cobas HPV for 5800/6800/8800 Systems – P190028/S009
This is a brief overview of information related to the FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for the FDA’s approval.
Product Name: cobas HPV for use on the cobas 5800/6800/8800 Systems
Applicant: Roche Molecular Systems, Inc.
Address: 4300 Hacienda Drive, Pleasanton, CA 94588
Approval Date: May 14, 2024
Approval Letter: Approval Order
What is it?
The cobas HPV for use on the cobas 5800/6800/8800 Systems (cobas HPV) is a laboratory test designed to detect human papillomavirus (HPV) in cervical samples (specimens) and self-collected vaginal samples.
The test includes a specific assortment of of kits, sample tubes, the 5800/6800/8800 Systems, and chemical substances (reagents) that are used to prepare the cervical or vaginal samples for chemical analysis. The test is programmed only for use on the cobas 5800, 6800, or 8800 software. The 5800/6800/8800 software processes the data and assigns positive, negative, or invalid test results which can be reviewed directly on the system screen, exported, or printed as a report.
This supplement expands the Indications for Use to include the use of the cobas HPV with self-collected vaginal specimens.
A health care provider collects a cervical sample using a specific brush or spatula and solution that is not included. Self-collected vaginal specimens, obtained in a health care setting, can be tested as an alternative specimen type when cervical specimens cannot be obtained. In the laboratory, the test detects DNA from 14 high risk (HR) human papillomavirus (HP) types that are associated with cervical cancer.
The test is used during routine cervical cancer screening according to professional medical guidelines. This includes testing patients with abnormal cervical cells, co-testing (adjunctive screen) with tests that use cells to diagnose or screen for cancer, and screening patients older than 25 years old for cervical cancer.
Patients who test positive or negative for the 14 HR HPV types should be followed up in accordance with professional medical guidelines, results from prior screening, medical history, and other risk factors.
Recommendations for clinical management after testing of either clinician-collected cervical samples or self-collected vaginal samples should follow professional guidelines.
In a clinical study, the cobas HPV was shown to be safe and effective to use for routine cervical cancer screening according to professional medical guidelines.
A second clinical study was performed to compared self-collected vaginal specimens to clinician-collected cervical specimens. The outcomes demonstrated the safety and effectiveness of the cobas HPV with self-collected vaginal samples.
The cobas HPV should not be used:
- For determining the need for treatment, such as cutting (excisional) or using a laser (ablative) treatment of the cervix, in the absence of cervical dysplasia.
- For patients who have undergone a hysterectomy.
- With samples other than those collected by a clinician by lightly scraping or brushing off the cervix or by using a cervical broom and being placed into the ThinPrep Pap Test PreservCyt Solution.
- With self-collected vaginal specimens obtained with collection devices not cleared for use with this test.
The use of this test has not been evaluated for women with prior ablative or excisional therapy, or who are pregnant.