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Clinical Laboratories and Pathology Groups

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In Canada, Shortage of Medical Laboratory Technologists and Radiology Technicians Continues to Delay Care

Insights learned from Canada’s experience may benefit clinical laboratories and anatomic pathology groups in the US as well

Canada continues to face a severe shortage of skilled healthcare professionals, especially among medical laboratory technologists (MLTs) and radiology technicians (RTs). According to the Canadian Society for Medical Laboratory Science (CSMLS), “In 2010, the Canadian Institute for Health Information (CIHI) identified that approximately half of all MLTs would be eligible to retire in 10 years, with the greatest impact felt in Canada’s rural and remote communities.” Today, “This staffing concern is currently affecting the professional community across all provinces and territories resulting in the decrease of workers, dramatically impacting organizations and their employees.”

One thing true of government-run healthcare programs is that they consistently underinvest in building new facilities, upgrading older facilities, and training/retaining enough physicians, nurses, and clinical laboratory/radiology workers. This is seen in the UK, Canada, New Zealand, and Australia, where varies combinations of facility, physician, and other healthcare professional shortages generate regular headlines about patient wait times—particularly for elective procedures—that may be six months to a year or more.

For example, officials at Pasqua Hospital in Regina, which serves patients in southern Saskatchewan, Canada, say diagnostics services may need to be shut down by the end of January as a result of “extended, chronic staffing shortages.”

“We’re barely struggling to keep up with urgent cases,” Christy Labreche, a nuclear medicine technologist told the Regina-Leader Post, which noted that people requesting non-urgent treatment may need to make appointments six to 12 weeks out.  

More than 1,500 Saskatchewan residents have been waiting for more than 90 days for computerized tomography (CT) scans, according to the Canadian Union of Public Employees (CUPE).

Pasqua Hospital leaders have asked province officials to take “immediate action,” but they feel their concerns are “falling on deaf ears,” the Leader Post reported.

Bashir Jalloh

“For over a decade, we have been sounding the alarm on behalf of our members that provide a vital service in the continuum of care,” said nuclear medicine technologist Bashir Jalloh (above) in a CUPE statement. Jalloh is President of CUPE 5430, Saskatchewan’s largest healthcare union which represents medical technologists in a variety of specialties. “Now, as waitlists grow, we are at risk of more disruptions of services and communities on bypass for critical care at a time when wait lists are as long as ever.” Clinical laboratory leaders in the US can gain valuable insights from the struggle with shortages taking place in Canada. (Photo copyright: Regina-Leader Post.)

MLT Needs Beyond Saskatchewan

The Canadian Alliance of Medical Laboratory Professionals Regulators (CAMLPR) is working with government authorities on the current and projected countrywide shortage of medical laboratory professionals.

In an article he penned for Today’s Clinical Lab, Adam Chrobak, BSc, MBA, MLT, Registrar/CEO of the College of Medical Laboratory Technologists of Manitoba, and Vice-Chair of the CAMLPR, noted that about 25,600 new medical laboratory jobs will open up by 2031. He pointed out, however, that only about 20,400 people (20% less than what is needed) are expected to pursue those lab jobs, according to employment data from Employment and Social Development Canada, an agency of the Canadian government.

Chrobak noted the following reasons for the deficit of MLTs in Canada:

  • An aging workforce: Many current lab scientists are over age 50, signaling a “potential shortage of medical laboratory technologists when seasoned professionals retire.”
  • Lack of awareness and representation: Other healthcare fields may benefit by being in the public spotlight, while “opportunities and rewards” of a medical lab technology career may not be apparent to job seekers.
  • Insufficient funding for educational programs: The need for laboratory professionals may supersede “scarce healthcare dollars that fund education programs.”
  • Barriers to registration: International applicants may be challenged in “recognition of existing field-of-practice competencies.”

Solutions: Improve Recruitment, Retention

To address the MLT shortages across Canada, CAMLPR aims to step up the registration of people interested in the medical laboratory profession through a project in partnership with the Canadian government called the Flexible Pathways to Registration for Medical Laboratory Technologists. The goal is to develop competency standards for entering the profession, ease the registration process, and increase the supply of qualified health professionals in Canada, according to a news release

This is not the first time Dark Daily has covered Canada’s lab worker shortages. 

In “Clinical Laboratories Suffer During the ‘Great Resignation’,” we reported how the so-called “Great Resignation” caused by the COVID-19 pandemic has had a severe impact on clinical laboratory staffs, creating shortages of pathologists as well as of medical technologists, medical laboratory technicians, and other lab scientists who are vital to clinical laboratories in both Canada and the US.

And in “Lab Staffing Shortages Reaching Dire Levels,” Dark Daily’s sister publication, The Dark Report, noted that CAP Today characterized the current lab staffing shortage as going “from simmer to rolling boil” and that demand for medical technologists and other certified laboratory scientists far exceeds the available supply. Consequently, many labs use overtime and temp workers to handle daily testing, a strategy that has led to staff burnout and a high turnover rate.

Shortages in other areas of Canadian healthcare are on the rise as well, which we covered in “Number of Unfilled Medical Residencies Increases in Alberta and Other Areas of Canada.” We reported that, according to the Angus Reid Institute, approximately half of all Canadians cannot find a doctor or get a timely appointment with their current doctor. And that, just like in many parts of America, certain provinces are experiencing severe medical staffing shortages that includes clinical laboratories and pathology groups.

Global Insights May Offer Ideas  

Dark Daily’s coverage of healthcare industry challenges in Canada, the US, and other countries is aimed at helping clinical laboratory managers and pathologists understand challenges faced by government-run healthcare systems, where there is constant pressure on the government to provide adequate funding. Capital is needed to modernize and expand hospitals and clinics. At the same time, there is need to expand training opportunities to solve the shortage of clinical laboratory scientists, medical laboratory and imaging technologists, doctors, nurses, and other medical professionals.

The insights gained by studying these healthcare systems may be of value to US-based hospitals and medical laboratories that face their own worker recruitment and retention issues. 

—Donna Marie Pocius

Related Information:

Pasqua Hospital Imaging Techs Say Shutdown Imminent Due to Staffing Shortfall

Critical Shortage of Radiological Technologists in Saskatchewan Risks Patient Care

Reduction of Lab and X-ray Services in La Ronge Due to Crisis in Staffing

Saskatchewan Announces $6.9 Billion Healthcare Budget for 2023-24

Solving the Shortage of Medical Laboratory Technologists in Canada

Flexible Pathways to Registration for Medical Laboratory Technologists

Clinical Laboratories Suffer During the ‘Great Resignation’

Lab Staffing Shortages Reaching Dire Levels

Number of Unfilled Medical Residencies Increases in Alberta and Other Areas of Canada

Electronic Health Records Vendors Now Adding Generative AI to Their Products

One goal of these new functions is to streamline physician workflows. However, these new EHRs may interface differently with clinical laboratory information systems

Artificial intelligence (AI) developers are making great contributions in clinical laboratory, pathology, radiology, and other areas of healthcare. Now, Electronic Health Record (EHR) developers are looking into ways to incorporate a new type of AI—called “Generative AI”—into their EHR products to assist physicians with time-consuming and repetitive administrative tasks and help them focus on patient-centered care. 

Generative AI uses complex algorithms and statistical models to learn patterns from collected data. It then generates new content, including text, images, and audio/video information.

According to the federal Government Accountability Office (GAO), generative AI “has potential applications across a wide range of fields, including education, government, medicine, and law” and that “a research hospital is piloting a generative AI program to create responses to patient questions and reduce the administrative workload of healthcare providers.”

Reducing the workload on doctors and other medical personnel is a key goal of the EHR developers.

Generative AI uses deep learning neural networks modeled after the human brain comprised of layers of connected nodes that process data. It employs two neural networks: a generator [generative network] which creates new content, and a discriminator [discriminative network] which evaluates the quality of that content.

The collected information is entered into the network where each individual node processes the data and passes it on to the next layer. The last layer in the process produces the final output. 

Many EHR companies are working toward adding generative AI into their platforms, including:

As our sister publication The Dark Report points out in its December 26 “Top 10 Biggest Lab Stories for 2023,” almost every product or service presented to a clinical laboratory or pathology group will soon include an AI-powered solution.

Girish Navani

“We believe that generative AI has the potential of being a personal assistant for every doctor, and that’s what we’re working on,” Girish Navani (above), co-founder and CEO of eClinicalWorks, told EHRIntelligence. “It could save hours. You capture the essence of the entire conversation without touching a keyboard. It is transformational in how it works and how well it presents the information back to the provider.” Clinical laboratory information systems may also benefit from connecting with generative AI-based EHRs. (Photo copyright: eClinicalWorks.)

Generative AI Can Help with Physician Burnout

One of the beneficial features of generative AI is that it has the ability to “listen” to a doctor’s conversation with a patient while recording it and then produce clinical notes. The physician can then review, edit, and approve those notes to enter into the patient’s EHR record, thus streamlining administrative workflows.

“The clinician or support team essentially has to take all of the data points that they’ve got in their head and turn that into a narrative human response,” Phil Lindemann, Vice President of Data and Analytics at Epic, told EHRIntelligence. “Generative AI can draft a response that the clinician can then review, make changes as necessary, and then send to the patient.”

By streamlining and reducing workloads, EHRs that incorporate generative AI may help reduce physician burnout, which has been increasing since the COVID-19 pandemic.

A recent study published in the Journal of the American Informatics Association (JAMIA) titled, “Association of Physician Burnout with Perceived EHR Work Stress and Potentially Actionable Factors,” examined physician burnout associated with EHR workload factors at UC San Diego Health System. The researchers found that nearly half of surveyed doctors reported “burnout symptoms” and an increase in stress levels due to EHR processes. 

“Language models have a huge potential in impacting almost every workflow,” Girish Navani, co-founder and CEO of eClinicalWorks, told EHRIntelligence. “Whether it’s reading information and summarizing it or creating the right type of contextual response, language models can help reduce cognitive load.”

Generative AI can also translate information into many different languages. 

“Health systems spend a lot of time trying to make patient education and different things available in certain languages, but they’ll never have every language possible,” Lindemann said. “This technology can take human language, translate it at any reading level in any language, and have it understandable.”

MEDITECH is working on a generative AI project to simplify clinical documentation with an emphasis on hospital discharge summaries that can be very laborious and time-consuming for clinicians.

“Providers are asked to go in and review previous notes and results and try to bring that all together,” Helen Waters, Executive Vice President and COO of MEDITECH, told EHRIntelligence. “Generative AI can help auto-populate the discharge note by bringing in the discrete information that would be most relevant to substantiate that narrative and enable time savings for those clinicians.”

Many Applications for Generative AI in Healthcare

According to technology consulting and solutions firm XenonStack, generative AI has many potential applications in healthcare including:

  • Medical simulation
  • Drug discovery
  • Medical chatbots
  • Medical imaging
  • Medical research
  • Patient care
  • Disease diagnosis
  • Personalized treatment plans

The technology is currently in its early stages and does present challenges, such as lack of interpretability, the need for large datasets and more transparency, and ethical concerns, all of which will need to be addressed. 

“We see it as a translation tool,” Lindemann told EHRIntelligence. “It’s not a panacea, but there’s going to be really valuable use cases, and the sooner the community can agree on that, the more useful the technology’s going to be.”

Since generative AI can be used to automate manual work processes, clinical laboratories and anatomic pathology groups should be alert to opportunities to interface their LISs with referring physicians’ EHRs. Such interfaces may enable the use of the generative AI functions to automate manual processes in both the doctors’ offices and the labs.

—JP Schlingman

Related Information:

How Four EHR Vendors Are Leveraging Generative AI in Clinical Workflows

NextGen Healthcare Unveils NextGen Ambient Assist, an AI Solution Designed to Boost Provider Efficiency

Science and Tech Spotlight: Generative Ai

What is Generative AI? Everything You Need to Know

Generative AI Could Revolutionize Health Care—But Not if Control is Ceded to Big Tech

Generative AI in Healthcare and Its Uses—Complete Guide

Association of Physician Burnout with Perceived EHR Work Stress and Potentially Actionable Factors

University of Oslo Research Study Suggests Most Cancer Screenings Do Not Prolong Lives

Norwegian researchers reviewed large clinical trials of six common cancer screenings, including clinical laboratory tests, but some experts question the findings

Cancer screenings are a critical tool for diagnosis and treatment. But how much do they actually extend the lives of patients? According to researchers at the University of Oslo in Norway, not by much. They recently conducted a review and meta-analysis of 18 long-term clinical trials, five of the six most commonly used types of cancer screening—including two clinical laboratory tests—and found that with few exceptions, the screenings did not significantly extend lifespans.

The 18 long-term clinical trials included in the study were randomized trials that collectively included a total of 2.1 million participants. Median follow-up periods of 10 to 15 years were used to gauge estimated lifetime gain and mortality.

The researchers published their findings in JAMA Internal Medicine titled, “Estimated Lifetime Gained with Cancer Screening Tests: A Meta-analysis of Randomized Clinical Trials.”

“The findings of this meta-analysis suggest that current evidence does not substantiate the claim that common cancer screening tests save lives by extending lifetime, except possibly for colorectal cancer screening with sigmoidoscopy,” the researchers wrote in their published paper.

The researchers noted, however, that their analysis does not suggest all screenings should be abandoned. They also acknowledged that some lives are saved by screenings.

“Without screening, these patients may have died of cancer because it would have been detected at a later, incurable stage,” the scientists wrote, MedPage Today reported. “Thus, these patients experience a gain in lifetime.”

Still, some independent experts questioned the validity of the findings.

Gastroenterologist Michael Bretthauer, MD, PhD (above), a professor at the University of Oslo in Norway led the research into cancer screenings. In their JAMA Internal Medicine paper, he and his team wrote, “The findings of this meta-analysis suggest that colorectal cancer screening with sigmoidoscopy may extend life by approximately three months; lifetime gain for other screening tests appears to be unlikely or uncertain.” How their findings might affect clinical laboratory and anatomic pathology screening for cancer remains to be seen. (Photo copyright: University of Oslo.)

Pros and Cons of Cancer Screening

The clinical trials, according to MedPage Today and Oncology Nursing News covered the following tests:

  • Mammography screening for breast cancer (two trials).
  • Prostate-specific antigen (PSA) testing for prostate cancer (four trials).
  • Computed tomography (CT) screening for lung cancer in smokers and former smokers (three trials).
  • Colonoscopy for colorectal cancer (one trial).
  • Sigmoidoscopy for colorectal cancer (four trials).
  • Fecal occult blood (FOB) testing for colorectal cancer (four trials).

As reported in these trials, “colorectal cancer screening with sigmoidoscopy prolonged lifetime by 110 days, while fecal testing and mammography screening did not prolong life,” the researchers wrote. “An extension of 37 days was noted for prostate cancer screening with prostate-specific antigen testing and 107 days with lung cancer screening using computed tomography, but estimates are uncertain.”

The American Cancer Society (ACS) recommends certain types of screening tests to detect cancers and pre-cancers before they can spread, thus improving the chances for survival.

The ACS advises screenings for breast cancer, colorectal cancer, and cervical cancer regardless of whether the individual is considered high risk. Lung cancer screenings are advised for people with a history of smoking. Men who are 45 to 50 or older should discuss the pros and cons of prostate cancer screening with their healthcare providers, the ACS states.

A CNN report about the University of Oslo study noted that the benefits and drawbacks of cancer screening have long been well known to doctors.

“Some positive screening results are false positives, which can lead to unnecessary anxiety as well as additional screening that can be expensive,” CNN reported. “Tests can also give a false negative and thus a false sense of security. Sometimes too, treatment can be unnecessary, resulting in a net harm rather than a net benefit, studies show.”

In their JAMA paper, the University of Oslo researchers wrote, “The critical question is whether the benefits for the few are sufficiently large to warrant the associated harms for many. It is entirely possible that multicancer detection blood tests do save lives and warrant the attendant costs and harms. But we will never know unless we ask,” CNN reported.

Hidden Impact on Cancer Mortality

ACS Chief Scientific Officer William Dahut, MD, told CNN that screenings may have an impact on cancer mortality in ways that might not be apparent from randomized trials. He noted that there’s been a decline in deaths from cervical cancer and prostate cancer since doctors began advising routine testing.

“Cancer screening was never really designed to increase longevity,” Dahut said. “Screenings are really designed to decrease premature deaths from cancer.” For example, “if a person’s life expectancy at birth was 80, a cancer screening may prevent their premature death at 65, but it wouldn’t necessarily mean they’d live to be 90 instead of the predicted 80,” CNN reported.

Dahut told CNN that fully assessing the impact of cancer screenings on life expectancy would require a clinical trial larger than those in the new study, and one that followed patients “for a very long time.”

Others Question the OSLO University Findings

Another expert who questioned the findings was Stephen W. Duffy, MSc, Professor of Cancer Screening at the Queen Mary University of London.

“From its title, one would have expected this paper to be based on analysis of individual lifetime data. However, it is not,” he wrote in a compilation of expert commentary from the UK’s Science Media Center. “The paper’s conclusions are based on arithmetic manipulation of relative rates of all-cause mortality in some of the screening trials. It is therefore difficult to give credence to the claim that screening largely does not extend expected lifetime.”

He also questioned the inclusion of one particular trial in the University of Oslo study—the Canadian National Breast Screening Study—“as there is now public domain evidence of subversion of the randomization in this trial,” he added.

Another expert, Leigh Jackson, PhD, of the University of Exeter in the UK, described the University of Oslo study as “methodologically sound with some limitations which the authors clearly state.”

But he observed that “the focus on 2.1 million individuals is slightly misleading. The study considered many different screening tests and 2.1 million was indeed the total number of included patients, however, no calculation included that many people.”

Jackson also characterized the length of follow-up as a limitation. “This may have limited the amount of data included and also not considering longer follow-up may tend to underestimate the effects of screening,” he said.

This published study—along with the range of credible criticisms offered by other scientists—demonstrates how analysis of huge volumes of data is making it possible to tease out useful new insights. Clinical laboratory managers and pathologists can expect to see other examples of researchers assembling large quantities of data across different areas of medicine. This huge pools of data will be analyzed to determine the effectiveness of many medical procedures that have been performed for years with a belief that they are helpful.

—Stephen Beale

Related Information:

Estimated Lifetime Gained with Cancer Screening Tests: A Meta-analysis of Randomized Clinical Trials

The Future of Cancer Screening—Guided without Conflicts of Interest

Most Cancer Screenings Don’t Extend Life, Study Finds, but Don’t Cancel That Appointment

Does Cancer Screening Actually Extend Lives?

Cancer Screening May Not Extend Patients’ Life Spans

Opinion: Cancer Screenings, Although Not Perfect, Remain Valuable Expert Reaction to Study Estimating Lifetime Gained with Cancer Screening Tests

Gen Z Set to Outnumber Baby Boomers and Will Be 75% of the Workforce within the Next Year, Report States

Zoomers’ unique approach to work and personal health could affect clinical laboratory workplaces, how staff is managed, and how they personally use lab tests

Would it surprise you to learn that Generation Z is poised to make up 75% of the workforce in the United States by 2025? This fact has many implications for clinical laboratories, genetic testing companies, and pathology practices. That’s because Zoomers, as they are called, will be dominant in two ways. First, they will make up the majority of the lab workforce. Second, they will be the majority of consumers and patients accessing medical laboratory testing services.

Zoomers (born 1997-2012) approach work and their own healthcare differently than previous generations. This is partly due to Zoomers being “digital natives who have little or no memory of the world as it existed before smartphones,” according to Pew Research.

Now, a recently released report by economic research firm Glassdoor on 2024 workplace trends states that Zoomers are about to overtake Baby Boomers (born 1946-1964) in the full-time workforce, and that the shift will “represent a pivotal moment of cultural change that US companies cannot ignore.” This includes clinical laboratories and pathology groups that employ them.

According to Glassdoor, Gen Z workers “care deeply about community connections, about having their voices heard in the workplace, about transparent and responsive leadership, and about diversity and inclusion.”

Zoomers bring unique requirements and attitudes to the workplace, but they may also be the fresh infusion of talent a shrinking healthcare workforce needs. It’s no secret that clinical laboratories and pathology groups are facing a labor shortage. An aging workforce combined with burnout from the COVID-19 pandemic have left the entire healthcare industry scrambling for workers.

“A recent survey by Elsevier Health predicts that up to 75% of healthcare workers will leave the profession by 2025. And a 2020 study conducted by the Association of American Medical Colleges (AAMC) projected a shortfall of up to 139,000 physicians by 2033,” Medscape reported.

In “Clinical Laboratories Suffer During the Great Resignation,” Dark Daily noted other causes that are behind the abundance of open positions, such as early retirements, graduating individuals experiencing more specialized training programs, and a shift in the way the current working generation views employment.

Thus, the current healthcare workplace should not only expect unique challenges as Zoomers take over, but also changes that come with adapting to a smaller, younger workforce.

Mark Beal

“[Gen Z] will pressure employers to establish a company’s purpose in a way that contributes to a better society and prioritize a company’s purpose along with profits,” Mark Beal (above), Assistant Professor of Professional Practice and Communication at Rutgers University, told Forbes. “Having succeeded at remote learning, they will influence an increased transition to hybrid and remote work as well as the four-day work week.” Clinical laboratories that understand Zoomers’ motivations will likely have more success integrating them into their workforce. (Photo copyright: Rutgers University.)

Generational Shift in Healthcare

Zoomers are the most technically-minded generation yet, especially considering they had to master remote learning during the COVID-19 pandemic. And, as we reported in “Despite Technical Challenges During COVID-19 Pandemic, Healthcare Networks Plan to Increase Investment in Telehealth Technologies,” healthcare systems that have increased their investment in telehealth technologies may benefit greatly from having these tech-savvy workers on board.

However, there could be unique challenges with a Zoomer workforce as well. According to Forbes, more than half of these new workers are willing to leave their jobs over “dissatisfaction with fulfillment (59%), professional development (57%), and providing value (53%).”

Although this may make some older workers scoff, each generation has entered the workforce with its own unique perspective based on personal values, and the workplace has shifted and changed to reflect the new workers. The same can be said of the clinical laboratory and pathology workforces.

The chart above shows the different generations as a proportion of the total population of the United States as of 2025. It dramatically illustrates why the largest number of working age individuals will be from Generation Z (aka, Zoomers). With their unique interests and traits, Zoomers will want their workplaces to be responsive in ways that are much different than the generations that preceded them. This will be equally true of how Gen Z accesses clinical laboratory testing services. (Graphic copyright: The Wall Street Journal.)

Gen Z Likes Automation

Another aspect to the increasing Zoomer workforce is Gen Z’s comfort with automated technology. Automation has always shifted how clinical laboratories work, and it can have great benefits for clinical pathology as well.

According to Today’s Clinical Lab, automation reduces error rates by more than 70% and reduces the time needed for each staff member per specimen by 10%.

However, the benefit does not come from automation replacing workers, rather that automated processes reduce repetitive work that takes time and attention away from workers. And, as noted, Gen Z workers tend to be extremely tech-savvy given the prevalence of technology in their lives.

Automation could fill gaps when it comes to labor shortages, not by replacing workers, but by helping adjust the workflow and avoiding worker burnout by automating tedious tasks. And Gen Z workers may be uniquely suited to engage with automated testing technologies.

Evolving Healthcare Workplaces

“The coming year will … represent a pivotal moment of cultural change that US companies cannot ignore as Gen Z workers—who care deeply about community connections, about having their voices heard in the workplace, about transparent and responsive leadership, and about diversity and inclusion—make up a rapidly growing share of the workforce,” the Glassdoor report stated, adding that 2024 “will test the robustness of workplace institutions,” The Hill reported.

Clinical laboratory managers and pathologists will be managing a multi-generational workforce, each with its own attributes and requirements. Thus, lab managers will need to reflect these difference in the management decisions they make and how they organize the laboratory workplace.

—Ashley Croce

Related Information:

Gen Z Set to Pass Baby Boomers in Workforce: Report

Glassdoor’s 2024 Workplace Trends

Physicians May Retire En Masse Soon. What Does That Mean for Medicine?

Clinical Laboratories Suffer During the Great Resignation

How Gen Z’s Impact on the Workplace Continues to Grow

Despite Technical Challenges During COVID-19 Pandemic, Healthcare Networks Plan to Increase Investment in Telehealth Technologies

Should Lab Staff Be Concerned about Automation?

FDA Grants Marketing Authorization to Diagnostic Tests for Chlamydia and Gonorrhea with At-Home Sample Collection

FDA says the move will make it easier to gain authorization for other clinical laboratory tests to utilize at-home collection kits

In another sign of how diagnostic testing is responding to changing consumer preferences, the US Food and Drug Administration (FDA) granted marketing authorization to LetsGetChecked for the company’s Simple 2 test for chlamydia and gonorrhea, which includes at-home collection of samples sent to the test developer’s clinical laboratories in the US and in Ireland.

This marks the first time the FDA has cleared a diagnostic test for either condition in which samples are collected at home. It’s also the first test with at-home sample collection to be authorized for any sexually transmitted infection (STI) other than HIV, the FDA said in a new release.

Simple 2 Home Collection Kits are available over the counter for anyone 18 or older. The kits employ Hologic’s Aptima collection devices, according to a company press release. A prepaid shipping label is also included to enable delivery to one of LetsGetChecked’s medical laboratories. The company performs the tests using the Hologic Aptima Combo 2 assay for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG).

Samples are collected through a vaginal swab or urine sample. “Results are delivered online in approximately 2-5 days with follow-up virtual consultations and treatment available if needed,” the company press release states.

Previously authorized tests for the conditions required sample collection at the point of care. The company also offers telehealth and online pharmacy services.

Jeff Shuren, MD, JD

“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” said Jeff Shuren, MD, JD (above), Director of the FDA’s Center for Devices and Radiological Health. “We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more healthcare into the home.” With this emphasis on at-home testing from the FDA, clinical laboratories in the US and Ireland will likely be processing more at-home collected samples. (Photo copyright: FDA.)

Simple 2 Process and Costs

Prior to collecting the sample, the user goes online to complete a questionnaire and activate the kit, the FDA news release notes.

LetsGetChecked, headquartered in New York City and Dublin, Ireland, says its US labs are CLIA– and CAP-certified. The company currently offers more than 30 at-home tests covering STIs, men’s health, women’s health, and COVID-19, at prices ranging from $89 to $249 per test.

The Simple 2 test costs $99, and is not covered by insurance, Verywell Health reported. Consumers can get discounts by subscribing to quarterly, semiannual, or annual tests.

New Regulatory Pathway

The FDA said it reviewed the test under its De Novo regulatory pathway, which is intended for “low- to moderate-risk devices of a new type,” according to the news release.

“Along with this De Novo authorization, the FDA is establishing special controls that define the requirements related to labeling and performance testing,” the agency stated. “When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type.”

This creates a new regulatory classification, the agency said, that will make it easier for similar devices to obtain marketing authorization.

Citing data from the federal Centers for Disease Control and Prevention (CDC), the FDA news release states that chlamydia and gonorrhea are the most common bacterial STIs in the US. The CDC estimates that there were 1.6 million cases of chlamydia and more than 700,000 cases of gonorrhea in 2021.

“Typically, both infections can be easily treated, but if left untreated, both infections can cause serious health complications for patients, including infertility,” the news release states. “Expanding the availability of STI testing can help patients get quicker results and access to the most appropriate treatment, ultimately helping to curb the rising rates of STIs.”

Experts Praise the FDA’s Authorization of the Lab Test

STI experts contacted by STAT said they welcomed the FDA’s move.

“There are many people who would like to be tested for STIs who may not know where to go or who have barriers to accessing medical care,” said Jodie Dionne, MD, Associate Professor of Medicine in the University of Alabama at Birmingham (UAB) Division of Infectious Diseases. “If we are going to do a better job of reaching more sexually active people for STIs … we need to be creative about how to get them tested and treated in a way that is highly effective and works for them.”

Family physician Alan Katz, MD, a professor at the University of Hawaii John A Burns School of Medicine, told STAT that the Hologic assay is also used by clinicians who treat people in remote locations to diagnose STIs and is regarded as being highly accurate.

“This option is exceptionally useful for individuals who live in rural areas or are geographically distanced from a clinic where STI testing can be done and there is no telehealth option available,” he told STAT.

With this latest move, the FDA is recognizing that it is time to give consumers more control over their healthcare. This is a signal to clinical laboratories that they should be developing their own strategies and offerings that serve consumers who want to order their own tests. Of course, many states still require a physician’s signature on lab test orders, but that is likely to change over time.

—Stephen Beale

Related Information:

FDA Grants Marketing Authorization of First Test for Chlamydia and Gonorrhea with At-Home Sample Collection

LetsGetChecked Receives US Food and Drug Administration (FDA) De Novo Authorization for At-Home Chlamydia and Gonorrhea Testing System

FDA Grants Approval for First Time to a Home Test for Chlamydia and Gonorrhea

FDA Authorizes First Home Test for Chlamydia and Gonorrhea

You Can Now Test for Chlamydia and Gonorrhea with an At-Home Kit FDA Approves Home Test for Chlamydia and Gonorrhea

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