September 2010 Clinical Chemistry News: FDA News

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September 2010: Volume 36, Number 9

FDA Issues Recommendations to Clarify Device Approval Process

FDA has released two comprehensive evaluations containing proposals designed to better define what devices can use the 510(k) approval process and when medical evidence is mandatory for approval. The agency hopes the recommendations will clarify the rules for medical devices that have been criticized for not being strict enough. In the upcoming months, the agency also plans to ask for public comment before any changes are put in practice.

IL’s Automated Bilirubin Assay for Newborns Cleared

FDA has given a green light to Instrumentation Laboratory (IL) to market the first-ever, rapid point-of-care, lab-quality blood test for measuring total bilirubin (tBili) in newborns. Aimed at improving neonatal results and decreasing the risk of hyperbilirubinemia and jaundice-related readmissions, the new tBili assay runs on IL’s GEM Premier 4000 critical care analyzer. It produces lab-quality test results in 90 seconds from whole blood, making it suitable for neonatal intensive care units. 

Roche’s CoaguChek XS Pro System for POCT Cleared

FDA has cleared the Roche Diagnostics CoaguChek XS Pro system, a new point-of-care anticoagulation monitor with a built-in barcode reader that can automatically scan and capture operator and patient identification information. The barcode reader and the RALS-Plus information management system work together to save time and eliminate errors that could occur due to manually entering information for PT/INR (blood clotting time) testing for patients on warfarin therapy.

PCR-based MRSA Test Gets Clearance

Roche announced the FDA has cleared its LightCycler MRSA Advanced Test for detection of methicillin-resistant Staphylococcus aureus. The polymerase chain reaction (PCR)-based test is a qualitative in vitro diagnostic test for direct detection of nasal colonization with bacterial MRSA. According to Roche, the test was created to aid in preventing and controlling MRSA infections in healthcare settings and can yield results in 2 hours. The test is runs on Roche’s LightCycler real-time PCR instrument.

Meridian’s C. difficile MDx Assay Cleared

FDA has cleared Meridian Bioscience’s illumigene C. difficile molecular amplification assay that detects the presence of the toxin-producing region in the DNA of Clostridium difficile. According to Meridian, the test can generate results in less than 60 minutes. The system allows for diagnosis of the disease with high levels of sensitivity, and its workflow requires minimal hands-on time per sample. The test is the first molecular diagnostic product for Meridian.

Green Light for First PCR-based Test Kit for Genital Herpes

EraGen Biosciences Inc. announced that the FDA has cleared its MultiCode-RTx HSV 1 & 2 Kit, the first polymerase chain reaction -based qualitative in vitro diagnostic test for the detection and typing of HSV-1 and HSV-2 from vaginal lesion swab specimens in symptomatic female patients. According to EraGen, the kit will be used as an aid in the diagnosis of genital herpes infection.

FDA Clears Prodesse MDx Test for Three Influenza A Virus Subtypes

FDA has green-lighted Prodesse’s ProFast+ assay, a real-time, multiplex real time polymerase chain reaction in vitro diagnostic test for identifying influenza A from nasopharyngeal swabs. The assay is the only FDA-cleared molecular diagnostic test to simultaneously detect and differentiate between three common influenza A virus subtypes, seasonal A/H1, seasonal A/H3, and 2009 H1N1. The assay uses the same internal control and format as other FDA-cleared tests for respiratory infectious diseases made by Gen-Probe’s Prodesse subsidiary. The ProFast+ assay can generate results in under 4 hours, compared to culture-based methods that can take days for results.

New Test System to Detect Lyme Disease Cleared

ZEUS Scientific has announced clearance of its AtheNA Multi-Lyte Borrelia Plus Test System. The new test system uses a patented mathematical model that incorporates two test results and combines them into a bioinformatics score to identify infection from B. burgdorferi. According to the company, the test is designed for the qualitative detection of specific human IgG antibodies to VlsE-1 and IgM antibodies to pepC10 in serum samples from symptomatic patients or those with a history of Lyme Borreliosis. 

Thermo Fisher Gains FDA Clearance of VRE Screening Test

FDA has granted Thermo Fisher Scientific clearance to market its Spectra VRE test for detecting vancomycin-resistant Enterococcus (VRE). The test is the first chromogenic media to identify colonization within 24 hours using rectal swabs and stool specimens, and it requires no confirmatory testing. According to Thermo Fisher Scientific, Spectra VRE was designed to provide healthcare settings with a high performing, economical solution that can easily be incorporated into routine microbiology laboratory workflows.

AdvanDx’s Rapid Candida Test Protocol Cleared

FDA has cleared a 90-minute version of AdvanDx’s Yeast Traffic Light PNA FISH test for indentifying several species of yeast that can contribute to hospital-acquired infections. The rapid protocol reduces the PNA FISH turn-around time to 90 minutes compared to the original 2 ½ hours by decreasing PNA probe hybridization from 90 minutes to 30 minutes. The protocol depends on a combination of fluorescence in situ hybridization and peptide nucleic acid probes targeting specific ribosomal RNA. The test can detect up to five Candida species from blood cultures. The Yeast Traffic Light PNA FISH test is designed to help healthcare workers pinpoint the most appropriate treatment, since Candida species display a range of antifungal drug responses and resistance.

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