TRENDS & PERSPECTIVES
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The HPV Test by Digene Corp. (Gaithersburg, MD). Digital Image by Digene Corp.
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According to Bruce Cranna,managing director and senior analyst at Leerink Swann & Co. (Boston), HPV test sales will become a billion- dollar market opportunity worldwide. “The HPV test market is very good. It is the backbone of molecular diagnostics right now.”
According to CDC, about 20 million Americans are infected with HPV, and there are about 6.2 million new cases each year. About 80% of women will have acquired sexually transmitted HPV by age 50. While many of these cases resolve spontaneously, about one-third of the 30 currently identified sexually transmitted subtypes can, in rare cases, cause cervical cancer, which leads to death in approximately 5000 U.S. women annually. If clinicians combine HPV screening with a Pap smear, they can say with greater than 99% certainty that a woman does not have cervical cancer if both tests are negative.
Kathy Menzel, senior international marketing manager for HPV at Roche Molecular Diagnostics (Pleasanton, CA), explains that the current market for HPV “is based on current clinical practice, where only approximately 20% of women over the age of 30 are screened for HPV using DNA-based tests in conjunction with a standard Pap smear.” That leaves a lot of room for growth.
To capitalize on the growing market, Roche and other IVD companies hoping to secure FDA approval are working on yes/no detection tests that indicate whether a woman is infected with HPV, and follow-up genotyping tests. If the yes/no test is positive, genotyping tests can help to determine the specific strain and whether it is one of those more highly implicated in cervical cancer. Most of the yes/no screens being developed test for 13 to 14 high-risk HPV strains.
Direct-to-consumer advertising has dramatically increased awareness of HPV and the role it plays in the etiology of cervical cancer. Merck’s HPV vaccine campaign and Digene’s HPV test campaign have amplified the buzz around the HPV–cervical cancer connection in the general population. Understandably, more molecular diagnostics companies want to enter the market.
Analysts and industry experts agree that HPV testing is a hot spot for growth and will likely continue to be for the next few years. Accordingly, companies like Roche, Third Wave Technologies Inc. (Madison, WI), Gen-Probe Inc. (San Diego) and SensiGen (Ann Arbor, MI) are actively entering the market.
Michael Watts, senior director of investor relations and corporate communications at Gen-Probe, is excited about the opportunities in the HPV test market. “It is a good fit where we are very strong already. Newer instrumentation technology will allow laboratories to perform these tests on a fully automated basis, based on proven technologies and capabilities.” Removing the need for manual intervention will reduce manual error and thus increase productivity for laboratories, an important priority for Gen-Probe. Watts also emphasizes the importance of developing high-sensitivity and high specificity tests.
But as Kevin T. Conroy, president and CEO of Third Wave, knows all too well, domination of the market by Digene also means some complicated market entry issues for potential competitors. Digene filed a lawsuit against Third Wave for alleged patent infringement.
Cranna explains, “Digene believes it has solid intellectual property rights concerning HPV subtypes 52, 58, and 68, but most in the industry believe the other 10 strains are pretty much in the public domain or will be shortly.”
However, according to Conroy, Digene’s lawsuit comes down to HPV type 52, one of the 13 high-risk types in Digene’s current assay. He asserts that Digene has a patent on a narrow method used to detect HPV subtype 52, which he points out only affects 1 out of 200 of those who test positive for HPV, according to Digene’s package insert. “Digene is not the exclusive owner of the right to detect HPV subtype 52,” Conroy asserts. “We have filed an antitrust counterclaim and feel very strongly about both suits.”
Conroy adds that Digene “is a really big company that has a monopoly on the HPV market and it wants to snuff out the competition. We have been very careful to respect other companies’ intellectual property, including Digene’s, and we believe our test does not infringe upon any current patents. We also question the validity of those patents.”
Cranna says that until Third Wave and Digene have their day in court, the outcome is unknowable. “Digene thinks it is cut and dried, and the other players say that just isn’t the case.”
“Ultimately, we respect Digene’s intellectual property, and we expect them to respect ours,” Conroy says, “but we will fight this fight with vigor and enthusiasm. We very much look forward to our day in court.”
