IBJNews

Hurdles remain for Roche Diagnostics on HPV test

Back to TopCommentsE-mailPrintBookmark and Share

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.

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in IBJ editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
 
Subscribe to IBJ
  1. John, unfortunately CTRWD wants to put the tank(s) right next to a nature preserve and at the southern entrance to Carmel off of Keystone. Not exactly the kind of message you want to send to residents and visitors (come see our tanks as you enter our city and we build stuff in nature preserves...

  2. 85 feet for an ambitious project? I could shoot ej*culate farther than that.

  3. I tried, can't take it anymore. Untill Katz is replaced I can't listen anymore.

  4. Perhaps, but they've had a very active program to reduce rainwater/sump pump inflows for a number of years. But you are correct that controlling these peak flows will require spending more money - surge tanks, lines or removing storm water inflow at the source.

  5. All sewage goes to the Carmel treatment plant on the White River at 96th St. Rainfall should not affect sewage flows, but somehow it does - and the increased rate is more than the plant can handle a few times each year. One big source is typically homeowners who have their sump pumps connect into the sanitary sewer line rather than to the storm sewer line or yard. So we (Carmel and Clay Twp) need someway to hold the excess flow for a few days until the plant can process this material. Carmel wants the surge tank located at the treatment plant but than means an expensive underground line has to be installed through residential areas while CTRWD wants the surge tank located further 'upstream' from the treatment plant which costs less. Either solution works from an environmental control perspective. The less expensive solution means some people would likely have an unsightly tank near them. Carmel wants the more expensive solution - surprise!

ADVERTISEMENT