Polaris Genomics’ Platform Is Modernizing Mental Health with Molecular Biomarkers
The company’s successful identification of biomarkers for post-traumatic stress disorder (PTSD) has evolved into mapping molecular biomarkers for a wide range of mental health diagnostics and novel therapeutics.
Written by Logan Plaster
Origin Story: A Seed Planted at Ground Zero
Some healthcare startups are born quickly, a lightning bolt eureka moment followed by a frenzy of activity. The story of Polaris Genomics is more like a slow growth tree, moving from the seed of an idea to a fruitful startup 20 years later.
It started just after 9-11, 2001, at Ground Zero in Manhattan.
Charles Cathlin deployed to New York City to help with recovery after the terrorist attacks as a US Public Health Service officer. He was charged with protecting his unit from environmental hazards, a role he’d served many times before as an Air Force engineer. It was a job well suited to an engineer: study the environment and the potential risks – whether a dangerous gas or harmful dust particles – and take precautions to keep people safe.
At Ground Zero, however, Cathlin came face to face with an environmental harm he couldn’t prevent, measure, or treat: trauma.
He was familiar with post-traumatic stress disorder (PTSD) and depression. He’d seen it in friends and family and fellow servicemen and women. But for the first time, Cathlin grappled with the unique clinical challenge of diagnosing and treating mental health conditions. The standard of diagnosis for conditions like PTSD and depression is observational, based on symptoms and self-reporting.
Cathlin, the engineer, felt there had to be a better way. There needed to be a more reliable, objective way to identify mental health challenges at the source, not just through outward symptoms. Solving this problem could not only improve the kinds of treatments offered to people in distress but also destigmatize the whole process.
The Winding Path
At first, Cathlin was a man who’d identified a problem but had no solution. So he went to work, intentionally building up the experiences and networks necessary so that when the time came to launch a startup, he’d be ready.
The first layer was a stint at the FDA where Cathlin worked on medical devices. Then he specialized in neurology devices, going deep into brain tech. Still, he found no clear solution to his question.
Next, he went back to school for a master's in public health. During this time, he studied all of the current military psychological health programs. He reviewed about 70, and none had a way to prove that they were working.
“All they had were patient satisfaction surveys,” says Cathlin. So the search for objective measurement tools continued.
He returned to the FDA as Chief of Neurology and enrolled in a life sciences entrepreneurship program at the Johns Hopkins Carey School of Business. At Hopkins, he once again focused on the gap in mental health research and care. But this time, he was ready to take action.
Cathlin culled through research databases to find any untapped intellectual property that included mental health biomarkers. Eventually, he was introduced to the work of a psychiatric researcher in New York City. For years she’d studied the effects of trauma in the brain and how trauma changes a person at a genetic level. She’d made critical connections between mental health conditions and RNA expression, connections that could lead to novel diagnostic tests. Cathlin found the missing link.
“What got me excited was that there was an actual biomarker to identify who actually had post-traumatic stress disorder,” says Cathlin. “The fact that you can introduce an objective tool to that process was a game changer.”
Polaris Takes Form
From what he could tell, this was amazing research and intellectual property in need of a commercialization strategy. So, in 2017, he made his pitch and won the right to license the IP for a new company he called Polaris Genomics, a nod to the North Star that sheds light on the pathway to liberation.
Progress accelerated at Polaris. Cathlin recruited co-founder Anne Naclerio, MD, MPH, a physician who’d served for 30 years in the US Army, including a stint as Chief Surgeon for the Army National Guard. The team was accepted into the Illumina Accelerator program, which is the “big dog on the block for all sequencing tech,” says Dr. Naclerio. “That’s really where our targeted neuropsychiatric RNAseq panel was born,” she added.
After finishing with Illumina Accelerator, the team was able to build out their blood-based biomarker model for PTSD, which led to two patents and more of their own IP.
“Think of your DNA as the blueprint,” explains Dr. Naclerio. “Your DNA gets expressed as RNA, which tells the proteins how to behave. The DNA does not change very much, and proteins change very rapidly, so we feel like RNA is the sweet spot. RNA does change, so it can be used to diagnose conditions, follow disease progression, or predict response to treatment, but it doesn’t shift so quickly that it’s hard to read. Beyond mental health diagnostics, RNA’s utility in pharma for mental health drug development has, until now, been untapped.”
Next Steps
Polaris is introducing a new methodology to the world of mental health R&D, diagnostics, and drug development that will revolutionize care and expand beyond the limits of the DSM-5.
But Cathlin and his team are quick to add that conditions like PTSD and depression are just the tip of the iceberg. In 2024, Polaris Genomics won an innovation challenge that expedited the company’s evolution from diagnostics to proprietors of a novel neuropsychiatric biomarker discovery platform. Polaris is becoming a resource for researchers who want to bring biological clarity and objectivity to the assessment, diagnosis, and treatment of mental health and neuropsychiatric conditions. They’re currently working with partners to validate use cases in neuropsychiatry conditions and psychiatric drug development.
“The utility of our ADAPT Platform has immense potential across clinical and pharmacologic use cases,” says Cathlin. “We use the same tools but apply them in different ways.”
Polaris has raised over $4.5 million dollars and has earned some early revenue using its platform to support brain injury research.
“We are leading a dawn of new therapeutic tools for neuropsych and mental health conditions,” says Cathlin. “We can really expedite the development of effective, novel drugs, and of precision mental health as a whole.”
“We can finally have parity between how we diagnose and treat mental health conditions and how we treat the rest of the body. Mental health isn’t just ‘in your head.’ It isn’t just something subjective you can walk off. These biomarkers will help reinforce that reality, and get people the care they need.”
That means less suffering in silence and more of getting the care people need, when they need it.
Join us in welcoming Charles Cathlin, Dr. Anne Naclerio, and the Polaris Genomics team into the StartUp Health community.
Connect with Polaris Genomics via email
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Published: Feb 6, 2025
