Hologic Receives FDA Approval for ThinPrep® Genesis™ Processor

Hologic, has announced the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of the Company’s ThinPrep® Genesis^TM processor for cytology processing and specimen transfer for downstream applications. The new instrument streamlines these workflows with advanced automation capabilities including chain of custody verification, which prevents sample misidentification and allows for more confidence in results.

 “At Hologic, we have been at the forefront of cervical cancer screening, advancing diagnostics and supporting our lab partners for more than 30 years,” said Kevin Thornal, president, Diagnostic Solutions at Hologic. “The launch of the ThinPrep Genesis processor shows our continued commitment to improving the testing experience for our laboratory partners and, ultimately, helping them and clinicians deliver accurate results for women.”

 The ThinPrep Genesis processor is the latest addition to Hologic’s suite of cytology instruments, which offer simple, versatile and scalable solutions for laboratories of all sizes. The instrument offers new automation capabilities and workflow enhancements. Features such as automated tube and slide labeling, barcode scanning, vial uncapping/capping and sample aliquoting were developed to reduce hands-on time and repetitive motions – thereby improving ergonomics and streamlining lab performance.

The launch of the ThinPrep portfolio with the first liquid-based Pap test in 1996 revolutionized and increased the accuracy of cervical cancer screening.¹ The product line also includes the ThinPrep® Imaging System, released in 2003. Independent studies have shown that automated, assisted imaging can increase the sensitivity of detecting suspicious cells compared to manual slide review.^2-5

 To learn more about the ThinPrep Genesis processor, please click here.

IMAGE SOURCE: www.hologic.com

 References

1. ThinPrep Genesis Processor [instructions for use].AW-17229-001, Rev. 002. Marlborough, MA: Hologic, Inc.; 2020.
2. Dziura B, et al. Performance of an imaging system vs. manual screening in the detection of squamous intra epithelial lesions of the uterine cervix. Acta Cytol. 2006;50(3):309-11.
3. Lozano R. Comparison of computer-assisted and manual screening of cervical cytology. Gynecol Oncol. 2007;104(1):134-8.
4. Miller FS, et al. Implementation of the ThinPrep imaging system in a high-volume metropolitan laboratory. Diagn Cytopathol. 2007;35(4):213-7.4.
5. Klug SJ, et al. A randomized trial comparing conventional cytology to liquid-based cytology and computer assistance. Int J Cancer. 2012;132(12):2849-57. doi:10.1002/ijc.27955.