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

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 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.

About Bloodstream Infections

Every year, close to 875,000 patients in the United States contract bloodstream infections, leading to over 150,000 deaths and significant costs to the healthcare system (5). The infection is detected when a culture of the patient's blood (i.e. a blood culture) turns positive with bacteria or 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 leading provider of advanced molecular diagnostic products for the diagnosis and treatment of life-threatening, bloodstream 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

Yeast Traffic Light® PNA FISH® is distributed by bioMerieux, Inc. in the United States.


  1. Clin. Infec. Dis. 42: 244-251. 2005
  2. Clin Infect Dis. 2005 Nov 15;41(10):1455-60
  3. J. Clin. Microbiol. 2006 44: 3381-338
  4. Poster 1382.  ECCMID 2008.  Barcelona, Spain.
  5. Infect. Control Hosp Epedimiol. 2009 Nov; 30(11):1036-44

Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. AdvanDx Submits Yeast Traffic Light PNA FISH(TM) for FDA 510(k) Clearance for Detection of Candida species in Positive Blood Cultures
2. Study Shows Use of AdvanDxs PNA FISH(TM) Test was Associated with an 82% Reduction in Intensive Care Unit Mortality Rates from Staphylococcus aureus Bloodstream Infections
3. AdvanDx Launches Fast, 90 Minutes Protocol for All CE-IVD Marked PNA FISH(R) Tests in Europe
4. AdvanDx Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for Identifying Gram-Negative Bloodstream Pathogens
5. AdvanDx Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for Identifying Staphylococcal Bloodstream Pathogens
6. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
7. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
8. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
9. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
10. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
11. CryoCor Receives FDA Approval for Right Atrial Flutter
Post Your Comments:
(Date:6/24/2016)... , June 24, 2016   Bay Area ... Network,s Dean Center for Tick Borne Illness ... and Rehabilitation, MIT Hacking Medicine, University of California, ... today announced the five finalists of Lyme ... disease.  More than 100 scientists, clinicians, researchers, entrepreneurs, ...
(Date:6/24/2016)... -- Dehaier Medical Systems Ltd. (NASDAQ: DHRM ... sells medical devices and wearable sleep respiratory products in ... agreement with Hongyuan Supply Chain Management Co., Ltd. (hereinafter ... 2016, to develop Dehaier,s new Internet medical technology business. ... leverage Hongyuan Supply Chain,s sales platform to reach Dehaier,s ...
(Date:6/24/2016)... 24, 2016   Pulmatrix, Inc ., (NASDAQ: ... inhaled drugs, announced today that it was added to ... its comprehensive set of U.S. and global equity ... an important milestone for Pulmatrix," said Chief Executive Officer ... of our progress in developing drugs for crucial unmet ...
Breaking Medicine Technology:
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library ... City Observer , brings up a new, often overlooked aspect of head lice: the parasite’s ... for fumigation is not a common occurrence, but a necessary one in the event that ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, ... at Work award to iHire in recognition of their exemplary accomplishments in worksite health ... annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. ...
(Date:6/24/2016)... ... 2016 , ... Marcy was in a crisis. Her son James, eight, was out of control. ... and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... rocks at my other children and say he was going to kill them. If ...
(Date:6/24/2016)... ... ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for ... $12 an hour by 2020 and then adjusting it yearly to increase at the same ... wage, assure the wage floor does not erode again, and make future increases more predictable. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Strategic Capital Partners, ... economy by obtaining investment capital for emerging technology companies. SCP has delivered ... already resulted in more than a million dollars of capital investment for five ...
Breaking Medicine News(10 mins):