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Dx Focus: Roche Cobas HPV; Quidel Strep Test; Luminex Norovirus Assay; Curetis Pneumonia Panel


Roche said this week that the US Food and Drug Administration has approved Roche's Cobas HPV test for use as a first-line primary screening test for cervical cancer in women 25 years and older.

The approval follows a unanimous recommendation issued last month by the Microbiology Devices Panel of the FDA's Medical Devices Advisory Committee, making Cobas HPV the first and only HPV test approved in the US for first-line primary cervical cancer screening.

Roche's test provides genotyping information for HPV 16 and 18, which are the highest-risk types responsible for about 70 percent of cervical cancer, while simultaneously reporting on the 12 other high-risk HPV types. It runs on Roche's Cobas 4800 platform, an automated molecular diagnostic system that runs PCR-based assays.

The Cobas HPV test was first approved by the FDA in April 2011 for screening patients age 21 and older with abnormal cervical cytology results, as well as for use adjunctively with normal cervical cytology in women ages 30 and over to assess the presence or absence of high-risk HPV genotypes.

Quidel said this week that it has received de novo clearance from the US Food and Drug Administration to market its Lyra Direct Strep multiplex real-time PCR assay.

The new test detects and differentiates between pyogenic Group A and pyogenic C or G streptococcal throat infections.

Group A Streptococcus are Gram-positive bacteria that reside primarily in the nose, throat, and skin and are responsible for several illnesses such as strep throat, skin infections, or toxic shock syndrome. Meantime, Group C and G Streptococcus are less understood than Group A, although some strains have been increasingly reported to cause infections similar to those caused by GAS. Most are treated with penicillin or other beta-lactams. These non-Group A strains are also found in a significant number of Group A-negative symptomatic patients, and treatment appears to shorten the symptomatic period of disease.

The new assay is part of Quidel's Lyra brand of ready-to-use PCR reagent kits specifically designed to be compatible with a laboratory's existing thermal cycler.

Luminex said this week that norovirus will be the fourth assay in the launch menu for Aries, its forthcoming sample-to-answer molecular diagnostics system.

The assay will be designed to test for both GI and GII genogroups in a single, easy-to-use cassette, Luminex said.

In November, Luminex unveiled the Aries system at the Association for Molecular Pathology meeting in Phoenix, Ariz. The platform combines real-time PCR chemistry obtained as part of Luminex's acquisition of EraGen Biosciences in 2012 with sample-to-answer molecular testing technology it acquired along with startup GenturaDx, also in 2012.

At the unveiling, Luminex said it hoped to commercially launch assays for Clostridium difficile, herpes simplex virus I and II, and combined influenza A/influenza B/respiratory syncytial virus in Europe in the second half of 2014 and in the US, assuming regulatory clearance, in early 2015.

In addition to running Luminex-developed assays, Aries will also enable users to create laboratory-developed tests using their own analyte-specific reagents or those sold by Luminex

Curetis this week announced positive clinical data from an independent study of its Unyvero P50 Pneumonia assay conducted by researchers from Maastricht University Medical Center in the Netherlands.

The data demonstrated high clinical sensitivity of the Unyvero P50 Pneumonia test in detecting pathogens, including in samples with low pathogen concentrations.

Specifically, the researchers compared the performance of Unyvero P50 with conventional microbiology culture in broncho-alveolar lavage fluid samples for the diagnosis of ventilator-associated pneumonia (VAP), a common complication in intensive care patients. The most frequent causes are Pseudomonas aeruginosa, Staphylococcus aureus and Enterobacteriaceae.

Using the quantitative culture standard, Unyvero P50 Pneumonia correctly detected eight different important pathogens in 44 VAP samples at 100 percent sensitivity. The overall sensitivity of the Unyvero P50 panel was 88.6 percent at clinically relevant pathogen concentration. Unyvero P50 was also able to detect eight different clinically relevant pathogens in 12 patient samples where conventional microbiology culture failed. This data confirms previous results where Unyvero had consistently detected pathogens missed by conventional culture, Curetis said.

Gerd Luedke, director of bio-assay development at Curetis, noted in a statement that "within four hours, our application identified close to 90 percent of all pathogens within the specified cutoff and even 60 percent with concentrations below this threshold."

The Unyvero P50 cartridge runs on the Unyvero Analyzer, an automated benchtop nucleic acid testing platform that combines a proprietary universal sample prep method with endpoint PCR and array-based detection.

The new data were presented at the Scientific Spring Meeting of the Royal Dutch Society for Microbiology and Dutch Association for Environmental Medicine in Arnhem, the Netherlands.