Hologic harnesses FDA nod for AI-powered Pap test analysis

For the second time just this week, an artificial intelligence-powered tool aimed at improving cervical cancer screening is taking center stage.

This time around, Hologic is the star of the show. Its Genius digital diagnostics system has earned FDA clearance, the company announced late Thursday, allowing it to be used in the U.S. to aid in cervical cancer detection.

The system is equipped with both imaging technology and deep learning AI to analyze Pap smear samples. Traditionally, after being sent off to a lab for interpretation, samples are transferred to a glass slide for a cytologist or pathologist to examine under a microscope; Hologic’s system, in contrast, creates a digital copy of the slide and automatically flags any potential signs of cervical cancer or precancerous lesions for further investigation by a clinician, either in a lab or remotely.

According to Hologic, the Genius technology is the first AI-powered digital cytology system to pass the FDA’s muster. The system previously earned CE-mark clearance in 2020 and began its European rollout a year later.

Hologic has positioned the Genius system as a tool that can be used to improve cervical cancer diagnosis rates. Suspicious cells can often go overlooked using traditional analysis methods—due to healthcare worker shortages and general human error—but Hologic said studies have found that its technology can reduce false negatives by nearly 30%.

“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,” Jennifer Schneiders, Ph.D., president of Hologic’s diagnostic solutions division, said in the company’s announcement.

The diagnostics division will likely welcome the boost: In an earnings report also released Thursday, Hologic calculated a 5.4% drop in revenue in the business’ cytology and perinatal segment for the first quarter of its fiscal year 2024.

Overall, the company clocked a 20% year-over-year decline in its total first-quarter revenues for the diagnostics division—though that change turned into a 0.1% increase when COVID-related earnings were excluded.

Hologic’s news comes hot on the heels of an update from BD with a similar focus on women’s health.

Earlier this week, BD announced that it has partnered with Techcyte to offer the latter’s digital cervical cytology system—which, like Hologic’s, uses AI to interpret digitized Pap test samples. Unlike the Genius system, however, Techcyte’s platform hasn’t yet earned FDA clearance, so the team-up will launch first in Europe, where the technology has already received a CE mark.