Ontario medical labs face critical staffing shortages, delaying test results. MLPAO urges $6M funding for student training to expand workforce capacity.
Medical laboratories across Ontario are facing persistent staffing shortages that are delaying test results and straining a workforce critical to clinical care and public health surveillance. In response, the Medical Laboratory Professionals Association of Ontario (MLPAO) is calling on the province to fund lab-based educator positions to expand student clinical placements and ease workforce pressures.
A recent MLPAO survey found that 68% of Ontario medical laboratories report shortages of medical laboratory technologists (MLTs). These professionals perform the diagnostic testing that supports physician decision-making, disease surveillance, and outbreak investigations across the healthcare system.
Staff Shortages Create Training Bottlenecks, Extend Test Turnaround Times
Staffing gaps are increasingly affecting laboratory operations. The association’s 2025 report indicates that shortages are contributing to longer turnaround times for diagnostic testing, including cancer diagnostics and sexually transmitted infection panels, delaying results for patients and clinicians.
Although laboratories remain understaffed, the MLPAO says the issue is not a lack of student interest. MLT students are required to complete clinical placements as part of their training, but many laboratories are unable to accept trainees because they lack sufficient staff to supervise and educate them.
Michelle Hoad, CEO of the MLPAO, told CBC Radio-Canada, “When a lab is short-staffed, they’re not able to take a student from that program.” She described the situation as a training bottleneck, noting that many laboratories maintain waitlists for clinical placements. (Photo credit: MLPAO)
The MLPAO is requesting $6 million over three years to fund educator positions within medical laboratories. The association argues that targeted funding would expand placement capacity, accelerate workforce entry for new graduates, and reduce reliance on overtime among existing staff.
Hoad said Ontario’s staffing challenges have been building for more than a decade and were intensified by the COVID-19 pandemic. “A lot of people were understaffed, overworked,” she said. “A lot of people that were eligible to take retirement, took early retirement.”
Lab Staffing Pressures Persist Across North America
Similar workforce pressures are being reported in the United States. The American Society for Clinical Pathology’s (ASCP) 2024 Vacancy Survey, reported on recently by Dark Daily, found that while vacancy rates in US medical laboratories have declined from pandemic-era highs, they remain well above pre-pandemic levels as retirements accelerate faster than the pipeline of newly trained professionals. Survey authors warned that workforce recovery has been “uneven and incomplete,” with sustained recruitment and retention challenges continuing to affect laboratory operations nationwide.
Ontario has made some investments aimed at strengthening the MLT pipeline. In 2024, the province added 700 new seats to MLT education programs, according to Ema Popovic, spokesperson for Health Minister Sylvia Jones. The government also expanded the Ontario Learn and Stay Grant to include MLT students, covering tuition and book costs in exchange for post-graduation service commitments in underserved areas.
The MLPAO welcomed those measures but said they have not resolved immediate operational challenges inside laboratories. Hoad noted that many technologists continue to work double shifts or delay vacation time to maintain testing volumes.
“It’s a very giving group,” Hoad said. “But that being said, we need to make sure that we don’t take advantage of them and we make sure that they’re properly staffed.”
Popovic did not respond to questions from CBC Radio-Canada about whether the Ministry of Health has received or is considering the MLPAO’s funding request for lab-based educators.
According to the MLPAO study, targeted funding could quickly expand training capacity. Among laboratories that currently do not accept students for clinical placements, 37% said they would be able to do so if a government-funded trainer were available.
For laboratory leaders, the association warns that failure to address training capacity risks prolonging workforce shortages, increasing burnout, and extending turnaround times—structural challenges mirrored across North America and with direct implications for diagnostic quality, patient care, and system resilience.
Investigators identified more than 100 proteins linked to inherited cancer risk and dozens of existing drugs that could be repurposed for cancer prevention.
Researchers at Vanderbilt University Medical Center (VUMC) and the University of Calgary have developed a new analytical framework that integrates genomic, proteomic, and electronic health record (EHR) data to uncover proteins linked to cancer risk and to identify existing drugs that may be repurposed for cancer prevention. The approach, described in a study published Dec. 2 in the American Journal of Human Genetics, represents a step toward translating large-scale genetic discoveries into actionable prevention strategies across multiple cancer types.
For clinical laboratory directors, the new framework offers a glimpse of how combined genomic, proteomic, and EHR datasets could soon reshape biomarker discovery and test development.
Genome-wide association studies (GWAS) have already identified hundreds of genetic variants associated with increased cancer risk, particularly for breast, colorectal, and prostate cancers, as well as dozens of variants linked to lung, pancreatic, and ovarian cancers.
However, most of these studies have focused on genetic variation and gene expression rather than the downstream proteins that ultimately drive biological function and are more directly targetable by drugs.
Xingyi Guo, PhD, associate professor of medicine in the Division of Epidemiology at VUMC and a co–senior author of the study said, “Previous research, including our work, has identified hundreds of putative cancer susceptibility genes that could be regulated by these risk variants; however, most dysregulated gene expression has not been thoroughly investigated at the protein level.” (Photo credit: VUMC)
Integrating GWAS and Proteomics to Identify Druggable Cancer Risk Proteins
To bridge that gap, the investigators combined large GWAS datasets for six major cancers—breast, colorectal, lung, ovarian, pancreatic, and prostate—with population-scale proteomics data drawn from more than 75,000 participants. The data came from multiple large cohorts, including the Atherosclerosis Risk in Communities (ARIC) study, deCODE genetics, and the UK Biobank Pharma Proteomics Project. The goal was to identify proteins whose circulating levels are associated with inherited cancer risk.
“To deepen the understanding of causal mechanisms and enhance drug discovery efforts, it is imperative to explore data from transcriptomic to proteomic studies,” said Zhijun Yin, PhD, MS, associate professor of biomedical informatics at VUMC and co–senior author, along with Quan Long, PhD, associate professor of biochemistry and molecular biology at the University of Calgary.
Using this integrated approach, the research team identified 365 proteins associated with cancer risk across the six cancer types studied. Through additional analyses to prioritize the most robust findings, they narrowed this list to 101 risk proteins. Notably, 74 of these proteins had not been previously reported as being linked to cancer susceptibility, highlighting the potential of proteomics to reveal novel biology that may be missed by gene-level analyses alone.
The researchers then evaluated whether these risk proteins could be therapeutically targeted. By systematically annotating the proteins using multiple pharmaceutical and drug-development databases, they assessed whether any were already the targets of approved drugs or agents in clinical testing. This step was designed to identify opportunities for drug repurposing—using existing medications for new preventive indications.
“Traditional drug discovery faces challenges of escalating costs, lengthy timelines, and high failure rates. Drug repurposing is a promising strategy to identify new applications for existing drugs with well-documented characteristics,” Guo said.
Among the 101 prioritized proteins, the investigators identified 36 that were considered druggable and potentially targetable by 404 drugs that are already approved or undergoing clinical trials. Of these, 19 proteins were targeted by drugs currently approved or in development for cancer treatment, suggesting a possible extension of oncology therapeutics into the prevention setting.
EHR-Based Analyses Suggest Reduced Cancer Risk with Certain Approved Drugs
To explore real-world relevance, the team leveraged more than 3.5 million de-identified EHRs from VUMC. Using this data, they conducted simulated clinical trials to examine associations between drug exposure and cancer risk. Several approved medications showed signals consistent with reduced cancer risk. One example highlighted in the study was acetazolamide, a diuretic, which was associated with a reduced risk of colorectal cancer in the EHR-based analyses.
“Our findings offer additional insights into therapeutic drugs targeting risk proteins for cancer prevention and intervention,” Yin said. “It is essential to evaluate the effects of the reported candidate drugs through both in vitro and in vivo assays in future research.”
EHRs are rich in diagnostic data, so there is a clear connection between the researchers’ drug discovery efforts and the information that clinical laboratory test results can provide.
The agency says shifting certain companion diagnostic tests from Class III to Class II could reduce regulatory burden, shorten review timelines, and encourage more manufacturers to enter the market.
The US Food and Drug Administration (FDA) has released a proposal that could significantly alter the regulatory pathway for oncology companion diagnostics, aiming to reduce barriers to market entry while maintaining assurances of safety and effectiveness.
In a notice published Nov. 25 in the Federal Register, the FDA said it plans to reclassify certain companion diagnostic assays from Class III medical devices to Class II devices. The proposal applies to specific nucleic acid–based in vitro diagnostic tests that are indicated for use with a corresponding FDA-approved oncology therapeutic product.
Under the current framework, Class III devices require premarket approval (PMA), the
FDA’s most rigorous and resource-intensive review process. Class II devices, by contrast, are typically cleared through the 510(k) premarket notification pathway, which is generally faster and less costly for manufacturers.
FDA Cites Maturing Technologies and Robust Safety Data to Support Reclassification
According to the agency, Class II devices are those for which “general controls by themselves are insufficient,” but for which “there is sufficient information to establish special controls to provide assurance of safety and effectiveness.” These special controls can include performance standards, postmarket surveillance, patient registries, and the development of guidelines and recommendations.
The proposed reclassification would cover in vitro diagnostic devices intended to detect specific genetic variants or other nucleic acid biomarkers in human clinical specimens. These tests rely on nucleic acid amplification technologies and/or sequencing technologies and are specifically tied to approved cancer therapies.
“Based upon the extensive [premarket approval] data available to FDA … published peer-reviewed literature studying the longstanding and well-understood technologies, and data available to the agency demonstrating a lack of significant postmarket safety signals with oncology therapeutic nucleic acid-based test systems, FDA believes there is sufficient information to reclassify these devices from Class III (premarket approval) into Class II (special controls),” the agency wrote.
The FDA emphasized that the proposal reflects both the maturity of the underlying technologies and the agency’s experience overseeing these products once they are on the market. Many companion diagnostics have been used clinically for years, generating substantial performance and safety data.
Reduced Regulatory Burden Could Accelerate Market Entry and Patient Access
If finalized, the change could have meaningful implications for diagnostic developers and patients alike. The FDA said the reclassification would “decrease regulatory burden on industry” by allowing manufacturers to pursue the “less burdensome” and “generally more cost-effective” 510(k) pathway rather than PMA.
“A 510(k) typically results in a shorter premarket review timeline compared to a PMA, which ultimately may provide more timely access of these types of devices to patients,” the agency said. “FDA expects that the reclassification of these devices would enable more manufacturers to develop these types of devices such that patients would benefit from increased access to appropriately safe and effective tests.”
The proposal comes as demand continues to grow for precision oncology tools that match patients with targeted therapies based on genetic and molecular profiles.
Companion diagnostics are often essential for determining whether a patient is eligible for a specific cancer drug, making regulatory timelines a critical factor in how quickly new therapies can reach the clinic.
The FDA stressed that the proposal does not eliminate oversight, but rather shifts it to a framework the agency believes is more proportionate to the risk profile of these tests. Special controls would still apply, and manufacturers would remain responsible for demonstrating that their devices are safe, effective, and substantially equivalent to legally marketed products.
The agency is seeking public input before finalizing the order. Comments on the proposal will be accepted through Jan. 26, 2026, giving stakeholders across the diagnostics, pharmaceutical, and healthcare sectors an opportunity to weigh in on how the change could affect innovation, competition, and patient care.
If adopted, the reclassification could mark one of the most consequential regulatory shifts for oncology companion diagnostics in years, potentially accelerating development timelines while expanding access to precision testing for cancer patients.
A new partnership between Intermountain Health and Testmate Health aims to bring rapid, lab-quality STI testing out of the central lab and into underserved communities, addressing persistent gaps in diagnosis and follow-up care.
Testmate Health and Intermountain Health have entered a strategic partnership and investment aimed at accelerating access to rapid, low-cost molecular testing for sexually transmitted infections (STIs) across the US.
For clinical laboratory leaders, the collaboration signals a growing push to move high-quality molecular diagnostics closer to patients, particularly those belonging to underserved and high-risk populations.
STIs continue to represent a major public health challenge, with an estimated 80% of chlamydia and gonorrhea infections going undiagnosed each year. Delays in testing and treatment are especially common among college students, LGBTQ+ populations, and patients served by rural or resource-limited clinics. The two organizations say their partnership is designed to close those gaps by making accurate, lab-quality testing available outside of traditional laboratory environments.
Bringing Molecular Diagnostics Beyond the Central Lab
Under the agreement, Intermountain Health will support the deployment of Testmate’s single-use, reader-free molecular tests for Chlamydia trachomatis and Neisseria gonorrhoeae. The tests are designed to deliver results in under 30 minutes and do not require central lab infrastructure. They can be used with urine or swab samples, offering flexibility for a range of care settings.
Karen Brownell, vice president of Lab Services at Intermountain Health said, “When these STI tests become FDA-approved in the US, Testmate’s innovative approach to molecular diagnostics will allow us to deliver lab-quality results outside traditional lab settings, directly impacting communities that have historically lacked access to timely testing.” (Photo credit: ContactOut)
Addressing Access, Turnaround Time, and Follow-Up
Testmate’s leadership emphasized that reducing barriers to testing is central to improving outcomes. Rapid turnaround times may help clinicians initiate treatment during the same visit, reducing loss to follow-up—a persistent issue in STI management.
The organizations say combining Testmate’s physician-developed diagnostics with Intermountain’s clinical infrastructure could also lower overall healthcare costs by enabling earlier detection and treatment.
For laboratory leaders, the collaboration highlights a broader trend toward decentralized molecular testing and point-of-care strategies that complement, rather than replace, core laboratory services. As health systems look to improve access and equity while managing costs, partnerships like this one may foreshadow how labs extend their impact beyond traditional walls.
The College of American Pathologists outlines standardized testing and typing methods aimed at reducing diagnostic variability and improving outcomes for patients with this rare but serious disease.
Clinical laboratory leaders facing growing demand for precision diagnostics now have new guidance to support one of pathology’s most complex diagnostic challenges. The College of American Pathologists (CAP) has published an evidence-based guideline designed to standardize laboratory approaches to diagnosing amyloidosis, a rare but life-threatening condition that often goes undetected until advanced stages.
Amyloidosis occurs when abnormal amyloid proteins accumulate in tissues and organs, leading to progressive damage. Because symptoms can mimic other diseases and diagnostic techniques vary widely between laboratories, delays and misclassification have long been a concern. CAP’s new guideline aims to reduce that variability by defining best practices for amyloid detection, fibril protein typing, and specimen evaluation.
The recommendations were developed by a multidisciplinary expert panel that reviewed more than 4,000 peer-reviewed studies. The result is a practical framework intended to help pathologists select the most accurate testing strategies while improving consistency across laboratories.
“This guideline is meant to improve the consistency and accuracy of laboratory diagnoses for systemic amyloidosis,” said Dylan V. Miller, MD, FCAP, guideline co-chair.
Dylan V. Miller, MD, FCAP, guideline co-chair noted, “Clearer standards will support more reliable diagnoses and ultimately better outcomes for patients.” (Photo credit: American Board of Pathology)
Best Practices for Amyloid Detection and Typing
Among the recommendations, the guideline reinforces Congo red staining as the diagnostic standard for detecting amyloid, while noting that fluorescence microscopy may enhance sensitivity in laboratories where it is available. Cytology, including fat pad aspirates, may be appropriate for initial screening due to its minimally invasive nature, but the guideline cautions that such samples are often insufficient for definitive subtyping.
For amyloid protein identification, the panel recommends mass spectrometry as the most accurate and sensitive method, particularly in complex or ambiguous cases. CAP emphasizes that precise protein typing is essential, as treatment options and prognoses vary significantly depending on amyloid subtype.
“Amyloid science is advancing rapidly, with new imaging, typing, and therapies reshaping the field,” said Billie Fyfe-Kirschner, MD, FCAP, guideline co-chair. “For pathologists, staying current is essential to ensure accurate diagnoses and guide patient care.”
Rising Need for Advanced Diagnostics and Long-Term Planning
From a management perspective, the guideline underscores the growing importance of advanced diagnostic capabilities, including access to validated staining methods and mass spectrometry. For lab leaders, this may influence decisions around test menus, referral relationships, and investment in specialized technologies.
CAP plans to reassess the guideline at least every five years, or sooner if major scientific or clinical advances occur. As amyloidosis awareness increases and targeted therapies expand, laboratory accuracy will play an increasingly central role in patient outcomes.
For clinical laboratory leaders and pathologists, the new guideline provides a roadmap for improving diagnostic confidence, standardizing workflows, and aligning laboratory practices with evolving expectations for precision medicine.
Vacancy rates in U.S. medical laboratories have declined since COVID-19 highs, but ASCP’s latest survey finds staffing levels remain well above pre-pandemic norms as retirements accelerate and recruitment challenges deepen.
The American Society for Clinical Pathology’s (ASCP) 2024 Vacancy Survey shows that staffing conditions inside U.S. medical laboratories have improved modestly since the peak of the COVID-19 pandemic but remain unresolved. Vacancy rates have declined compared with 2020–2022, yet they are still significantly higher than pre-pandemic levels, underscoring persistent recruitment and retention challenges that continue to affect laboratory operations nationwide.
Conducted every two years for the past 37 years, the ASCP Vacancy Survey is the most widely cited barometer of workforce conditions in laboratory medicine. The 2024 survey gathered responses from 1,027 laboratory leaders and human resources professionals, representing staffing data for 18,626 laboratory employees across the United States. Participants came from hospitals of all sizes, reference laboratories, academic medical centers, public health laboratories, blood centers, government facilities, and industry settings.
Retirements Accelerate as Workforce Recovery Remains Uneven
“Although vacancy rates are lower than those reported during the pandemic, laboratories are still operating under sustained workforce pressure,” the authors wrote. “The data suggest that recovery has been uneven and incomplete.”
Retirement trends emerged as a major concern. Ten of the 17 laboratory departments included in the survey reported rising retirement rates compared with previous cycles. As experienced professionals exit the workforce, laboratories face the dual challenge of replacing technical expertise while maintaining service levels amid already-elevated vacancy rates. Survey authors warned that retirements are accelerating faster than the pipeline of newly trained professionals entering the field.
AI Readiness and Workforce Gaps Vary Widely Across Laboratories
“Continued challenges in recruitment, combined with increasing retirements, pose a serious risk to long-term workforce stability,” the report stated. Without intervention, ASCP cautioned that shortages could deepen, particularly in highly specialized laboratory disciplines.
The survey also sheds light on how laboratory leaders are thinking about artificial intelligence. Respondents most frequently cited “adapting to emerging technologies” as their top concern related to AI adoption.
However, enthusiasm for AI’s potential to transform laboratory operations remains strong. Laboratories that had already implemented AI tools or provided AI training to staff reported significantly more optimism and confidence.
“Enthusiasm about AI was notably higher in laboratories that demonstrated AI proficiency among laboratory professionals and other experts,” the authors noted, suggesting that education and hands-on experience play a critical role in shaping perceptions of new technology.
Geographic and departmental trends further highlight workforce disparities. Blood bank and transfusion medicine departments accounted for the largest share of reported personnel, while flow cytometry represented the smallest. Regionally, the South Central Atlantic reported the highest participation, while the Central Southwest reported the lowest. The states with the most respondents were New York, Florida, Texas, Pennsylvania, and California.
Testing volumes varied widely. Nearly 40% of respondents reported performing more than 100,000 clinical pathology tests annually, while fewer than one in five laboratories reported anatomic pathology volumes exceeding 50,000 cases per year, reflecting the diverse operational scales represented in the data.
New Analytics Underscore Urgent Need for Laboratory Workforce Advocacy
The 2024 survey also marked a methodological shift. ASCP transitioned its analysis from traditional statistical software to Python-based data processing, allowing for more flexible analysis and integration of qualitative feedback. According to the authors, this change enhances reproducibility and aligns the survey with modern data-science practices increasingly used in healthcare analytics.
Ultimately, the report calls for urgent, coordinated action. ASCP emphasized the need for stronger advocacy for laboratory professionals, expanded credentialing pathways, and increased investment in education and training programs. “There is an urgent need for advocacy on behalf of laboratory professionals and an increase in the number of laboratory education and training programs,” the authors stated.
For laboratory executives and pathologists, the message is clear: while the worst of the pandemic staffing crisis may be over, structural workforce challenges remain unresolved and without sustained attention, they threaten the long-term resilience of the nation’s diagnostic infrastructure.
