C2N Diagnostics’ Alzheimer's blood test was introduced into the clinic in October of 2020, a breakthrough healthcare innovation for patients, advocates, and physicians who have long awaited an easy to administer test that can help them better understand Alzheimer’s disease. C2N developed this groundbreaking test based upon longtime GHR partner Dr. Randall Bateman’s initial discovery of how to measure amyloid proteins in blood, validating its results in a clinical trial of 686 patients. 

From C2N Diagnostics: ​

"C2N Diagnostics, a leader in advanced brain health diagnostics, today announced the release of the PrecivityAD2 blood test, a clinical care assay that meets the standard of care with currently available PET scans and cerebrospinal fluid tests. This blood test is designed to alleviate the bottleneck and unmet needs of healthcare providers and patients in evaluating patients with signs and symptoms of Alzheimer’s disease (AD) and other causes of cognitive decline. 

'We believe the PrecivityAD2 test represents the next generation in blood biomarker tests and will help establish a new standard in Alzheimer’s disease diagnosis. The 2022 Clinical Trials on Alzheimer’s Disease Task Force report outlined that combined biomarkers can be especially helpful in avoiding misdiagnosis, and PrecivityAD2 does just that by harnessing two established biomarkers in one assay. We believe the test addresses a major unmet need for an accurate, safe, non-invasive, and accessible alternative to amyloid PET scans and lumbar punctures,' says Dr. Joel Braunstein, C2N’s president and CEO. 'This announcement is timely with the approval of new disease modifying therapies and others on the way along with the ability for healthcare providers to more easily refer patients to sites or to mobile phlebotomists where their blood can be drawn for diagnosis.'"

Read the full press release here. 

L: Dr. Randall Bateman updates Board and leadership on therapy research at Washington University’s Bateman Lab. R: GHR and C2N Diagnostics teams reviewed groundbreaking blood tests at the BioSTL innovations building.

Members of GHR’s Board and executive leadership traveled to St. Louis, Missouri for visits with key Biomedical partners at The Washington University School of Medicine and C2N Diagnostics. The trip provided a unique opportunity for the GHR team to gain a deeper understanding of the groundbreaking research supported by the Alzheimer’s Initiative, and to build relationships with leading scientists behind recent and significant breakthroughs.

Beginning with a focus on GHR’s support for prevention trials in the genetic early-onset population, the trip commenced with a visit to the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) at the Washington University School of Medicine in St. Louis. There, Dr. Bateman and team shared progress underway with the DIAN Network, which supports families with genetic mutations that cause them to develop early-onset Alzheimer’s Disease. The group had the opportunity to hear from a dedicated DIAN participant, who shared their personal story and journey with the DIAN team at WashU. The group then toured the Bateman Lab at the Tracy Family SILQ Center where researchers are using basic science to develop novel therapies for Alzheimer’s and other dementias.

This was followed by a visit to the offices of C2N Diagnostics, the company established to bring new diagnostic inventions to patients. Offering an overview of groundbreaking diagnostics development, the visit included a tour of the C2N lab and progress updates from the C2N team.
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Thanks to these committed researchers and study participants, our shared goal of preventing Alzheimer’s Disease is within reach.

From Nature:

"AD pathology should be targeted before the onset of dementia. Research has shown that AD develops in the course of 20–30 years10,11. By the time AD manifests as dementia, the brain can no longer be rescued. This provides a huge window of opportunity for preventive action. To optimally employ these possibilities, we need a paradigm shift with a focus on (1) individual characteristics and preferences and (2) the stages before dementia to ultimately (3) prevent progression to dementia. Effective deployment of preventive strategies requires timely identification of individuals who would benefit the most. Further development of diagnostic tests to detect early AD pathophysiological changes, also capturing differences in pathological pathways between patients, is therefore warranted. Individual preferences and patient-reported outcomes should be the starting point for high-quality individualized care."

​Read more. 

Excitement and anticipation are building for the use of blood tests to detect Alzheimer’s Disease. A recent article in the Washington Post detailed the work of GHR partner C2N Diagnostics and the groundbreaking research of its co-founder, Dr. Randall Bateman.

From The Washington Post:

“For C2N, the journey to this moment began years ago. It started, like many advances in science, with a few seemingly simple questions that Bateman, then a postdoctoral research fellow, asked Holtzman, his mentor. Why do people — but not other mammals — get amyloid plaques in their brains? Is the protein accumulating and not being cleared? In 2004, Bateman launched a groundbreaking experiment to measure how quickly amyloid is produced and cleared by the brain. For 36 hours, spinal catheters collected cerebrospinal fluid from several participants, some of whom had Alzheimer’s. Bateman served as his own first subject. The study showed that Alzheimer’s patients produced amyloid beta at the same rate as other people but cleared it more slowly. Bateman theorized that the clearance rates might form the basis for a diagnostic test, but ultimately went in a different direction. Brain abnormalities develop 10 to 20 years before symptoms emerge, suggesting people might be able to take steps to delay or prevent the disease. Blood tests could alert individuals to their risks, allowing them to receive a preventive therapy, if one is developed, or pursue better exercise and diet.”

Read more on the the Alzheimer's blood test research landscape.

GHR’s goal is to help patients and families live full lives in a world where Alzheimer’s Disease becomes a preventable condition. GHR aims to halt Alzheimer's disease prior to the onset of cognitive symptoms by supporting new diagnostic tools and prevention trials. Learn more about our work on Alzheimer’s prevention.

C2N Diagnostics’ Alzheimer's blood test was introduced into the clinic in October of 2020, a breakthrough healthcare innovation for patients, advocates, and physicians who have long awaited an easy to administer test that can help them better understand Alzheimer’s disease. C2N developed this groundbreaking test based upon longtime GHR partner Dr. Randall Bateman’s initial discovery of how to measure amyloid proteins in blood, validating its results in a clinical trial of 686 patients. 

From C2N Diagnostics: 

"C2N Diagnostics today announced its latest innovative offering for enhancing care in brain health: a high-resolution mass spectrometry-based plasma tau multi-analyte assay (p-tau MAA) for Research Use Only (RUO). 

This assay uses a small sample of blood to precisely and simultaneously measure different phosphorylated and nonphosphorylated forms of the tau protein, including forms with phosphorylation at the tau217 and tau181 sites. The assay draws upon prior discoveries by medical researchers that complex interactions among abnormal tau and beta-amyloid proteins and several other factors play a vital role in Alzheimer’s-related brain changes."

​Read more. 

From the NIH National Institute on Aging:

"As we mark the 10-year anniversary of the National Plan to Address Alzheimer’s Disease, which arose from the National Alzheimer's Project Act (NAPA), it’s striking to pause for a moment and consider how far we have come. Thanks to increased congressional funding, NIH spending on Alzheimer’s and related dementias research advanced nearly 4.5-fold between fiscal years 2015 and 2020, reaching $2.87 billion. This momentum has enabled NIA-funded science to take significant strides forward.

NIA small business innovation research funding helped validate and commercialize the PrecivityAD™ test, a more affordable and less invasive alternative to traditional Alzheimer’s tests like spinal taps or brain scans. This blood biomarker-based test is now widely available to doctors and researchers across the United States."

​Read more.

From the National Institute on Aging at NIH:
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Scientists have demonstrated that a new blood test can accurately predict the presence of beta-amyloid plaques in the brain, according to a new study funded in part by NIA. Published in Neurology, the study analyzed the ability of a blood test to predict the presence of Alzheimer’s disease-associated protein beta-amyloid in the brain. The new blood test, which performs comparably to existing brain scan- or spinal tap-based tests, could lower costs and expand the availability of diagnostic studies for Alzheimer’s disease.

Read more.

.From USA Today:

• New blood tests could offer easier way to detect signs of the disease in older adults with memory issues
• The tests may be helpful in identifying subjects for clinical trials or to screen for treatment.
• Alzheimer’s disease afflicts an estimated 6.5 million Americans.

As pharmaceutical companies spend hundreds of millions of dollars on a potential treatment for Alzheimer’s disease, other researchers are focusing on a more elemental question.

How can you tell whether a family member or loved one has Alzheimer’s or another form of dementia?

Read more.

A blood test developed at Washington University School of Medicine in St. Louis has proven highly accurate in detecting early signs of Alzheimer’s disease in a study involving nearly 500 patients from across three continents, providing further evidence that the test should be considered for routine screening and diagnosis.

The study is available in the journal Neurology.

“Our study shows that the blood test provides a robust measure for detecting amyloid plaques associated with Alzheimer’s disease, even among patients not yet experiencing cognitive declines,” said senior author Randall J. Bateman, MD, the Charles F. and Joanne Knight Distinguished Professor of Neurology.

“A blood test for Alzheimer’s provides a huge boost for Alzheimer’s research and diagnosis, drastically cutting the time and cost of identifying patients for clinical trials and spurring the development of new treatment options,” Bateman said. “As new drugs become available, a blood test could determine who might benefit from treatment, including those at very early stages of the disease.”

Developed by Bateman and colleagues, the blood test assesses whether amyloid plaques have begun accumulating in the brain based on the ratio of the levels of the amyloid beta proteins Aβ42 and Aβ40 in the blood.

Researchers have long pursued a low-cost, easily accessible blood test for Alzheimer’s as an alternative to the expensive brain scans and invasive spinal taps now used to assess the presence and progression of the disease within the brain.

Evaluating the disease using PET brain scans – still the gold standard – requires a radioactive brain scan, at an average cost of $5,000 to $8,000 per scan. Another common test, which analyzes levels of amyloid-beta and tau protein in cerebrospinal fluid, costs about $1,000 but requires a spinal tap process that some patients may be unwilling to endure.

This study estimates that prescreening with a $500 blood test could reduce by half both the cost and the time it takes to enroll patients in clinical trials that use PET scans. Screening with blood tests alone could be completed in less than six months and cut costs by tenfold or more, the study finds.

A commercial test based on Bateman’s research was certified in 2020 under the Clinical Laboratory Improvement Amendments (CLIA) program. The CLIA certification program is run by the Food and Drug Administration in partnership with the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services.

Known as Precivity AD, the commercial version of the test is marketed by C2N Diagnostics, a Washington University startup founded by Bateman and his colleague David Holtzman, MD, the Barbara Burton and Reuben M. Morriss III Distinguished Professor of Neurology. Bateman and Holtzman are inventors on a patent the university licensed to C2N.

CLIA certification makes the test available for doctors in the United States. It is intended to provide information that will aid the medical evaluation and care of patients who already have symptoms of cognitive decline. A similar certification makes the test available in Europe. The test is not yet covered by most health insurance.

The current study shows that the blood test remains highly accurate, even when performed in different labs following different protocols, and in different cohorts across three continents.

Scientists didn’t know if small differences in sampling methods, such as whether blood is collected after fasting or the type of anti-coagulant used in blood processing, could have a big impact on test accuracy because results are based on subtle shifts in amyloid beta protein levels in the blood. Differences that interfere with the precise measurement of these amyloid protein ratios could have triggered a false negative or positive result.

To confirm the test’s accuracy, researchers applied it to blood samples from individuals enrolled in ongoing Alzheimer’s studies in the United States, Australia and Sweden, each of which uses different protocols for the processing of blood samples and related brain imaging.

Findings from this study confirmed that the Aβ42/Aβ40 blood test using a high-precision immunoprecipitation mass spectrometry technique developed at Washington University provides highly accurate and consistent results for both cognitively impaired and unimpaired individuals across all three studies.

When blood amyloid levels were combined with another major Alzheimer’s risk factor – the presence of the genetic variant APOE4 – the accuracy of the blood test was 88% when compared to brain imaging and 93% when compared to spinal tap.

“These results suggest the test can be useful in identifying nonimpaired patients who may be at risk for future dementia, offering them the opportunity to get enrolled in clinical trials when early intervention has the potential to do the most good,” Bateman said. “A negative test result also could help doctors rule out Alzheimer’s in patients whose impairments may be related to some other health issue, disease or medication.”

C2N Diagnostics’ Alzheimer's blood test was introduced into the clinic in October of 2020, a breakthrough healthcare innovation for patients, advocates, and physicians who have long awaited an easy to administer test that can help them better understand Alzheimer’s disease. C2N developed this groundbreaking test based upon longtime GHR partner Dr. Randall Bateman’s initial discovery of how to measure amyloid proteins in blood, validating its results in a clinical trial of 686 patients. 

From Fierce Biotech:

A study of C2N Diagnostics’ blood test showed it could help predict which people may be at an increased risk for Alzheimer’s disease based on the level of amyloid proteins found in the brain. 
Typically, measuring those plaques has required PET scans, spinal taps or biopsies for cerebrospinal fluid to help spot these biological signs, which are thought to precede cognitive decline.
The study—which received funding from the National Institutes of Health and drugmaker Eisai and was presented at the Clinical Trials on Alzheimer's Disease conference—showed C2N’s PrecivityAD blood test was 81% accurate in predicting the levels of amyloid buildup that would be seen in a PET scan.

"Blood-based screening is a giant leap forward in detecting changes in the brain among people who do not yet show memory loss symptoms," Reisa Sperling, M.D., co-principal investigator for the study, said in a statement.

Aside from its potential use for screening the general public, C2N expects its blood test to help accelerate the recruitment of prospective Alzheimer’s patients into clinical trials for new therapies—a task that has traditionally been time-consuming and expensive, relying on more subjective examinations of cognitive symptoms. 

"New blood test technology can help identify those more likely to have Alzheimer's disease changes in their brains, which enables them to enroll in prevention or treatment trials as early as possible,” added Sperling, who serves as director of the Center for Alzheimer Research and Treatment at Brigham and Women's Hospital at Harvard Medical School.

Going forward, a clinical study that aims to enroll more than 1,100 participants will employ the Fierce 15 winner’s blood test to help screen people as young as 55 years old for high amyloid levels. 
Conducted in partnership with the Alzheimer's Clinical Trial Consortium and Biogen, the placebo-controlled, phase 3 trial will examine the ability of Eisai’s lecanemab antibody treatment to help clear those plaques from the brain over four-plus years.
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The Japanese Big Pharma has a longstanding development agreement for lecanemab with Biogen, whose controversial Aduhelm therapy for Alzheimer's disease received an accelerated approval from the FDA this past June. The regulatory nod was based on data tracking the destruction of amyloid plaques instead of a proven ability to slow cognitive decline—relying on the hypothesis that those protein buildups eventually coalesce into neurodegenerative symptoms. 

However, many other investigational therapies chasing amyloid's connection to Alzheimer's have failed to cross the regulatory finish line and demonstrate clinical benefit. Some proponents say success may be found in treating affected patients earlier, before the disease takes hold—and a more accessible screening tool such as C2N's blood test may make it easier to see whether that theory holds up.

This September, C2N expanded into a new CLIA lab testing facility in its home of St. Louis to help boost its clinical screening services. The PrecivityAD diagnostic, available in 49 states minus New York, employs liquid chromatography and mass spectrometry techniques to identify amyloid plaques and other proteins captured in a blood sample. The prescription test is intended for use in individuals experiencing memory and thinking issues.