Nanomix revealed the first rapid diagnostic test panel designed to quickly evaluate patients affected by sepsis, which runs on the company's simple-to-use, handheld diagnostic system, the Nanomix eLab.
Designed for emergency medical and other point-of-care needs, the new test employs a single patient blood, plasma, or serum sample to provide actionable results within 10 minutes.
Currently screening tests for sepsis can take hours or days, are costly, and require the use of multiple instruments that are most often operated by skilled technicians within a central hospital laboratory.
The company said it plans to initiate formal clinical trials of the sepsis panel by mid-2017, and if successful, seek both CE-mark and 510K approvals by 2018. Sepsis, characterized by the body's overwhelming response to infection potentially leading to tissue damage, organ failure, and death, is the third leading cause of death in the United States.
"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, Nanomix President and Chief Executive Officer.
"Our rapid sepsis panel, formatted into a disposable microfluidics test cartridge that the user inserts into our hand-held eLab, incorporates enzymatic and immuno-assays for three key sepsis markers. As such, it represents the first set of sepsis-related screening diagnostics that can be performed quickly at the first point of contact between a patient and the healthcare provider.”
Time matters in treating sepsis and we believe that the information provided by this novel diagnostic will enhance the clinician's ability to quickly and accurately assess patient status, enabling more timely and appropriate treatment, and improved patient outcomes."
"The Nanomix eLab system opens the door to many testing applications that can improve patient outcomes and potentially lower the cost of healthcare," said Mr. Ludvigson.
The Nanomix eLab system is comprised of a mobile, handheld diagnostic device and a disposable microfluidics test cartridge. The device is simple to operate via an intuitive user interface on a color touch screen and incorporates a proprietary nano-biosensor for high quality, reliable performance.
The single-use disposable test cartridge uses the patient's whole blood, without sample preparation.