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Nanomix Advances Rapid Diagnostic Panel to Aid Emergency Evaluation of Sepsis

Nanomix, Inc. today 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. "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."

About the Nanomix eLab System

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. All test functions are controlled and automatically processed by the device. The robust system design supports use in almost any setting, inside or outside of the traditional laboratory environment. The eLab device is Bluetooth enabled for rapid communication of results. Internal testing by Nanomix scientists, their clinical partners, and other outside evaluators has shown the eLab to produce results equivalent to those produced by expensive central laboratory testing systems.

Economic Impact of Point of Care Testing

The National Academy of Medicine estimates that $750 billion – 30% of the U.S. annual healthcare budget -- is wasted on unnecessary medical services, inefficient delivery, excessive administrative costs and prevention failures. Testing patients at the point of first contact can help reduce a significant amount of these excess costs. In addition to reducing the time to diagnosis in the Emergency Department, portable, rapid testing technology could also be used outside the hospital to help determine if patients can be treated in place or if they need to be transported to a hospital for treatment. Nanomix envisions the eLab system finding usage in settings such as Skilled Nursing Facilities, Elderly Care Centers, Convalescent Centers, Urgent Care Clinics, or even the home for monitoring patients with chronic health conditions. Reducing the time to diagnosis and treating patients in place can not only increase patient satisfaction and improve outcomes, but could also lower costs by potentially more than a billion dollars.

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