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.