial sequencing of lung cancer tissue, achieving roughly 15 billion reads in just one hour. Roche also presented a target enrichment method using the SBX-Simplex workflow, which employs Unique Molecular Identifiers (UMIs) to generate highly accurate reads from minimal input, an approach that could be particularly valuable in oncology research requiring deep sequencing coverage.
For diagnostics and research laboratories, Roche’s progress with SBX represents more than a technical milestone, it points to new operational opportunities. Potentially faster turnaround times, deeper insights across multiple molecular layers, and improved workflows could help labs expand their research portfolios and strengthen partnerships in precision medicine. As sequencing continues to evolve from discovery to real-world application, forward-thinking lab leaders will want to keep an eye on how SBX’s scalability and speed might redefine their own genomic testing strategies.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
Seventy-five healthcare systems will benefit from NETEC’s gift, applications open.
Infectious disease management is getting a significant lift, on October 15, 2025 the National Emerging Special Pathogens Training and Education Center (NETEC) announced their $37.5m grant aimed at High-Consequence Infectious Diseases (HCID), a NETEC press release announced. Labs working with High-Consequence Pathogen and Pathology will find this increased area of focus relevant and may look to encourage their employers apply to become one of the 75 facilities that will receive the grant in the US.
The grant, funded by the Administration for Strategic Preparedness and Response (ASPR) is slated to provide or upgrade the chosen 75 healthcare facilities within the US with a Level 2 Special Pathogen Systems (NSPS) status, NETEC added.
Selected hospitals will “receive up to $500,000 each to improve critical infrastructure, conduct staff training, and obtain specialized equipment aligned with NSPS Level 2 requirements,” according to the American Hospital Association (AHA).
“Level 2 centered are the backbone of a resilient, skilled response to special pathogen threats,” Shelly Schwedhelm, MSN, RN, NEA-BC, Executive Director of NSPS told NETEC. (Photo credit: UNMC)
“This initiative accelerates our mission to develop top tier care closer to communities nationwide while strengthening protective measures for our healthcare workers,” Shelly Schwedhelm, executive director of NSPS, told NETEC. The grant comes by way of the NSPS Level 2 Special Pathogen Treatment and Network Development (STAND) Award.
Positive Focus & Raising the Bar
The union of emergency providers and public health partners is crucial for disease maintenance, and NETEC’s vision paired with the grant aims to “provide safe, high-quality care during HCID outbreaks,” the press release noted.
Facilities moving into Level 2 status set the tone for more specialized care. These facilities are “specialized treatment centers that care for patients throughout the duration of illness,” the NETEC noted. To help facilities achieve this status is significant, John Lowe, PhD, NETEC co-principal investigator at University of Nebraska Medical Center, told NETEC. “This grant provides indispensable support for facilities striving to meet NSPS standards—from infrastructure upgrades to advanced training—making readiness both realistic and sustainable,” he commented.
The Importance of HDICs
HDICs, defined by the NETEC as having “high death rates and intense illnesses with limited remedies available,” are important to tackle for reasons beyond the obvious, NETEC noted.
“HDICs pose a significant threat to domestic and global security…some can be used as bioterrorism agents,” the Centers for Disease Control (CDC) noted on their site. They added that many HDICs spread from animals to humans and are contagious.
Looking Ahead
“We have a vision of a future with fewer infections and less suffering caused by high-consequence pathogens and disabling illnesses of unexplained causes,” CDC stated.
How to Apply
Labs interested in applying for the grant must have their employer submit proposals by 12/2/2025. Eligible hospitals must be in the US and offer inpatient services, emergency departments and critical care ability, as well as have airborne infection isolation capability. Both federal facilities and those already at Level 1 are not eligible.
With the government shutdown now stretching beyond two weeks, clinical laboratory leaders are beginning to feel the pinch. Experts warn that delays in Medicare payments could soon create cash-flow crunches and backlog claims well into November.
As the federal government shutdown stretches into its third week, laboratory leaders are warning of mounting financial pressure and potential payment delays that could disrupt operations and strain cash flow.
While clinical laboratories can continue to submit Medicare and Medicaid claims, the timing of reimbursements could soon become unpredictable. According to William Baus, a laboratory revenue cycle expert, who shared a visual on LinkedIn, “a government shutdown doesn’t stop you from submitting claims—but it can affect when you get paid.”
In his Oct. 11 post, Baus outlined the timeline of expected payment impacts. If the shutdown lasts fewer than 14 days (at the time this piece was written, the government shutdown entered its 17th day), Medicare reimbursements would have remained unaffected, since the Centers for Medicare and Medicaid Services (CMS) typically maintains a 14-day payment floor. But if the shutdown continues beyond that window (which it now has), the system begins to back up quickly.
For a 20-day shutdown, for instance, “payments are delayed about five business days,” Baus noted. Claims submitted October 1 would not pay out until October 21, creating a rolling backlog into November. “Bottom line,” he wrote, “a short shutdown = no impact. A longer shutdown = temporary cash-flow crunch.”
For independent laboratories and pathology groups, especially those with thin operating margins, these delays could create significant short-term liquidity challenges. Many smaller or privately owned labs depend on steady reimbursement cycles to cover payroll, reagents, and lease expenses. Even a week-long delay in large Medicare payments can tighten available cash.
Hospital and health-system labs may have more flexibility, but even they face potential ripple effects if system-wide financial operations slow down or if supply purchases and contractor payments need to be deferred.
Medicaid and ACA Impacts
Ann Lambrix, vice president of revenue cycle management at Lighthouse Lab Services, echoed those concerns in a LinkedIn post of her own, warning that providers should brace for payment delays as the shutdown continues. “Healthcare providers should prepare for potential delays in claim processing and payments from Medicare,” Lambrix wrote. She noted that while “Medicaid [is] funded through Q1 of next year,” proposed cuts to enhanced subsidies “may threaten ACA coverage for individuals choosing to obtain health insurance through marketplace plans.” Lambrix thanked William Baus for his visual summary of the shutdown’s financial ripple effects, underscoring how even temporary disruptions in federal operations can upend reimbursement timelines across the healthcare sector.
Operational Preparedness
Lab leaders should prepare contingency plans, including:
Closely monitoring accounts receivable aging reports for delayed remittances.
Reviewing cash reserves and establishing short-term credit options if needed.
Communicating with vendors and staff about possible timing issues.
Staying in contact with billing vendors and clearinghouses to track any system backlogs.
“Claims can still be submitted and processed electronically,” Baus emphasized, “but the payment cycle may slip depending on how long the shutdown lasts.”
The Takeaway
In the short term, laboratories should brace for administrative slowdowns rather than outright denials. Yet as the shutdown continues, payment backlogs could cascade, especially for labs heavily reliant on Medicare revenue.
For now, experts recommend vigilance, conservative spending, and clear communication with financial teams. As the shutdown persists, even well-run labs could feel the pinch of delayed federal payments before November begins.
Genetic, toxicology, and even routine panels can create pitfalls for clinical laboratories.
Clinical laboratory professionals involved with diagnostic billing and coding should double check claims submitted for routine, toxicology, and genetic testing. Those three testing types are inviting private payer scrutiny and possibly worse.
“Between audits, denials, and government crackdowns, the risks are higher than ever,” said Jamel Giuma, founder and CEO at JTG Consulting Group, a laboratory IT consulting company.
Routine Panels Can Create Headaches for Lab Billing
Giuma explained that when it comes to diagnostic billing and coding, three testing areas often get oversized attention from commercial payers and the Medicare program:
Routine panels. Lab professionals should beware of overordering these types of tests, such as lipid or metabolic panels. High volumes have attracted payer audits, Giuma said. The US Department of Health and Human Services’ Office of Inspector General (OIG) has previously noted investigations where lipid panels were billed with direct low-density lipoprotein cholesterol tests to the same patient on the same day, which the OIG said was medically unnecessary.
Toxicology tests. Some drug testing panels to detect pain management or substance abuse have received scrutiny in 2025 for their ordering frequency.
Genetic testing. Expensive DNA and molecular assays may get an extra look from insurers, particularly services that get tagged with CPT code 81479. The code is a vague catch-all for unlisted molecular pathology procedures. The Dark Report has noted that using 81479 is essentially begging a payer to review the claim. Giuma added that this can be a tricky area for labs developing investigational tests.
Giuma said based on data he has reviewed, payers initially deny one in five clinical lab billing claims. “That is staggering,” he noted.
Jamel Giuma noted that one of every five clinical lab billing claims gets denied by payers, making the submission process a thorny one for laboratories. (Photo credit: JTG Consulting)
Investigators Eye Laboratory Test Fraud
Meanwhile, the OIG, auditors from the Centers for Medicare and Medicaid Services, and investigators from the US Department of Justice also scrutinize diagnostic billing and coding patterns.
“They’re looking for repeat offenders or systematic over-coding,” Giuma said.
Earlier this year, as part of the largest healthcare fraud bust in US history, dozens of clinical laboratories were charged with Medicare fraud for alleged telemedicine and genetic testing schemes where deceptive telemarketing campaigns targeted Medicare beneficiaries.
Even the most scrupulous labs should heed the indictments from the fraud investigations. All laboratories can run into trouble if they don’t stay on top of compliance efforts to detect fraud risks.
Documentation of billing code justifications and claims submissions are a solid first line of defense, Giuma said.
Also, labs should closely monitor prior authorization processes and understand associated rules from payers, he added.
Giuma’s advice emphasizes that diagnostic billing and coding is an area that clinical labs can unnecessarily get snarled in if providers are not careful about how and when they order tests.
A new analysis shows why models fall short in practice, how liability and equity issues slow adoption, and what lab leaders should consider as AI becomes a growing part of diagnostic workflows.
Artificial intelligence (AI) has made notable advances in medical imaging, but radiologists are not being displaced. For laboratory and diagnostic leaders, a recent analysis in Works in Progress highlights why AI has not replaced human expertise in radiology—and what this means for managing technology adoption in labs and hospitals.
In 2016, AI pioneer Geoffrey Hinton declared that “people should stop training radiologists now.” Since then, more than 700 FDA-cleared radiology AI models have entered the market, covering everything from stroke detection to lung cancer screening.
Companies such as Annalise.ai, Lunit, Aidoc, and Qure.ai offer tools that can identify dozens of diseases across modalities, reorder worklists, or generate structured draft reports. “On paper, radiology looks like the perfect target for automation,” the article noted, citing its reliance on digital images, pattern recognition, and quantitative benchmarks. Yet demand for radiologists has never been higher. In 2025, US residency programs offered a record 1,208 positions, and vacancy rates remain high as well.
Why Hasn’t AI Taken Over?
For leaders overseeing diagnostic services, three key elements are why AI has not replaced radiologists.
First, models struggle in real-world deployment. “Performance can drop by as much as 20 percentage points” when systems trained on narrow datasets are applied across different scanners, imaging protocols, or patient populations, the article explained. What works in a benchmark test may falter in a hospital with diverse workflows.
Second, liability and regulatory hurdles remain high. Assistive models that require physician review face fewer barriers, but autonomous systems must self-abort on poor image quality, identify unfamiliar equipment, and withstand rigorous scrutiny. Insurers have also drawn hard lines: one malpractice policy states that “coverage applies solely to interpretations reviewed and authenticated by a licensed physician; no indemnity is afforded for diagnoses generated autonomously by software.” Another bluntly imposes an “Absolute AI Exclusion.” For labs, this underscores the importance of risk management before deploying AI tools.
Photo credit: “Artificial Intelligence – Resembling Human Brain” by deepakiqlect is licensed under CC BY 2.0. To view a copy of this license, visit https://creativecommons.org/licenses/by/2.0/?ref=openverse.
Photo credit: “Cancer” by davis.steve32 is licensed under CC BY 2.0. To view a copy of this license, visit https://creativecommons.org/licenses/by/2.0/?ref=openverse.
Third, radiologists do much more than read scans. “Human radiologists spend a minority of their time on diagnostics and the majority on other activities, like talking to patients and fellow clinicians,” the commentary pointed out. Oversight of imaging protocols, interdisciplinary consultations, and patient communication all fall outside the reach of algorithms. Even as AI improves, demand for imaging may increase rather than decrease—a version of the Jevons paradox where greater efficiency leads to higher use. “The better the machines, the busier radiologists have become,” the article observed.
For laboratory leaders, the takeaway is not to fear replacement but to prepare for integration. AI tools are proving valuable in triaging urgent cases, flagging abnormalities, and drafting reports, but they remain narrow in scope—stroke, lung cancer, and breast lesions account for about 60% of models, yet represent only a fraction of total imaging work. As the article concluded, “Models can lift productivity, but their implementation depends on behavior, institutions and incentives.”
The challenge for labs is to create environments where AI augments human expertise rather than attempts to replace it. That means aligning technology adoption with clinical needs, providing training for staff, and working with insurers and regulators to ensure coverage and compliance.
For now, radiologists and the labs that support them are not going away. They are adapting, and AI will be a partner in that evolution.
