A new computerized diagnostic tool designed to assist in the early detection of cancerous and pre-cancerous cervical lesions, called DySIS™ Advanced Cervical Imaging System, is making its U.S. debut, after undergoing extensive testing and review in Europe.
Endorsed by the U.K. National Institute of Health and Care Excellence, the new FDA-cleared medical device is praised by physicians for its ability to help identify abnormalities on the cervix, which can sometimes escape detection during a standard colposcopy. A colposcopy is a diagnostic exam, usually administered after an abnormal Pap smear, in which a doctor applies a special solution to the cervix. Then, peers into a binocular viewer, called a colposcope, to look for areas that turn white, indicating abnormal cells and that a cervical biopsy may be needed.
“The DySIS system is a next generation colposcope, offering important advancements that improve the examination procedure for both doctors and patients,” said Dr. Holt Harrison of the Northeast Georgia Physicians Group Heritage OB/GYN in Gainesville, one of the first OB/GYN practices in the U.S. to offer the new computer-assisted screening device.
The DySIS Advanced Cervical Imaging System is used by the examining physician as follows:
- A high-resolution digital image of the cervix is displayed on the DySIS touch screen to allow normal assessment of the cervical area. Image color, brightness, contrast, and magnification of the displayed image can be adjusted.
- Acetic acid, which turns abnormal cervical cells white, is applied to the surface of the cervix by the physician via a built-in syringe with a diffuser for instant homogenized coverage over the cervix.
- The operator uses the intuitive touch screen interface to conduct a standard colposcopic examination while DySIS uses Dynamic Spectral Imaging to record the entire acetowhitening process.
- The system then produces a DySISmap™ Advanced Cervical Scan, which is like a weather map, in that it shows the precise areas of the cervix where acetowhitening is most extreme and most likely to contain abnormal cells.
- The physician refers to the DySISmap and marks biopsy points that may be needed based on the information displayed, as well as other examination information.
- The scanned digital image of the cervix and DySISmap showing acetowhitening and biopsy points are then saved, along with patient notes entered via the touch screen.
A traditional colposcopy can often be very frightening for a patient, because, during the examination, they have no idea what the doctor is looking at or thinking, Dr. Harrison said:
“Thirty seconds of silence can seem like five minutes, and a patient’s imagination can begin to race as they assume the doctor has discovered the worst.”
With the DySIS system, a patient is able to view what the doctor is viewing in real-time, and discuss the meaning of the colorized zones and markings on the DySISmap, which Dr. Harrison said, enables the patent to be involved and more at ease during the examination procedure.
“Since many patients with dysplasia don’t need immediate treatment due to the possibility of spontaneous resolution, careful long-term follow up is vital,” Dr. Harrison said. “The DySIS system stores high resolution images, which allows the physician to detect changes over time with greater accuracy.”
Examinations performed using the DySIS Advanced Cervical Imaging System do not result in any additional out-of-pocket expenses for the patient.