SYNAPS Dx Completes $10 Million Series A Investment
Accelerates Commercialization of DISCERN™: First Minimally Invasive Test for Accurate Diagnosis of Alzheimer’s Disease
There are approximately 500,000 new cases of dementia each year in the United States, with about 2 million patients in years 0-3 of the disease at any given time. With the emergence of new drugs and therapies intensifying payer focus on approving and prescribing the most appropriate, cost-effective treatment for Alzheimer’s disease (AD), SYNAPS Dx (SDx) is poised to make a substantial difference.
We have achieved a significant milestone by closing the Series A $10 million investment, including private equity, individual and family funds, and corporate investors. Proceeds will be used to scale-up production and meet market demand for DISCERN™, the first autopsy-validated, highly accurate, minimally invasive test for the definitive diagnosis of AD versus other forms of non-AD dementias and those with AD and other degenerative pathologies.
DISCERN has been granted breakthrough designation by the FDA and a de novo will be submitted. The data supporting the DISCERN assays have been published in neurology and AD focused peer-reviewed publications, including Science, Proceedings of the National Academy of Sciences of the USA (PNAS), Journal of Alzheimer’s disease. As a Laboratory Developed Test, DISCERN is the first AD test of its kind to earn Proprietary Laboratory Analyses (PLA) Codes 206U and 207U. According to the American Medical Association CPT® Editorial Panel, which approves this code set, PLA codes are alpha-numeric CPT® codes with a corresponding descriptor for labs or manufacturers to more specifically identify their test. Tests with PLA codes must be performed on human specimens and must be requested by the clinical laboratory or manufacturer that offers the test. With more payers examining the cost and impact of new drugs and therapies for AD, DISCERN is positioned as a critical, essential component of patient-centric, value-based strategies.
Meeting Significant Market Need
After decades of research and development, including the involvement and dedication of leading, world-class scientific research teams, statisticians and analysts, investor receptivity and confidence in our breakthrough solution allows us to bring a timely, accurate diagnosis of AD to the marketplace.
Our goal is to meet a significant unmet market need to potentially reduce the economic burden of AD across the healthcare system. With demand for early-stage diagnosis of AD at an all-time high, our market entry could not come at a better time.
Our competitive barriers to entry include the SDx strong global IP portfolio and autopsy-validated clinical data, which takes many years to collect and confirms that the test is highly accurate with 95% sensitivity/specificity for diagnosing AD.
Strong Clinical Data
DISCERN reflects 30 years of research at the National Neurologic Institute, NIH to map the molecular pathways that create memory with mechanisms that are conserved across evolution, i.e. from marine snails progressing through mammals, with confirmation provided by a collaboration with the Harvard Brain Bank.
This research demonstrated that the protein PKC-Epsilon is a Synaptic Growth “Master Switch” for memory formation. Furthermore, for more than a decade at the Rockefeller Neurosciences Institute, researchers conducted a series of human subject studies—culminating in autopsy-validated trials—and correlated AD-specific changes to the PKC-Epsilon cascades, which could be identified through deficiencies in skin fibroblast networks.
R&D showed that AD often presents with the loss of recent memory with phenotypical expression taking place in the brain, but also with pathophysiological expression peripherally.
This research, which has been published in many peer-reviewed papers, resulted in the development of three SDx AD biomarkers that accurately identify and distinguish AD. These results were validated using the NIH “Gold Standard” of dementia in life and autopsy confirmation of amyloid plaques and neurofibrillary tangles.
Because so many people are touched in some way by AD, we hope DISCERN will help guide drug discovery, development and dosing and, as a result, enhance peace of mind for more patients and families.
To learn more visit https://discerntest.com/.