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. Uh, sorry Johnnie, but you are incorrect. Despite the assertions by yourself and various defenders and captains, sports attendance is NOT off significantly at most sporting events in the US. Variances in attendance has been in the range of single digits, both + & - for years now. MLB has had most of its best overall attendance nubers in the last decade, and that trend has been consistent for most major sporting events. The number one issue cited by most fans when asked about attendance is the overall cost of attending. The presence of HD and big screen televisions in home doesn't even register, as a factor for not attending an event. VALUE in the product is the key, and apparently is something lacking in the current ICS. What other explanation is there when with what is routinely touted as the "best" racing on the planet, fans are staying away in DROVES. A "close" title battle into the last event at Fontana, with the "cars and stars" of the ICS, and who showed up? MAYBE 8K. Sorry, but HD TV isn't to blame for that kind of fan apathy.

  2. Do you need finance to establish your business ? Are you interested in getting a loan at 3% from our private company? If so please Email: suntrust_oil@blumail.org

  3. If she was worth the $ the public outcry over direct tv dropping them would have kept them on their dishes as we have seen with other companies. I too quit watching channel 13 after she showed up since I left channel 8 because of her all show rather than production results. When Randy on 8 corrected her she had a big head and incorrectly challenged his correction for pronunciation of a city. Other antics while she matures was too much for me with her very inaccurate forecasts. All the forecasters were predicting rain until Thursday except Chris. They predicted sunny on Thursday but instead of rain until Thursday upon which the sun would finally make it out in full glory Chris was right on the money just as I too predicted looking at the radar on weather.gov. One thing I love about Angela is the fear you can see in her every time it thunders in the winter. It far exceeds the entertainment value of her body language (high heel noise drags, depression, etc) when her forecasts are so incorrect. Her hair stands on end, you have to see it!!!

  4. Good Day, Apply For A Loan I am Mr Fernadez Antonio, a private Loan lender and a cooperate financial for real estate and any kinds of business financing. I also offer Loans to individuals, Firms and cooperate bodies at 3% interest rate We offer any kind of loans. email us via fernadezloaninvest@outlook.com LOAN APPLICATION FORM First name:......................... Middle name:......................... Last name:........................................ Date of birth (yyyy-mm-dd):....................... Gender:........................................... Marital status:................................... Total Amount Needed............................... Loan Duration.................................... Address:.......................................... City:............................................. State/province:................................... Zip/postal code:.................................. Country:.......................................... Phone:............................................ Fax:.............................................. Mobile/cellular:.................................. Monthly Income.................................... Occupation:....................................... Best Regard, Mr Fernadez Antonio.

  5. i will love to share my testimony to you all the people in world i got married to my husband about 2 year ago we start having problems at home like we stop sleeping on the same bed,fighting about little things he always comes home late at night,drinking too much and sleeping with other women out side i have never love any man in my life except him. he is the father of my child and i don't want to loose him because we have worked so hard together to become what we are and have today .few month ago he now decided to live me and the kid,being a single mother can be hard sometimes and so i have nobody to turn to and i was heart broken.i called my mom and explain every thing to her,my mother told me about DR.okoro how he helped her solve the problem between her and my dad i was surprise about it because they have been without each other for three and a half years and it was like a miracle how they came back to each other. i was directed to DR. okoro on his email:okorospell@gmail.com and explain everything to him,so he promise me not to worry that he will cast a spell and make things come back to how we where so much in love again and that it was another female spirit that was controlling my husband he told me that my problem will be solved within two days if i believe i said OK So he cast a spell for me and after two days my love came back asking me to forgive him i Am so happy now. so that why i decided to share my experience with every body that have such problem contact Dr okoro the great spell caster on his email addresses spellcasterforlove@outlook.com

ADVERTISEMENT