This story originally appeared in Biocommerce Week, a newsletter that has been discontinued.
Cepheid last week said that it plans to use a family of human papillomavirus patents it has exclusively licensed from the Swedish company Quantovir to develop a PCR-based diagnostic test for HPV that will predict a woman’s risk for developing cervical cancer.
Cepheid said the test, which will run on the GeneXpert system, will harness Quantovir's technology to create a diagnostic that will measure HPV viral load. This capability, the company said, may help to identify patients most at risk of developing cervical cancer and will also make the test unique among current HPV DNA testing products.
Separately, Cepheid also announced last week that the US Centers for Disease Control and Prevention had terminated a contract with the firm to develop a molecular diagnostic test for influenza.
Cepheid CEO John Bishop said in a statement that the company expects the HPV test to "provide accurate PCR results in minutes rather than days in a variety of clinical settings."
Cepheid estimated that the market for HPV diagnostic preventative testing may be between $600 million and $700 million, though other competitors have put it as high as $1 billion.
A Cepheid spokesperson was unable to comment on the development timeline for the HPV test.
To date, only one molecular HPV test has been cleared for use in both the US and Europe: Digene’s Hybrid Capture HPV test, which is now part of Qiagen’s portfolio following its $1.6 billion acquisition of Digene this summer (see BioCommerce Week 6/6/2007).
However, Qiagen CEO Peer Schatz noted at this week’s UBS Global Life Sciences Conference in New York that the firm’s test has captured only a small slice of the potential HPV testing market (see related article). He called HPV “the most important target in molecular testing over the next 10 years.”
Schatz also was asked during a breakout session at the conference for his thoughts on Cepheid’s licensing deal with Quantovir. He said that research has shown that using “viral load in HPV [testing] is not very prognostic … [and] not very promising.”
Cepheid responded by citing a paper published in The Lancet in 2000 by a team of researchers at Sweden’s University of Uppsala that found that the risk of cervical carcinoma increased with the amount of HPV 16 DNA in a study of 478 women with cervical carcinoma in situ and 608 controls.
During a breakout session following Cepheid’s presentation at the UBS conference this week, David Persing, executive vice president and chief medical and technical officer, told analysts, “I’m sure you’ll see some blowback from Qiagen” regarding the HPV test, but stressed that Qiagen’s test is “not quantitative.”
Persing said that the HPV market is an “interesting opportunity” for the company and acknowledged that the field is likely to grow more competitive over the next few years.
Nevertheless, he noted that the company is approaching the market in a different manner than its competitors. Specifically, he said that Cepheid has identified an opportunity to begin HPV screening much earlier — beginning at age 18 rather than 30 for current tests — and then follow infected patients over time to measure viral load. This approach, he said, will enable tracking of type-specific resistance over a period of time and will indicate whether a patient is suffering from chronic HPV infection, which is associated with a higher risk of developing cancer.
In addition to Qiagen, Cepheid also faces competition from Third Wave, which hopes to launch its own HPV molecular test next year. Third Wave and Qiagen are currently locked in litigation over HPV patents (see BioCommerce Week 3/7/2007).
In response to a question regarding Cepheid’s IP position in the HPV market, a company spokeswoman said, “The track record of the company has demonstrated that Cepheid does not knowingly infringe on the intellectual property of others.”
Other potential competitors in the HPV molecular testing market include Greiner Bio-One, which is developing a PCR-based test, and the world’s largest molecular diagnostics player, Roche Diagnostics, which submitted two genotyping tests for HPV to the US Food and Drug Administration this year.
Quantovir was founded in 2001, when it was spun out from the Genetics and Pathology department at Uppsala University.
Financial terms of the licensing deal with Cepheid were not released.
CDC Flu Test Contract Terminated
In a separate announcement last week, Cepheid said that its contract with the CDC to develop an influenza virus molecular diagnostic has been terminated.
The firm did not explain why the CDC terminated the contract to develop a rapid point-of-care diagnostic to detect influenza viruses A and B and the H5N1 avian flu virus in human respiratory specimens.
However, Cepheid does not expect the terminated contract to have much of a financial impact. CEO John Bishop said in a statement that the company's financial guidance for 2007 "remains unchanged."
The CDC awarded a $2.4 million contract to Cepheid in December 2006 to develop an automated test for use on its GeneXpert system using real-time PCR, which would not require specific expertise or specialized training.
At the same time, the CDC issued a small flurry of influenza diagnostic contracts totaling over $12 million, including $4.5 million to Nanogen, $3.8 million to Iquum, and $700,000 to MesoScale.
CDC Director Julie Gerberding had said upon awarding the grants that the center was aiming to discover "promising technology that could help doctors treat their patients faster and help public health authorities track influenza viruses that could spur a pandemic."
A company spokesperson said that Cepheid successfully completed the original $2.4 million contract.