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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Jun 8, 2007 | Compliance, Legal, and Malpractice, Laboratory News
Earlier this week, Digene Corporation (Nasdaq: DIGE) announced that it would be acquired by Dutch firm Qiagen (Nasdaq: QEN) for a purchase price of approximately $1.6 billion. Digene has been involved in patent infringement lawsuits during the past year in efforts to protect its HPV patents.
It was announced on Monday, June 4, that Digene will be purchased by Qiagen, a Dutch maker of tools for gene research. This gives Quiagen access to Digene’s patented HPV test, and tests for sexually transmitted diseases. Digene’s HPV test is the only one that has been approved in the U.S. and Europe. The purchase gives Qiagen “instantaneous market and technology leadership” in molecular diagnostics and will be “a catalyst for growth,” Peer M. Schatz, CEO of Qiagen, said.
It was announced back in January that Digene was suing Third Wave Technologies (Nasdaq: TWTI) over alleged patent infringement. The suit alleged that Third Wave infringed on a biotechnology patent involving human detection of the human papilloma virus (HPV).
Third Wave countersued Digene in early March by filing an anti-trust suit that alleged that Digene “abused its monopoly power to thwart competition” in the HPV diagnostic market. The current legal action is interesting because Digene and Third Wave had earlier entered into an agreement to dismiss, without prejudice, a declaratory judgment action filed by Third Wave against Digene for the same HPV detection technology. It was January 2006 when both parties agreed to throw out that lawsuit.
Digene has also been pursuing legal action against Ventana Medical Systems (Nasdaq: VMSI) in another patent infringement lawsuit. Last month the U.S. District Court for the State of Deleware denied Digene’s motion for a preliminary injunction against Ventana. “Although we are disappointed with the court’s ruling, the denial of our preliminary injunction request was not unexpected given the pending expiration of the patents at issue in May and June,” said Daryl Faulner, President and CEO of Digene. In the ruling, the court noted that there remains a substantial question as to whether Ventana has a license to the relevant HPV patents.
Digene’s acquisition by a larger in vitro diagnostics (IVD) manufacturer is another example of the ongoing consolidation in the IVD industry. Along with the strong price Qaigen is paying, it demonstrates the high interest investors have in molecular diagnostics. Interestingly, during May, another major IVD company in cervical cancer screening was acquired. Cytyc Corporation (Nasdaq: CYTC) is being sold to Hologic (Nasdaq: HOLX) in a deal valued at $6.2 billion and expected to close during the third quarter.
Should acquisitions continue in the IVD industry at the current pace, it will certainly change the competitive landscape. Further, much of the molecular technology currently finding its way into new clinical assays has been developed by start-up companies. For that reason alone, the established IVD giants will need to scramble to develop or acquire comparable molecular technology that will help them maintain market share.
Related Articles:
Digene sues Third Wave over patent
(last article at the bottom of the page)
Digene Files Infringement Suit Against Third Wave Technologies
Third Wave files countersuit vs. Digene in patent case
Preliminary Injunction Denied in Digene’s Case Against Ventana Medical Systems
Qiagen to Buy Digene, Maker of Tests for Cancer-Causing Virus
