News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

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Infectious Disease Management Gets Big Boost With $37.5m Grant

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.

—Kristin Althea O’Connor

CDC Reinstates Hundreds of Federal Workers Who Were Axed in April

Some of the former employees worked for public health labs involved in tracking HIV, hepatitis, and STDs

More than 450 federal employees who were laid off from the Centers for Disease Control and Prevention (CDC) during the April cutbacks are being reinstated by the Department of Health and Human Services (HHS).

Nearly half (214) worked for the National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention (NCHHSTP), which includes specialized public health laboratories. Another 158 worked at the National Center for Environmental Health (NCEH). Others were employed by the Immediate Office of the Director and Global Health Center.

News of the reinstatements was first reported by Fox News and later confirmed by other media outlets.

“I think people are very tacitly hopeful that this means they can get their jobs back and continue serving in ways that they love,” NCEH health scientist Kathryn Sisler, MPH, told NPR. “But there has been so much instability and chaos that I think a lot of people would hesitate to say it is good news.”

Sisler, who works in NCEH’s Division of Environmental Health Science and Practice, received an email notification of her reinstatement on June 11, NPR reported.

She described the rehiring as “a step in the right direction,” but noted that she was among some employees in her division who had moved away from Atlanta, where the CDC is based. “Other employees had taken other jobs or had been offered them,” NPR reported.

In an interview with NPR, Scott Becker, CEO of the Association of Public Health Laboratories, admitted to being “happily flabbergasted” to hear about HHS’ offer to rehire the former federal workers. (Photo copyright: Association of Public Health Laboratories.)

Impact at Critical Labs

As part of the cutbacks, the CDC shut down two laboratories at NCHHSTP that were involved in tracking viral hepatitis and sexually transmitted diseases, even as “some of those scientists performed disease surveillance work unlike any other labs in the world,” NPR noted.

NCHHSTP staffers told NPR that some of the division’s labs were damaged due to the “lapse in activity” during April and May, and that “some disease outbreaks had not been properly tracked.” One employee said that, due to the cutbacks, the division’s hepatitis lab was unable to assist health workers tracking a hepatitis C outbreak in Florida. The CDC employees requested anonymity.

“It’s great to see that there is some recognition of the importance of these workers and that being in those positions is critical for the public health of America and that they are being reinstated in order to continue their important work,” Carmen J. Marsit, PhD, of Emory University’s Rollins School of Public Health, told NPR. He added, however, that “there’s still a lot of people that are not being reinstated.”

HIV Not Being Tracked

KFF Health News reported that the reinstatements included “dozens of HIV experts” who were laid off in April. At the time, they were working on a national survey conducted among 30,000 individuals at risk of acquiring the infection. They haven’t been told if the project will resume.

Public health departments use data from the survey as part of their efforts to reduce spread of the disease, KFF Health News stated, noting that “preventing HIV is far cheaper than treating people once they’re infected.”

Since the cutbacks, many HIV researchers at CDC have obtained new jobs or moved. Some employees “called the reinstatements perplexing because the notices don’t say what they’ll be doing when they return and for how long,” KFF Health News reported.

“I am concerned about how many of the people have already moved on or might move on and the trauma that they really must be going through with the uncertainty,” Scott Becker, CEO of the Association of Public Health Laboratories, told NPR about the reinstatements at CDC. “But all in all, it’s good news and I’ll take it.”

Programs Cut by Mistake

The reinstatements amount to approximately 20% of the 2,400 CDC employees laid off following the March 27 announcement of a massive restructuring at HHS.

HHS secretary Robert F. Kennedy, Jr. told ABC News in early April that some programs had been cut by mistake. “Personnel that should not have been cut were cut—we’re reinstating them, and that was always the plan,” he said.

In May, Kennedy said that 328 employees of the CDC’s National Institute for Occupational Safety and Health (NIOSH) would be reinstated, NPR reported, following “considerable pushback from labor organizations and congressional lawmakers.”

NPR and other outlets had earlier reported that HHS planned to cut at least 900 NIOSH employees, amounting to 90% of the institute’s workforce.          

—Stephen Beale

Sudden Shutdown of CLIAC Leaves the Clinical Lab Community without an Important Voice

Industry commenters point to a void since the federal government shuttered the Clinical Laboratory Improvement Advisory Committee

For readers wondering what has happened to the Clinical Laboratory Improvement Advisory Committee (CLIAC), the bottom line is the panel has been terminated, causing a significant void for the lab industry at the federal level.

Dark Daily’s sibling brands, including The Dark Report, G2 Intelligence, and Today’s Clinical Lab, have been exploring various aspects about the demise of CLIAC.

The Centers for Disease Control and Prevention (CDC) confirmed to G2 Intelligence that CLIAC was terminated as of March 31, citing an executive order from President Donald Trump intended to reduce federal advisory committees. The decision blindsided even those closest to CLIAC. Incoming committee chairman Jordan Laser, MD, revealed in an email to colleagues that he did not have more insight into CLIAC’s demise beyond media reports, G2 reported.

Since its founding in 1992, CLIAC has played an influential—though non-regulatory—role in shaping updates to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The committee brought together pathologists, lab directors, public health leaders, and representatives from federal agencies such as the CDC, Centers for Medicare and Medicaid Services, and Food and Drug Administration.

The federal government’s decision to eliminate CLIAC “risks stalling progress in laboratory medicine, which could ultimately hinder efforts to improve patient care,” CAP President Donald Karcher, MD, FCAP, told The Dark Report. (Photo copyright: College of American Pathologists.)

‘Critical Venue’ for Labs Has Been Eliminated

Industry groups are sounding alarms about what comes next. In an interview with Today’s Clinical Lab, Anthony Killeen, MD, PhD, president of the Association for Diagnostics and Laboratory Medicine (ADLM), said CLIAC was an important forum for medical lab scientists to discuss CLIA.

“[CLIAC] served as a critical venue for working through current problems with the rule and also for expert input on how new technologies—such as next-generation sequencing, digital pathology, and artificial intelligence-assisted diagnostics—should be assessed and integrated under CLIA,” Killeen said.

ADLM has formally urged Department of Health and Human Services Secretary Robert F. Kennedy, Jr. to reverse the CLIAC decision. In a May letter, the association emphasized that CLIAC’s work was funded entirely through user fees paid by clinical laboratories rather than taxpayer dollars—a point many in the lab industry say underscores CLIAC’s value.

CAP President Wonders about Future Communication Gaps

The Dark Report noted that the disbanding of CLIAC may cost labs time in certain cases, a commodity that few diagnostic settings have in abundance.

“The absence of this advisory body may lead to gaps in communication and slower response times in addressing [industry] challenges,” Donald Karcher, MD, FCAP, president of the College of American Pathologists (CAP), told The Dark Report.

The absence of CLIAC raises uncertainty for clinical labs because federal agencies have lost a prime source to gather specialized input on complex scientific and operational issues facing the lab industry. Dark Daily’s partner brands will continue to track this matter closely. If you’re not a subscriber, you can check out The Dark Report’s insider coverage with a 14-day free trial.        

—Scott Wallask

FDA Tussles with Medical Community over COVID-19 Vaccines

The federal agency says it will mandate randomized, controlled clinical trials for vaccination of younger, healthy individuals

It’s been a confusing past few weeks in terms of what the general public’s access to COVID-19 vaccinations will be like in the future.

Public health experts have been verbally jousting with the federal Department of Health and Human Services (HHS) about moves its health officials made recently regarding the vaccines. This could put clinical laboratories on the front lines to help determine whether COVID cases—particularly severe ones—eventually rise as a result.

Food and Drug Administration (FDA) commissioner Martin A. Makary, MD, MPH, and Vinay Prasad, MD, MPH, who leads the agency’s vaccine oversight, announced on May 20 that the agency will require randomized, controlled clinical trials before approving COVID vaccines for healthy individuals under age 65.

They revealed the new policy in a commentary in the New England Journal of Medicine (NEJM) and later discussed it on YouTube.

“While all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe COVID-19, the United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months,” Makary and Prasad wrote in NEJM.

Under the new framework, they noted, the agency expects that it will continue to approve vaccines for adults over 65 as well as younger people with health conditions that put them at high risk of severe outcomes from COVID-19.

The range of diseases is “vast, including obesity and even mental health conditions such as depression,” they wrote. “Estimates suggest that 100 million to 200 million Americans will have access to vaccines in this manner.”

In their NEJM commentary, FDA commissioner Martin Makary, MD (left), and Vinay Prasad, MD (right), wrote, “Moving forward, the FDA will adopt the following COVID-19 vaccination regulatory framework: On the basis of immunogenicity—proof that a vaccine can generate antibody titers in people.” (Photo copyrights: Wikimedia Commons.)

Former CDC APIC Member Pushes Back

The announcement drew criticism from public health and medical experts.

“The FDA guidance presented in the NEJM was not released in the Federal Register, did not invite comment, and provided only a general outline for COVID-19 vaccine licensure,” wrote pediatrician and vaccinologist Kathryn M. Edwards, MD, in a commentary for STAT. Edwards is a former member of the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), which makes vaccine recommendations to the agency.

On June 9, in an opinion piece for The Wall Street Journal, HHS Secretary Robert F. Kennedy Jr. announced that he’s removing all 17 current members of ACIP.

“The FDA mandate is to ensure safe and effective vaccines based on the clinical studies performed, but not to develop specific recommendations for their use,” Edwards added. “Providing recommendations on vaccine use for the civilian population is the mandate of the ACIP.”

Edwards contended that extensive data is already available on the safety and effectiveness of COVID-19 vaccines. She stated that “there is no precedent for mandating continued placebo-controlled randomized clinical trials for vaccines that have already been licensed.”

New Policy Announcement Raises Questions

The New York Times notes that many questions remain about the specifics of the new policy and how broadly the vaccines will be available.

A likely scenario, the paper reported, is that health insurers will play a role as “gatekeepers by demanding medical documentation of an underlying condition before agreeing to cover the cost.” Without insurance coverage, people would likely pay approximately $140 per shot out of pocket.

This stands in contrast to European countries, where outreach campaigns target specific populations based on public health recommendations. according to Forbes. However, “in virtually all instances, COVID-19 vaccines can be gotten free of charge across Europe regardless of health or age status,” the article notes.

In their NEJM commentary, Prasad and Makary noted that adoption of the annual COVID-19 booster shot is already low. The CDC reported that 23% of Americans 18 and older received vaccinations in the 2024-2025 season, up slightly from 21.6% in 2023-2024.

Kennedy Steps In

On May 27, Kennedy announced in a video on X that the CDC would remove the COVID-19 vaccine from the recommended immunization schedule for healthy children and healthy pregnant women. Previously, the CDC recommended the vaccine for everyone ages six months and older.

Kennedy was joined in the video by Makary and National Institutes of Health director Jay Bhattacharya MD, PhD.

However, CDC staffers were “blindsided” by the announcement, NPR reported, citing an agency official who requested anonymity.

“Hours after the post on X, CDC staffers received a directive from Secretary Kennedy—dated May 19, but sent May 27—rescinding the department’s 2022 acceptance of the CDC’s recommendations for the use of COVID shots in children and during pregnancy,” NPR reported.

It now appears that HHS has at least partially backtracked on Kennedy’s announcement.

The CDC’s immunization schedule now states that vaccination of healthy children should be a matter of “shared clinical decision-making” between the doctor and parent or patient.

“After confusing, mixed messages from leaders at HHS earlier this week, we are relieved to see today that the CDC updated its schedules for child and adolescent immunizations to allow families to maintain the choice to immunize their children against COVID in consultation with their doctor,” American Academy of Pediatrics president Susan Kressly said in a statement from the organization.

In a June 1 interview with the CBS News program “Face the Nation,” Makary confirmed that the recommendation to vaccinate “should be with the patient and their doctor.”

However, he also criticized ACIP as a “kangaroo court where they just rubber stamp every single vaccine put in front of them.”

—Stephen Beale

New Washington University Medicine Blood Test Can Diagnose and Track Progression of Alzheimer’s Disease with 92% Accuracy

Findings could lead to clinical laboratory test that can both track the disease’s progress and differentiate it from other forms of dementia

Another research study is underway with hopes of developing a new clinical laboratory blood test to aid in the diagnoses of Alzheimer’s disease and help physicians determine the best course of treatment.

Researchers at the Washington University School of Medicine (WashU Medicine) in St. Louis and Lund University in Sweden have developed a test that focuses on the presence of a protein called MTBR-tau243, a potential biomarker for Alzheimer’s. This protein is correlated to the toxic accumulation of tau aggregates in the brain and the severity of the disease, according to a WashU new release.

Cognitive tests and brain imaging are also used to diagnose the condition. However, existing tests cannot establish how far the illness has progressed. Alzheimer’s therapies are most effective during early stages, so determining the disease’s progression could provide insights doctors need to devise the most effective treatment protocols.

Washington University’s new blood test that identifies MTBR-tau243 protein could lead to new biomarkers as well as identifying how far the disease has progressed.

“This blood test clearly identifies Alzheimer’s tau tangles [aka, neurofibrillary tangles], which is our best biomarker measure of Alzheimer’s symptoms and dementia,” said co-senior author Randall J. Bateman, MD, professor of neurology at WashU Medicine in the WashU news release.

The researchers published their findings in the journal Nature Medicine titled, “Plasma MTBR-tau243 Biomarker Identifies Tau Tangle Pathology in Alzheimer’s Disease.”

“In clinical practice right now, we don’t have easy or accessible measures of Alzheimer’s tangles and dementia, and so a tangle blood test like this can provide a much better indication if the symptoms are due to Alzheimer’s and may also help doctors decide which treatments are best for their patients,” said co-senior author Randall J. Bateman, MD, professor of neurology at WashU Medicine in a news release. (Photo copyright: Washington University.)

Distinguishing between Alzheimer’s and Other Forms of Dementia

The WashU scientists tested the study participants in three main stages of Alzheimer’s disease:

  • Pre-symptomatic.
  • Early stage with mild cognitive impairment.
  • Late symptomatic where patients have been diagnosed with dementia.

The study included 108 volunteers from WashU Medicine’s Charles F. and Joanne Knight Alzheimer Disease Research Center and a subset of 55 people from the Swedish BioFINDER-2 study, which aims to discover key mechanisms in neurodegenerative disorders. The scientists validated their results in an independent dataset involving 739 other people in the BioFINDER-2 database. The patient information used for the study represented patients from all stages of the disease.

Alzheimer’s disease involves an accumulation of amyloid into plaques in the brain, which turn into tangles of tau proteins. When these tau tangles become detectable, cognitive symptoms begin to occur and exacerbate as the tangles spread. WashU’s new blood test can detect MTBR-tau243 levels in the brain with 92% accuracy. The researchers also found that MTBR-tau243 levels were significantly higher for patients in the mild cognitive stage of the disease and up to 200 times higher for patients in the late symptomatic stage.

“MTBR-tau243 is a chipped (off) piece of the protein in Alzheimer’s tau tangles,” Bateman told Medical News Today. “The blood test measures this piece of tau tangles in the blood as a measure of how many tangles are in the brain.”

The researchers also found that MTBR-tau243 levels were normal in patients with cognitive symptoms attributed to diseases other than Alzheimer’s, suggesting that the test can distinguish Alzheimer’s dementia from other forms of dementia.

“We’re about to enter the era of personalized medicine for Alzheimer’s disease,” said Kanta Horie, PhD, voluntary research associate professor of neurology at WashU Medicine, co-first and co-corresponding author of the study, in the WashU news release.

More Studies Needed

According to the Centers for Disease Control and Prevention (CDC), Alzheimer’s is the seventh leading causes of death in the US. It accounted for more than 120,000 deaths in 2022, the most recent year for available data. With the ebbing of COVID-19, which was ranked number four in 2022, Alzheimer’s is assumed to be higher in ranking for more recent years.

Washington University’s new blood test for Alzheimer’s may one day enable earlier detection of the disease, earlier intervention, and slowing of its advancement. However, more research and trials are needed into the theory behind this study.

“The initial study needs to be replicated in larger and more diverse populations to confirm its accuracy and reliability across different demographics, ethnicities, and stages of the disease,” Manisha Parulekar, MD, director of the Division of Geriatrics at Hackensack University Medical Center, told Medical News Today. “This includes testing individuals with other neurological conditions to ensure specificity. Clear and standardized protocols for blood collection, processing, and analysis must be established to ensure consistent and reproducible results across different laboratories and healthcare settings.”

—JP Schlingman

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