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."

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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."

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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.

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.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.

From Business Wire:  

“A pressing need exists for affordable and accessible testing in dementia care,” stated Joel Braunstein, MD, CEO of C2N. “We are highly appreciative of GHR Foundation’s partnership.  With their support, GHR is enabling a future that positively impacts the fate of Alzheimer’s in people at risk for the disease. Earlier detection will improve clinical care and facilitate new ways to change the course of disease through treatment and prevention.” 

C2N expects to soon be able to provide practicing clinicians with a blood test that they can order for their patients who are showing early signs of memory loss.  The test will help doctors determine the likelihood that Alzheimer’s pathology is present. In addition to supporting C2N’s launch of the APTUS-A™ test under CLIA, GHR’s funding will also fuel C2N’s global growth and pipeline of other neurologic diagnostic tests. 

 “C2N’s entrepreneurial mindset combined with their deep commitment to help patients are central to GHR’s goal of Alzheimer’s prevention,” stated Amy Goldman, CEO and Chair of GHR Foundation. “We are delighted to support the team and look forward to serving their potential as, together, we reimagine what’s possible in preventing this disease.”        

From The Times: 

"A simple blood test that can detect the onset of Alzheimer’s has been developed by scientists in a breakthrough for combating the disease.

The test could speed up diagnosis in GP surgeries and boost the development of drugs to tackle the condition. At present there is no effective treatment but the illness will affect 600,000 Britons by 2025.

Researchers showed that the test had more than 90 per cent accuracy in spotting toxic proteins in the brain that can be an early indication of the disease. This could enable doctors to identify the illness before memory loss or mental decline."

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