Hologic | GenomeWeb

Hologic

Seegene will use its proprietary assay development technologies to create highly multiplexed tests for the Hologic Fusion platform. 

Solid MDx revenue growth was driven primarily by sales of Aptima women's health products on the Panther and Tigris platforms.

The expanded claim for the Aptima Zika test widens the testing window for the virus to 14 days. 

The new platform, called Fusion, is an addition to the Panther system and will run qPCR assays with three "mini panels" currently in the works.

The new guidance could benefit Hologic and Roche, both of which market molecular blood screening tests authorized by the FDA under an investigational new drug study protocol.

Laboratories have access to a growing number of antibody and molecular tests, thanks in part to FDA Emergency Use Authorizations, but they need more serology resources.

Revenues from the company’s molecular diagnostics business grew 6 percent, driven by continued strength in sales of women's health products.

The firm's Aptima Zika test for patients will be marketed to Ob/GYN physicians and labs with Panther systems, while the blood screen test will be used by the Red Cross.

The firm has been granted Emergency Use Authorization for a Zika test for patient samples, and Investigational New Drug approval for a blood screening assay.

Researchers in San Diego collaborated with the American Red Cross to enable molecular testing, reducing incidence in the zip codes where screening was offered.

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