FDA clears Genius Digital Diagnostics System for cervical cancer screening

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Hologic's Genius Digital Diagnostics System, the first FDA-cleared digital cytology system using AI and advanced imaging, promises improved sensitivity in detecting pre-cancerous lesions and cervical cancer cells.

FDA clears Genius Digital Diagnostics System for cervical cancer screening | Image Credit: © wladimir1804 - © wladimir1804 - stock.adobe.com.

FDA clears Genius Digital Diagnostics System for cervical cancer screening | Image Credit: © wladimir1804 - © wladimir1804 - stock.adobe.com.

The FDA has provided clearance to the Genius Digital Diagnostics System for identifying pre-cancerous lesions and cervical cancer cells, according to Hologic Inc.

Takeaways

  1. The Genius Digital Diagnostics System, employing artificial intelligence (AI) and advanced imaging, has received FDA clearance for cervical cancer screening, offering improved sensitivity.
  2. In 2024, an estimated 13,820 cervical cancer diagnoses in the United States with 4,360 expected mortalities highlight the importance of early detection.
  3. Pap tests have been the traditional methods for cervical cancer screening, though are often combined with HPV tests for optimal screening.
  4. The system, using AI and volumetric imaging, reduces false negatives for high-grade lesions by 28%, providing more accurate insights for timely patient care.
  5. The Genius Digital Diagnostics System, expected in early 2024, allows remote case review, connecting patients with experts and potentially contributing to decreasing cancer rates.

The American Cancer Society has stated that in 2024, an estimated 13,820 invasive cervical cancer diagnoses will be confirmed in the United States, with approximately 4360 associated mortalities. Early detection is vital to reduce incidence and mortality.

Cervical cancer is highly treatable when detected early. Traditionally, a Pap test is used to screen for cervical cancer, though the most significant sensitivity has been observed from a combination of a Pap test and HPV test. Samples are obtained at an ob-gyn office, and then sent to a lab to be reviewed on a glass slide under a microscope.

The Genius Digital Diagnostics System is the first digital cytology system using deep-learning-based artificial intelligence (AI) and advanced volumetric imaging technology for cervical cancer screening to receive FDA clearance. It uses digitally imaged glass slides and determines cells for review with an AI algorithm.

Improved sensitivity from the algorithm was reported, with the rate of false negatives for high-grade squamous intraepithelial reduced by 28%. This will support healthcare professionals in providing timely and effective care to their patients.

“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,” said Jennifer Schneiders, PhD, President of Diagnostic Solutions at Hologic. “The system delivers more actionable and accurate insights for laboratories and healthcare professionals to enhance patient care.”

The Genius Digital Diagnostics System was designed for use in present and future laboratories. It will allow remote review of cases, letting patients receive help from geographically dispersed experts. Commercial availability in the United States is expected in early 2024.

Reference

Hologic announces first and only FDA-cleared digital cytology system – Genius Digital Diagnostics System. Hologic. February 01, 2024. Accessed February 02, 2024. https://investors.hologic.com/press-releases/press-release-details/2024/Hologic-Announces-First-and-Only-FDA-Cleared-Digital-Cytology-System--Genius-Digital-Diagnostics-System/default.aspx

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