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Published on 07/13/1998 All articles from this issue

Local device improves early breast cancer detection

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By Carol Tiegs

Special to the Town Crier

A new weapon, developed in Los Altos, has just been added to the battle against breast cancer.

Late last month, Los Altos-based R2 Technology received U.S. Food and Drug Administration approval of the ImageChecker, a computerized scanner that enhances radiologists' abilities to spot subtle features on mammography film that could signal the presence of cancer. That means earlier detection of breast cancer.

Alan Stein, R2's vice president of regulatory sales, compares the ImageChecker to the spell-check program on a computer.

"It acts as a sophisticated pattern recognition system, a feature detector," Stein said. He emphasized that the ImageChecker doesn't diagnose. "It just makes sure (radiologists) don't miss subtle features."

While screening radiologists are accurate in detecting 80 of 100 cancers through mammography, Stein said there are several screening challenges. These include searching a complex image, using only a magnifying glass for better viewing, to detect "very subtle features."

Radiologists typically review 40 to 50 cases in an hour, which can mean reviewing 320 to 400 individual films, Stein said. It also means a short viewing time per film.

The "extremely low incidence" of cancer - 40 to 50 cancers out of 10,000 screening mammograms - also creates challenges for screeners," Stein said. It's easier to spot something you see frequently.

R2 won FDA approval for ImageChecker by demonstrating it could increase a radiologist's accuracy by 10 percent.

The ImageChecker scans mammography film that has been digitized, seeking signs of calcification or dense masses that could mean cancer. It marks these for the radiologist's review, using unique symbols, or pointers, for each type of trigger signal.

"The pointers indicate not only where to look but what to look for," Stein said.

Extrapolating from the ImageChecker's clinical trials, Stein said that for every 100,000 cancers currently detected during screening mammography, an additional 12,800 women could have their cancer detected each year by adding ImageChecker technology.

R2 Technology's investigational sites for ImageChecker included El Camino Hospital in Mountain View as well as Kaiser Permanente medical offices in Redwood City, Sacramento, San Francisco and South San Francisco.

"We find (ImageChecker) to be helpful," said Dr. Herb Steinhardt, chief of Kaiser Permanente's radiology department in South San Francisco. "In a sense it's saying, 'look really carefully in this area.'"

Steinhardt said his department's ImageChecker has become a regular part of their operation.

The ImageChecker computer system, including digitizing processor and display unit, will cost about $175,000.

Stein said the five-year survival rate with early-stage breast cancer detection is 96 percent, with an average treatment cost of $11,000. With late-stage detection, he said, the five-year survival rate plummets to 20 percent, while the average cost of treatment soars to $140,000.

R2 Technology has entered into a joint venture with General Electric to co-develop a totally digital mammography unit, Stein said.

Located on Distel Drive in Los Altos, R2 Technology was founded in 1993 by S. P. Box Wang. The privately held company has about 60 employees.