“It’s one thing to have an exciting technology, even one with strong unmet clinical needs. It’s another thing entirely to get a code and convince someone to pay for it.”
In 2021, Polaris Genomics won the Inaugural SLS SE Color Pitch Competition for its novel approach to identify earlier, and more effectively diagnose and treat, mental health disorders.
From our 2021 spotlight, “The current system lets people fall off the cliff while the ambulance waits at the bottom,” Charles said. “We’re building guardrails to intervene ahead of the tragic outcomes that come from undiagnosed, untreated mental health disorders.”
In the past two years, the Polaris team continues to forge ahead through a variety of industry partnerships, including a direct approach to reimbursement strategy with Ilumina and Optum Genomics.
“We’ve been working hard to get our initial, 250 patient datasets analyzed, including our machine learning and AI component, to develop our model and algorithm for identifying the RNA pattern in those individuals most likely to have PTSD versus another condition,” Polaris Genomics Co-Founder and CEO Charles Cathlin said. “Last year we hired Dr. Rick Herrera as Chief Data Science Officer to lead these efforts, expanding our capabilities and accelerating our clinical and commercial pathways.”
“Partnerships with the Canadian Military, the United States Air Force and Army, organizations we certainly see as future customers, represent solid market validation for our technology and directly support additional validation next steps.”
In 2022, Polaris was selected to support the U.S. Department of Veterans Affairs “Mission Daybreak” suicide prevention grand challenge to support their path forward as well, with strong potential to add another VA [site or program] for a clinical validation study in the near future.
Accelerating Innovation Adoption Through “Arm-In-Arm” Payer Collaboration
Of significant interest to those following Polaris’ story, especially prospective investors, Polaris Genomics was selected as the inaugural participants in Illumina and Optum Genomics’ Clinical Catalyst Program.
“Launched in 2022, Illumina and Optum Genomics are collaborating to identify and accelerate new applications of genomics that have the potential to improve patient care and health outcomes. The Clinical Catalyst Program intends to identify promising applications, evaluate the test evidence for clinical validity and clinical utility, and support clinical readiness and patient access through evidence planning.
“The motivation for this program is the realization that companies utilizing Illumina’s technology for development of innovative applications face market access challenges. Often, coverage requests for genomic tests arrive at payer discussions with an incomplete or unclear value proposition or intended use. Through this program, Illumina aims to identify and assess the fitness of innovative clinical applications along with recommendations for more effective market access strategies.”
“Medical reimbursement plays a huge role in our business model,” Cathlin said. “It’s one thing to have an exciting technology, even one with strong unmet clinical needs. It’s another thing entirely to get a code and convince someone to pay for it. Our work with Illumina, Optum and the Catalyst Program provides direct insight into what a payer wants and needs for successful entry and adoption into the commercial payer market.
“How is a new technology, especially a diagnostic, going to change existing clinical practices and flows? Will it translate into the best treatment pathway faster? Will it ultimately reduce costs to the system including the patient and payer? That’s what they want to know and that’s what we’re working to prove directly with a party potentially responsible for payment.”
Earlier this year, Polaris also entered JLabs@Washington, DC, Johnson & Johnson’s newest life science incubator, to explore ways Janssen’s neuroscience division can use Polaris’ technology for analysis of prospective depression therapeutics.
Fundraising To Ensure Life To Fight Another Day, As Many Days As Possible
“Beyond our clinical validation and reimbursement activities, we are currently raising a $10 million price round intended to supplement our current revenue and non-dilutive funding sources like a recent AFWERKS Phase II $1.25 million award. The upcoming funding round will support continued product development efforts, regulatory and reimbursement efforts for product/market fit and personnel to generate additional revenue from our available Discovery Platform in advance of the ultimate availability of our clinical product for PTSD screening.”
Interested parties should contact info@polarisgenomics.com for more information.
Southeast Life Sciences applauds Polaris Genomics’ work and thanks the team for helping us share their story here.