FDA approves Roche's HPV self-collection solution


Roche's innovative human papillomavirus self-collection solution offers a breakthrough in cervical cancer screening, providing accessible and reliable testing to combat underscreening rates and increase early detection.

FDA approves Roche's HPV self-collection solution | Image Credit: © Rochu_2008 - © Rochu_2008 - stock.adobe.com.

FDA approves Roche's HPV self-collection solution | Image Credit: © Rochu_2008 - © Rochu_2008 - stock.adobe.com.

The FDA has granted approval to Roche’s human papillomavirus (HPV) self-collection solution, making it one of the first HPV self-collection solutions available in the United States.1


  1. Roche's human papillomavirus (HPV) self-collection solution has received FDA approval, marking a significant advancement in cervical cancer screening in the United States.
  2. With over 50% of cervical cancer patients in the United States underscreened, Roche's solution aims to reduce barriers to screening and increase access to timely detection and treatment.
  3. The IMPACT trial demonstrated the clinical benefits of Roche's cervical cancer portfolio, showcasing its efficacy across a diverse population, including Hispanic, Black, and Alaska Native patients.
  4. Patients can collect their own vaginal samples using Roche's solution in a healthcare setting, providing a convenient and accurate alternative to traditional clinician-led procedures.
  5. Roche's cobas HPV test can detect 14 high-risk HPV genotypes, including HPV 16 and 18, contributing to early identification of cervical cancer risk factors and enabling prompt follow-up care.

HPV has been linked to over 95% of cervical cancers, making screening vital for identifying cervical cancer risk among women and providing timely treatment. However, over 50% of cervical cancer patients in the United States are underscreened. This indicates a need to reduce barriers and increase access to screening.

Over 13,000 cervical cancer diagnoses are reported per year in the United States, along with approximately 4000 deaths. Roche’s HPV self-collection solution provides an accessible screening method, allowing HPV to be identified and treated before cervical cancer development.

When using the self-collection solution, patients collect their own vaginal sample in a health care setting to be sent for laboratory analysis using Roche’s cobas molecular instrument. Continued care with a health care provider should then be given to any patient with a positive result.

The clinical benefits of the Roche cervical cancer portfolio were assessed in the IMPACT trial. The trial had a diverse population, with 24% of patients being Hispanic, 21% Black, and 0.3% Alaska Native.

In a standard health care setting, patients undergo an HPV test or Pap test in a doctor’s office or clinic.2 A Pap test involves doctor analysis of the vagina using a speculum to determine if the cells appear normal or infected. Patients with abnormal but not cancerous cells are considered precancerous.

The Centers for Disease Control and Prevention (CDC) recommends patients begin to receive Pap tests when aged 21 years, undergoing testing every 3 years if results remain normal. Patients aged 30 to 65 years may receive an HPV test only, a combination HPV and Pap test, or a Pap test only.

It may take up to 3 weeks for patients to receive test results. Those with abnormal results will often be contacted by their doctor to determine the most appropriate follow-up. While the risk of developing cervical cancer is low among patients with normal results, the CDC recommends they undergo regular checkups with their doctor.

Currently, many individuals with cervical cancer in the United States are screened infrequently and do not receive routine screening.1 Factors influencing participation in cervical cancer screening include health care access, social and economic barriers, traumatic experiences, cultural concerns, and embarrassment.

By offering an alternative method of collection than clinician collection procedures, Roche’s self-collection solution can reduce barriers to screening. This method also retains accuracy and provides reliable results, supporting appropriate decision making about patient care.

The cobas HPV test included in the Roche portfolio can also detect 14 types of high-risk HPV genotypes associated with increased cervical cancer risk, including HPV 16, HPV 18, HPV 12, and other high-risk pooled genotypes. The cobas test runs on a fully automated system, leading to up to 96 results in approximately 3 hours and 384 results in 8 hours.

Special preparation is not necessary before an HPV test.2 Additionally, HPV testing can be performed during a patient’s period, allowing more patients to receive screening.


  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. May 15, 2024. Accessed May 15, 2024. https://www.globenewswire.com/news-release/2024/05/15/2882048/0/en/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.html
  2. What should I know about screening? Centers for Disease Control and Prevention. Accessed May 15, 2024. https://www.cdc.gov/cancer/cervical/basic_info/screening.htm
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