Roche Diagnostics Corp. could enjoy a huge increase in sales of its HPV tests if all doctors and women follow a recommendation issued last week by an advisory committee at the U.S. Food and Drug Administration.
The committee unanimously recommended that Roche’s HPV test replace Pap smears as the standard way to screen women for cervical cancer. The FDA does not have to follow the recommendations of its advisory committees, but it usually does.
Still, wrinkles in the U.S. health care system present several high hurdles before Roche can turn that recommendation into reality—and claim the substantial commercial success it could bring.
Physicians ordered 31.8 million Pap smears in 2010, the most recent year for which data are available from the U.S. Centers for Disease Control and Prevention. By comparison, doctors ordered just 4.2 million HPV tests that year.
HPV stands for human papillomavirus, which causes 99 percent of the 12,000 annual cases of cervical cancer in the United States. Roche’s HPV test can detect the presence of the two most dangerous strains of HPV—genotypes 16 and 18—which are responsible for 70 percent of cervical cancer cases.
If Roche, which operates its laboratory testing business out of Indianapolis, could get more women not receiving Pap smears to instead use its test, that would not only generate a steady stream of revenue, but even more important, it would help it sell more of its pricey testing machines to hospitals and doctors.
As of 2011, those machines, called the cobas 4800, cost $250,000 to $300,000.
Roche first won FDA approval for its HPV test in 2011. In a 47,000-patient clinical trial, Roche found that one in seven women who had a normal Pap smear result actually had the presence of HPV’s strain 16.
“Through technological and scientific advancement, we now have a better screening tool for cervical cancer. Women around the world deserve the best tool to know their risk and reduce their chances of developing cervical cancer,” said Roland Diggelmann, chief operating officer of Roche Diagnostics, in a prepared statement.
But while the FDA advisers were convinced, it will take longer before physician groups agree to change their practice, Dr. David Chelmow, who led development of the American College of Obstetricians and Gynecologists' screening guidelines, told the Reuters news service.
“It will take some time for the ACS (American Cancer Society), the U.S. Preventive Services Task Force and other big groups to get a chance to look at the data," Chernow said. "There is little comparative effectiveness data comparing primary HPV screening with co-testing."
Dr. Vijay Kumar, an analyst for ISI Group, said in a research note that convincing doctors to use the Roche test as their only tool "will be a huge task, and you will need a head-to-head trial versus Pap testing before doctors even begin to be convinced."
Another barrier to change, according to Kumar, is the fact that pathologists make money on Pap tests and referrals, while with HPV tests, the test provider makes the bulk of the profit.
Roche has been having success in its professional and molecular diagnostic divisions. Those two units combined in 2013 to produce North American revenue of 1.7 billion Swiss francs, or $1.6 billion, up 6 percent over the previous year.