European clinicians will have a new weapon to combat cervical cancer with the introduction of Abbott Molecular's real-time polymerase chain reaction (PCR) based diagnostic test for human papillomavirus (HPV). The CE-marked assay can identify patients infected with specific viral genotypes known to pose the highest risk for progression to cervical cancer. Unlike other HPV tests, the Abbott RealTime High Risk HPV assay detects the 14 highest risk HPV genotypes and, in the same procedure, can identify women infected with the HPV 16 and HPV 18 genotypes, which account for more than 70 percent of cervical cancer cases. The assay can rapidly identify HPV-infected patients at risk for cervical cancer by combining two diagnostic tools in one test - HPV high- risk screening and viral genotyping.
"The Abbott RealTime HPV assay is a major advance that provides clinicians with three results in one assay: detection of the 14 HPV high risk types as well as genotyping to determine if the highest risk HPV 16 and 18 genotypes are present in the sample," said Jack Cuzick, Ph.D., professor of epidemiology, Barts and the London, Queen Mary's School of Medicine and Dentistry. "Women with abnormal PAP smear test results will know right away if they are at risk for developing cervical cancer. A negative result from this test will assure them with almost 100 percent certainty that cervical cancer will not occur in the next few years."
He added that the Abbott RealTime High Risk HPV assay could save time and money for follow-up testing to confirm or eliminate cervical cancer diagnosis.
In scientific evaluations at clinical sites across Europe, the Abbott RealTime High Risk HPV assay demonstrated high accuracy, with specificity of 99.4 percent and sensitivity of 97.5 percent for qualitative detection of the 14 high-risk HPV genotypes.
The new assay uses liquid-based cytology specimens and runs on the Abbott m-Systems - m2000™ for large-volume testing laboratories and m24sp™ or manual for labs performing small- to mid-sized volumes.
The range of automated systems provides laboratories the flexibility and efficiency to accommodate various workloads.
Cervical cancer is the second most common malignancy in women worldwide. In Europe, some 33,000 new cases of the disease are diagnosed each year and it causes 15,000 deaths annually. The average time from HPV infection to development of cervical cancer is 15 years, and the likelihood of progression from infection to disease increases with age. However, most HPV (80 percent) found in the genital tract is benign and clears spontaneously.
There are 100 different HPV genotypes and 40 infect mucosal and genital cells. Of these, there are 14 genotypes classified as high risk HPV from their association with invasive cervical cancer. The HPV 16 and HPV 18 genotypes progress to disease faster than other high-risk genotypes.
Other tests available on the Abbott m2000 system include real-time PCR tests for HIV-1 viral load, hepatitis B viral load, Chlamydia detection, chlamydia/gonorrhea (CT/NG) multiplexed assay, hepatitis C viral load, HCV genotyping, CMV and EBV. Except for RealTime HIV-1 and CT/NG, no other tests are currently available on the m2000 in the United States. Additional information is available on Abbott Molecular's website at www.abbottmolecular.com.
About Abbott Molecular
Abbott Molecular is an emerging leader in molecular diagnostics - the analysis of DNA, RNA, and proteins at the molecular level. Abbott Molecular's instruments and reagents detect pathogens and subtle but key changes in patients' genes and chromosomes, which permits earlier diagnoses, the selection of appropriate therapies and improved monitoring of disease progression.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 68,000 people and markets its products in more than 130 countries.