FDA Green Lights ThinPrep Integrated Imager for Pap Testing in More Labs
Use of the device is appropriate for small- and mid-sized laboratories.
Hologic Inc., announced that the US Food and Drug Administration (FDA) granted premarket approval for the ThinPrep Integrated Imager which will allow for automated imaging of Pap tests to be more broadly available in laboratories and cytologists in the US.
The approval is backed by studies that demonstrate the automated, assisted imaging increasing the sensitivity of detecting suspicious cells compared to manual slide review.
“Approval of the ThinPrep Integrated Imager brings the benefits of ThinPrep automated Pap imaging to small- and mid-sized laboratories in the US, and of course to their patients,” Tom West, president, diagnostic solutions division, Hologic, said in a statement.
A majority of the ThinPrep Pap tests are currently run in high-volume reference laboratories that employ automated imaging and the ease of dual slide review into a single, automated microscope, which brings increased sensitivity for cervical disease detection to all-sized laboratories.
The device guides cytology technicians to areas showing potential abnormal cells, imaging slides in approximately 90 seconds.
Using optical density analysis, the integrated imager identifies diagnostically-relevant cells or cell groups, storing coordinates of the 22 fields of interest. The 22 fields are presented to the cytotechnologist for interpretation, and if no abnormalities are identified, the slide can be signed out as negative or proceed through the laboratory quality control system. A complete slide review is required if the user detects any suspicious cells within the 22 fields of view.
The dual review process combines human interpretative expertise with computer imaging power.
ThinPrep combines an imaging station and review scope into a single desktop system that offers high-quality optics and an easy-to-use interface that provides technicians with a convenient, flexible workflow. The imager can also be used as a conventional microscope to save space.
Throughout the last 40 years, the number of cervical cancer cases has been cut in half largely due to regular testing, which can identify abnormalities before becoming cervical cancer.
