C2N Diagnostics Announces Follow-on Investment from GHR Foundation as It Builds on Success in Novel Diagnostics to Aid in Alzheimer’s Disease Fight

ST. LOUIS — February 16, 2023 — C2N Diagnostics, LLC, a leader in advanced brain health diagnostics, today announced it has received a $15 million program-related investment from GHR Foundation. This financing, an expansion of GHR’s initial $20 million program-related investment to C2N in early 2020, signifies the foundation’s deep commitment to the company and to reducing the global burden of Alzheimer’s disease through early detection and prevention.
 
C2N will allocate the additional GHR funding to support its newest generation blood test, PrecivityAD2™, which is expected to perform with similar accuracy to PET imaging and cerebrospinal fluid analysis, but with considerably better accessibility, affordability, and logistical ease. The company also will conduct additional clinical studies to continue building real-world evidence around the use of the PrecivityAD® and PrecivityAD2™ blood tests in clinical care. The investment will enable broader market access, expanded medical education, biomarker pipeline development, and infrastructure growth to facilitate global expansion.
 
C2N also will invest capital to expand workflow efficiencies to prepare for higher testing volumes and substantial growth in the commercial demand for its family of Precivity™ blood tests.
 
C2N recently marked the two-year anniversary of the launch of the PrecivityAD® blood test. The PrecivityAD® blood test is the first to be a widely accessible blood test that assists healthcare providers with Alzheimer’s diagnosis. GHR’s support was an essential part of C2N’s success in positioning the PrecivityAD® blood test for entry into the clinic.
 
“As a hope-fueled global funder in service to people and their limitless potential for good, GHR Foundation is honored to partner with the C2N Diagnostics team and bolster the difference they’re making in the lives of patients and families dealing with the uncertainty of an Alzheimer’s diagnosis,” says Amy Rauenhorst Goldman, Chief Executive Officer and Chair of GHR Foundation.
 
As part of the financing, Fred Miller, GHR’s Chief Operating Officer and Managing Director of Biomedical Programs, will become a Board Observer to C2N. Mr. Miller says, “C2N has made great progress since our initial program-related investment in 2020. GHR continues to believe that C2N’s technology will play a critical role in the early and accurate diagnosis of Alzheimer’s disease. We look forward to deepening our partnership with the C2N team and supporting the next phase of their work.”       
 
Dr. Joel Braunstein, C2N president and CEO, says, “We thank Ms. Goldman, Mr. Miller and the entire GHR Foundation team for their tremendous support that will allow us to continue leading the way in biomarker innovation and quality. Our team is committed to helping patients with cognitive impairment receive a timely and accurate diagnosis so that they may begin a proper treatment plan. Having GHR Foundation by our side enables us to amplify our impact and global presence, thereby, bringing us one step closer to realizing our full ambitions.”

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.

GHR partner C₂N Diagnostics, a leader in advanced brain health diagnostics, has entered several important partnerships in the last quarter that will advance access to its PrecivityAD blood test. The PrecivityAD test is an innovative new blood test intended for use in patients with cognitive impairment. The test aims to help healthcare providers determine the presence or absence of amyloid plaques in the brain, a hallmark sign of Alzheimer’s disease.

Two of these new partnerships expand access to the test in Brazil and Australia. In Brazil, C2N is partnering with Grupo Fleury, one of Brazil’s leading healthcare companies. The partnership will introduce the most advanced set of plasma biomarkers to detect changes that indicate the presence of Alzheimer’s disease pathology in patients experiencing memory difficulties. In Australia, a partnership with Healius Ltd, one of Australia's leading listed healthcare companies, will enable the use of C₂N’s PrecivityAD blood test and related brain health biomarkers in memory and dementia care.

In addition, C2N and Eisai, Inc. are partnering to build awareness about how blood-based assays for cognitive impairment, including Alzheimer’s disease (AD), may help patients receive a timely diagnosis and appropriate treatment, especially in traditionally underserved communities. The development and adoption of blood-based assays in everyday clinical practice is an important step in improving care for people in remote and underserved communities where access to the traditional diagnostic tools of positron emission tomography (PET) and lumbar punctures are not viable options. 

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. 

Learn more about C₂N Diagnostics’ partnerships.

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. 

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.
​
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.

C2N Diagnostics’ Alzheimer's blood test has been introduced into the clinic, 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. Earlier this year, GHR made a Program-Related Investment (PRI) in C2N to provide the resources necessary to develop and launch this innovation. 

The test is a highly sensitive blood test using mass spectrometry and is performed in C2N’s CLIA-certified lab. While the test by itself cannot diagnose Alzheimer’s disease — which is a clinical diagnosis made by a health care provider — the test is an important new tool for physicians to aid in the evaluation process. 

Joel B. Braunstein, MD, CEO of C2N says, “Our mission is to translate exceptional science into unique diagnostics that can help as many people as possible. This blood test introduces a new option for patients, families and the medical community that have eagerly awaited innovative tools to address Alzheimer’s troubling problems.” 

GHR Foundation is partnering boldly with a consortium of government, industry, academic research and other philanthropists on a game-changing undertaking – the prevention of Alzheimer’s disease. Learn more here.  

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.”