Hologic, Inc.'s Aptima® HBV Quant Assay for Quantitation of Hepatitis B Viral Load Receives PMA Approval
January 25, 2018 at 01:17 pm
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Hologic, Inc. announced that the United States Food and Drug Administration (FDA) has granted PMA approval for the Aptima® HBV Quant Assay for quantitation of hepatitis B viral load on the fully automated Panther® system. The Aptima HBV Quant assay represents the newest addition to the Panther system's viral load menu, joining the previously approved Aptima HIV-1 Quant Assay (for human immunodeficiency virus) and Aptima HCV Quant Dx Assay (for hepatitis C virus). All three new assays use Hologic's proprietary real-time transcription-mediated amplification (TMA), which provides highly sensitive and specific performance. The HBV Quant assay reliably quantitates HBV DNA across all major genotypes A-H. These Aptima assays run on the Panther system, which provides full, sample-to-result automation and substantially reduces hands-on time with random and continuous access. With the Panther system, laboratorians can now run viral load assays for HIV-1, HCV and HBV in parallel, or even from a single patient sample. The Aptima HBV Quant assay offers a unique, dual-target approach that delivers accurate quantitation over a broad linear range and tolerates potential mutations in the HBV genome. The Aptima HBV Quant assay's linear range is one of the broadest on the market (from 10 IU/mL to 1 billion IU/mL). This helps ensure precise quantitation even for samples with the high viremia often associated with chronic HBV infection. The HBV assay joins a growing menu of tests available on the Panther system in the U.S. market. In addition to the three viral load assays, the Panther menu includes tests for sexually transmitted infections including chlamydia, gonorrhea, trichomonas, human papillomavirus (HPV), and herpes simplex virus (HSV). Hologic has a long-term legacy in the virology space, beginning two decades ago and spanning development of nucleic acid tests to screen the blood supply for HIV, HCV and HBV. This expertise was applied to the development of the viral load portfolio on the Panther system. In Europe, the Aptima HBV Quant assay is CE-IVD marked for viral load monitoring. In addition, both the Aptima HIV-1 Quant Dx assay and Aptima HCV Quant Dx assays are approved in Europe for both diagnosis and viral load monitoring.
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. 
