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.
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.
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.
