Dutch biotech Qiagen expands, develops new HPV test
While most biotechs anxiously watch their cash burn and eye prospective investors as they try to bring a product to market, Qiagen Sciences, the U.S. research and development subsidiary of Dutch diagnostics giant Qiagen NV, is riding a wave.
Since purchasing the locally grown molecular diagnostics firm Digene for about $1.6 billion last year, Qiagen has used the old Digene facilities in Gaithersburg and its Germantown laboratories 3 miles north to develop new products, expand its workforce — and even claim a Nobel Prize connection last week.
"We call it Gaitherstown," said spokeswoman Shelley Ducker, referring to the combined Montgomery County operations. "A good chunk" of Qiagen's strong revenue growth this year comes from its former Digene divisions, she said, without disclosing specifics.
The company's second-quarter revenues totaled $217.9 million, up 11 percent from the previous quarter and 61 percent over the second quarter of 2007, partly reflecting the Digene purchase. Revenues are expected to exceed $1 billion this year.
Qiagen employs more than 600 in Montgomery County. When it was purchased, Digene's workforce totaled close to 400. It had partnered with Qiagen in Germantown for 12 years.
The Montgomery County Chamber of Commerce will present Qiagen with its 2008 Corporate Achievement Award at its business awards dinner next month. Chamber president and CEO Georgette "Gigi" Godwin noted in last week's chamber newsletter that Qiagen Sciences had expanded on German scientist Harald zur Hausen's Nobel Prize-winning discovery of the cause of cervical cancer — the human papillomavirus — and translated it into commercial applications that today are saving women's lives.
Digene had built upon zur Hausen's discovery to identify and sequence the DNA of the high-risk HPV strains that cause cervical cancer, then develop a molecular diagnostic test to detect the virus.
Cervical cancer is the second-most common form of cancer in women worldwide, according to the World Health Organization.
Digene's flagship product, the digeneHPV Test, is sold by Qiagen in 40 countries and is recognized as a standard of care, along with the Pap test, to help women 30 years and older prevent cervical cancer.
"Qiagen wholeheartedly congratulates Professor zur Hausen on the Nobel Prize Award for his groundbreaking discovery. His vision and scientific excellence created a new paradigm for cancer research and led to such great strides in cervical cancer prevention," Qiagen CEO Peer Schatz said in a statement.
Qiagen's 2009 revenues could be hurt by a now-rising U.S. dollar, analyst Peter Lawson of Thomas Weisel Partners wrote to investors this month.
But, "Qiagen's market-dominating positions in life science research and its growing molecular diagnostic portfolio, led by its leading HPV assay, provides relative shelter from the credit market turmoil as well as broader economic downturns," Lawson said.
The test is mostly marketed in developed countries. But Qiagen announced last month that its new low-cost HPV test, CareHPV, was 90 percent accurate in detecting cervical cancer in women from the Shanxi province in eastern China, according to an article in Lancet Oncology, and will be available to low-income women in the developing world.
The idea of the inexpensive test came out of discussions several years ago between the test's inventor, Attila Lorincz, then Digene's chief scientific officer, and Mark Schiffman of the National Cancer Institute in Rockville.
With $2.1 million from the Bill and Melinda Gates Foundation to help fund development of the new test, Digene signed an agreement with the nonprofit Program for the Introduction and Adaptation of Contraceptive Technology, which stipulated that it be affordable in poor nations.
"Personally I am very happy that the development of careHPV has been so successful and that Qiagen is willing to manufacture the test and make it available at low cost worldwide," Lorincz wrote."
"The surprising part is that there was an assumption was that this test would have a significantly lower accuracy. But it has passed all the expectations … It is very, very exciting," said Paul S. Eder, now director of Qiagen's research and development.
"And the important thing is that the genesis began, continued and concluded all in Gaithersburg. All locally grown as it began here," he said.
The company expects only modest sales from the new test, Eder said, "but sales is secondary. Many tens of millions of women need it."
The careHPV test can detect 14 types of HPV in just 2 1/2 hours, allowing rural women who are traveling to clinics from isolated villages to be tested and treated in the same day.
Qiagen and the Chinese Academy of Sciences last month announced a collaboration to develop new molecular testing solutions to improve the safety of food products. Qiagen's QIAplex multiplex assays will be deployed for highly sensitive molecular tests for up to 50 different pathogens in a single run. Although the equipment will not be manufactured at Qiagen's Maryland sites, "food safety and general product safety in China is a local issue to everyone, given the huge level of imports from China and the problems that have arisen," Ducker said.