View Treatment Algorithm

Patient management based on HPV status

Brief Overview of HPV Types

There are more than 100 types of HPV. They usually don't cause any problems. However, when they do, the most frequent effect is the common wart, such as those found on the hands and feet.

About 30 HPV types are spread through genital contact. Each is identified with a number, in the order of their discovery. In addition, they are divided into two groups:

"Low-risk" types of HPV
There are about 12 types of HPV that are called low-risk because they do not cause cervical cancer. They can, however, cause genital warts or minor cell changes on the cervix. These low-risk types of HPV are known by the numbers 6, 11, 40, 42, 43, 44, 53, 54, 61, 72, 73 and 81. Types 6 and 11 – which are linked to about 90 percent of genital warts – are the most common.

"High-risk" types of HPV
There are more than a dozen types of high-risk HPV that can trigger the development of cervical intraepithelial neoplasia (CIN). These types of high-risk HPV of most concern are known by the numbers 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68. Types 16 and 18 are the most dangerous, since they cause about 70 percent of cervical cancers. In one study, the National Cancer Institute found that about 10 percent of women with HPV type 16 or 18 developed CIN 3 within three years (compared to just 4 percent of women with any type of HPV), and 20 percent did so in 10 years (compared to 7 percent).

The HPV vaccine

Gardasil®, the HPV vaccine developed by Merck and the only one currently approved in the United States, is designed to protect against HPV types 16 and 18 - which cause about 70 percent of cervical cancers. In addition, it protects against the two most common types that cause genital warts - 6 and 11.

The digene HPV Test*

The digene HPV Test, the first FDA-approved HPV test, identifies whether a patient has one or more of the 13 most important high-risk types of the virus. (Although QIAGEN also makes a test for low-risk HPV types, its routine use is not recommended in medical guidelines or reimbursed by insurance.)

Currently, the digene HPV Test does not determine which high-risk type(s) of the virus a woman has. However, under existing medical guidelines, the extra exams and other follow-up care she should get are the same no matter what type of high-risk HPV she has.

That may change in the future. QIAGEN and other companies are developing genotyping tests that could determine the specific types of high-risk HPV carried by a particular patient.

* "The digene HPV Test" was approved by the U.S. FDA and is also known to laboratories and physicians as the "hc2 High-Risk HPV DNA Test®" and "DNAwithPap® Test." This does not refer to the QIAGEN product that tests for several types of the virus commonly referred to as "low-risk HPV," which are not associated with cervical cancer.