New HPV Tests Approved by FDA

Human papillomavirus (HPV) is the most common sexually transmitted infection, but few people know they have it and many have no symptoms. It’s important to detect because certain types of HPV can cause cancer.

According to the CDC, HPV may be low-risk (wart-causing) or high-risk (cancer-causing). Some good news is that in 90% of cases, your immune system might clear both low- and high-risk HPV infections naturally within two years. However, discussing testing with your doctor is still a good idea. If a high-risk HPV infection isn’t defeated by the immune system, it may stay around for many years and turn into cancer over time.

Cervista HPV HR is designed to detect the 14 high-risk types of HPV that cause cervical cancer. It’s the first HPV DNA test approved by the FDA in more than 10 years.

Cervista HPV 16/18 is the first HPV test approved for genotyping for HPV types 16 and 18 — associated with around 70% of all cervical cancers in the US.

Both of these tests have recently been approved for use by the FDA.

Benefits of the new tests:

Cervista HPV HR reduces the potential for false negative results and may minimize inconclusive results. It’s also designed to minimize false positives, potentially reducing unnecessary patient anxiety.

Cervista HPV 16/18 identifies the two most cancer-causing and persistent types of HPV. Some studies have shown that HPV types 16 and 18 are respectively 5.5 times and 4.5 times more likely to cause cancer than all other high-risk HPV types combined.

According to the test makers Hologic, Cervista HPV HR test has been approved for two uses:

To screen patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy.

Used adjunctively with cervical cytology to screen women 30 years and older to assess the presence or absence of high-risk HPV types.

The Cervista HPV 16/18 test has been approved for two uses:

In women 30 years and older the test may be used adjunctively with the Cervista HPV HR test in combination with cervical cytology to assess the presence or absence of specific high-risk HPV types.

Used adjunctively with the Cervista HPV HR test in patients with ASC-US cervical cytology results, to assess the presence or absence of specific high-risk HPV types. (The results of this test are not intended to prevent women from proceeding to colposcopy.)

Have you discussed your cervical cancer risk with your doctor?

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