C2N Year in Review
Letter from the CEO Dr. Joel Braunstein
On behalf of the C2N Diagnostics team, I hope this letter finds all our friends and colleagues in a festive mood during this holiday season. The end of the year is an ideal time to reflect on what the entire Alzheimer’s disease field has accomplished in 2024; there are many reasons to be proud and hopeful.
Journal of the American Medical Association (JAMA) published a large clinical study examining the ability of the PrecivityAD2™ Amyloid Probability Score 2 (APS2) algorithm to improve the diagnostic accuracy of Alzheimer’s disease (AD) in primary care settings, where most patients with cognitive concerns turn to for initial answers about their memory loss. The study found similar robustness for the APS2 algorithm in patients who saw memory care specialists. The APS2 algorithm delivered a highly statistically significant accuracy of over 90% at a pre-defined, single binary cutoff compared to cerebrospinal fluid (CSF) analysis or amyloid PET analysis.
The article, “Blood Biomarkers to Detect Alzheimer’s Disease in Primary Care and Secondary Care,” also stated that these results involving over 1,200 patients were substantiated despite a relatively high rate of medical comorbidities such as cardiovascular disease, high cholesterol, chronic kidney disease, and diabetes among prospectively enrolled patients in both primary and secondary care. This study was among the most viewed articles of JAMA in 2024, highlighting its impact on a global scale and the significant interest in new clinical pathways for better and earlier AD detection.*
U.S. Food and Drug Administration’s approval of donanemab (Kisunla™)** for the treatment of early AD was a vital development. This new drug approval follows on the heels of lecanemab’s (Leqembi®)*** approval by FDA in 2023 and further improves the access of innovative treatment options for many patients dealing with early AD. Researchers used C2N’s Precivity-p-tau217 blood biomarker in its Phase 3 clinical trial and analysis for donanemab, which was highlighted in the article “Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial” in JAMA.
C2N Diagnostics announced its participation in an accurate diagnosis initiative from the Davos Alzheimer's Collaborative (DAC). DAC has launched a global effort to streamline the diagnosis of Alzheimer’s disease and related dementias (ADRD). As a partner in this initiative, healthcare providers use C2N’s blood biomarkers.
In a major technology milestone and a move that we believe will have an impact on our Precivity™ blood tests on a truly global scale, we announced our plans to create a fully automated, standardized, high-resolution liquid chromatography-mass spectrometry (LC-MS) platform with invitro diagnostic tests to enable the local deployment of C2N’s precise innovation in its clinical and research biomarkers for use in clinical reference labs.
C2N received a minimum of $25 million and up to $37 million in financing from partners. This included a $15 million program-related investment from GHR Foundation (GHR) to support the next generation of highly innovative tests specific to neurofibrillary “tau” tangle pathology. The Alzheimer’s Drug Discovery Foundation’s (ADDF) Diagnostics Acceleratorinitiative, which is focused on efforts to develop cutting-edge biomarkers and novel diagnostic technologies that aid in the early detection and diagnosis of Alzheimer’s and clinical trial design, provided up to $7.025 million.
Throughout the year, C2N was proud to highlight other research findings. On behalf of the QUIP II investigators, I highlighted the following at the recent Clinical Trials for Alzheimer’s Disease (CTAD) conference in Madrid:
With the PrecivityAD2 blood test, clinicians’ diagnostic confidence in Alzheimer’s disease rose from approximately 50-60% to over 90%, guiding treatment decisions and reducing unnecessary testing.
Patients with a negative APS2 score (which would be inconsistent with an Alzheimer’s disease diagnosis) had an over 70% reduction in drug use (drug used for AD care).
Patients with a positive APS2 score (which would be consistent with an Alzheimer’s disease diagnosis) had a 35%re increase in drug use (drug used for AD care).
Clinicians prescribed the blood test in high accordance with its intended use criteria.
This year, we also entered into a non-exclusive agreement with Mayo Clinic Laboratories for inclusion of the Precivity tests in Mayo Clinic Laboratories’ test offerings to its clients and an exclusive partnership with Unilabs to bring the Precivity tests to 75 countries throughout Europe and around the world. We also announced a partnership agreement with Mediford Corporation, a PHC Holdings Corporation (TSE 6523) Group Company and premier provider of clinical research to the biopharma industry throughout Japan. The agreement further enhances access to C2N Biopharma Clinical Research Services, which offers highly sensitive mass spectrometry-based identification, quantification, and monitoring of proteins, protein fragments (peptides) and other biomolecules implicated in human neurological diseases and overall brain health.
The next 12 months promise plenty of opportunities to engage with healthcare providers and share additional details about the role of the Precivity blood tests in detecting amyloid plaques in the brain, a pathological hallmark of Alzheimer's disease, and to inform medical management and treatment decisions. Importantly, we’ll discuss the importance of biomarker ratios that the Precivity tests rely on, intended to improve robustness of test results across diverse patients of different ages, comorbidities, races, and ethnicities.
Beyond our lab and conference settings, we’re excited to announce that C2N is a sponsor of “Taking Care,” a documentary following the journey of acclaimed filmmakers Seth Rogen and Lauren Miller Rogen as they navigate the complexities and heartbreak of Lauren’s mother’s advancing Alzheimer’s disease. Through humor, heart, and an unwavering commitment to change, Taking Care imparts a message of hope, resilience, and the profound impact individuals can have when they seek solutions to society’s greatest challenges. Learn more at www.takingcarefilm.com.
All of us at C2N wish you the best for the holidays and the year ahead.
*JAMA Network Online E-Update, December 13, 2024
**KISUNLA™ is a trademark of Eli Lilly and Company
***LEQEMBI® is a registered trademark of Eisai R&D Management Co., Ltd.
About C2N Diagnostics, LLC
C2N Diagnostics is a specialty diagnostics company with a vision to bring Clarity Through Innovation™. C2N strives to provide exceptional laboratory services and products in the field of brain health. C2N’s biomarker services and products are used for: clinical decision making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health. For more information visit www.C2N.com.