Immunexpress is a company creating molecular diagnostics for sepsis. Its product pipeline aims to address the overwhelming unmet clinical needs of sepsis patients, clinicians, payers, and healthcare systems. Pulse 2.0 interviewed Immunexpress CEO Rollie Carlson to learn more about the company.
Rollie Carlson’s Background
What is Carlson’s background? Carlson said:
“Growing up by the ocean and having a longtime interest in scuba diving led me to a Ph.D. studying toxic marine dinoflagellates in the Caribbean and their role in ciguatera poisoning. After earning my degree, I started my industry career at Abbott Laboratories, which were looking to develop natural products from marine environments in their programs, leading to a 20-year career in medical device R&D.”
“After transitioning into leadership roles at the company, I had an opportunity to lead the molecular diagnostics firm Vysis as an affiliate of Abbott after it was acquired. During my time at Vysis, the revenues grew >45% per year, and we secured key FDA clearances for several molecular diagnostic tools, including bladder cancer detection test UroVysion.”
“UroVysion became the number one reimbursed molecular test in the U.S. Vysis eventually merged into Abbott Molecular Diagnostics and I took the experience I had gained and transitioned into CEO roles at Asuragen, WaferGen BioSystems, and now at Immunexpress.”
Formation Of Immunexpress
How did the idea for the company come together? Carlson shared:
“There was an obvious need for a rapid and accurate diagnostic tool for sepsis given its impact, with millions of lives lost globally, and given the financial impact it has on healthcare systems. The original work that formed the basis for Immunexpress was done in Australia and involved our CSO, Richard Brandon.”
“A horse model of sepsis, endotoxemia, was the basis of early research, and provided a proof of concept that an analysis of the expression of specific genes in white blood cells from a sample of peripheral blood could be used to identify sepsis in its early stages. Further clinical studies identified specific biomarkers of human sepsis.”
Core Products
What are Immunexpress’ core products and features? Carlson explained:
“The core product of Immunexpress is the SeptiCyte RAPID test, a gene expression-based test for sepsis which measures immune response, as opposed to the identity of a specific causative pathogen. When identifying sepsis, typically in an emergency room setting, every hour that passes is of crucial importance in terms of patient outcomes.”
“SeptiCyte RAPID is designed to be easy-to-use, and provides accurate results in about an hour to differentiate infection-positive (sepsis) from infection-negative systemic inflammation response syndrome from samples of whole blood. This allows clinicians to quickly and appropriately respond to sepsis.”
Favorite Memory
What has been yourfavorite memory working for the company so far? Carlson reflected:
“One of my favorite memories is meeting with the team when I first joined Immunexpress in 2018. Of course, I already knew the need for an accurate and rapid test for sepsis, but understanding the dedication of the employees to providing reliable diagnostic tools to address what really constitutes a medical emergency posed by the incorrect diagnosis of sepsis made me fully understand the opportunity I had in leading this company. It was clear this was a purpose-driven company.”
Challenges Faced
What challenges have youand the team faced in building the company? Carlson acknowledged:
“We were actually in the midst of final clinical trials when COVID hit, and so that was a significant obstacle and slowed things down as many hospitals were obviously being overwhelmed with patients. We also looked at this as an opportunity, however, and we completed additional trials with COVID patients and found that the test was very useful in identifying viral sepsis in critically ill COVID patients and in predicting disease progress.”
Evolution Of Immunexpress’ Technology
How has Immunexpress’ technology evolved since launching? Carlson noted:
“Although the SeptiCyte RAPID test is relatively new to market, we are always open to ways to improve the product, and to making the product more accessible in order to reach the greatest number of patients. With that goal in mind, we recently sought and received FDA clearance for the use of EDTA blood compatible cartridges with SeptiCyte RAPID, allowing the use of a small volume from the most universally used blood collection tubes to promote wider adoption across U.S. healthcare systems.”
Significant Milestones
What have been some of Immunexpress’ most significant milestones? Carlson cited:
“Our goal has always been to improve prospects for sepsis patients globally. In order to do that, we have been focused on taking steps to make our products commercially available. In 2020, we received a CE Mark for SeptiCyte RAPID to be sold in the European Union. In late 2021, SeptiCyte RAPID obtained FDA clearance in the U.S.”
“We recently received regulatory clearance from the Australian Therapeutic Goods Administration to allow for the sale, use, and further commercial testing of SeptiCyte RAPID throughout Australia. Another important milestone was the receipt of an ICD-10-PCS code specifically for SeptiCyte RAPID from the Centers for Medicare and Medicaid Services in 2023 which helps facilitate billing and claims reimbursement for sepsis.”
Customer Success Stories
After asking Carlson about customer success stories, he highlighted:
“After being involved in the validation process, the medical director of critical care services at FirstHealth of the Carolinas was key in driving the adoption of the SeptiCyte RAPID test across four hospitals in Pinehurst, Troy, Rockingham, and Raeford, North Carolina.”
Total Addressable Market
What total addressable market (TAM) size is the company pursuing? Carlson assessed:
“Sepsis is a significant issue in hospitals, causing millions of fatalities worldwide per year, and places a large burden on healthcare systems, while interfering with antibiotic stewardship efforts through over-treatment with antibiotics. There is a great need for rapid and reliable sepsis diagnostics, and recent estimates value the sepsis diagnostics market at over $1 billion.”
Differentiation From The Competition
What differentiates the company from its competition? Carlson affirmed:
“One critical differentiator is regulatory approval: SeptiCyte RAPID is the only on-market FDA-cleared sepsis test at the molecular level using the patient’s own immune response to infection in the U.S., and also has regulatory clearance in the European Union and in Australia. A second crucial differentiating aspect of SeptiCyte RAPID is that it has been rigorously tested in multiple clinical trials, and numerous publications provide strong support for the technology.”
Future Company Goals
What are some of the company’s future goals? Carlson pointed out:
“We aim to continue to expand and to get our potentially life-saving product into the hands of more patients. We continue to evaluate the product in specific clinical use cases such as patients that are immunocompromised or neutropenic with interested health systems, as we believe that the ability to test the product will make its value clear to health systems and individual clinicians.”
Additional Thoughts
Any other topics to discuss? Carlson concluded:
“I would like to emphasize the potential for making a meaningful impact on patient care when it comes to sepsis. In the United States, sepsis is the most common cause of in-hospital deaths and costs more than $24 billion on an annual basis, according to the National Institutes of Health. This is a serious unmet need, and I am proud to be a part of a team that is working to make a difference.”
