Actionable diagnostic information at the time of patient examination is more often than not unavailable in crucial time dependent situations. For example, for patients with suspected infection, confirming the presence of infection is crucial in order to determine whether or not antibiotics should be prescribed.
Yet this information is typically unavailable to the physician, because current methodology relies on time consuming culture methods to determine the source of infection. Aside from the length of time required for the infecting organism to grow, results for any test sent to a central laboratory will typically not be available for hours, even if ordered on a stat basis.
Consequences of lack of actionable diagnostic information are that in the case of infection, physicians are left with a "Hobson's choice" -- treat with antibiotics and risk creating more antibiotic resistant organisms if the problem is not bacterial, or don't treat with antibiotics and risk a worsening condition for a patient with a bacterial infection, perhaps even to the extent of sepsis and septic shock.
A solution for actionable diagnostic information at all points of care is a small portable device capable of providing quantitative information about white blood cell count, differentials, cell surface markers, and plasma protein levels. Preferably, this device should be CLIA waived to enable its use in all settings without the need for trained laboratory personnel. This is the target of our development efforts.
A simple cartridge-based system with the capabilities described above will have many diagnostic applications. Our initial focus is on the use of CD64 neutrophil activation for infection/sepsis early detection and monitoring of recovery.
Beyond this initial application we are working to identify which targets should be our next as we develop a menu of test for our platform. We intend to focus on applications that have significant societal and economic cost such that a successful device will provide a major improvement in patient care and a reduction in health care costs. Such potential applications may be urinary tract infection detection, the status of HIV infected patients, leukemia typing as well as other applications.
Our approach is based on a cost and medically effective point of care technology. The key element of this technology is a disposable cartridge that automates the sample preparation on a small sample volume and a reader which reads the sample as it flows in the cartrdidge reading channel. The spend sample stays in the disposable cartridge and the reading instrument is not exposed to any biological material or reagent.
The earlier work on the National Space Biomedical Research Institute (NSBRI) funded project has demonstrated the promise of a simple cartridge and reader system capable of white blood cell counting and differentiation as well as cell surface marker analysis and plasma protein quantitation.
We are currently focused on completing the development of our instrument and disposable cartridge.