By GREGORY ZELLER //
A Northwell Health clinical study is targeting a notorious killer that preys on weakened hospital patients.
By testing white blood cells and monitoring “expression biomarkers,” SeptiCyte – a proprietary technology of Seattle-based Immunexpress – aims to provide faster and more accurate diagnosis of sepsis, a common blood poisoning caused by disease-spreading microorganisms.
Pulmonary specialist Mangala Narasimhan, Northwell Health’s director of critical care, is leading a SeptiCyte human trial at North Shore University Hospital in Manhasset, one of several concurrent tests Immunexpress is conducting around the globe. The Northwell study commenced in April, joining human trials at Baltimore’s Johns Hopkins Medicine and Chicago’s Rush University Medical Center, while Immunexpress is conducting related trials in London and Australia.
The human tests follow two years of prep work at Intermountain Healthcare, a nonprofit health system in Utah, where non-human beta testing set the stage. The goal of the Northwell study, according to Narasimhan, is to more quickly and accurately identify patients at higher risk for sepsis, allowing providers to both “stop antibiotics and not over-treat some people, and also say ‘this patient is really sick, let’s keep a closer eye here.’”
The need, Narasimhan added, is great: Sepsis can be and often is deadly, affecting 1 million Americans annually – some organizations peg the worldwide number at 30 million – and killing more than 258,000. The blood disease is most likely to target infants and the elderly, though it will and does strike anyone and causes nearly half of all U.S. hospital deaths, making it “the leading cause of mortality in the hospital, for sure,” Narasimhan noted.
“We see sepsis every single day,” she said. “It affects everybody. It’s the biggest problem we see in the ICU.”
Compounding the problem: Sepsis’ most-common symptoms are difficult to distinguish. Chills, lightheadedness, low blood pressure, moderate fevers and rapid heartbeats hardly stand out, especially in emergency-care settings.
“It’s hard to tell,” Narasimhan noted. “A lot of people come in looking like they may have sepsis. So how do we narrow that window?”
Immunexpress offers two ways. While current sepsis-detection methods search for microbes that might have caused an overwhelming immune-system response in a patient already spiraling into septicemia, SeptiCyte analyzes hundreds of protein and nucleic acid biomarkers – a “host response technology” that monitors biological activity to recognize sepsis and perhaps identify at-risk patients before the blood poisoning occurs.
Which leads to SeptiCyte’s second purported advantage: speed. While current sepsis tests can take days, SeptiCyte’s expression biomarkers return data within hours, according to Immunexpress President and CEO Roslyn Brandon.
“Our first product delivers a result to the clinician from the hospital lab in under four hours,” Brandon told Innovate LI. “We are currently developing a product that will provide a result in about 60 to 90 minutes at the bedside of a patient in the hospital.
Just as exciting as that rapid response is SeptiCyte’s accuracy, Brandon added.
“Instead of simply trying to find the pathogen causing the septic response, which can take days and only delivers actionable clinical information in up to 50 percent of patients with suspected sepsis, our technology delivers actionable information in 100 percent of suspected sepsis cases,” the CEO said.
Northwell, where four of the validated biomarkers will be analyzed, was chosen as a human trial site through a bit of serendipity. According to Narasimhan, David Bernstein, Northwell’s vice chairman of medicine for clinical trials, happened to sit next to Brandon on a plane ride; the two started talking, and soon Immunexpress principals were visiting Manhasset, discussing SeptiCyte’s protocols and vision.
The Washington State biotech also wanted to know “about our experience with sepsis,” Narasimhan added, noting North Shore University Hospital has reduced its sepsis mortality rate from 30 percent to 12 percent over the last five years “based only on recognition and early treatment.”
Immunexpress liked what it heard and asked Northwell to host a human trial. While the trial could lead to breakthrough sepsis treatments and techniques, Narasimhan stressed that it won’t affect the health system’s current sepsis-treatment protocols.
“It’s not going to interfere with our treatment at this point,” she noted. “We’re just looking to validate the protocol for the FDA.”
To do that, the system will seek volunteers meeting certain criteria – ICU patients between 18 and 80 with elevated temperatures, heartrates and white blood cell counts – for a blood-draw study. How long the study will take depends on how quickly Northwell can find enough qualified volunteers; according to Narasimhan, the study is slated to include 40 patients overall, and in its first month tested 10.
Although it’s still early in the Northwell trial, Narasimhan is already enthused about SeptiCyte’s potential – though perfecting the technology, she predicted, will prove difficult.
“I think it’s going to tell us who has a super-high likelihood for sepsis and who is not at risk at all, and that will help us,” she said. “I think the in-between patients, the ones in the middle range, will be more difficult to identify.
“But today, seven patients out of 13 who are septic suffer low blood pressure and become extremely sick,” Narasimhan added. “If we can alter how we treat that patient population, it will make a huge difference.”