Hologic

In June, the FDA cleared tests for a broad range of conditions, including Group B strep, systemic rheumatic disease, and chlamydial or gonococcal urogenital disease.

Clinicians are using Roche's Cobas Omni Utility Channel to run lab-developed PCR tests alongside in vitro diagnostic kits, freeing valuable resources for labs.

The Fusion module is an in-lab upgrade to Hologic's Panther instrument, which enables labs to extend the testing capabilities of their existing Panther. 

Roche received several clearances, including for its Cobas CT/NG assay and for modifications to previously cleared blood clotting systems.

Despite the astronomical costs, it may prove challenging to reverse course and discontinue Zika testing according to a commentary article accompanying a NEJM study.

Although revenues from the firm's global diagnostics business were down 6 percent year over year, molecular diagnostic product revenues were up 6 percent.

Hologic's device will potentially increase sensitivity for cervical disease detection in US laboratories that employ the firm's automated imaging system.

The company unveiled forthcoming products for high-throughput molecular testing, diagnostic lab informatics, and microbiology automation.

One outcome of a recent FDA workshop about the potential for using self-collection for Pap testing was that it might be better to do self-collection in combination with molecular testing.

Overall, revenues were up 8 percent. In the diagnostics segment, molecular product sales were driven primarily by continued strength across Aptima women's health products.

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