The test for cervical cancer screening previously received the IVD mark and US Food and Drug Administration approval on the Cobas 4800 system.
A special issue of Preventive Medicine tackles issues surrounding HPV testing as a primary screening method for cervical cancer in a range of clinical settings.
The test will be developed in Global Good labs and ported onto QuantuMDx's handheld molecular platform.
The vice president of clinical programs at ACP discusses what's happened in the five years since a report made recommendations on how to cut down on unnecessary testing.
Solid MDx revenue growth was driven primarily by sales of Aptima women's health products on the Panther and Tigris platforms.
Papilloplex, a kit to detect and differentiate all 14 high-risk HPV genotypes, can be used on cervical swabs and urine samples.
Professional, molecular, and tissue diagnostics sales continued to grow during the first three quarters, while diabetes care sales remained in decline.
The pre-market approval application is based on data collected during a two-year prospective study of more than 33,000 women.
Diagnostic systems strength was driven by strong growth in molecular and installations in Western Europe .
Revenues from the company’s molecular diagnostics business grew 6 percent, driven by continued strength in sales of women's health products.