FDA clears Hologic’s cervical cancer screening system

The US Food and Drug Administration (FDA) has cleared Hologic’s digital cytology platform in a move that could allow doctors to more accurately detect cervical cancer.

The platform, according to Hologic, combines AI with advanced volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells.

The system, comprised of a digital imager, an algorithm for image analysis, an image management server and a review station for examining patient samples, aims to detect cervical cancer, improve cytology workflow and enhance patient care.

The American Cancer Society estimates that 13,820 cases of invasive cervical cancer will be diagnosed in the US in 2024 and approximately 4,360 women will die from the disease.

However, early detection greatly improves the chances of successful treatment, lowering a person’s chance of dying from cervical cancer.

Screenings for cervical cancer include a smear test, where a sample is collected at a doctor’s office, and the cervical cells are sent to a lab where they are transferred to a glass slide. To date, this glass slide has been reviewed under a microscope.

With Hologic’s Genius Digital Diagnostics System, the glass slides are digitally imaged and an AI algorithm is applied to pinpoint the cells that cytologists and pathologists should review.

The new process and technology, Hologic claims, have demonstrated an overall improvement in sensitivity without a corresponding decrease in specificity.

The company says the system has also been shown to offer the opportunity for greater collaboration across lab and other healthcare settings, allowing cytologists and pathologists to review cases remotely.

Jennifer Schneiders, president, diagnostic solutions at Hologic, said: “Hologic is a leading innovator in women’s health with a commitment to advancing cervical and breast cancer screening technologies, from the first liquid-based cytology test to the first 3D mammography system and now the first FDA-cleared digital cytology platform.

“Our technologies have had a tremendous impact on decreasing cancer rates in women, and we are incredibly excited by the promise of Genius Digital Diagnostics.

“The system delivers more actionable and accurate insights for laboratories and healthcare professionals to enhance patient care.”