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Roche wins approval of HPV test

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Roche Diagnostics Corp. won regulatory approval for a new HPV test, giving it a technological edge in the $300 million market for automated cervical cancer tests.

The Swiss giant, which runs its U.S. operations out of Indianapolis, will offer the HPV test as part of its cobas 4800 system of medical laboratory analyzers.

HPV, or human papillomavirus, is the leading cause of cervical cancer, which afflicts 12,000 new women every year in the United States, leading to 4,200 deaths annually, according to the National Cancer Institute.

Roche’s new product is the first, the company said, to test simultaneously for HPV 16 and 18, the two strains of the virus most likely to cause cervical cancer.

Roche’s HPV test is likely to compete with automated tests from Netherlands-based Qiagen NV and Massachusetts-based Hologic Inc., according to a report from MarketWatch, which estimated the automated HPV test market at $300 million in the United States. Automated tests are rarely used outside the United States, but Roche officials told MarketWatch they expect their test to gain traction.

The traditional smear tests for cervical cancer are still common around the world, but they require the analysis of doctors, which leads to errors. Roche’s clinical trials of its cobas HPV test found that one in 10 women received a false negative from smear tests. Roche's test confirmed that those women did, in fact, have cervical cancer.

“We look forward to working with laboratories and physicians to introduce the cobas HPV Test into routine cervical cancer screening,” Daniel O’Day, chief operating officer of Roche Diagnostics, said in a statement.

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  1. You are correct that Obamacare requires health insurance policies to include richer benefits and protects patients who get sick. That's what I was getting at when I wrote above, "That’s because Obamacare required insurers to take all customers, regardless of their health status, and also established a floor on how skimpy the benefits paid for by health plans could be." I think it's vital to know exactly how much the essential health benefits are costing over previous policies. Unless we know the cost of the law, we can't do a cost-benefit analysis. Taxes were raised in order to offset a 31% rise in health insurance premiums, an increase that paid for richer benefits. Are those richer benefits worth that much or not? That's the question we need to answer. This study at least gets us started on doing so.

  2. *5 employees per floor. Either way its ridiculous.

  3. Jim, thanks for always ready my stuff and providing thoughtful comments. I am sure that someone more familiar with research design and methods could take issue with Kowalski's study. I thought it was of considerable value, however, because so far we have been crediting Obamacare for all the gains in coverage and all price increases, neither of which is entirely fair. This is at least a rigorous attempt to sort things out. Maybe a quixotic attempt, but it's one of the first ones I've seen try to do it in a sophisticated way.

  4. In addition to rewriting history, the paper (or at least your summary of it) ignores that Obamacare policies now must provide "essential health benefits". Maybe Mr Wall has always been insured in a group plan but even group plans had holes you could drive a truck through, like the Colts defensive line last night. Individual plans were even worse. So, when you come up with a study that factors that in, let me know, otherwise the numbers are garbage.

  5. You guys are absolutely right: Cummins should build a massive 80-story high rise, and give each employee 5 floors. Or, I suppose they could always rent out the top floors if they wanted, since downtown office space is bursting at the seams (http://www.ibj.com/article?articleId=49481).

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