Invasive candidiasis is a life-threatening infection caused by the fungus Candida albicans. Invasive candidiasis is a serious problem in the hospital setting and is the most common invasive fungal infection in countries with advanced medical care. Patients with the highest risk of developing invasive candidiasis are those who have extended stays at intensive care units, long-term catheterization, solid organ transplantation, and immunodeficiency.
Early initiation of treatment critically affects the clinical outcome. Despite the importance of early treatment, no clear methods have been developed for the early diagnosis of infection that is essential to early treatment. Identification of C. albicans by blood culture is still the gold standard, however, blood cultures are only positive in 50% of cases and may take 24-72 hours before results become available. As a consequence, a positive diagnosis may occur, but the window of opportunity to use the information in a meaningful way has closed.
Identification of invasive candidiasis by culture requires the one thing a clinician cannot afford – time. A delay in treatment by 12 hours causes a 20% increase in patient mortality. DxDiscovery seeks to reduce the amount of time-to-diagnosis by shifting to a diagnostic assay that can be used at the patient point-of-care. Lateral flow immunoassays (LFA) are fast (∼15 min), accurate, and cost-effective. The LFA relies on the detection of pathogen-specific biomarkers in patient blood; much the same as a home pregnancy test detects hCG in urine. The founders of DxDiscovery developed a novel biomarker discovery platform (InMAD) in their academic laboratories at the University of Nevada, Reno. The InMAD platform has successfully identified biomarkers for pathogens such as Tier 1 biothreats B. pseudomallei and F. tularensis. Work is currently underway at DxDiscovery to identify multiple biomarkers for diagnosis of C. albicans.
There are over 60,000 cases of invasive candidiasis in the United States each year. Some reports estimate the annual health-care related costs to be $4 billion. Few companies have investigated strategies for the development of rapid and early diagnostics for Invasive Candidiasis; those that do, however, have been met with enthusiasm from clinicians and investors.
Current diagnosis of invasive candidiasis is based on a reactive user – any patient with fever of unknown origin who does not respond to antibiotic treatment for bacterial infection is suspected to have invasive candidiasis. Antifungal therapy, however, will typically begin only after patient blood cultures are positive for C. albicans growth. DxDiscovery aims to use Candida biomarkers as a surrogate for detection of the C. albicans organism in a manner that is low-cost, non-invasive, and delivers rapid results. This innovation will introduce a new paradigm in the diagnosis of invasive candidiasis. Clinicians will become prospective users of the technology and have the ability to continuously monitor all at risk patients; the result will be initiation of appropriate therapies before symptoms occur. This is a disruptive change in diagnostic strategy that dramatically increases the size of the market that is available to DxDiscovery.
In June 2013, DxDiscovery was awarded a two-year Phase I STTR grant from the NIH/NIAID for almost $600,000 to pursue biomarker discovery for invasive candidiasis.