With FDA clearance already approved, hospital infection control teams and their clinical laboratories may have another diagnostic tool for diagnosing blood infections
Controlling sepsis in hospitals continues to be a major concern in nations around the world, including in the United States. Now, a new 10-minute clinical laboratory blood test that uses artificial intelligence (AI) and digital images to spot biomarkers of the potentially fatal condition may soon be available for use in hospitals. The test, which was approved to be marketed in the US in 2022 by the federal Food and Drug Administration (FDA), may be “one of the most important breakthroughs in modern medical history,” according to US researchers, Good News Network (GNN) reported.
“Early detection of sepsis is an invaluable capability for healthcare professionals. Quickly identifying sepsis is critical to saving lives, but until now, we’ve lacked a reliable tool to either recognize the condition or explore alternate diagnoses,” said O’Neal in an LSU press release.
“IntelliSep is truly a game changer,” said Hollis O’Neal, MD (above), Associate Professor of Medicine at Louisiana State University Health Sciences Center in Baton Rouge. “The test provides hospital staff with information needed to identify and treat septic patients efficiently and reduce the financial and health burdens of overtreatment for hospitals and patients.” Clinical laboratories may have a new blood test for sepsis by the end of the year. (Photo copyright: Louisiana State University.)
How IntelliSep Works
The IntelliSep test analyzes blood samples extracted from emergency room patients who present with sepsis symptoms by squeezing white blood cells through a tiny tube to determine how the cells react and if they change shape. White blood cells in patients with sepsis are softer and spongier and their shape compresses and elongates, increasing the likelihood of developing sepsis.
Images are taken of the cells using an ultra-high-speed camera that can capture up to 500,000 frames per second. The images are the analyzed by an AI-powered computer which calculates the total number of elongated white blood cells to determine if sepsis is present.
IntelliSep then separates patients into three bands of risk for developing sepsis:
Band 1 (low)
Band 2 (medium)
Band 3 (high)
Results of the test are available to emergency room personnel in less than 10 minutes.
“Sepsis is notorious as the ‘silent killer’ because it is so easily missed early on, when a patient’s symptoms can often be mistaken for other less serious illnesses,” Michael Atar, PhD, DDS, Associate Professor, Pediatric Dentistry at New York University told Good News Network. “Rapid diagnosis and treatment is crucial to a good outcome, but there has never been a single, reliable diagnostic test available to doctors, costing precious time and people’s lives.”
Atar is a lead medical technology investor and an advisor to Cytovale.
‘Holy Grail’ of Sepsis Diagnosis
To complete the IntelliSep study, researchers enrolled 1,002 ER patients who presented with signs of sepsis. IntelliSep correctly identified patients who did not have sepsis with an accuracy rate of 97.5%. The technology showed an accuracy rate of 55% for positive sepsis results. Researchers also used IntelliSep to quickly diagnose and assess the severity of a sepsis infection.
There were no sepsis deaths reported in patients with low-risk scores. This indicates the test could help physicians rule out sepsis and seek other diagnoses for those patients.
“Cytovale’s IntelliSep device is, by any objective measure, the ‘holy grail’ that the medical community has been so desperate to find,” Atar told Good News Network. “The technology behind it is genuinely groundbreaking and it has the real-world, tried-and-tested potential to save millions of lives, year on year, across the planet.”
The technology is currently being used in a few hospitals in Louisiana and the inventors hope to have it available in at least 10 other hospitals by the end of the year.
Our Lady of the Lake Regional Medical Center, a not-for-profit Catholic healthcare ministry located in Baton Rouge, was one of the first hospitals to implement IntelliSep.
“Cytovale’s innovative technology will help drastically decrease the number of sepsis-related deaths in hospital settings, and we are honored that, since day one, we have been a part of the research that led to this technology,” said Chuck Spicer, President of Our Lady of the Lake Health in a news release.
Saint Francis Medical Center in Monroe, La., announced on September 3 that it has started using the IntelliSep test in its emergency rooms and staff are impressed by the impact on hospital efficiency.
“If it turns out negative then you don’t have to treat as many patients as you did before, which runs up costs, hospital bills and causes people to be in the hospital for longer periods of time,” said pulmonary disease physician Thomas Gullatt, MD, President, St. Francis Health, told KNOE News.
Patient Expectations for Treatment
Sepsis, also known as septicemia or blood poisoning, is a serious medical condition that occurs when the body improperly reacts to an infection or injury. The dangerous reaction causes extensive inflammation throughout the body and, if not treated early, can lead to organ failure, tissue damage, and even death.
The Centers for Disease Control and Prevention (CDC) reports at least 1.7 million adults develop sepsis annually in the US and at least 350,000 die as a result of the condition. It also states sepsis is one of the main reasons people are readmitted to hospitals.
Clinical laboratories should be aware of developments in the use of this new diagnostic assay and how it is aiding the diagnosis, antibiotic selection, and monitoring of patients with this deadly infection. Patients often learn about new technologies and come to their hospital or provider expecting to be treated with these innovations.
Program is open to providers that exclusively offer telehealth services, and those providers that offer the telehealth services to other hospitals
In another sign that telehealth is now an established presence in the healthcare marketplace, The Joint Commission recently implemented a new Telehealth Accreditation Program. The initiative, which took effect on July 1, 2024, aims to provide “updated, streamlined standards” enabling “safe, high-quality” delivery of telehealth services to patients, according to a press release. The organization announced the program in April.
Dark Daily has regularly commented on the importance for clinical laboratories to recognize this trend and add the necessary services to meet the expectations and needs of telehealth/virtual doctor visits where the physician orders medical laboratory tests for the patient.
“The use of telehealth in the United States increased 154% during early stages of the COVID-19 pandemic and stabilized at levels 38 times higher than levels in 2019,” said Joint Commission President and CEO Jonathan B. Perlin, MD, PhD, in the press release.
“As telehealth continues to evolve, it was imperative to create a new accreditation program to provide a framework to support the integrity of patient safety regardless of the care setting,” he added.
The accrediting organization is reacting to market demand. Patient and doctor acceptance of virtual doctor visits and telehealth consults is now an established fact.
[PHOTO OF PERLIN HERE]
“Our new Telehealth Accreditation Program helps organizations standardize care and reduce risk so that all patients, including those obtaining services remotely, receive the safest, highest-quality care with outcomes consistent with traditional settings,” said Jonathan B. Perlin, MD, PhD (above), President/CEO, The Joint Commission, in a press release. Clinical laboratory accreditation nationwide is also handled by the not-for-profit organization. (Photo copyright: International Hospital Federation.)
Eligibility
The Joint Commission describes itself as “the nation’s oldest and largest standards-setting and accrediting body in healthcare.” The not-for-profit organization certifies more than 22,000 healthcare providers in the US, according to its website, including hospitals and medical laboratories. Its evaluations are based on surveys in which qualified experts conduct inspections of the facilities to ensure compliance with patient safety and quality standards.
Accreditation is not mandatory, however many states have licensing, certification, or contracting requirements that mandate accreditation by The Joint Commission or other accrediting bodies.
The program is open to providers that exclusively offer healthcare services “via telehealth or remote patient monitoring, with no in-person visits or encounters,” according to The Joint Commission website. This can include organizations that provide:
Primary care, specialty care, or urgent care,
Medical or behavioral consultation,
Remote patient monitoring, and
TeleICU, telestroke, telepsychiatry, or teleimaging services to hospitals.
Hospitals or other healthcare providers can also apply if they have contracts to offer “care, treatment, and services via telehealth to another organization’s patients,” The Joint Commission states. Examples include acute care or psychiatric hospitals that provide telehealth services to other facilities. In this case, the hospitals can obtain telehealth accreditation for the contracted services while maintaining their current accreditation for services provided onsite.
Requirements for Certification
The requirements for accreditation are similar to those in other Joint Commission programs, the organization says. This includes “requirements for information management, leadership, medication management, patient identification, documentation, and credentialing and privileging.”
In addition, it includes requirements specific to telehealth. For example, emergency management requirements have been streamlined to account for services provided remotely. It also contains standards related to telehealth equipment as well as provider and patient education about use of the technology.
“Additionally, the program’s standards may be filtered based on the telehealth modality or service provided,” the organization’s website notes.
Other Accrediting Organizations
The Joint Commission is not the only organization that offers telehealth accreditation or certification. The Utilization Review Accreditation Commission (URAC) provides accreditation programs for telehealth and remote patient monitoring, as well as a certification program for telehealth support services.
The telehealth accreditation program consists of three modules accounting for different forms of delivery:
Provider-to-provider (one provider offers services such as consultation to another provider).
The accreditation process takes up to four months, URAC says.
The Accreditation Commission for Health Care (ACHC) offers what it describes as a telehealth “Distinction” for certain kinds of healthcare providers that it has accredited, including:
Additionally, in April 2022, ACHC announced a telehealth certification program open to “any healthcare provider or organization that delivers health-related services via electronic information and telecommunication technologies,” regardless of whether they are accredited, according to a press release.
“The pandemic really pushed healthcare providers to adopt and grow telehealth services to maintain access for patients and, as a result, many of our clients were seeking ways to optimize this offering in the context of providing quality services,” said program director Teresa Hoosier, RN, in the press release. “ACHC Telehealth Certification establishes national standards. It promotes best practices for digital healthcare services. Certification confirms quality, safety, and consistency—strengthening trust in an organization and assuring patients that they are receiving the best care possible.”
This development is a reminder that clinical laboratory managers need a consumer/patient focused strategy and operational capability to collect specimens and provide medical laboratory tests for telehealth visits when the doctors order tests. It confirms that the trend of consumers/patients using remote healthcare is real, robust, and has legs.
Scientists suspect that the plastics can be linked to a host of medical conditions, but clear evidence is elusive without appropriate biomarkers for clinical laboratory testing
Recent research indicates that microplastics and nanoplastics (MNPs) are accumulating in human organs at an increasing rate. The health impact is not entirely clear, but the research suggests that clinical laboratories could someday find themselves testing for levels of MNPs in patients.
In one study, scientists at the University of New Mexico and Oklahoma State University analyzed autopsy samples of liver, kidney, and frontal cortex brain tissue collected in 2016 and 2024. “Brains exhibited higher concentrations of MNPs than liver or kidney samples,” they wrote. However, “all organs exhibited significant increases from 2016 to 2024.”
“The concentrations we saw in the brain tissue of normal individuals, who had an average age of around 45 or 50 years old, were 4,800 micrograms per gram, or 0.5% by weight,” lead author Matthew Campen, PhD, Regents’ Professor, Pharmaceutical Sciences, University of New Mexico, and Director of the New Mexico Center for Metals in Biology and Medicine (CMBM), told CNN. “Compared to autopsy brain samples from 2016, that’s about 50% higher.”
Researchers have not yet uncovered clear evidence of specific health risks, but “what scientists worry about is several trends in disease prevalence that have been unexplained—Alzheimer’s disease and dementia, colorectal cancer in people under 50, inflammatory bowel disease, and global reductions in sperm count,” Campen told Everyday Health.
In another recent study, a different team of researchers at the University of New Mexico found high levels of microplastics in human and canine testicular tissue.
“At the beginning, I doubted whether microplastics could penetrate the reproductive system,” said lead author Xiaozhong Yu, MD, PhD, Professor, University of New Mexico College of Nursing in a university news story. “When I first received the results for dogs I was surprised. I was even more surprised when I received the results for humans.”
“The rate of increase in microplastics in the environment is exponential and we have every reason to believe that the concentrations in our bodies will continue to increase in the coming years and decades,” Matthew Campen, PhD (above), of the University of New Mexico told Everyday Health. As studies continue to produce evidence that nanoplastics affect human health, testing companies may develop biomarkers for clinical laboratory tests that measure the amount of microplastics in different organ locations. (Photo copyright: University of New Mexico.)
Landrigan told CNN that most people are exposed to MNPs through their diet, “but inhalation is also an important route.”
However, he added, “it’s important not to scare the hell out of people, because the science in this space is still evolving, and nobody in the year 2024 is going to live without plastic.”
CNN noted that experts consider nanoplastics to be the biggest concern [as opposed to microplastics] because they can infiltrate human cells.
“Somehow these nanoplastics hijack their way through the body and get to the brain, crossing the blood-brain barrier,” Campen told CNN. “Plastics love fats, or lipids, so one theory is that plastics are hijacking their way with the fats we eat which are then delivered to the organs that really like lipids—the brain is top among those.”
The US Food and Drug Administration (FDA) states that microplastics typically measure less than 5mm, whereas nanoplastics are less than a micron (micrometer). However, the agency notes that “there are currently no standard definitions for the size of microplastics or nanoplastics.”
What Are the Health Risks?
Scientists suspect that MNPs could be associated with cancer, cardiovascular disease, kidney disease, Alzheimer’s disease, and infertility, The Washington Post reported, but that they “still don’t have a clear sense of what these materials are doing to the human body.”
“In a 2021 study, researchers in Switzerland identified more than 10,000 chemicals used in the manufacture of plastic—of which over 2,400 were potentially ‘of concern’ for human health,” The Post noted.
“To be able to say we have a health impact, we need to have a direct correlation between a product and a health outcome,” Phoebe Stapleton, PhD, Associate Professor at the Rutgers University Ernest Mario School of Pharmacy (EMSOP), told The Post. “It’s very narrow, that straight line. And there’s so many different health outcomes there could be, and we’re finding these particles in so many different tissues.”
One study published in the New England Journal of Medicine (NEJM) suggested that MNPs in arteries could be risk factors for heart attacks or strokes. But even here, the authors wrote, “direct evidence that this risk extends to humans is lacking.”
Yu suspects that MNPs could be a factor in a global decline in sperm count, along with other environmental contaminants such as heavy metals and pesticides. His study found that polyethylene was the most prevalent plastic in dogs, followed by polyvinyl chloride (PVC). Higher levels of PVC correlated with lower sperm count, but there was no correlation with polyethylene.
“PVC can release a lot of chemicals that interfere with spermatogenesis, and it contains chemicals that cause endocrine disruption,” he said in the UNM news story.
Clinical laboratory managers should recognize that interest in identifying micro- and nanoplastics in every organ of the human body will increase. At some point, physicians may want labs to test their patients for microplastic levels in certain organ sites. This will likely be when enough published studies show a correlation between high levels of microplastics in certain locations of the body and specific disease states.
Findings may lead to new clinical laboratory biomarkers for predicting risk of developing MS and other autoimmune diseases
Scientists continue to find new clinical laboratory biomarkers to detect—and even predict risk of developing—specific chronic diseases. Now, in a recent study conducted at the University of California San Francisco (UCSF), researchers identified antibodies that develop in about 10% of Multiple Sclerosis (MS) patients’ years before the onset of symptoms. The researchers reported that of those who have these antibodies, 100% develop MS. Thus, this discovery could lead to new blood tests for screening MS patients and new ways to treat it and other autoimmune diseases as well.
The UCSF researchers determined that, “in about 10% [of] cases of multiple sclerosis, the body begins producing a distinctive set of antibodies against its own proteins years before symptoms emerge,” Yahoo Life reported, adding that “when [the patients] are tested at the time of their first disease flare, the antibodies show up in both their blood and cerebrospinal fluid.”
That MS is so challenging to diagnose in the first place makes this discovery even more profound. And knowing that 100% of a subset of MS patients who have these antibodies will develop MS makes the UCSF study findings quite important.
“This could be a useful tool to help triage and diagnose patients with otherwise nonspecific neurological symptoms and prioritize them for closer surveillance and possible treatment,” Colin Zamecnik, PhD, scientist and research fellow at UCSF, told Yahoo Life.
“From the largest cohort of blood samples on Earth, we obtained blood samples from MS patients years before their symptoms began and profiled antibodies against self-autoantibodies that are associated with multiple sclerosis diagnosis,” Colin Zamecnik, PhD (above), scientist and research fellow at UCSF, told Yahoo Life. “We found the first molecular marker of MS that appears up to five years before diagnosis in their blood.” These findings could lead to new clinical laboratory tests that determine risk for developing MS and other autoimmune diseases. (Photo copyright: LinkedIn.)
UCSF Study Details
According to the MS International Foundation Atlas of MS, there are currently about 2.9 million people living with MS worldwide, with about one million of them in the US. The disease is typically diagnosed in individuals 20 to 50 years old, mostly targeting those of Northern European descent, Yahoo Life reported.
To complete their study, the UCSF scientists used the Department of Defense Serum Repository (DoDSR), which is comprised of more than 10 million individuals, the researchers noted in their Nature Medicine paper.
From that group, the scientists identified 250 individuals who developed MS, spanning a period of five years prior to showing symptoms through one year after their symptoms first appeared, Medical News Today reported. These people were compared to 250 other individuals in the DoDSR who have no MS diagnosis but who all had similar serum collection dates, ages, race and ethnicities, and sex.
“The researchers validated the serum results against serum and cerebrospinal fluid results from an incident MS cohort at the University of California, San Francisco (ORIGINS) that enrolled patients at clinical onset. They used data from 103 patients from the UCSF ORIGINS study,” according to Medical News Today. “They carried out molecular profiling of autoantibodies and neuronal damage in samples from the 500 participants, measuring serum neurofilament light chain measurement (sNfL) to detect damage to nerve cells.
“The researchers tested the antibody patterns of both MS and control participants using whole-human proteomeseroreactivity which can detect autoimmune reactions in the serum and CSF,” Medical News Today noted.
Many who developed MS had an immunogenicity cluster (IC) of antibodies that “remained stable over time” and was not found in the control samples. The higher levels of sNfL in those with MS were discovered years prior to the first flare up, “indicating that damage to nerve cells begins a long time before symptom onset,” Medical News Today added.
“This signature is a starting point for further immunological characterization of this MS patient subset and may be clinically useful as an antigen-specific biomarker for high-risk patients with clinically or radiologically isolated neuroinflammatory syndromes,” the UCSF scientists wrote in Nature Medicine.
“We believe it’s possible that these patients are exhibiting cross reactive response to a prior infection, which agrees with much current work in the literature around multiple sclerosis disease progression,” Zamecnik told Yahoo Life.
It “validates and adds to prior evidence of neuro-axonal injury occurring in patients during the MS preclinical phase,” the researchers told Medical News Today.
Implications of UCSF’s Study
UCSF’s discovery is a prime example of technology that could soon work its way into clinical use once additional studies and research are done to support the findings.
The researchers believe their research could lead to a simple blood test for detecting MS years in advance and discussed how this could “give birth to new treatments and disease management opportunities,” Neuroscience News reported.
Current MS diagnosis requires a battery of tests, such as lumbar punctures for testing cerebrospinal fluid, magnetic resonance imaging (MRI) scans of the spinal cord and brain, and “tests to measure speed and accuracy of nervous system responses,” Medical News Today noted.
“Given its specificity for MS both before and after diagnosis, an autoantibody serology test against the MS1c peptides could be implemented in a surveillance setting for patients with high probability of developing MS, or crucially at a first clinically isolated neurologic episode,” the UCSF researchers told Medical News Today.
The UCSF discovery is another example of nascent technology that could work its way into clinical use after more research and studies. Microbiologists, clinical laboratories, and physicians tasked with diagnosing MS and other autoimmune diseases should find the novel biomarkers the researchers identified most interesting, as well as what changed with science and technology that enabled researchers to identify these biomarkers for development.
As this therapeutic approach gains regulatory approval, clinical laboratory tests to determine condition of patient’s gut microbiota and monitor therapy will be needed
Some developments in the clinical laboratory industry are less about diagnostic tests and more about novel approaches to therapy. Such is the case with a new carbon bead technology developed by researchers from University College London (UCL) and the Royal Free Hospital intended to remove harmful bacteria toxins from the gut before they leak to the liver. The macroporous beads, which come in small pouches, are delivered orally and could be utilized in the future to treat a number of diseases.
Why is this relevant? Once a new treatment is accepted for clinical use, demand increases for a clinical laboratory test that confirms the therapy will likely work and to monitor its progress.
In collaboration with Yaqrit, a UK-based life sciences company that develops treatments for chronic liver disease, the UCL and Royal Free Hospital scientists engineered the carbon beads—known as CARBALIVE—to help restore gut health. They measured the technology’s impact on liver, kidney, and brain function in both rats and mice.
“The influence of the gut microbiome on health is only just beginning to be fully appreciated,” said Rajiv Jalan, PhD, Professor of Hepatology at UCL in a press release. “When the balance of the microbiome is upset, ‘bad’ bacteria can proliferate and out-compete the ‘good’ bacteria that keeps the gut healthy.
“One of the ways [the ‘bad’ bacteria] do this is by excreting endotoxin, toxic metabolites, and cytokines that transform the gut environment to make it more favorable to them and hostile to good bacteria,” he continued. “These substances, particularly endotoxin, can trigger gut inflammation and increase the leakiness of the gut wall, resulting in damage to other organs such as the liver, kidneys, and brain.”
“I have high hopes that the positive impact of these carbon beads in animal models will be seen in humans, which is exciting not just for the treatment of liver disease but potentially any health condition that is caused or exacerbated by a gut microbiome that doesn’t work as it should,” said Rajiv Jalan, PhD (above), Professor of Hepatology, University College London, in a press release. “This might include conditions such as irritable bowel syndrome (IBS), for example, which is on the rise in many countries.” Though not a clinical laboratory diagnostic test, new therapies like CARBALIVE could be a boon to physicians treating patients with IBS and other gastrointestinal conditions.
Developing the Carbon Beads
The team discovered CARBALIVE is effective in the prevention of liver scarring and injury in animals with cirrhosis when ingested daily for several weeks. They also found a reduced mortality rate in test animals with acute-on-chronic-liver-failure (ACLF).
After achieving success with CARBALIVE in animals, the researchers tested the technology on 28 cirrhosis patients. The carbon beads proved to be safe for humans and had inconsequential side effects.
“In cirrhosis, a condition characterized by scarring of the liver, it is known that inflammation caused by endotoxins can exacerbate liver damage,” Jalan explained. “Part of the standard treatment for cirrhosis is antibiotics aimed at controlling bad bacteria, but this comes with the risk of antibiotic resistance and is only used in late-stage disease.”
The beads, which are smaller than a grain of salt, contain an exclusive physical structure that absorbs large and small molecules in the gut. They are intended to be taken with water at bedtime as harmful bacteria is more likely to circulate through the body at night which could result in damage. The carbon beads do not kill bacteria, which decreases the risk of antibiotic resistance. They eventually pass through the body as waste.
“They work by absorbing the endotoxins and other metabolites produced by ‘bad’ bacteria in the gut, creating a better environment for the good bacteria to flourish and helping to restore microbiome health,” said Michal Kowalski, M.Sc.Eng, Director and VP of Operations at Yaqrit, in the UCL news release.
“This prevents these toxins from leaching into other areas of the body and causing damage, as they do in cirrhosis,” he added. “The results in animal models are very positive, with reduction in gut permeability, liver injury, as well as brain and kidney dysfunction.”
Additional Research
The researchers plan to perform further clinical trials in humans to determine if the carbon beads are effective at slowing the progression of liver disease. If the benefits that were observed in lab animals prove to be compelling in humans, the technology may become an invaluable tool for the treatment of liver disease and other diseases associated with poor microbiome health in the future.
According to the American Liver Foundation, 4.5 million adults in the US have been diagnosed with liver disease. However, it is estimated that 80 to 100 million adults have some form of fatty liver disease and are unaware of it. Liver disease was the 12th leading cause of death in the US in 2020 with 51,642 adults perishing from the disease that year.
According to BMC Public Health, globally there were 2.05 million new cases of liver cirrhosis diagnosed in 2019. In that year, 1.47 million people around the world died from the disease.
More research and clinical studies are needed before this novel technology can be used clinically. When and if that happens, the demand for clinical laboratory tests that measure microbiome deficiencies and monitor patient progress during therapy will likely be high.
As new diagnostic assays are cleared by regulators, clinical laboratories will play a key role in identifying appropriate patients for new less-invasive Alzheimer’s tests
With multiple companies racing to develop a blood-based test for Alzheimer’s disease (AD), clinical laboratories may soon have new less-invasive diagnostic assays for AD on their menus.
Why a race? Because a less-invasive clinical laboratory test that uses a venous blood draw (as opposed to a spinal tap)—and which has increased sensitivity/specificity—has a potentially large market given the substantial numbers of elderly predicted to develop Alzheimer’s over the next decade. It has the potential to be a high volume, high dollar diagnostic test.
In fact, Mordor Intelligence estimates that the market for Alzheimer’s disease therapeutics will grow from $7.7 billion in 2024 to $10.10 billion by 2029.
Alzheimers.gov, an official website of the US government, says, “Researchers have made significant progress in developing, testing, and validating biomarkers that detect signs of the disease process. For example, in addition to PET scans that detect abnormal beta-amyloid plaques and tau tangles [abnormal forms of tau protein] in the brain, NIH-supported scientists have developed the first commercial blood test for Alzheimer’s. This test and others in development can not only help support diagnosis but also be used to screen volunteers for research studies.”
Additionally, the US Food and Drug Administration (FDA) is clearing new Alzheimer’s drugs for clinical use. The pharma companies behind these drugs need clinical laboratory tests that accurately diagnosis the disease and confirm that it would be appropriate for the patient to receive the new therapeutic drugs, a key element of precision medicine.
“The big promise for blood tests is that they will eventually be accessible, hopefully, cost-effective, and noninvasive,” Rebecca Edelmayer, PhD (above), Vice President, Scientific Engagement, Alzheimer’s Association, told USA Today. “The field is really moving forward with use of these types of tests,” she added. Clinical laboratories may soon have these new assays on their test menus. (Photo copyright: Alzheimer’s Association.)
Companies in the Race to Develop Blood-based Alzheimer’s Tests
Researchers found that C2N’s blood test can detect brain amyloid status with “sensitivity, specificity, positive and negative predictive values that approximate those of amyloid positron emission tomography (PET) imaging,” according to a news release.
“The PrecivityAD2 blood test is intended for use in patients aged 55 and older with signs or symptoms of mild cognitive impairment or dementia who are undergoing evaluation of Alzheimer’s disease or dementia. Only a healthcare provider can order the PrecivityAD2 test,” the news release noted.
“The PrecivityAD2 blood test showed strong clinical validity with excellent agreement with brain amyloidosis by PET,” the researchers wrote.
The PrecivityAD2 test, which is mailed directly by C2N to doctors and researchers, is performed at the company’s CLIA-certified lab, according to USA Today, which added that the cost of $1,450 is generally not covered by insurance plans.
Expanding Test Access with IVD Companies
ALZpath, Inc. has a different approach to the Alzheimer’s disease test market. The Carlsbad, Calif.-based company, set up an agreement with in vitro diagnostics (IVD) company Roche Diagnostics for use of its phosphorylated tau (pTau)217 antibody “to develop and commercialize an Alzheimer’s disease diagnostic blood test that will be offered on the Roche Elecsys platform,” according to a news release.
Roche received FDA breakthrough device designation on the Elecsys pTau217 test earlier this year and will work with pharmaceutical company Eli Lilly to commercialize the test.
Estimates show 75% of dementia cases go undetected—a number which could grow to 140 million by 2050, according to data shared by Roche with Fierce Biotech.
“We plan to leverage our installed base of diagnostic systems, which is the largest in the world, to ensure we are able to create access to this test for those who need it the most,” Matt Sause, CEO, Roche Diagnostics, told Fierce Biotech.
Another IVD company, Beckman Coulter, recently signed an agreement to use ALZpath’s pTau217 antibody test in its DxI 9000 Immunoassay Analyzer. In a news release, Kathleen Orland, SVP and General Manager of the Clinical Chemistry Immunoassay Business Unit at Beckman Coulter, said that the test had “high performance in detecting amyloid pathology” and could “integrate into our advanced DxI 9000 platform to support broad-based testing.”
Clinical Laboratory Participation
The FDA is drafting new guidance titled, “Early Alzheimer’s Disease: Developing Drugs for Treatment” that is “intended to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic Alzheimer’s disease (AD) that occur before the onset of overt dementia.”
Pharma companies intent on launching new drugs for Alzheimer’s will need medical laboratory tests that accurately diagnosis the disease to confirm the medications would be appropriate for specific patients.
Given development of the aforementioned pTau217 antibody tests, and others featuring different diagnostic technologies, it’s likely clinical laboratories will soon be performing new assays for diagnosing Alzheimer’s disease.
