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  6. Ventana Medical Systems CINtec PLUS Cytology - P190024
  1. Recently-Approved Devices

Ventana Medical Systems CINtec PLUS Cytology - P190024

CINtec PLUS Cytology

This is a brief overview of information related to 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 FDA’s approval.

Product Name: CINtec® PLUS Cytology
Applicant: Ventana Medical Systems, Inc.
Address: 1910 E. Innovation Park Drive, Tucson, AZ 85755
Approval Date: March 10, 2020
Approval Letter: Approval Order

What is it? CINtec® PLUS Cytology is a laboratory test doctors can use to detect proteins, called p16 and Ki67, in Pap test specimens obtained from women that have the human papilloma virus (HPV). The doctor uses the results of the HPV test and the CINtec® PLUS Cytology test to make treatment decisions. 

How does it work? A doctor uses the same sample of cells from the patient’s Pap test or HPV test. At a laboratory, the cells are placed on a glass microscope slide and mixed with several test solutions. If the cells have the p16 and the Ki67 protein, the test solution will react with the proteins in the cells and change the color of the cells. The laboratory clinician (pathologist) looks at the slide under the microscope and informs the doctor of the test result.

When is it used? The test is used for women 25 – 65 years old who have tested positive for HPV. If the patient is positive for the HPV 12 Other type and is also positive for the CINtec® PLUS Cytology test, then the doctor can perform additional medical procedures immediately, including a biopsy. If the patient is positive for the HPV 16/18 type and positive for the CINtec® PLUS Cytology test, then the doctor will look at the patient medical history, health risk factors and professional guidelines to decide the next steps in the care of the patient.

The test is also used for women 30 – 65 years old who tested negative with the Pap test and positive for the HPV. If the patient is positive for the HPV12 Other type and CINtec® PLUS Cytology test, then the doctor can perform additional medical procedures immediately, including a biopsy. If the patient is positive for the HPV 16/18 type and positive for the CINtec® PLUS Cytology test, then the doctor will look at the patient medical history, health risk factors and professional guidelines to decide the next steps in the care of the patient.

What will it accomplish? The CINtec® PLUS Cytology test helps doctors to decide if a women who has HPV should have a biopsy to detect pre-cancer or cancer of the cervix.

When should it not be used? There are no known reasons not to use the test.

Additional information (including warnings, precautions, and adverse events): 

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