WOBURN, Mass.and VEDBAEK, Denmark, July
29 /PRNewswire/ — AdvanDx today announced that it has
received FDA 510(k) clearance for a fast, 90 minutes protocol for
its Yeast Traffic Light® PNA FISH® test. The faster
protocol reduces the PNA FISH turn-around time from the original
2.5 hours to 90 minutes by reducing PNA probe hybridization from 90
minutes to 30 minutes. Clinical validation studies performed
at hospitals in the United States
demonstrated excellent equivalence between the 90 minutes protocol,
the original PNA FISH protocol and conventional identification
methods, ensuring the faster protocol maintains the very high
sensitivity and specificity required versus slower, conventional
methods.
Candidemia, a bloodstream infection caused by Candida
species is one of the most serious hospital acquired infections,
afflicting over 24,000 patients in the U.S. every year.
Immunocompromised transplantation, oncology and AIDS patients
are especially at risk for contracting the infection with mortality
rates as high as 50% (1). While identification of the
infecting Candida species is used to guide effective
antifungal therapy, conventional laboratory methods can take up to
5 days or longer (2). Therefore, patients are often treated
empirically either with fluconazole, a relatively inexpensive,
generic antifungal agent, or with an echinocandin, a new class of
antifungal drugs that have broad activity against Candida
species but are also substantially more expensive. As a
result, patients often receive inappropriate, inadequate or
sometimes unnecessarily broad therapy.
Yeast Traffic Light PNA FISH is the only FDA cleared method that
can identify, in a single test, up to five Candida species
directly from positive blood cultures i
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