Ella Promises Better Clinical Care for Acute Respiratory Failure and Sepsis

TOWARD BIOMARKER-GUIDED PRECISION MEDICINE

Custom-fit therapies, based on the individual’s own biology, promise more effective responses and higher safety margins, which, together, ensure overall better patient care. At the center of personalized medicine and “getting the right treatment to the right patient, at the right dose at the right time” is the need for reliable biomarkers and their swift and accurate measurement. Michael Matthay, M.D., Ph.D., a Professor of Medicine at the University of California San Francisco is pioneering precision medicine biomarker-based research and methods for managing acute clinical conditions. His core focus? Improving the care of patients with acute respiratory failure from acute respiratory distress syndrome (ARDS) and sepsis¹. Carolyn S. Calfee, MD, MAS is a Professor of Medicine and she and Dr. Matthay work closely together on the biology and clinical issues associated with ARDS and Sepsis.

After a comprehensive review of the literature, Drs. Matthay and Calfee and colleagues identified several promising prognostic ARDS biomarkers, namely IL-6, IL-8, ANG-1 and soluble TNF R11. In addition, they uncovered molecular subphenotypes of ARDS that may have therapeutic implications². Moreover, Drs. Calfee, Matthay et al. previously published on a combined approach using retrospective clinical data and specific biomarkers for the classification of ARDS patients into two subgroups: hyperinflammatory and hypo-inflammatory, and their association with different clinical outcomes². “This same approach was used to re-analyze data from randomized trials, uncovering that various biomarkers were indeed indicative of differential outcomes from different treatments. This conclusion would not be obvious by looking at just a bulk group versus distinct sub-populations,” he adds.

WHEN WAITING ON BIOMARKER RESULTS IS ACTUALLY LIFE-THREATENING

Advancements in analytical technologies have made characterizing a person’s genome and proteome a present-day reality. Most of these approaches take time, which may be fine in cases where disease progression is slow and the demand to rush the characterization of a patient’s biology is lessened. But for those afflicted with acutely life-threatening conditions, results cannot wait. In the case of ARDS, for example, a common cause of sepsis, rapid identification and treatment are critical. The need for biomarker-driven results is of the ASAP nature, and, unfortunately, most analytical platforms just cannot turn high-quality quantitative data around fast enough.

BIOMARKER DATA ASAP WITH ELLA

With Ella™, Drs Calfee and Matthay and team monitor concentrations of key biomarkers in human plasma in close to real-time in their research studies! The group uses the 16x4 multianalyte cartridge to measure IL-6, IL-8, ANG-1 and soluble TNF R1 in parallel. “We can match our research results with traditional clinical data, such as serum bicarbonate, from which we could more accurately stratify patients to receive the most effective treatment,” Dr. Matthay envisions. Analysis on Ella takes place in just 75 minutes, plus the protocol’s handsfree after adding diluted samples and wash buffer to the cartridge. The workflow does not only accelerate the time to result for Dr. Matthay, but because it eliminates the need for manual processing, it gives a higher level of precision too.

And he will need both of these critical attributes to deliver actionable results foreseeably.

Biomarker analysis and quick results that are within reach of the bedside are vital to fulfilling the promise of precision medicine. Dr. Matthay and his colleagues have realized that future for Ella in their research. “There is enormous potential value for applying Ella in a personalized medicine setting and I look forward to the improvements in patient care to come because of this platform and its future potential adaptation to certified FDA approved use in the clinical setting,” he affirms.