FDA has granted premarket approval (PMA) authorization to Hologic Inc, Marlborough, Mass, for the company’s ThinPrep Integrated Imager. Approval of the system will make automated imaging of Pap tests more broadly available to laboratories and cytologists in the United States. Studies have shown that automated, assisted imaging can increase the sensitivity of detecting suspicious cells compared to manual slide review.1–4
Most ThinPrep Pap tests are currently performed in high-volume reference laboratories that employ automated imaging via the Hologic ThinPrep Imaging System. The ThinPrep Integrated Imager combines the power of ThinPrep computer-assisted imaging and the ease of dual-slide review into a single, automated microscope, which company officials say will improve detection of cervical diseases.
Over the past 40 years, the number of cervical cancer cases has been cut in half thanks largely to regular testing, which can identify abnormalities before they become cervical cancer.5
The ThinPrep Integrated Imager guides cytology technicians to areas showing potential abnormal cells, and images slides in approximately 90 seconds. It combines an imaging station and review scope into a single desktop system offering high-quality optics and an easy-to-use interface to enable a convenient, flexible workflow. Also able to be used as a conventional microscope, the imager consolidates the needs of the cytotechnologist into one device.
In conjunction with the ThinPrep Integrated Imager, Hologic is also launching the Compass stainer in the United States. The automated stainer has a smaller footprint than most, and thus offers a more affordable solution to smaller labs needing to perform both routine and special staining protocols.
For more information, visit Hologic.
- Dziura B, Quinn S, Richard K. Performance of an imaging system vs. manual screening in the detection of squamous intraepithelial lesions of the uterine cervix. Acta Cytol. 2006;50(3):309–311; doi: 10.1159/000325959.
- Lozano R. Comparison of computer-assisted and manual screening of cervical cytology. Gynecol Oncol. 2007;104(1):134–138; doi: 10.1016/j.ygyno.2006.07.025.
- Miller FS, Nagel LE, Kenny-Moynihan MB. Implementation of the ThinPrep imaging system in a high-volume metropolitan laboratory. Diagn Cytopathol. 2007;35(4):213–217; doi: 10.1002/dc.20627.
- Klug SJ, Neis KJ, Harlfinger W, et al. A randomized trial comparing conventional cytology to liquid-based cytology and computer assistance. Int J Cancer. 2013;132(12):2849–2857; doi: 10.1002/ijc.27955.
- Cancer Facts and Figures 2017. Atlanta: American Cancer Society, 2017. Available at: www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2017/cancer-facts-and-figures-2017.pdf. Accessed June 11, 2018.