U.S. Food and Drug Administration Grants PMA Approval for Hologic, Inc.'S Aptima Hiv-1 Quant Assay
January 03, 2017 at 08:00 am
Share
Hologic, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted PMA approval for the Company's HIV-1 viral load monitoring assay. The Aptima HIV-1 Quant assay is a nucleic acid amplification test for the quantitative detection of RNA from HIV in plasma specimens. The Aptima HIV-1 Quant assay runs on Hologic's Panther® system, a market-leading, integrated platform that fully automates all aspects of testing, from sample to result. The system substantially reduces hands-on time for laboratories by providing random and continuous access with rapid turnaround time. A number of published studies have compared the performance of the Aptima HIV-1 Quant assay with other HIV viral load monitoring assays currently on the market. The results of these studies demonstrate that the Aptima HIV-1 Quant assay provides repeatable, reliable results for consistent quantitation. 1-4 This consistency is critical for patient management, as it ensures that detected changes in viral load are due to potential clinical changes rather than assay variation. The Hologic Aptima HIV-1 Quant assay uses a dual target approach against highly conserved regions in the HIV genome and is designed to deliver reliable, consistent quantitation across HIV-1 groups and subtypes. Availability of the assay on the Panther system enables every step, from sample to result, to be completed within a single integrated instrument.
Hologic, Inc. is the world leader in the design, manufacturing and marketing of diagnostic products, medical imaging systems and surgical products dedicated to women's health. Net sales break down by area of application as follows:
- molecular diagnostics (46.7%): rapid diagnostic tests for human diseases detection (sexually transmitted infections, respiratory diseases, viral diseases, infectious diseases, cancers of the cervix and prostate, etc.) and fetal fibronectin;
- breast health (35.5%): digital mammography and breast biopsy solutions and systems;
- gynecological surgery (15%): endometrial ablation devices, minimally invasive intervention systems for the hysteroscopic elimination of targeted intrauterine diseases (including fibroids and polyps). The group also offers fluid management systems for use in hysteroscopic procedures;
- bone health (2.8%): bone imaging systems, bone sonometers and osteodensitometers for bone structure and density, and osteoporotic fractures risk assessment.
Net sales break down by source of revenue between sales of products (81.4%) and services (18.6%).
Net sales are distributed geographically as follows: the United States (75.9%), Europe (12.9%), Asia/Pacific (6.3%) and other (4.9%).
HOLOGIC, INC. 
