ST. LOUIS--(BUSINESS WIRE)--C2N Diagnostics announced today that it has received a $20 million Program-Related Investment from GHR Foundation, an independent global philanthropy. The funds will position C2N’s Alzheimer’s blood test for entry into the clinic. The investment provides resources to build out C2N’s clinical laboratory testing facility in St. Louis, Missouri and to establish a premium quality, patient testing service. It also accelerates C2N’s efforts to secure an in vitro diagnostics (IVD) label for its first test – APTUS-Aβ™ with FDA and reimbursement by the Center for Medicare and Medicaid Services (CMS).
GHR Foundation “exists to be of service to people and their limitless potential for good”. The philanthropy has been a leader in providing critical support to some of the largest research efforts in Alzheimer’s prevention. With GHR’s most recent investment in C2N, the opportunity exists for introducing a simple, yet precise test to many individuals at risk for the development of Alzheimer’s disease.
“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. After a patient provides a sample of blood, the sample will be sent to C2N’s Clinical Laboratory Improvement Amendments (CLIA) certified lab facility for measurement. After analysis, C2N will report the results back to the patient’s doctor for sharing with the patient. The test will help doctors determine the likelihood that Alzheimer’s pathology is present. In addition to supporting C2N’s launch of the APTUS-Aβ™ 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.”
The APTUS™-Aβ blood test is an in vitro diagnostic under development for predicting brain amyloidosis as determined by PET scan results. It currently combines mass spectrometry-based quantification of plasma amyloid beta (Aβ) isoforms Aβ42 and Aβ40, ApoE status, and age to provide a probability score for the presence of amyloid pathology. C2N has shown that a lower plasma Aβ42/Aβ40 ratio correlates with brain amyloidosis determined by amyloid PET scans as well as other methods. Amyloid PET scans accurately detect amyloid plaques – one of the hallmarks of Alzheimer’s disease – and are used in the work up and management of people with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline. In early 2019, C2N was granted Breakthrough Device Designation for the APTUS™-Aβ test from the US FDA.
About C2N Diagnostics
C2N Diagnostics, LLC was formed by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, MO and LifeTech Research, a technology research and venture development firm. C2N is commercializing a panel of blood tests under the APTUS™ platform to enable early detection and progress monitoring of a variety of neurodegenerative disorders. C2N has also developed a portfolio of anti-tau antibodies (including ABBV-8E12) for the treatment of Alzheimer’s disease and other neurological disorders, and in March 2015 C2N formed a global partnership with AbbVie to develop and commercialize these antibodies. www.C2Ndiagnostics.com
About GHR Foundation
GHR Foundation is an independent philanthropy of service to people and their limitless potential for good. Alongside its partners around the world, GHR reimagines what is possible when pursuing impact on issues related to Children in Families, Education, Alzheimer's disease and more. For 50-plus years, the pioneering legacy of founders Gerald and Henrietta Rauenhorst has guided its optimistic and transformational philanthropic approach. www.GHRfoundation.org