FDA Approves Self-Test for HPV


The federal agency gave the nod to Roche’s human papillomavirus (HPV) self-collection and gives women the ability to gather their own sample in a health care setting, which can then be sent off for lab results.

FDA logo; Image credit: FDA

The FDA approved Roche Diagnostic’s HPV self-collection solution works with the company's cobas HPV test.

Image credit: FDA

The FDA approved Roche Diagnostic’s HPV self-collection solution, one of the first to be made available in the United States. Screening for HPV can help identify women who are at risk of developing cervical cancer.1

According to Roche, the HPV self-collection is an accessible screening option. In a health care setting, an individual collects their own vaginal sample, which is sent to a laboratory for analysis with Roche’s cobas molecular instrument.

“Our HPV self-collection solution helps support this goal by reducing barriers and providing access to HPV screening by allowing people to privately collect their own sample for HPV testing,” said Roche Matt Sause, CEO of Roche.1

According to the company, The HPV self-collection solution is approved for use with Roche's cobas HPV test. The cobas HPV test runs on the cobas 4800 and the fully automated cobas 5800/6800/8800 Systems, which can provide up to 96 results in about 3 hours, and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight hour shift.1

The Impact of HPV
HPV causes more than 30,000 cancers annually. Although many people typically associate HPV with cervical cancer, the most common HPV-associated cancer is actually head and neck.2

According to data from the Centers for Disease Control and Prevention (CDC), there are 2200 women and 11,800 men diagnosed with oropharyngeal (back of the throat) cancers annually in the United States. And HPV is thought to cause 70% of oropharyngeal cancers in the United States, according to CDC.2

The CDC reports that HPV vaccination can prevent over 90% of cancers caused by HPV, as well as anal, vaginal, cervical, and vulvar precancers. More than 4 out of every 10 cases of cancer caused by HPV occur among men. Over 14,000 men get cancers caused by HPV in the US annually, so the HPV vaccine is also recommended for boys and young men.2

HPV Vaccination
A 2022 study demonstrated that HPV vaccination can reduce oral HPV infection by 88%. The recommendation has been to administer the vaccine at ages 11 or 12 years, before contact with the HPV virus. However, the CDC says the vaccine can be also be administered to teens and young adults through the age 26. And some adults ages 27 through 45 may elect to get the vaccine although there is less benefit as exposure to HPV has likely happened.2

The vaccine series is 2 shots for children before the age of 15, and administered 6 to 12 months apart. The HPV vaccines can be given starting at age 9. For those who begin their HPV vaccine series on or after the age of 15, they will need 3 doses, given over 6 months.2

And for those who are playing catch-up for HPV vaccines, individuals do not need to start over.2

“You start from where you left off,” Beomjune Kim, DMD, MD, FACS, who is a Head and Neck and Microvascular reconstructive surgeon at the Cancer Treatment Centers of America in Atlanta. “For example, if you received the first dose and then 5 years later you want to catch up, you start from second dose.” He explains that patients will need 2 shots and patients go by the recommended interval protocol of at least 12 weeks between the second dose and third dose. After administration of the third dose, patients are considered fully vaccinated.2

“With vaccinations, innovative diagnostic tools and screening programs, achieving the WHO’s goal of eliminating cervical cancer by 2030 is within reach,” said Sause.1

1. Roche announces FDA approval of one of the first HPV self-collection solutions in the U.S., expanding access and screening options to help eliminate cervical cancer. Roche media statement. MAY 15, 2024. Accessed May 15, 2024.

2. Parkinson J. HPV Vaccination: A Prevention Measure Against Numerous Cancers. Contagion. June 3, 2022. Accessed May 15, 2024.
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