FDA Approves New Chest X-Ray Scanning Software

Jenni Laidman

January 18, 2012

January 18, 2012 — Software that could lead to low-cost early detection of lung cancer won US Food and Drug Administration (FDA) clearance this month, according its manufacturer, Riverain Technologies.

Development of an inexpensive tool for early diagnosis could have a tremendous effect on cancer screening and disease survival, said Neal Dunlap, MD, a clinical professor at the University of Louisville, Kentucky, and radiation oncologist at the university's James Graham Brown Cancer Center. Dr. Dunlap has no connection to the manufacturer or its technology.

"If this screening test proves to be of high sensitivity and cheap for patients, that would be enormously huge for this field," Dr. Dunlap told Medscape Medical News.

The new Temporal Comparison software helps radiologists better detect changes in lung tissue by improving comparisons between a new chest X-ray and one taken previously, according to a company news release. The software superimposes the new image on the old one and highlights areas of change, using pattern-recognition and machine-learning algorithms. Normally, radiologists draw conclusions about suspicious tissue changes by conducting side-by-side X-ray comparisons.

In an unpublished study conducted for the manufacturer at Georgetown University in Washington, DC, the detection of solitary nodules improved with the new software. Fifteen radiologists reviewed 422 chest X-ray pairs side-by-side (standard practice in lung-cancer detection), scoring areas that require further action, Steve Worrell, the manufacturer's chief technology officer, told Medscape Medical News. The radiologists then saw the lung X-ray view created with the new software and reevaluated the scans. Detection scores of solitary nodules improved 12.4% with the new software, Worrell said. Riverain provided software for the testing but was otherwise not involved in the research, he added.

"We've really been struggling on how we can capture the disease early in its development, and so improve survival, and do it in a way that's cost-effective," Dr. Dunlap said. To date, computed tomography (CT) scans are the best way to catch lung cancer early. A 2010 study by the National Cancer Institute comparing chest X-rays with CT scans in more than 50,000 people showed that those patients in the CT-scan group saw a 20% reduction in mortality because of early diagnosis. However, widespread application of CT scanning has been stymied by the costs of the testing, which insurance companies are reluctant to reimburse without a prior diagnosis, Dr. Dunlap said.

Worrell said that using his company's software would be "an order of magnitude" cheaper than CT scanning. However, he notes, there is a trade-off, because a CT scan provides a 3-dimensional view that an X-ray cannot.

No more than 20% of patients in the United States are diagnosed with lung cancer when treatment is most likely to succeed, at stage 1, Dr. Dunlap said. Five-year survival for patients with stage 1 lung cancer can be as high as 60%, he added, noting that 5-year survival for stage 2 disease is between 30% and 40%. However, later diagnosis is far more common, with 5-year survival no higher than 25% for stage 3a cancer, and essentially zero for stage 4 cancer, Dr. Dunlap said.

Worrell said that a single server with the new software could serve all of a facility's X-ray equipment. Scans go directly to the server, which searches the facility's picture archive and communication system for prior scans. If a prior scan exists, the 2 X-rays are aligned and the difference image goes into the patient file. "From a user standpoint, the system is totally transparent," Worrell, said. "Radiologists are reviewing our image on their existing viewer."

The Temporal Comparison technology is combined with the company's Bone Suppression software, which was approved by the FDA in early 2010.

"If you could use a standard chest X-ray and some new algorithm to diagnose patients earlier, that's a gold mine for the patients," Dr. Dunlap concluded.

Dr. Dunlap has disclosed no relevant financial relationships. Mr. Worrell is the chief technology officer for Riverain.