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 Alzheimer's Disease
ROCKVILLE, Md.–(BUSINESS WIRE)–SYNAPS Dx (SDx), a privately held company focused on the research, development and commercialization of diagnostics for neurodegenerative disorders and conditions, including Alzheimer’s Disease (AD), announces the close of its 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. As payers examine 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.
Frank Amato, CEO and president, SDx, says, “Following decades of research and development, including the involvement and dedication of leading, world-class scientific research teams, statisticians and analysts, we are thrilled to close our series A financing. Investor receptivity and confidence in our breakthrough solution allows us to bring a timely, accurate diagnosis of AD to the marketplace. As we meet a significant unmet market need to potentially reduce the economic burden of AD across the healthcare system, our market entry could not have come at a better time — as demand for early-stage diagnosis is at an all-time high. The emergence of new drugs and therapies has intensified payer focus on approving and prescribing the most appropriate, cost-effective treatment.”
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. 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.
Dr. Daniel Alkon, chief scientific advisor, SYNAPS Dx, explains, “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.”
Alkon says that the 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 over 300 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, thereby, enhance peace of mind to more patients and families.”
About SYNAPS Dx
SYNAPS Dx is privately held company focused on the research, development and commercialization of diagnostics for neurodegenerative disorders and conditions, including Alzheimer’s Disease. The Company offers DISCERN™, the first accurate, minimally invasive test for the definitive diagnosis of Alzheimer’s disease (AD) versus other forms of dementia. SYNAPS Dx’s laboratory in Rockville, MD is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing.