AdvanDx Receives FDA 510(k) Clearance For 90 Minutes Protocol For Yeast Traffic Light® PNA FISH®

AdvanDx 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 including C. albicans and/or C. parapsilosis, C. tropicalis, and C. glabrata and/or C. krusei. Studies show that Candida
species display varying resistance to commonly used antifungal agents.
While C. albicans and C. parapsilosis are generally susceptible to the
antifungal drug fluconazole, C. tropicalis may display intermediate
resistance to the drug while C. glabrata and C. krusei
display the highest level of fluconazole resistance (2). At the same
time, recent reports indicate that echinocandins may be less potent
against C. parapsilosis (3). As a result, Yeast Traffic Light PNA FISH was designed to provide identification of critical Candida
species in hours instead of days, enabling clinicians to optimize
antifungal drug selection much earlier for patients with candidemia.


A study performed by Della-Latta et al. at Columbia University Medical
Center demonstrated that rapid PNA FISH results led to an early switch
to caspofungin, an echinocandin, for 81% of patients with C. glabrata
patients treated empirically with fluconazole. The rapid results also
led to an early switch to fluconazole for 70% of patients with C. albicans
infections treated empirically with caspofungin. Based on the study
results, the authors concluded that the PNA FISH test "can impact the
appropriate selection of the most effective antifungal therapy, thereby
making it a clinically relevant diagnostic assay."(4) With the
introduction of the 90 minutes PNA FISH protocol, laboratories will now
be able to further improve turn-around times for critical results and
thereby help clinicians further improve care for patients with
candidemia."The FDA clearance for Yeast Traffic Light PNA FISH completes our
ambitious initiative to transition all PNA FISH tests to the shorter, 90
minute protocol in just six months," said Thais T. Johansen, President
and CEO of AdvanDx. "Hospitals can now obtain accurate, actionable
species identification results for the most common bloodstream pathogens
in just 90 minutes, enabling clinicians to improve antimicrobial
therapy, care and outcomes for their patients," Johansen concluded.

Source:http://www.medicalnewstoday.com/articles/196292.php