BioROSA: Early Blood Test for Autism

BioROSA is building a blood-based test for diagnosing autism. Autism currently is diagnosed at age four, on average, with behavioral testing. Children are missing critical windows of opportunity where early diagnosis and access to treatment could improve prognosis. At BioROSA, we are mission-driven to enable earlier detection, potentially even before the child is born, in order to achieve better outcomes for children.

What got you into autism research?

John: It started way back in high school as one of my best friend’s brother has a severe form of autism. Seeing such an impaired person at an early point in my life made me wonder what could make the brain function that way, and this led me to do a lot of different neuroscience work in college. I was working on clinical studies in neurology and rehabilitation medicine for stroke and traumatic brain injury patients at UPenn for a while after college, doing some really cool brain imagining research. At Arkansas Children’s Hospital, where I worked from 2010 to 2017, I got involved in cutting-edge autism research and clinical operations while working on clinical studies involving biomarkers for detection and studies aimed at developing treatments to address core symptoms of autism. While at Arkansas Children’s, our team created one of the leading clinical and research operations in this country. It was an amazing group of scientists committed to improving patients’ lives, and the mission and values of that team live on in BioROSA. We highly value these collaborations and relationships with excellent clinicians and researchers.

What prompted you to start the company and how did you meet your co-founders?

John: Working in academia, I was frustrated with how slowly research and development progressed, and I was introduced to entrepreneurship and startup culture at a time when I was losing my passion for academic research. While we were doing amazing, cutting-edge research and changing lives for patients in the clinic, the pace of the work and the inability to treat or see patients from around the world who couldn’t afford to come to see us clinically was really heartbreaking. Though we were seeing amazing outcomes and were publishing a lot, we were too boxed in from an administrative perspective and I started to feel that we weren’t doing enough for patients in need. I feared we would never be able to truly address the autism problem from inside the walls of academia, something needed to change in order for advancements to occur. Thus, BioROSA was born. We have licensed intellectual property to commercialize a novel diagnostic test that can transform autism clinical care and diagnosis. What’s amazing is that our technology is based on what I worked on in Arkansas with a scientist I truly admire and adore, Dr. Jill James.

In working to find a co-founder for BioROSA, I had researched companies who had previously tried to do something similar. One of the most noteworthy was a company called SynapDx, in which Dr. Marie Causey was a co-founder, and when I contacted her she luckily happened to be available. It was serendipitous that she was interested in becoming co-founder and CSO at BioROSA, Marie’s experience in the startup world, in establishing diagnostic labs, and in developing clinical tests is a great fit. We make probably an unorthodox but great co-founding team. We bring different perspectives and she holds me accountable and practical for my big picture dreams!

Let’s talk about your technology. What is the key insight and how did you come up with this diagnostic?

John: We have a body of research based on over 15 years of data in which metabolic systems have been consistently shown to be abnormal in patients either diagnosed with or at risk for autism. Dr. Jill James, another co-founder in BioROSA, made the key biomarker discoveries, but the breakthrough came when our SAB member and collaborator Dr. Juergen Hahn applied machine learning to come up with a robust classification algorithm. We have obtained a global exclusive licensed to Dr. Hahn’s IP from RPI. Juergen is our number one champion and a constant contributor that is extremely hands on.

During the IndieBio program, what are some lessons you’ve learned transitioning from scientists to entrepreneur?

John: First off, I don’t consider myself to actually be a scientist but more an entrepreneur with a passion for science and improving healthcare for patients. I’m fortunate to be surrounded by amazing scientists on our team. As far as lessons learned? You must really get out there, hustle, and be a constant driving force in order to ensure your company has a chance of success. As Arvind said from day one, “nobody cares”. It is your job as a founder to make them care and show why you will change the world and why your team is the capable group that can get things done. You must have extreme perseverance, resilience, structure, organization, meticulous thinking, and as much as I hate it, patience, in order to get things going and for you to position your company into the best chance to take flight. I think that really getting outside of the office, really trying to promote your business, knowing what your customers really want, and trying to promote your cause can go a long way in getting that initial traction. Once you start figuring these things out and getting those first bits of traction can be a pivotal inflection point for your ultimate ability to scale, grow, and succeed.

How do you think the success of your company will change the way autism is currently being diagnosed?

John: We will provide clinicians with a much-needed tool that is missing in the current process for determining who’s at risk for autism and to get at-risk children into services faster than is possible today. In a way, this allows the system to be more proactive instead of reactive in diagnosis and treatment. The ultimate goal is to create opportunities that can lead to prevention, or at least more optimal outcomes, for children.

What are the milestones you’re hitting in the near future?

John: Our first milestones is to conduct a prospective clinical trial of 800 patients in a multicenter study within the next 18 months to bring our first product, an ASD screening tool, to market. The success of this opens the way for the development of our flagship product, a pediatric ASD diagnostic test that will detect autism before children ever develop behavioral symptoms. We plan to secure contracts with pharmaceutical partners to conduct studies to demonstrate the clinical utility of our test as a companion diagnostic for ASD therapeutics as well and to create a new standard of care based on biology (instead of behavior) for this challenging disorder.

Watch BioROSA pitch on IndieBio Demo Day, Tuesday Nov. 6th in San Francisco or via LiveStream. Register here!

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