AI breast cancer diagnostic tool Gets FDA clearance

There are few things in life more frightening than a possible cancer diagnosis. Now the machines are here to help. Paragon Biosciences and Qlarity Imaging have figured out a way to harness the power of artificial intelligence to help humans catch cancer earlier and more accurately.

QuantX recently became the first-ever computer-aided breast cancer diagnosis system cleared by the FDA for use in radiology, but it’s not putting radiologists out of a job any time soon. “Radiology is the backbone of diagnosing many diseases today,” said Jeffrey Aronin, chairman and CEO of Paragon Biosciences. “We believe the future is radiologists with technology.”

The combination of humans and machines apparently works really well. In a clinical study, QuantX helped radiologists interpret MRIs, noting the differences between cancerous and noncancerous breast lesions. Using the AI-fueled software led to a 39% reduction in missed breast cancers, as well as a 20% overall diagnostic improvement. It’s a win for the machine age as well as for women anxiously awaiting the results of their breast MRIs. (Currently, the technology is just for women who require a breast MRI, typically used for women with a higher than average risk of breast cancer.)



“Today, about 30 million women are screened for breast cancer each year in the U.S., and we all have women in our lives who have to go through this,” says Meghan Harrison, head of product and COO at Qlarity Imaging.

She adds that if there are any suspicious findings, women have to go through the harrowing process of further imaging, further testing, and more waiting. “The process of going through that biopsy, waiting for your procedure to be scheduled, waiting for your results can create a lot of anxiety with those women,” Harrison says. “And yet 75% of those biopsies come back negative, meaning no cancer was found. We believe that Qlarity can do better, help radiologists make better diagnoses with our software. We can help them deliver better patient care.”

QuantX was initially developed at the University of Chicago based on research led by Dr. Maryellen L. Giger and incubated at Quantitative Insights, a startup that had been launched with the support of the University of Chicago’s Polsky Center for Entrepreneurship and Innovation. It was acquired by Qlarity and brought into the Paragon Biosciences fold. While QuantX is currently only approved for use in breast cancer diagnosis, Qlarity plans to expand the diagnostic applications of its AI technology to additional medical conditions.



Qlarity is in an early rollout phase of QuantX and is currently working with radiologists at MD Anderson Cancer Center at the University of Texas and the University of Chicago, gathering feedback from users in the field. Soon, though, the AI-assisted doctor will be seeing you.