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AdvanDx Receives FDA 510(k) Clearance for Yeast Traffic Light PNA FISH(TM)
Date:9/23/2008

New Product Provides First Capability To Rapidly Identify Five Candida

Species Directly From Positive Blood Cultures In One Test

WOBURN, Mass., Sept. 23 /PRNewswire/ -- AdvanDx today announced it received FDA 510(k) clearance of the Yeast Traffic Light PNA FISH(TM) to identify Candida yeast species directly from positive blood cultures. The Yeast Traffic Light(TM) is the latest addition to AdvanDx's easy-to-use, molecular-based PNA FISH(TM) diagnostics platform that provides rapid identification of bloodstream pathogens in hours instead of days.

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. For the first time, laboratories can identify, in a single Yeast Traffic Light 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 in hours instead of days, enabling clinicians to provide early, effective and appropriate antifungal therapy for patients afflicted with candidemia.

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 caspofungin, a newer and more expensive broad-spectrum antifungal drug, may be less potent against C. parapsilosis.(3) Yeast Traffic Light was designed to identify these Candida species as early as possible and provide rapid and actionable results to help clinicians guide appropriate antifungal therapy.

A recent study by Della-Latta et al. presented at the 2008 ECCMID meeting in Barcelona, Spain demonstrated that rapid identification of Candida species using PNA FISH can significantly impact antifungal selection and care for patients with candidemia. In the study, rapid identification of C. albicans led to a switch to fluconazole for 70% of the patients that had been on caspofungin. At the same time, rapid identification of C. glabrata, a Candida species with high levels of resistance to fluconazole, led to an 81% switch to caspofungin for those patients that had otherwise been given fluconazole. 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)

"The Yeast Traffic Light PNA FISH test demonstrates AdvanDx's commitment to developing cutting-edge molecular diagnostic products that provide fast results for these serious infections," said Thais T. Johansen, President and CEO of AdvanDx. "The test will ultimately enable clinicians to provide more appropriate care, improve antifungal selection and hopefully improve outcomes for their patients," Johansen concluded.

About Bloodstream Infections

Every year, 350,000 patients contract bloodstream infections, causing over 90,000 unnecessary deaths and significant costs to the healthcare system. The infection is detected when a culture of the patient's blood (i.e. a blood culture) turns positive with bacteria and yeast. Rapid and accurate identification of the specific infecting pathogen is crucial to ensure early and appropriate therapy and save patient lives.

About AdvanDx

AdvanDx is the world's leading provider of advanced molecular diagnostic products for the prevention, diagnosis and treatment of life-threatening, bacterial infections. AdvanDx's easy-to-use products provide fast and accurate results that enable dramatic improvements in patient care and help to save lives and reduce hospital costs.

AdvanDx's products employ standard laboratory techniques and equipment to reduce startup, implementation, technician and maintenance time, while providing fast results without sacrificing accuracy. Major medical centers, reference labs, government institutions and community hospitals throughout the United States, Europe and Asia rely on AdvanDx products as integral parts of their medical care.
For more information visit http://www.AdvanDx.com

CONTACTS:

Company Contact: Media Inquiries:

Joen T. Johansen Joe Romano

Director of Marketing Partner

AdvanDx HighGround, Inc.

+1-339-227-4052 +1-781-939-5800 Ext 208

jtj@advandx.com jromano@highgroundinc.com

References:

1. Spellberg et al. Current Treatment Strategies for Disseminated Candidiasis. Clin. Infec. Dis. 42: 244-251. 2005

2. Pfaller et al. Epidemiology of invasive candidiasis: a persistent public health problem. Clin Microbiol Rev. 2007 Jan;20(1):133-63.

3. Aperis et al. Developments in the treatment of candidiasis: more choices and new challenges. Expert Opin Investig Drugs. 2006 Nov;15(11):1319- 36.

4. Della-Latta et al. Impact of Rapid Identification of C. albicans and C. glabrata Directly from Blood Cultures using PNA FISH Technology on Selection of Antifungal Therapy. Poster 1382. ECCMID 2008. Barcelona, Spain.


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