HILDEN, Germany and GERMANTOWN, Maryland, May 8, 2011 /PRNewswire/ —
– Growing U.S. market penetration and other regions’ adoption of HPV testing in cervical cancer screening programs drive global deliveries of digene HC2 HPV Test
– digene HC2 HPV Test remains the “gold standard” in screening women for risk of cervical cancer based on clinical data published in over 300 studies involving one million women
– QIAensemble program to develop next-generation automation platforms updated after review of customer needs, competitor profiles, commercial and technical factors
QIAGEN N.V. (NASDAQ: QGEN ; Frankfurt Prime Standard: QIA) today announced a milestone with the delivery of more than 75 million digene HPV tests worldwide – the gold standard in screening women for human papillomavirus, which is the primary cause of cervical cancer – since the first U.S. regulatory approval of this important molecular diagnostics test in 1999.
The announcement was made at the start of two international medical society meetings, EUROGIN in Portugal and Clinical Virology Symposium (CVS) in Florida, where QIAGEN highlighted its role as a major driver in the adoption of molecular screening solutions for disease prevention based on the success of its digene HC2 HPV Test. It was the first molecular diagnostics test to receive FDA approval to determine the need for colposcopy/biopsy referral for women with borderline abnormal cytology results and for co-testing with cytology to screen women age 30 and over to assess risk of cervical cancer caused by persistent unresolved HPV infection.
The value of HPV testing is increasingly recognized in treatment guidelines around the world, particularly in the U.S. where nearly 45% of women who receive the traditional Pap test also undergo HPV screening. Many countries have established or are evaluating co-testing, primary screening or reflex HPV screening as a cornerstone of cervical cancer prevention programs. With about 500,000 new cases and 300,000 related deaths annually around the world, cervical cancer is the second most frequent cancer in women. Early detection has been proven to reduce the burden of this disease, as cervical cancer can be effectively treated if found in its early stages.
[Note from SaneVax: Unfortunately for medical consumers, this test does not incorporate the ‘gold standard’ for HPV testing – there is absolutely no DNA sequencing involved. Since there is no DNA sequencing involved, no one will know exactly which strains of HPV may be present. Does this mean even more unnecessary cervical biopsies for unsuspecting medical consumers? Probably…. How many women will be harmed by these unnecessary biopsies? No one knows…. How many years will this company get by with marketing a substandard test? No one knows.
Scientifically speaking, it is becoming more apparent every day that medical consumers are on their own. Do your research – demand safety, efficacy and need!]