Apr 23, 2014 | Digital Pathology, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Findings may help physicians tailor cervical cancer therapies to specific gene mutations and improve the accuracy of diagnostic screening tests for this disease
New scientific knowledge about the role of human papillomavirus (HPV) in the growth of cervical cancer is creating excitement within the medical community. Among other things, these findings could encourage more widespread vaccination against HPV. That in turn would lead to reduced Pap smear testing by pathology laboratories over time.
For these reasons, cytopathologists and cytotechnologists will be particularly interested in the research findings that were published as a first-ever, international genomic study of cervical cancer, which was published online December 25, 2013, at Nature.com. Researchers discovered that the location where HPV integrates itself into the human genome, is where it causes amplified gene expression that promotes and elevates mutated gene activity that may cause cervical cancer to develop. (more…)
Mar 19, 2012 | Laboratory Management and Operations, Laboratory Operations, Laboratory Pathology
Annual growth rates of 11% or more is predicted for molecular diagnostics in coming years
Just as consolidation and acquisitions reshaped the in vitro diagnostics (IVD) manufacturing industry and concentrated market share among just a handful of multi-billion dollar IVD giants, a similar consolidation can be seen in the molecular diagnostics sector. Today it is estimated that just nine global companies control 75% of the molecular diagnostics market.
That market concentration means clinical laboratories and anatomic pathology groups have a just a handful of primary vendors from which to purchase many of the molecular diagnostic assays and genetic tests that are used most frequently in clinical care.
Frost and Sullivan published a detailed study about the molecular diagnostics marketplace. The consulting firm estimated that worldwide sales of molecular diagnostics totaled $4.1 billion in 2010. By contrast, total IVD sales globally were about $48 billion in 2010. That total includes the routine, reference, and esoteric test kits, reagents, and supplies used every day by medical laboratories.
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Nov 15, 2010 | Laboratory Management and Operations, Laboratory News, Laboratory Pathology
Professor Peter Sasieni says women vaccinated for HPV may only need two cervical cancer screening tests during their lifetime
Here’s a spicy new subject for debate among pathologists and women’s health specialists. Would it be safe for a woman who has been vaccinated for HPV (human papillomavirus) to get just two cervical cancer screening tests in her lifetime—one at age 30 and the other at age 45? A prominent professor in the United Kingdom recently advocated just such a medical laboratory testing protocol.
Earlier this month, at the United Kingdom’s National Cancer Research Institute conference in Liverpool, England, Professor Peter Sasieni made a presentation about HPV vaccinations and cervical cancer screening that generated press headlines throughout the United Kingdom. Sasieni believes enough progress has been made in vaccinating young women for HPV in the U.K. that it would be clinically appropriate to change the current guidelines for cervical cancer screening.
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Mar 14, 2007 | Laboratory News, Laboratory Pathology
Because of HPV’s link to cervical cancer, and because cervical cancer screening is a major activity in the laboratory industry, big pharma efforts to make money from HPV-related products are worth watching. That’s because big pharma has the resources to powerfully influence public opinion and legislative action.
Here in Texas, home to Dark Daily and The Dark Report, it was big news last month when our Republican Governor, Rick Perry, bypassed the state Legislature and signed an order making Texas the first state to require that schoolgirls get vaccinated against HPV. Because HPV is considered a sexually-transmitted virus that causes cervical cancer, of course there were the usual public harangues about the moral implications of this order by folks from the right and from the left. Shortly thereafter, all the buzz died down.
But that’s not the end of the story, because Governor Perry’s order caused the media to look more deeply into why more than 20 state legislatures were actively considering bills to mandate HPV testing for school-aged children. How was it that so many state legislators were suddenly inspired to champion this cause, at almost the same time? It turned out that Merck & Co, the manufacturer of Gardasil, the only FDA-approved vaccine for HPV in the market, was supporting an active, behind-the-scenes lobbying program.
Within a couple of weeks after news stories made this connection public, Merck announced that it was suspending its support of programs designed to lobby state legislators in favor of laws to require HPV vaccinations of school-age children. There were numerous reasons for this suspension. Merck identified negative publicity as the primary one, but groups sighted potential damaging effects of the vaccine on young girls, the fact that this vaccine was quite different from other vaccines required by school systems (those vaccines are for diseases passed by casual contact), and a slew of other reasons. Doctors were happy to see the lobbying stop for another reason entirely, however.
Pediatricians and gynecologists nationwide are refusing to stock Gardasil, the HPV vaccine, because of its $360 price and “totally inadequate” reimbursement from most insurers. Pediatricians, in particular, are fed up after years of declining reimbursement for vaccines, an explosion of new vaccines, and fast-escalating vaccine prices. Vaccines pose a problem for practices because they tie up $50,000 or more in inventory, run multiple refrigerators, require vaccine insurance, and require inventory management. Practices also must absorb the cost of broken or wasted vials.
With insurance companies reimbursing just $2 to $15 over the $120 per dose (3 doses required for the whole vaccine) charged by Merck, most doctors have chosen to either not give the vaccine or to require a surcharge. Pediatrician Dr. Herschel Lessin pointed out on CNN that it was ironic that insurers wouldn’t give physicians an extra $25 to cover their costs, but they would spend tens of thousands if a patient developed cervical cancer without question.
The issue of coverage for HPV vaccination won’t disappear. That’s because GlaxoSmithKline expects regulatory approval for its own HPV vaccine, called Cerverix. When that happens, there will be two deep-pocketed pharma giants with an economic motive to increase the rate of HPV vaccination. For laboratory directors and pathologists, it is an opportunity to watch a business school case study play out in the real world. There will also be as-yet-undetermined, but direct, consequences to current cervical cancer screening guidelines. As a larger proportion of the female population is vaccinated for HPV, it will be necessary to revamp cervical cancer screening guidelines. That may eventually reduce the volume of Pap testing done annually in the United States.
Related Articles:
HPV Vaccine Lobbying Suspended
Texas governor orders anti-cancer vaccine for schoolgirls
