Studies have shown that pap testing, the standard method to screen for cervical cancer, can range from 55% to 80% in accuracy of detecting high-grade lesions—and that regular screening significantly lowers the death rate associated with the disease.
A new artificial intelligence-powered tool from Hologic is aiming to make those stats even better. The Genius digital diagnostics system uses deep learning AI and volumetric imaging technologies to spot pre-cancerous lesions and cancer cells, enabling earlier diagnosis of cervical cancer.
The system is now commercially available in Europe, Hologic announced this week, following the CE mark approval for the system nearly a year ago. It’s not yet available or approved in the U.S., but another version of the Genius software designed to detect breast cancer in mammography images was cleared by the FDA in December.
The system comprises a variety of digital tools to streamline the entire process of collecting and analyzing cytological samples. That process begins with Hologic’s ThinPrep pap test being used to collect a cell sample, after which the Genius Digital Imager captures high-definition images of those cells.
From there, the Genius Cervical AI algorithm analyzes the images. The deep learning-based AI studies each cell to identify potential signs of cancer—even before a lesion has turned malignant—and generates a report to guide healthcare providers through diagnosis and treatment options.
The report can be accessed through the Genius Review Station software, while the images are stored on the Genius Image Management Server. Altogether, the entire multipart system is designed to be broadly accessible and easily updated and expanded by labs across networks and around the world.
“The technology enhances the capabilities of individual laboratories and also has the potential to radically transform how cervical cancer screening is carried out, by enabling laboratories within the same network to collaborate across the world to manage the caseload,” said Andrew Pieprzyk, vice president of Hologic’s international division of strategic development diagnostics.
The European launch of the Genius digital diagnostics system comes mere days after the women’s health-focused medtech unveiled the latest addition to its NovaSure family of endometrial ablation devices.
The NovaSure V5 device will mark its official launch at the annual meeting of the American Association of Gynecologic Laparoscopists in mid-November. It builds on previous iterations of the radiofrequency energy-emitting tool by offering more accurate treatment of abnormal uterine bleeding and adapting to the individual anatomies of more patients.
Both of these debuts are poised to continue building on the momentum Hologic has experienced first with the massive earnings from its COVID-19 testing production in 2020 and then with its efforts to direct that windfall into a variety of tuck-in acquisitions over the last year.
In a newly released report summing up its fiscal year 2021, which ended in late September, Hologic shared that those efforts—plus sustained growth in its core surgical and diagnostics businesses—led to a nearly 50% increase in revenue, which totaled more than $5.6 billion for the year.