ChromaVision Soars on FDA Approval

ChromaVision Medical Systems Inc.’s shares more than tripled Tuesday after regulators gave broader marketing approval to its Acis test designed to determine whether and how breast cancer patients will be treated with Genentech Inc.’s Herceptin.

The test detects, counts and classifies the HER2 protein, giving doctors a better understanding of whether a patient will be helped by Herceptin, the company said. Acis software has been on the market since 2000 and has about 100 applications, ChromaVision Chief Financial Officer Stephen Dixon said.

The FDA’s decision allows ChromaVision to broaden its marketing and make specific claims about the test’s ability to predict a patient’s response to treatment, the company said. More than 200,000 new cases of breast cancer are diagnosed in the U.S. each year, ChromaVision said.

“The key is being able to pre-screen patients,” said John McCamant, editor of the Medical Technology Stock Letter in Berkeley. “As we get drugs that are more expensive, that’s how you justify the cost.”

Shares of the San Juan Capistrano-based company rose $2.69 to $3.92 in Nasdaq trading. That made the shares the second-highest percentage gainer and the fifth most actively traded, according to Bloomberg data. Before Tuesday, ChromaVision shares had fallen 7.4% this year.

Acis would complement privately held Danish company DakoCytomation’s HercepTest to help evaluate patients who may receive the Herceptin cancer medicine, the company said.

ChromaVision, founded in 1993, markets the Acis test to hospitals, cancer centers, laboratories and university and medical researchers in the U.S. and Europe, according to the company’s website. Acis and a simplified version of the test are the company’s only products on the market, Dixon said.