AdvanDx Receives FDA 510(k) Clearance for Fast Yeast Traffic Light PNA FISH

AdvanDx announced that it has received FDA 510(k) clearance for a fast, 90-minute protocol for its Yeast Traffic Light® PNA FISH® test. The faster protocol reduces the PNA FISH turnaround 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 minute 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.

Yeast Traffic Light PNA FISH is the only FDA-cleared method that can identify, in a single test, up to five Candida species—including C. albicans and/or C. parapsilosis, C. tropicalis, and C. glabrata and/or q—directly from positive blood cultures. 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. At the same time, recent reports indicate that echinocandins may be less potent against C. parapsilosis. 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 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.” With the introduction of the 90-minute PNA FISH protocol, laboratories will now be able to further improve turnaround 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 6 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.”

Source: AdvanDx

Bio-Rad Submits Premarket Approval for Fourth-Gen HIV Assay

Bio-Rad Laboratories Inc has submitted a Premarket Approval application to the FDA for its fourth-generation HIV assay, the GS HIV Combo Ag/Ab EIA (enzyme immunoassay).

The GS HIV Combo Ag/Ab EIA detects HIV antigens (proteins that are part of the HIV virus) and HIV antibodies (proteins that are produced by the body to fight the HIV infection), offering early detection of HIV infections as well as acute HIV infections. Clinical studies were performed at five major institutions in the United States on a large sample population including adult and pediatric patients with HIV infections, individuals in high- and low-risk groups, and pregnant women.

“The rate of acute HIV infections continues to increase in the United States and around the world,” said John Goetz, Bio-Rad vice president and group manager clinical diagnostics. “We look forward to being able to offer this assay in the US as it is able to detect a significant number of additional cases of acute HIV infections compared to HIV antibody testing alone.”

Source: Bio-Rad

IL Cleared for Automated Total Bilirubin Assay

Instrumentation Laboratory (IL) announced that it has received clearance from the FDA to market the first-ever, rapid point-of-care, lab-quality blood test for measuring total bilirubin (tBili) in newborns. Bilirubin, a toxin, can, in high amounts, lead to irreversible brain injury in neonates. The new tBili assay is performed on IL’s GEM Premier 4000 critical care analyzer. It allows clinicians to receive lab-quality test results in 90 seconds from whole blood in the Neonatal Intensive Care Unit (NICU), rather than waiting up to an hour for results from the lab, using traditional chemistry methods.

During the first few days of life, the body breaks down fetal red blood cells, producing bilirubin. More bilirubin is produced than the liver can remove, and it remains circulating in the blood. This results in jaundice, the most common condition requiring medical attention in newborns—present in approximately 70% of them. However, in 8% to 10% of newborns, jaundice progresses to severe hyperbilirubinemia. Left untreated, hyperbilirubinemia can quickly evolve into kernicterus, a devastating, irreversible neonatal brain injury.

“Over the past decade, kernicterus has reemerged due to a variety of factors,” said neonatologist Anthony Napolitano, MD, medical director, Neonatal/Pediatric Transport Program, at All Children’s Hospital, St Petersburg, Fla, and medical director, Sarasota Memorial Hospital, Sarasota, Fla. “The ability to assess bilirubin in the NICU with accuracy and precision is a tremendous advantage and has the potential to prevent this absolutely devastating outcome and reduce hospital readmissions.”

The American Academy of Pediatrics recommends that a risk-assessment for bilirubin be performed on every newborn to reduce the incidence of adverse events. “Now, with the addition of the tBili assay to the GEM Premier 4000 analyzer, screening can be performed immediately, with the highest quality results assured,” said Ramon Benet, VP of US Sales and Worldwide Service and Marketing at IL. “No other analyzer can provide lab-quality tBili results in the NICU.”

Source: Instrumentation Laboratory

Sysmex America Begins Distribution of CellaVision DM1200

Sysmex announced the addition of the CellaVision® DM1200 cell image analysis analyzer to the Sysmex hematology product offering. The DM1200 enables Sysmex America to meet the growing demand for automated cell image analysis, which improves both the quality of results and the productivity of laboratories performing mid-volume testing.

The CellaVision DM1200 opens up new ways of handling manual differentials traditionally performed on a microscope by automatically performing a preliminary differential count on peripheral blood. The analyzer preclassifies the white blood cells, precharacterizes parts of the red morphology, and provides functionality for platelet estimation. By automating the manual differential, laboratories can experience enhanced turnaround times without sacrificing quality. Its high degree of automation allows for an escalating workload without increasing labor.

“The CellaVision DM1200, which locates, identifies, and preclassifies blood cells by means of automatic microscopy and advanced image processing, greatly enhances Sysmex America’s hematology product offering. We trust this addition to our hematology portfolio will serve our customers well as they continue to navigate through a challenging health care environment,” said John Kershaw, president and CEO, Sysmex America Inc.

Sysmex America and CellaVision first initiated their working relationship in 2004. Today, Sysmex Corp and CellaVision have an extended and broadened working relationship via the completion of a recent global distribution agreement. The agreement gives Sysmex a nonexclusive right to sell CellaVision’s products in hematology laboratories worldwide. As of April 1, 2010, the nonexclusive agreement comprises all international markets but Canada.

Source: Sysmex