San Diego Business Journal

Gen-Probe HPV Test Gains FDA Approval

By Kelly Quigley Tuesday, November 1, 2011

San Diego-based Gen-Probe Inc. said on Oct. 31 that the U.S. Food and Drug Administration approved its Aptima HPV assay, a new molecular test to detect the virus that causes cervical cancer.

The company said its test will give doctors and patients a more accurate way to screen for cervical cancer and that it will boost testing efficiency on the lab side. The test has been approved to run on Gen-Probe’s automated Tigris instrument system; there are 200 such systems being used today in U.S. clinical laboratories.

Carl Hull, Gen-Probe’s president and CEO, said developing the assay was the largest and most complex diagnostic R&D program the company has ever completed, and called FDA approval a “major milestone for the company.”

The Aptima HPV assay detects 14 high-risk strains of human papillomavirus that are associated with cervical cancer and precancerous lesions. Unlike other FDA-approved DNA-based HPV tests, Gen-Probe’s assay detects messenger RNA over-expressed from two potentially cancer-causing genes, the company said.

“Most HPV infections clear up on their own, so it’s important to identify those persistent, high-risk infections that are most likely to lead to cervical cancer,” said Tom Wright, professor of pathology and cell biology at the Columbia University Medical Center. He said that Gen-Probe’s clinical studies involving 45,000 women have shown that the Aptima test is highly accurate and less likely than other tests to give false alarms.

Gen-Probe expects to launch Aptima in the U.S. within the next two weeks and anticipates revenues from the assay to begin in the later part of the first quarter of 2012.

Gen-Probe, which trades on NASDAQ under the symbol GPRO, was trading at $61.35 on the morning of Oct. 31, down 42 cents — less than 1 percent — from Friday’s closing price.