Sepsis is the third leading cause of death in the United States. When a patient enters the emergency room with this life-threatening condition, every minute counts. California-based Nanomix, Inc. is working to make the evaluation of sepsis much faster. The company has developed the Nanomix eLab instrument, a handheld diagnostic system that can provide results within 10 minutes of taking a single patient sample (either blood, plasma or serum), with no sample prep required. Nanomixs touts the technology as the first rapid diagnostic test panel designed to assess patients with sepsis—it is formatted in a disposable microfluidics test cartridge (incorporating enzymatic and immuno-assays for three key sepsis markers) that the clinician inserts into the e-Lab instrument. Currently employed sepsis screening tests can take several hours or days and may require the use of several instruments.
“Rapid diagnosis and aggressive clinical intervention is critical for patients to survive sepsis, and even short delays in sepsis identification and administration of treatment can negatively impact patient outcomes and increase mortality,” said David Ludvigson, president and CEO of Nanomix in a press release. “The Nanomix eLab system opens the door to many testing applications that can improve patient outcomes and potentially lower the cost of healthcare. While sepsis-related diagnostic tests are a first step, over time, we believe the eLab System will enable point-of-care testing for many of the critical and routine tests now performed in hospital and reference laboratories.”
The Bluetooth-enabled system is designed for use both inside and outside the lab environment. Nanomix plans to begin formal clinical trials by mid-2017 and will pursue CE-mark and 510(k) approvals by 2018 if the trials are successful.