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Dx Focus: BioFire Diagnostics, IntelligentMDx, Cepheid, Enigma Diagnostics


BioFire Diagnostics said this week that it has commenced clinical and analytical studies to evaluate its FilmArray Gastrointestinal Panel with plans to seek both CE IVD marking and US Food and Drug Administration clearance.

The 23-target panel tests for common bacteria, viruses, and protozoa that cause infectious diarrhea. The test is performed in about an hour directly from stool in transport media.

The clinical study is being conducted at several hospital-based clinical laboratories in the US and is funded by an NIH R01 grant, BioFire said.

BioFire said that it plans to launch the GI panel in the second half of 2014 in both the US and Europe. It will be the third clinical diagnostic test to run on the company's FilmArray system, which integrates sample preparation, amplification, detection, and analysis, performing PCR to initially amplify nucleic acids from target pathogens and melt curve analysis for multiplexed detection.

IntelligentMDx said this week it has received US Food and Drug Administration clearance for its molecular diagnostic test for vancomycin-resistant enterococci, or VME.

IMDx's assay detects the presence of vanA and vanB genes that have been associated with VME that are responsible for healthcare-related infections including surgical wound, urinary tract, and bloodstream infections.

The test runs on Abbott's fully automated m2000 platform, and is part of a broad menu of real-time PCR tests developed for use on the instrument under a multiyear distribution agreement between the companies (PCR Insider, 3/17/2011).

The automated assay is performed directly on human peri-rectal swabs, rectal swabs, or stool samples, and allows laboratories to obtain results for up to 46 patient samples in less than three hours, and up to 94 samples in less than four hours.

The US Food and Drug Administration has granted 510(k) clearance to Cepheid's Xpert MTB/RIF test.

Xpert MTB/RIF is designed to rapidly detect Mycobacterium tuberculosis complex DNA and, in specimens where MTB-complex DNA is detected, mutations of the rpoB gene that are associated with rifampin resistance.

The test is less complex to perform than other previous FDA-cleared tests for the detection of TB bacteria, FDA said. Test results are available in approximately two hours, whereas traditional methods to detect drug-resistant TB usually require one to three months, according to the agency.

Cepheid was already selling Xpert MTB/RIF outside the US as part of its high-burden developing country program.

While TB in the US is at its lowest level since 1953, rapid and accurate diagnosis of the disease continues to be a challenge, especially among immunocompromised patients and the elderly, Cepheid said. According to the US Centers for Disease Control and Prevention, in 2012, 63 percent of reported TB cases in the US occurred in foreign-born persons, with case rates that were 11.5 times higher than among US-born persons. Returning US travelers may also carry the disease.

Enigma Diagnostics said this week that it has successfully completed analytical and diagnostic verification of its FluAB-RSV diagnostic assay on the Enigma ML (mini laboratory) system.

The evaluation was completed at Guy's and St. Thomas' National Health Service Foundation Trust. Enigma said that it will conclude clinical validation and CE marking of the assay in 2013.

Enigma has installed a number of ML instruments at Guy's and St. Thomas' for use at the Trust's Centre for Clinical Infection and Diagnostics Research. During May and June 2013, several hundred clinical samples obtained by Enigma from patients in Africa with symptoms of respiratory disease were processed on the Enigma ML and compared with data from the Luminex xTAG respiratory viral panel, showing comparable sensitivity and specificity between the two systems.

The Enigma ML achieved both negative predictive and positive predictive values of 100 percent for the FluB and respiratory syncytial virus components of the assay and NPV and PPV of 97 percent and 100 percent, respectively, for the FluA component of the assay.

The Enigma ML system can deliver PCR-based results from a raw sample in about 60 minutes, the company said. In addition to the FluAB-RSV test, Enigma is developing a series of multiplexed assays including panel tests for respiratory viruses, multi-drug resistant tuberculosis, and other respiratory infections.