Monday, September 22, 2008
Qiagen's low-cost, rapid HPV test, CareHPV, was 90 percent accurate in detecting cervical cancer in women from the Shanxi province of eastern China, according an article to be published in Lancet Oncology today.
Designed specifically by the Germantown biotech for use in rural areas of developing world, CareHPV can detect 14 types of human papillomavirus in just 2 1/2 hours. The quick diagnosis allows women, who are often traveling to clinics from isolated villages, to get tested and treated in the same day.
Most Western countries use Pap smears to detect HPV. But these tests are expensive, require a clinical setting, special equipment and a highly skilled clinician.
"The idea of replicating that in the developing world, where resources are scare, doesn't make sense," said Linda Alexander, Qiagen's vice president of women's health and global advocacy.
Cervical cancer is the second-most common form of cancer in women worldwide. Each year there are about 500,000 new cases and 300,000 deaths, more than 85 percent in the developing world.
The most common screening tool in rural areas is a procedure in which a woman's cervix is painted with vinegar to highlight abnormalities. She is then examined by a doctor or nurse. But this test is too unreliable.
So in 2003, Path, a Seattle-based global health nonprofit, received a $13 million grant from the Bill & Melinda Gates Foundation to develop a new test. Path partnered with Gaithersburg's Digene, which was acquired by Qiagen last year, to modify a test that uses molecular technology to detect the presence of high-risk types of HPV. That test had been approved by the Food and Drug Administration.
The China study tested more than 2,388 women ages 30 to 54. It required no electricity or running water and was administered by a minimally trained support staff.
Qiagen will sell the test to governments and nongovernmental organizations, though the company has not set a fixed price.
"We're not going to turn anyone down," said Pamela Rasmussen, a Qiagen spokeswoman. "We are going to make it affordable for companies and entities that want to get this out to women."
-- Kendra Marr