September 2020
Vol 7 | Issue 337

Q&A with Elizabeth Donley, NeuroPointDX

CEO and Founder

Principal Series:

NeuroPointDx has developed a robust and reproducible proprietary platform for identifying changes in metabolism for diagnosis and more precise treatment of neurological disorders. These tests allow segmenting of complex neurological disorders, such as autism, into subtypes for earlier diagnosis and more precise treatment – similar to how cancer is diagnosed and treated based upon the biology of the tumor. The Company is commercializing the first diagnostic blood test for autism. The NPDX ASD Test was validated in an NIH funded clinical study, the Children’s Autism Metabolome Project (CAMP). CAMP is the largest study of the metabolism of children with autism ever conducted. The results have been peer reviewed and published in Biological Psychiatry in September 2018 and in Autism Research in June 2020.

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The Company is raising a Series C Preferred round but has $700,000 available on a convertible bridge note as well. The convertible note offers a 20% discount on the Series C as well as 8% interest.

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How will NeuroPointDX and the NPDX ASD Test revolutionize the way autism is diagnosed and treated?

NeuroPointDX is the first to develop a more precise way to diagnose and inform treatment of complex neurological disorders by segmenting them into subtypes based upon biology. Twenty years ago, cancer diagnosis and treatment underwent a similar process. Today, it is the standard of care to test the tumor for more precise diagnosis and treatment.

Parents and physicians often try interventions to treat autism ranging from modified diets and dietary supplements to attention deficit medicines and psychotropic drugs but there is no precision in how these interventions are chosen. NeuroPointDX is revolutionizing how interventions are chosen for more precise treatment with its diagnostic tests.

Like Foundation Medicine and Myriad’s genetic tests have revolutionized cancer diagnosis and treatment. NeuroPointDX’s metabolism-based tests will revolutionize diagnosis and treatment of notoriously hard to diagnose and treat brain disorders.

Autism Spectrum Disorder is recognized for the diverse cognitive, behavioral and genetic profiles of persons living with autism and yet, very little is done to identify treatments that address the underlying biology of the disorder. Autism is now diagnosed in 1 in 54 children in the US. This means each year 75,000 children are diagnosed and added to the 3.5 million people in the US living with autism. Earlier and more precise intervention can change outcome and improve the lives of children and families. NeuroPointDX’s approach allows diagnosis as young as 18 months and helps to identify differences in metabolism that can inform treatment.

What is the plan to complete the clinical development and commercialize the NPDX ASD Test?

The Company has met many important de-risking milestones. It has already completed clinical validation of its flagship autism diagnostic tests, published the results in two peer reviewed journals and obtained regulatory approval. NeuroPointDX operates a CLIA and CAP accredited laboratory in Madison, Wisconsin where its tests are currently being offered in a beta program to a limited number of doctors.

The Company is raising $10,000,000 to build a small commercialization team in two key markets and to hire customer care staff for a full-scale commercialization of its autism diagnostic tests in early 2021. The Company is in discussions with several large diagnostic companies to establish a national distribution contract for full-scale commercialization of its diagnostic tests.

What’s next in the product development pipeline for NeuroPointDX?

Anxiety and depression are another area of huge unmet need. The current standard of care lacks precision in treatment selection which can result in patients becoming more depressed and suicidal. NeuroPointDX is beginning a project in bipolar disorder in collaboration with University of Michigan Medical School as a place to begin understanding the underlying biology of these brain disorders. NeuroPointDX also plans to bring its novel approach to schizophrenia, Alzheimer’s and Parkinson’s disease.

Elizabeth Donley, NeuroPointDX

Elizabeth Donley, JD, MBA, MS, Chief Executive Officer, is a C-suite executive, lawyer and scientist. This multi-faceted leader brings a wide variety of skills with deep domain expertise in intellectual property, business and securities law, finance, and biotechnology. Her diverse experience allows her to identify opportunities, make connections and provide innovative solutions. As the parent of a young man with autism, she knows firsthand about delays in diagnosis and searching for solutions and treatments. It is with this lens that Ms. Donley built NeuroPointDX. Currently, as President and CEO, Elizabeth combines every facet of her diverse experience. Raising capital, building market strategy, leading execution of complex strategic partnerships and moving scientific innovation from discovery through clinical validation and regulatory approval to market.

Previously, Elizabeth was the General Counsel and Director of Business Development for the Wisconsin Alumni Research Foundation (WARF), a $3 billion non-profit responsible for patenting and licensing technology developed at the University of Wisconsin-Madison. During her tenure, she was responsible for founding and leading both WARF subsidiaries, WiCell Research Institute, which served as the NIH National Stem Cell Bank; and WiSys Technology Foundation, which patents and licenses technology developed at the other University of Wisconsin System schools. She led the initiative to establish the Wisconsin Institutes for Discovery and the Morgridge Institute for Research, a $400 million research institute. Contact Beth: