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Hologic assay is first FDA-cleared test to detect M. genitalium

February 2019—The Food and Drug Administration granted clearance for Hologic’s Aptima Mycoplasma genitalium assay. This is the first test the FDA has authorized for M. genitalium detection.

The FDA reviewed data from a clinical study that included testing of 11,774 samples. The FDA says the study showed that the Aptima assay correctly identified M. genitalium in approximately 90 percent of vaginal, male urethral, male urine, and penile samples. It correctly identified M. genitalium in female urine and endocervical samples 77.8 percent of the time and 81.5 percent of the time, respectively. Vaginal swabs are the preferred sample type owing to better clinical performance. Alternative sample types, such as urine, can be used if vaginal swabs are not available. In addition, the study showed that the test correctly identified samples that did not have M. genitalium present 97.8 to 99.6 percent of the time.

The FDA reviewed the Aptima M. genitalium assay through the de novo premarket pathway.

Roche launches uPath enterprise software

Roche launched its uPath enterprise software for digital pathology, which the company says improves on Ventana Virtuoso, its previous version. uPath software reduces image rendering times, integrates automated image analysis, and improves efficiency, Roche says, by enabling an improved workflow for sharing cases between pathologists.

To aid in the development of uPath software, Roche acquired the Leeds Virtual Microscope (LVM) technology from the University of Leeds, U.K., and the Leeds Teaching Hospitals NHS Trust. With this technology, pathologists can diagnose a patient case more quickly by viewing all slides in a case in a single seamless view and viewing all patient information simultaneously. Multiple slides appear on a canvas-like display, enabling pathologists to move seamlessly between a variety of stains in a single view. The LVM technology operates on displays that range from laptops to ultra-high definition Powerwalls.

“With this launch, we are able to deliver an improved digital pathology experience consisting of the Ventana DP 200 slide scanner and uPath software, which are the foundation to further enrich our portfolio of automated clinical algorithms for pathologists,” Jill German, head of Roche Tissue Diagnostics, said in a statement.

This launch follows the March 2018 release of the Ventana DP 200 slide scanner.

FDA clears DiaSorin Molecular Bordetella test

DiaSorin Molecular received FDA clearance for its Simplexa Bordetella Direct moderate-complexity assay.

It is designed for use on the Liaison MDX to provide qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis in nasopharyngeal swabs. The assay is performed directly from nasopharyngeal swab samples without extraction and provides results in about an hour.

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