Cytovale’s IntelliSep test helped the hospital improve compliance with the controversial SEP-1 measure.
In a study of patients at an emergency department in Baton Rouge, Louisiana, a blood test designed for early detection of sepsis helped improve compliance with a controversial quality measure implemented by the US Centers for Medicare & Medicaid Services (CMS). Researchers reported that a treatment protocol incorporating Cytovale’s IntelliSep test increased the rate of compliance with SEP-1, a set of interventions recommended by CMS when a patient presents severe sepsis or septic shock. The study, which was funded by Cytovale, was presented Sept. 7 at the American College of Emergency Physicians (ACEP) conference in Salt Lake City.
“The clinical criteria for the SEP-1 bundle may not always support identification of sepsis early on in the progression of disease,” said principal investigator Hollis O’Neal, MD, medical director of research at Our Lady of the Lake Regional Medical Center (OLOLRMC) in Baton Rouge, in a press release from Cytovale. “IntelliSep, which looks at a patient’s immune dysregulation, has been a critical tool in helping us quickly identify patients during our initial ED triage who otherwise didn’t ‘look septic.’”
The Mayo Clinic describes sepsis as “a serious condition in which the body responds improperly to an infection. The infection-fighting processes turn on the body, causing the organs to work poorly.” In some cases, it can lead to septic shock, “a dramatic drop in blood pressure that can damage the lungs, kidneys, liver and other organs.”
A 2021 task force report from the Infectious Diseases Society of America (IDSA) stated that sepsis “is a major cause of hospital death in the United States and is associated with over 850,000 annual emergency department visits.” The report also noted “the inherent difficulty in establishing the early diagnosis of sepsis.”
The IntelliSep Test
Cytovale, based in South San Francisco, Calif., was founded in 2013 by researchers from MIT and UCLA. IntelliSep is the company’s primary product.
As explained by the company, sepsis causes changes to the biomechanics of white blood cells, including size, deformability, and how they behave in fluid.
In the IntelliSep test, a blood sample is loaded into a device that uses hydrodynamic forces, high-resolution imaging, and computer vision to analyze the cells’ biomechanical properties. The system then presents a numeric value that indicates if the patient has a low, medium, or high probability of sepsis.
The test takes about eight minutes to run. Cytovale cautions that “all results should be interpreted in the context of the other clinical observations and laboratory test results for the patient.”
The US Food and Drug Administration issued a 510(k) clearance for the test in January 2023.
Study Shows Improved Compliance
The OLOLRMC study, which involved 598 patients, measured the impact of the test on compliance the SEP-1 guidelines, which specify how sepsis cases should be managed. For example, clinicians are advised to measure a patient’s lactate level, collect a blood culture, and administer antibiotics within three hours after presentation of severe sepsis.
In July 2024, when the hospital began incorporating the test, SEP-1 compliance was 61.2%, the authors reported. By September, the rate had increased to 72.5%, and it increased to 78.9% by December. They reported that the test enabled clinicians to begin treating the highest-risk patients earlier, increasing the number who received recommended interventions within the three-hour window mandated by SEP-1.
“Unlike traditional approaches that may boost SEP-1 performance by broadly applying sepsis protocols—often at the cost of overtreatment—we integrated IntelliSep into our sepsis protocol to gain objective insight into sepsis risk, ensuring we deliver the SEP-1 bundle to the right patients from the start,” said study co-author Christopher Thomas, MD, of Our Lady Health System, in a press release from Cytovale. “This approach yielded significant results, enabling OLOL to achieve meaningful compliance gains in a short time.” (Photo credit: LSU Health Sciences Center)
Questioning SEP-1
The SEP-1 guidelines are controversial. CMS contends that they reduce hospital mortality. However, in 2023, a coalition of professional societies—including the IDSA, Society of Hospital Medicine, and American College of Emergency Physicians—urged the agency to retire SEP-1.
“The SEP-1 measure does not take into account that many serious conditions present in a similar fashion to sepsis,” they argued. “Pushing clinicians to treat all these patients as if they have sepsis leads to overuse of broad-spectrum antibiotics, which can be harmful to patients who are not infected, those who are infected with viruses rather than bacteria and those who could safely be treated with narrower-spectrum antibiotics.”
They also cited studies showing that SEP-1 has not improved patient outcomes. That position was bolstered earlier this year as a systematic literature review in Annals of Internal Medicine“found no moderate- or high-level evidence to support that compliance with or implementation of SEP-1 was associated with sepsis mortality,” according to the authors.
As noted in the Substack publication PulmCCM, CMS introduced SEP-1 in 2015 as a pay-for-reporting measure, meaning that hospitals were required to report compliance rates, but were not penalized for non-compliance. However, in 2023, CMS proposed making it a pay-for-performance measure as part of the Hospital Value-Based Purchasing Program. As a result, beginning in 2026, payments to hospitals will be adjusted based on their SEP-1 compliance rates.
Rapid adoption of automated storage systems in clinical and research labs is expected to support a compound annual growth rate of 11.1% through 2034.
As clinical laboratories push for greater efficiency in their processing of blood, urine, and tissue samples, research firm Global Market Insights (GMI) projects massive growth in the international market for automated systems used to safely store and retrieve these samples as well as chemical compounds used in drug discovery and research.
Key Growth Drivers: Biobanking, AI Integration, and Lab Digitalization
The market for automated sample storage systems in life sciences will grow from an estimated $1.3 billion in 2024 to $3.6 billion in 2034, a compound annual growth rate (CAGR) of 11.1%, GMI stated in a July 2025 report.
“This high growth is attributed to several factors including the growing need for biobanking and maintaining biorepositories, digital transformation across clinical and research laboratories, growth in drug discovery and development, and growing focus on sample integrity and compliance,” GMI stated in a summary of the report.
Market Breakdown: Compound vs. Biological Sample Storage
The market includes a wide range of products used to manage sample storage and retrieval in healthcare, medical research, and drug development. Systems used to store, track, and retrieve chemical compounds accounted for nearly 60% of the market in 2024, with pharmaceutical companies as the primary drivers. Systems used to manage biological samples amounted to approximately 30% of the market.
The report identifies several key factors that are driving this growth. Among them, an increase in the number of biobanks and high-throughput genomic research programs is “significantly driving the growth in sample volumes,” GMI noted. “This trend is boosting the demand for scalable automated storage systems in laboratories.”
Photo copyright: Artem Podrez
Other drivers include new technologies such as artificial intelligence (AI). GMI noted that these systems are increasingly deploying AI “to automate sample identification, optimize retrieval processes, and reduce errors.” In addition, labeling techniques such as radio frequency identification and 2D barcodes “have minimized manual intervention while decreasing human mistakes to allow quicker inventory assessments and enhanced traceability,” GMI stated.
However, GMI also noted challenges that could hinder market growth, including high upfront costs and questions about data security.
Regional Trends and Leading Companies in Sample Storage Automation
North America currently boasts the largest market for these systems, an estimated $533.3 million in 2024, GMI reported. However, the Asia Pacific region will see the highest CAGR, growing at a rate of 11.9% through 2034.
GMI identified Brooks Automation as the market leader with a 20% share in 2024. The company’s product line includes PathFinder systems designed to automate management of biological samples in pathology labs, such as sorting, decapping, sealing, and archiving of specimens.
Interestingly, the report noted several recent developments involving Hamilton Company, including a 2024 deal with Platomics to register its liquid handling systems with the latter’s PlatoX regulatory platform. This will make it easier for clinical labs in the EU to comply with the region’s In Vitro Diagnostic Regulation (IVDR) when deploying internally developed tests, the companies stated in a press release.
The market, estimated at $1.02 billion in 2024, will grow to $3.12 billion by 2034, a CAGR of 11.9%, the company said.
The report noted many of the same growth drivers—and challenges—identified by GMI. Drivers include technological advancements as well as the growth of personalized medicine and the need for long-term sample preservation for research related to cancer, cardiovascular, and neurological disease.
“The automated biobanking market is on the cusp of a revolution, not only enhancing the speed and precision of sample management but also enabling cross-border biomedical collaboration, rare disease research, and pandemic preparedness,” the company stated in a press release. “As personalized medicine and digital health accelerate, investments in smart biorepositories will become foundational to innovation in diagnostics, drug discovery, and population health.”
UK researchers have identified a link between womb lining issues and recurrent miscarriage, leading to a new test that may help detect risks before pregnancy.
Researchers in the UK have identified a malfunction in the womb lining as a significant contributor to recurrent miscarriages—even when embryos are healthy. The new study entitled “Stalling of the Endometrial Decidual Reaction Determines the Recurrence Risk of Miscarriage,” was published June 25 in the journal Science Advances. The scientists’ findings have led to the development of a new diagnostic tool aimed at identifying women at risk before pregnancy begins.
The study, led by scientists at the University of Warwick, sheds light on a poorly understood biological process called the “decidual reaction,” which prepares the endometrium—the inner lining of the uterus—for embryo implantation.
“This is about identifying preventable miscarriages,” said lead author Joanne Muter, PhD of Warwick Medical School in a press release. “Many women are told they’ve just had ‘bad luck’, but our findings show that the womb itself may be setting the stage for pregnancy loss, even before conception takes place.”
The team analyzed 1,555 biopsies from 1,308 women who sought care at the Implantation Research Clinic at University Hospitals Coventry and Warwickshire (UHCW) NHS Trust. These patients had experienced one or more miscarriages or ongoing fertility issues.
In many of these women, the researchers observed that the decidual reaction did not activate or progress as it should. This disruption results in an unstable uterine environment that still allows embryos to implant but increases the likelihood of early pregnancy loss.
Senior author Jan Brosens, PhD, Professor of Obstetrics & Gynaecology at Warwick and UHCW NHS Trust and Scientific Director of the Tommy’s National Miscarriage Research Centre noted in the press release, “It is well-established that chromosomal errors in embryos account for the rise in miscarriage rates in women older than 35 years. This study shows that each miscarriage increases the risk of an embryo implantation in an abnormal womb, regardless of age.”
“… we now have the tools to screen for the risk of preventable miscarriage and to evaluate treatments that improve the womb lining before pregnancy,” said Senior Author Professor Jan Brosens. (Photo credit: University of Warwick)
“The endometrium’s role is to receive the embryo and support the development of the placenta throughout pregnancy,” the researchers explained in the release. “The decidual reaction transforms the womb lining into a supportive tissue for the embryo to implant.
When it doesn’t fully activate or becomes dysregulated, it creates an unstable environment that, while still allowing embryos to implant, increases the risk of bleeding and early pregnancy loss.”
New Test Measures Womb Readiness and Immune Cell Activity
To detect these abnormalities, the research team developed the Digital Endometrium Function Test—abbreviated as (d)EFT—which is currently undergoing a large-scale pilot trial at UHCW. According to the university, more than 1,000 patients have already received the test as part of their clinical care.
The (d)EFT test requires a small biopsy of the womb lining, according to the Warwick Medical School website. In addition, patients provide a blood sample—used to measure progesterone level—and undergo a transvaginal ultrasound scan. They must also use an ovulation test or wearable device to determine their peak fertility day.
The test evaluates three key markers:
Endometrial readiness: Digital PCR technology measures biomarkers that indicate whether the endometrium can support embryo implantation.
Timing of implantation window: PCR results combined with mathematical modeling determine when the womb lining is most receptive.
uNK cell levels: Digital image analysis measures uterine natural killer cells, which, in abnormal numbers, are linked to IVF failure or increased miscarriage risk.
“High uNK cells are linked to implantation and IVF failure, whereas low levels of uNK cells may increase the risk of miscarriage,” according to the Warwick Medical School website.
The research, funded by UK pregnancy charity Tommy’s, has the potential to shift how clinicians assess and treat miscarriage risk. Current diagnostics often focus on embryo quality, hormone levels, or genetic issues—overlooking the role of the uterine environment.
By offering a more targeted, womb-centered approach, the researchers hope their work will lead to effective new treatments for the estimated 15% of pregnancies that end in miscarriage.
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.
“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.
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio test measures blood biomarkers associated with the disease
Clinical laboratories could soon find themselves playing a significant role in Alzheimer’s care as the US Food and Drug Administration (FDA) announced its first-ever clearance of a blood test to assist in diagnosing the cognitive disease.
The agency issued a 510(k) clearance for the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio test from Fujirebio Diagnostics, Inc. The test is intended for “the early detection of amyloid plaques associated with Alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease,” according to an FDA press release.
“Nearly seven million Americans are living with Alzheimer’s disease, and this number is projected to rise to nearly 13 million,” said FDA Center for Devices and Radiological Health Director Michelle Tarver, MD, PhD, in the press release. “Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for US patients earlier in the disease.”
“Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Martin A. Makary, MD, MPH, in the FDA press release.
“Knowing that 10% of people aged 65 and older have Alzheimer’s, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients,” said FDA Commissioner Martin A. Makary, MD, MPH, in the FDA press release. (Photo copyright: Johns Hopkins University.)
Blood Protein Test Details
Fujirebio’s test calculates the ratio of two blood proteins, pTau217 and β-amyloid 1-42. “This ratio is correlated to the presence or absence of amyloid plaques in the patient’s brain, reducing the need for a PET scan,” the press release states.
The FDA said it has already authorized or cleared similar tests that use cerebrospinal fluid (CSF) samples obtained through an invasive spinal tap. “This new Lumipulse test only requires a simple blood draw, making it less invasive and much easier for patients to access,” the FDA said.
In granting the clearance, the agency looked at data from a clinical study of 499 adults displaying signs of cognitive impairment. Close to 92% of participants with positive test results had amyloid plaques as determined by amyloid PET scan or CSF test results. Approximately 97% with negative results from the Lumipulse test were also shown to be negative in the PET scan or CSF test. Fewer than 20% of the patients received indeterminate results, which would require additional testing.
The primary risks of the test are false positive or false negative results, the federal agency noted.
“Importantly, the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is not intended as a screening or stand-alone diagnostic test and other clinical evaluations or additional tests should be used for determining treatment options,” the FDA said.
‘Wild West’ Marketplace
In their reporting of this story,MedPage Today and the Associated Press both noted that some laboratory-developed tests can already measure plasma biomarkers associated with Alzheimer’s.
“But those tests aren’t reviewed by the FDA and generally aren’t covered by insurance,” the AP reported. “Doctors have also had little data to judge which tests are reliable and accurate, leading to an unregulated marketplace that some have called a ‘wild west.’”
Neurologist Richard S. Isaacson, MD, told CNN that he’s already using the test for research purposes. “It can provide better clarity into whether a person experiencing memory loss may have Alzheimer’s disease,” he said.
However, he cautioned that more research is needed to allow doctors to make best use of the test.
“I think the next step as a field is, we need to advance education about what these tests mean and what they don’t and who they should be used for,” he told CNN. “Because they mean different things in different people depending on their risk factors and whether they have symptoms. So, we’re still early.”
“The results must be interpreted in conjunction with other patient clinical information,” the FDA acknowledged in their press release.
Other Alzheimer’s Tests
The FDA said it reviewed the Lumipulse test through the 510(k) premarket notification pathway, in which the federal agency determines if a device is “substantially equivalent to a legally marketed predicate device.”
In this case, the agency found that the test is substantially equivalent to Fujirebio’s Lumipulse G β-amyloid Ratio (1-42/1-40), which measures the same proteins in CSF samples. The FDA authorized that device in 2022, according to a Fujirebio press release. That test uses Fujirebio’s automated Lumipulse G1200 instrument system.
Other companies including Roche, Eli Lilly, and C2N Diagnostics are also developing Alzheimer’s tests they intend to submit for FDA review, the AP reported.
